The Coronavirus Is Plotting a Comeback. Here’s Our Chance to Stop It for Good.

Many scientists are expecting another rise in infections. But this time the surge will be blunted by vaccines and, hopefully, widespread caution. By summer, Americans may be looking at a return to normal life.

Why the $400M HCA Deal Is a ‘Win-Win Transaction’ for Brookdale

Brookdale Senior Living Inc. (NYSE: BKD) revealed Wednesday that it’s selling an 80% stake in its health care services business to HCA Healthcare (NYSE: HCA) for $400 million.

At first glance, the transaction could be interpreted as a savvy move that enables Brookdale to cash in on its sizable home health, hospice and outpatient therapy business amidst an incredibly difficult environment for senior living operators. But the sale is so much more than that, according to Brookdale President and CEO Cindy Baier.

“Our top priority is the health and well being of our residents,” Baier said during a Thursday morning conference call on Brookdale’s fourth quarter financial results. “Part of this commitment is to offer many services in our communities, with a keen focus on resident and patient needs.”

Since last spring, the Brentwood, Tennessee-based Brookdale has battled declining occupancy rates throughout its senior living portfolio of 726 independent living, assisted living, memory care and continuing care retirement communities (CCRCs).

The entire senior living industry has experienced similar declines due to the COVID-19 pandemic, with industry-wide occupancy figures dropping to a historic low of 80.7% in the fourth quarter of 2020, according to National Investment Center for Seniors Housing & Care (NIC) data.

“Clearly, occupancy was a significant issue in 2020,” Baier said. “And it will take a while to rebuild the census.”

In the immediate future, Brookdale expects its senior living occupancy rates to improve as COVID-19 vaccines become more readily available, both inside its buildings and across the general U.S. population.

As of Thursday’s call, every single one of Brookdale’s communities had held at least one vaccine clinic, with at least 600 having held two. Overall, roughly 90% of Brookdale’s residents have received their first vaccine shot, according to the company.

“The points of pride for me are that, in the first month of vaccine availability, we executed our vaccine clinics two-and-a-half times faster than the entire industry,” Baier said. “We have more residents vaccinated than anyone else.”

On a long-term basis, however, Brookdale leadership believes the company’s success in maintaining and growing occupancy is tied to its ability to provide a range of services throughout its communities. Once the pandemic subsides, prospective residents and their families will likely continue seeking options that they consider safe and well-positioned for any unforeseen difficulties that may surface.

That’s where the Nashville, Tennessee-based HCA Healthcare comes into play, Baier explained.

Helmed by CEO Sam Hazen, HCA Healthcare is comprised of more than 180 hospitals and 2,000 sites of care in 21 states, plus the U.K. Its locations include surgery centers, freestanding ERs, urgent care centers, walk-in clinics and more.

“As we pursued this business opportunity, it was extremely important to find the right strategic partner with the same dedication to care,” Baier said. “Our new partnership is designed to deliver value for our shareholders, and it ensures continuity of quality care for our residents and patients while improving access to additional health care services.”

Bottom-line benefits

Certain metrics rank Brookdale as one of the top-10 home health providers in the country, at least in terms of fee-for-service Medicare volumes. That scale brings significant value to Brookdale, as does the company’s hospice line.

Internally, Brookdale has somewhat struggled to grow its home health footprint, analysts have pointed out in the past. It has had better luck with hospice, partly due to a more stable regulatory and payment landscape.

Currently, the company operates 57 home health agencies and 22 hospice locations across 26 states.

Overall, Brookdale’s home health business posted full-year 2020 revenue of about $249.2 million, down 23.9% compared to all of 2019. Home health revenue fell to $60.7 million in the fourth quarter of last year, down 21.6% compared to the same period in 2019.

Meanwhile, Brookdale’s hospice business reported full-year 2020 revenue of about $95.5 million, down just 0.8% compared to 2019. Hospice revenue dipped to $25.4 million in Q4 2020, down 2.4% compared to the same period in the prior year.

Despite up-and-down figures, HCA Healthcare must see untapped upside in the two post-acute care service lines moving forward, Mertz Taggart Managing Partner Cory Mertz told Home Health Care News.

“Their home health line has really struggled financially over the past 12 months,” Mertz said in an email. “They took it on the chin with the Patient-Driven Groupings Model (PDGM) and haven’t recovered from early COVID census losses. Despite that, if you back out today’s market value for a nearly 1,700-patient hospice, it’s clear HCA saw significant value in the home health operation.”

PDGM has been a past challenge for the company’s health care services segment, but its financial results in Q4 were mostly affected by labor disruptions related to the coronavirus.

“Some associates were required to self-quarantine,” Brookdale CFO Steven Swain said on Thursday’s call. “While clearly the right thing to do, we believe [that] translated into lost opportunity for higher growth in the quarter.”

Brookdale also still sees upside in its health care services, reflected in the company maintaining a substantial stake in the segment. Instead of going it alone, it’s now betting on stronger growth in years to come with HCA Healthcare’s added resources and expertise.

“For Brookdale, this looks like a really nice deal,” Mertz said. “First, it gives them much-needed liquidity. Second, by holding a 20% stake, they remain connected to their home health, hospice and outpatient services. So they don’t lose that, but gain a key hospital partnership with HCA. It adds another key piece of the care continuum for their residents.”

Baier similarly described the sale structure as a “win-win transaction” and joint decision.

“This transaction is great for our shareholders,” she said. “It’s wonderful for our residents, for our patients, and it’s really good for our associates. We believe — both HCA Healthcare and us — this is a great alignment of interest. HCA needs to continue to ensure that the penetration rates in our communities are strong and that Brookdale has the services offered to residents.”

Under HCA Healthcare’s umbrella

The patient population within Brookdale’s health care services segment is about evenly split between residents and individuals living outside of the company’s communities. About 65% of Brookdale units are served by its home health business, with 25% and 20% served by hospice and outpatient therapy, respectively.

As Baier noted, that penetration stands as a big advantage for HCA Healthcare moving forward.

“HCA Healthcare’s objective is to be the health care system of choice in the communities we serve through the development of comprehensive services and by delivering high quality, convenient care to our patients,” Hazen said in a statement. “We believe this opportunity to partner with Brookdale will expand the services we offer and enhance our ability to deliver a better experience for our patients as well as for Brookdale residents.”

HCA Healthcare’s U.S. hospitals provide about 5% of all in-patient hospital services in the country, according to company statistics. It had over 35 million individual patient encounters in 2019.

Mertz said he has “wondered for years” why HCA hadn’t gotten into home health care prreviously.

“I guess they were looking for the right opportunity at the right time,” he said. “The service area overlap with Brookdale is significant. And I suspect that — in light of COVID and the continuing evolution of value-based and risk-sharing payment models — HCA looks at home-based care services as an essential piece of the evolving care continuum.”

The post Why the $400M HCA Deal Is a ‘Win-Win Transaction’ for Brookdale appeared first on Home Health Care News.

The Winter Surge Is Melting Away

Editor’s Note: The Atlantic is making vital coverage of the coronavirus available to all readers. Find the collection here.

All major indicators of COVID-19 transmission in the United States continued to fall this week. Nationally, cases have been falling for six weeks, hospitalizations have been dropping sharply for five weeks, and deaths have been declining for four weeks. The average number of people in the hospital with COVID-19 this week was just under the average we saw during the high points of the April and July hospitalization surges. States and territories reported 14,463 COVID-19 deaths in the past seven days, the first weekly total under 15,000 we’ve seen so far in 2021.

 4 bar charts showing weekly COVID-19 metrics for the US. Tests, cases, average weekly hospitalized, and deaths all fell this week - cases by 14%, deaths by 5%.

The decline in cases and deaths appears to have slowed this week. After so many weeks of very rapid improvements in reported cases and deaths, a slowing of those declines was inevitable. But we don’t think that a true plateau is the only or even likeliest explanation for what we’re seeing this week. Instead, we think we’re once again seeing the equivalent of a holiday-reporting effect.

Two confounding events that occurred last week—Presidents’ Day and the beginning of a major winter storm that knocked out power for millions of Americans—resulted in slowdowns in case reporting. As we’ve seen with other holidays and storms, these kinds of disruptions produce a predictable series of reporting artifacts: first an artificial drop, then an artificial rise. We should always look for confounding factors before interpreting the data as suggesting a change in the direction of the pandemic—and in this week’s data, we found them. Artificially low numbers from last week’s disruptions make this week’s case and death declines look smaller by contrast, and make the daily numbers look as though they’re reversing direction, especially as backlogs roll in.

bar chart showing COVID-19 cases by day in the US with 7-day average line. The right half of the graph shows the percent change by day of that 7-day average in more detail. Low case numbers last week may be making this week's higher case counts a bit misleading. Show less

The death-reporting process was also affected by the federal holiday and the storm, producing similar artifacts in the data. Even hospitalization numbers appear to have wobbled in a similar way, probably as a result of both small reductions in reporting and small reductions in the number of people who sought care at hospitals over the three-day weekend and during major regional storms.

[Read: A simple rule of thumb for knowing when the pandemic is over]

daily bar chart displaying the percent change by day in the number of people currently hospitalized with COVID-19 in the US. The weekly average of those bars is also shown. This week saw hospitalizations decline, but at a slower pace than prior weeks.

We’ve also seen large numbers of deaths from much earlier periods reported this month, including a backlog of more than 1,500 deaths in Indiana reported on February 4, nearly 4,500 old but previously unreported deaths in Ohio reported from February 11 to 13, plus a smaller addition of deaths in Virginia (total size still unknown), which the state notes is due to processing death certificates from the postholiday (January) surge.

This brings us to a crucial point that news summaries frequently get wrong: The deaths that states and territories report on a given day do not represent people who died on that day. Reported deaths lag behind cases by two to three weeks on average, and many reported deaths actually took place substantially earlier. When reported cases rose during previous surges, deaths lagged weeks behind. The same is true now, as cases decline.

Why this matters: We have every reason to believe that far fewer people actually died of COVID-19 this week than in previous weeks, because cases and hospitalizations continue to drop. But we won’t see those smaller death numbers for weeks to come—probably for more than two or three weeks, as previously overwhelmed public-health officials are able to catch up on processing death certificates.


The backlogs in reported deaths have also affected our numbers for nursing homes and other long-term-care facilities: Indiana added 659 historical resident deaths and one staff death to its cumulative total for the week ending February 17, and Ohio added 1,150 historical resident deaths. We can chart a national trajectory of deaths in long-term-care facilities despite these and other recent large additions by working with the data from the 52 jurisdictions that have not included major backlogs or reassignments in recent months.

The resulting visualization is an incomplete representation of deaths in LTC facilities in absolute numbers, but it allows us to understand the national trend: Weekly deaths in long-term-care facilities continue to decline.

bar chart showing weekly deaths in long-term-care facilities from COVID-19. Deaths this week are down 68.5% from their peak on January 14th. Chart excludes certain states (IN, NY, MO, OH) that have updated their data inconsistently.

If we view deaths in long-term-care facilities in these 52 jurisdictions as a share of COVID-19 deaths in the U.S., we see that the percentage of the country’s COVID-19 deaths that are occurring in these facilities also continues to decline.

weekly bar chart showing the COVID-19 deaths occurring in long-term-care facilities as a percentage of all COVID-19 deaths in the US. LTC's share of deaths for the week of Feb 18 is down to 16% after being above 30% for much of the 2020 winter.

The New York Times also recently analyzed trends in nursing-home cases and deaths in relation to national case and death figures.

[Read: The last days of loneliness ]

When our project ceases data compilation on March 7, the only comparable, public federal data set will be the CDC/Centers for Medicare and Medicaid Services data set on COVID-19—which is only partially comparable, as it includes only nursing homes and not other long-term-care facilities, such as assisted-living and independent-living facilities. These nursing-home data have been reported weekly by facilities to CMS since May 17 through the CDC’s National Healthcare Safety Network. Cases and deaths are reported as cumulative and weekly totals, and some facilities include cumulative data dating back to January 1, 2020. We’ll be writing more about that in next week’s additions to our series of trainings on federal COVID-19 data.


Although COVID-19 has disproportionately harmed Black, Latino, and Indigenous people in many areas of the U.S., it appears that vaccinations are not being proportionately administered to many of these communities. The Verge visualized vaccine administration in Chicago, New York City, and Washington, D.C., and found substantial mismatches between areas with the highest case or death rates and areas with the highest vaccine administration. A Los Angeles Times investigation likewise found that the areas hardest hit by COVID-19 in and around Los Angeles currently have the lowest vaccination rates. Inequities in vaccine distribution and administration result from many factors, including inaccessible systems, state-level decisions, fixed age cutoffs, and problems with people actively circumventing the processes established.

Federal vaccine data include race and ethnicity for slightly more than half of all reported doses, but aren’t broken down by state and don’t allow for crucial age-race cross-comparison. Data from the 40 states that publicly report race and ethnicity data for vaccinations, compiled by KFF and others, track vaccinations by race and ethnicity, but most states do not include age breakdowns, and some are missing race and ethnicity data for more than 30 percent of vaccinations. Reporting at the metro level and rough analysis within states have given us plentiful warning that vaccine rollouts are currently missing many of the communities at the greatest risk from COVID-19. Without better data about who has been vaccinated across all U.S. jurisdictions, we will not be able to identify and address the full range of inequities in the rollout.


Mandy Brown, Artis Curiskis, Alice Goldfarb, Erin Kissane, Kara Oehler, Jessica Malaty Rivera, and Peter Walker contributed to this report.

Amedisys Hunts Future Gains with SNF-at-Home, Predictive-Staffing Investments

Amedisys Inc. (Nasdaq: AMED) was able to grow in 2020 amid unprecedented turmoil. Its executives are now bullish on where the company stands among its peers at the back half of the COVID-19 crisis.

To keep the momentum going, too, Amedsys is investing significant energy and focus into improving staffing moving forward.

“We generally try to avoid hyperbole,” Amedisys CEO Paul Kusserow said on Thursday during the company’s Q4 earnings call. “But considering all of the challenges that 2020 threw our way, our performance has been nothing short of spectacular.”

Baton Rouge, Louisiana-based Amedisys delivers home health, hospice and personal care services to about 415,000 patients per year. It has 514 care locations in 39 states and Washington, D.C.

The company’s Q4 net service revenue totaled $550.7 million in 2020, a 10% increase compared to $500.7 during the same quarter in the previous year. Overall, Amedisys’ net service revenues totaled $2.07 billion in all of 2020, an increase of over 5% compared to $1.96 billion in 2019.

The revenue breakdown in Q4 included $329.4 million from home health, $203.9 million from hospice and $17.4 million from personal care services. While revenue increased significantly in the home health and hospice segments year over year, personal care services revenue fell slightly.

In 2021, the company expects to continue growing as government relief subsides for agencies across the country that could be in trouble.

“As the unsustainable subsidies subside,” Kusserow said. “We expect to capture more and more market share over the coming years as we roll up our respective industries.”

Amedisys is also confident that it can gain an even larger share of business from other post-acute care providers thanks to the fallout from COVID-19.

“COVID is accelerating trends of doing more in the home, and no one is better positioned than Amedisys to take advantage of the shared shift into the home,” Kusserow said. “And as we grow our SNF-at-home capabilities, technology innovations and other high acuity programs, we expect to take even more share from other post-acute providers.”

Facing staffing issues head on

Amedisys is still dealing with COVID-19-related staffing troubles. Mandatory quarantine periods have been throwing the scheduling process for a loop ever since a COVID-19 infection peak in December.

“Quarantines certainly have an impact on us, and we did see some harm in the quarantining of clinicians in Q4 as COVID cases rose,” Amedisys CFO and Executive VP Scott Ginn said. “We think we peaked at the end of the end of December. So that certainly is working its way down, but it’ll be a slow drop.”

The company said that 40% of its clinicians are now vaccinated, which should go a long way to curb quarantine-related time off, as will COVID-19 cases dropping off overall.

At the beginning of January, the seven-day rolling average of new daily COVID-19 cases in the U.S. was close to 260,000. Now, that number has dipped down to less than 70,000 cases per day, according to New York Times data.

Amedisys’ turnover rate in 2020 was 18.3%, which marked good progress for the company, especially during a turbulent year, Amedisys COO and President Chris Gerard said.

“In a year in which numerous unforeseen challenges impacted our daily lives and work lives, I’m very proud of the progress we made in supporting and retaining our talent,” Gerard said. “We made good progress, but we still have work to do, especially within our clinical staff. Reducing nursing turnover is a key initiative for us in 2021.”

In order to help retain talent and drive that turnover rate down even further, Amedisys has implemented a predictive staffing model that aims to foresee when a clinician or caregiver may be leaving before they do.

While the model is new, it has been reliable since its advent.

“We’ve developed a very good predictive model, which can basically tell when we’re going to lose people, between 60 and 90 days ahead of the time,” Kusserow said. “So we’re being very proactive now about [using] this model to drive down turnover, and we’ve seen some very good early results.”

The company believes that its growth in Q4 could have been even better if it had a greater clinical capacity.

“Because it was coming so fast, and we were fighting quarantine with our clinicians and utilizing contract nurses, we know we could have done a little bit better,” Gerard said. “So really it opened our eyes to making sure that we’re building out this clinical capacity this year, making sure the back door is shut in terms of any nurses choosing to leave the organization.”

During the call, Amedisys appeared to be self aware about its staffing situation. Although its turnover numbers weren’t poor, per se, a better staffing effort could have helped yield greater growth for the company in Q4 and 2020 overall.

As the company realizes the amount of opportunities that lie ahead, it wants to be ready to take advantage of them. That will require a shored up workforce, executives believe.

“We’re just people. We have no real assets.and therefore, the assets are people,” Kusserow said. “And we have to have incredible understanding, particularly when there is more burnout and when there is a shortage of clinicians. So we feel very good about where we are, but we’re going to continue to really drive in the vanguard of understanding how to predict labor utilization, how to predict burnout and how to predict turnover.”

Both Gerard and Ginn were both recently granted promotions, Amedisys announced Wednesday. Gerard’s title is now president and COO, while Ginn’s is now CFO and executive vice president.

Kusserow continues his role as chairman of the Amedisys board and CEO.

The post Amedisys Hunts Future Gains with SNF-at-Home, Predictive-Staffing Investments appeared first on Home Health Care News.

Listen: Infections, Vaccinations, and Other Questions

On this episode of the podcast Social Distance, listeners with mild COVID-19 cases call in with their questions. James Hamblin explains why he thinks the summer could be wonderful. And Maeve Higgins shares nun news from Ireland.

Listen to their conversation here:

Subscribe to Social Distance to receive new episodes as soon as they’re published.


What follows is a transcript of the episode, edited and condensed for clarity:

Maeve Higgins: I’ve been dying to tell you about the latest Irish news. Ireland is under pretty severe lockdown at the moment. You’re not allowed to move from county to county. But some nuns put this video online of them performing an exorcism in Dublin, and they’re not from Dublin.

James Hamblin: Oh, and you’re not allowed to … do exorcisms outside of your locality?

Higgins: I mean, you’re allowed to, but you’re just not allowed to break COVID guidelines to go and do an exorcism.

Hamblin: What happened to them? Are they in trouble?

Higgins: Nothing’s happened to them. The government was already keeping an eye on them. It’s just these two nuns. They’re in a group called the Carmelite Sisters of the Holy Face of Jesus. And they got in trouble just before the Christmas holidays too, because they were selling potions online, so the nuns were, like, known to the authorities and then they broke the COVID rules and came and did an exorcism.

Hamblin: Speaking of religion and COVID, when we talk about people forgoing vaccines, religious exemptions have been a huge thing here in the United States for kids going to school unvaccinated. I’m foreseeing some pretty big debates in the coming months and maybe years about requirements for vaccination and religious beliefs. There’s going to be a lot to unpack there.

Higgins: There is. And Jim, I read your piece about how a COVID-vaccinated summer could be wonderful. And I want to ask you about population-level immunity. You wrote that “no other country has endured so much death and illness. But for all the failures that led to this point, the U.S. does finally seem to be experiencing some protective effects of population-level immunity.” Could you tell me more about that?

Hamblin: The numbers in the U.S. look really promising. Cases are going down really quickly and deaths are plummeting because, among those cases, the high-risk people are being vaccinated or have been vaccinated. Add to that the effects of places that have already been hit really hard, where the virus seemed to be kind of burning out, at least temporarily, on its own.

And you’ve got warm weather on the horizon where people could be outside. It’s a coalescing moment, and I don’t know that it’ll last, but things are looking really promising for the summer. And I’ve been trying to deal with how you genuinely let yourself be pulled forward by the hope and joy in being able to do things that we couldn’t do for a long time, while not getting complacent and declaring things “over” or repeating the same mistakes we’ve been making for the last year.

Higgins: So many people are still catching and experiencing COVID. And we get so many brilliant messages from listeners, so I thought it could be really fun to hear from them today.

Hamblin: Yeah, that would be great. Honestly, the voicemails we get are my favorite part of this whole podcast.

Higgins: The first caller is a 68-year-old in central Pennsylvania. His name is Patrick. And he recently got a mild COVID case and wanted to talk about his immunity—and if and when he needs to schedule a vaccination appointment.

Hamblin: Hello, Patrick. How are you feeling?

Patrick: Not too bad, actually. I had a fairly mild run of this, and the only symptom left over is sort of a foggy-headed lightness. I can give you a pretty concise timeline [of my illness]. In the vaccine rollout here in this area, my wife was entitled to a first shot. She got her first Moderna shot on January 23 and showed her first symptoms of COVID on the 29th. On the 31st, she tested positive and went through a 10-day period where she had mild symptoms. I tested twice negative during that period. On the 13th of February, I started showing symptoms and tested positive on the 14th.

Higgins: You tested positive on Valentine’s Day?

Patrick: I did.

Higgins: And you got it from your wife?

Patrick: (Laughs.) I did.

Higgins: Patrick, I’m sorry. What a gift.

Hamblin: Well, I’m glad you’re both doing okay now. I hope things continue to improve for you. And so you’re specifically wondering about vaccination now, after having gone through this?

Patrick: Yes. For both of us. My wife’s already had her first shot. She’s due for her second. Should she get it? And I actually have an appointment scheduled for March 3 that I haven’t canceled yet. And I’ve heard several things from primary-care doctors. And I’m just curious to see what your take is.

Hamblin: Well, I never want to contradict anyone’s own doctor, because everyone has unique considerations. What’s the gist of what you’re hearing?

Patrick: [That I should wait] three months. And the reason given to me is: “because you would have the immunity, and that is the current guideline.” So at least part of that answer has to do with current distribution protocol, I suppose.

Hamblin: So with a lot of diseases, you don’t want to get vaccinated right after you’ve had it, because there can be an increased rate of side effects. If you already have high levels of this acute immune reaction going on, and then you get vaccinated, your body could react more strongly than it would otherwise. We don’t know a lot yet about how that would work with this vaccine, because it’s so new, and I think it’s very reasonable to wait that amount of time.

I doubt that it would be a high-risk thing to go ahead and get it. But I also would expect that you have enough protection, having just been sick, that it would be almost impossible for you to get a serious bout of COVID in that time. You are protected, essentially, at least from severe disease. So I don’t think you can go wrong by waiting that period. I certainly wouldn’t wait a year. I wouldn’t expect the immunity that you’re going to have after this infection lasts extremely long or is going to be 100 percent. We’re not seeing people have reinfection cases really shortly after being sick, so I think that should be reassuring.

Patrick: What about my wife’s case of getting a second shot?

Hamblin: People seem to be pretty well protected after the first dose. The second dose is yet another exposure to this spike protein, which you just naturally got. They’re not exactly comparable, but I expect the effect is similar. It’s like your immune system is doing push ups: Is it better if you do 10 or 20? Sure, do 20 if that makes you stronger, but 10 also is nice. I wish I could be more definitive here. And if there were a serious risk in either direction, I would definitely tell you. But I don’t see one.

Patrick: Thank you both for doing this. I’ve followed this podcast since the beginning, and it’s been quite helpful.

Hamblin: That’s great to hear. It’s been a pleasure to do. And it’s great to hear from you.

Higgins: Okay, Jim, now we’re going to hear from Camie in Idaho.

Hamblin: Hi, Camie. How are you feeling?

Camie: As well as can be expected, I guess, under the circumstances. I definitely don’t have it as bad as many people have had it. So we feel very blessed.

My husband was in quarantine for 10 days. I’m actually in quarantine for 21 days because of underlying health conditions. My doctor just wants to be on the very safe side, which I appreciate. And that started me thinking that, when we’re done with this, what does that mean? Should we be just disinfecting when we recover, just like with any cold or flu? How much of this is sticking to surfaces, and what exactly do we have to clean? It made me think also about when the cruise ships came back and they were finding active, live coronavirus weeks and weeks after.

Hamblin: Are there other people in your household?

Camie: No, it’s just my husband and I, but we have a new grandbaby. We want to go see her, and I don’t want to inadvertently infect her when we go see her eventually.

Hamblin: Absolutely. This has been a point of a lot of confusion over the course of the pandemic. I and most other people making recommendations this time last year were much more about surfaces, about hand hygiene, about sterilizing high-touch surfaces. And then, over the course of the year, it’s really turned out that the virus doesn’t linger very long on surfaces. And when it does, it doesn’t seem to happen in infectious doses. You’re just very unlikely to get enough of a viable virus onto your hand after you touch something and then touch your face and infect yourself.

There are other infections that certainly work that way. But just because you are able to detect some RNA of that virus on, say, a cruise-ship doorknob or something, that doesn’t mean that someone who touched that would get sick. It’s kind of a fine distinction, but we had to play it safe at the time. So we sort of overestimated that and didn’t pay enough attention to air. It seems like surface transmission can happen from touching something, but it would have to be within a very short period. Say, someone came into your office right after you’ve been working at a desk for eight hours and then for some reason had to put their face onto your desk.

Briefly touching a handrail as you went down a staircase and then someone coming by an hour later and using that same handrail—that seems like as close to a zero percent possibility as possible. And so the time period in which the virus is persisting on surfaces at all is short enough that once you and your husband are clear of needing to quarantine, the surfaces in your house should not be expected to contain any lingering virus.

Camie: Should we stay away from the grandbaby, even after my 21 days of quarantining?

Hamblin: If you’re going to see people, stay outdoors, wear a mask, don’t have prolonged close contact unless this person is in your tight bubble and you’re all being really vigilant. But no, there’s no reason to expect that you’re at any increased risk of infecting other people in that period.

Higgins: Camie, thanks so much. And I hope you just feel 100 percent really soon.

Camie: Thank you so much. I so appreciate your help. Wonderful to talk with you.

Pennant Plans to ‘Put Capital to Work’ in Its Home Health Business

The Pennant Group Inc. (Nasdaq: PNTG) is sitting on a newly increased revolving line of credit, giving it plenty of M&A firepower to work with moving forward. The company specifically plans on putting “a lot of capital to work” in its home health business, executives noted during a Thursday earnings call.

The Eagle, Idaho-based Pennant announced it extended its credit facility — arranged by Truist Bank — by $75 million to a total of $150 million on Tuesday.

“We have deployed a significant amount of capital opportunistically in the home health and hospice segment,” Pennant CEO Daniel Walker said during Thursday’s call. “Our capacity to deploy even more continues to increase because we have multiple healthy operating markets and a strong leadership pipeline. We are grateful to our lending partners for entrusting us with increased borrowing capacity to execute our disciplined growth strategy.”

Pennant is a holding company of independent operating subsidiaries that provide health care services through 80 home health and hospice agencies, in addition to 54 senior living communities.

As of Tuesday, $131.7 million remained “undrawn on the revolver,” providing the company substantial dry powder to continue its growth strategy, according to Jennifer Freeman, Pennant’s CFO.

Those added resources may soon come into play, as the company saw ample dealmaking opportunities during the fourth.

Over the last three months of 2020, Pennant announced the acquisitions of one home health agency and one hospice agency. In November, the company also established two de novo hospice agencies.

“We expanded strategically within existing geographies and into adjacent markets,” Derek Bunker, Pennant’s chief investment officer, said during the call. “We expanded the continuum by adding home health services where we have a hospice agency and vice versa. We acquired large regional providers with a strong local reputation that we expect to further develop in our operating model. We acquired small budding agencies that have significant long-term organic growth potential. We executed multiple startups consistent with our history of successful startup ventures.”

Additionally, the company formed Seaport Scripps Home Health — a home health joint venture — with Scripps Health.

Bunker noted that Pennant’s track record of being aggressive on acquisitions is a good indicator of the company’s future growth rate.

The company will likely ease up on senior living transactions in the near term, however.

In general, senior living providers have seen occupancy rates take a dip as a result of the COVID-19 emergency. Capacity in senior living is down by nearly 6% in major markets, according to the National Investment Center for Seniors Housing & Care (NIC).

“That’ll be the order of the day until we see significant, consistent signs of strength in the senior living business and recovery there,” Walker said. “The equation on the home health and hospice side is very much intact with strong markets, a strong leadership pipeline and great momentum. We’ll put a lot of capital to work in that space.”

So far, Pennant already has one home health acquisition under its belt for 2021.

In January, the company acquired Sacred Heart Home Health Care — a provider that operates in Phoenix and Tucson, Arizona.

In total, Pennant’s 2020 revenue was $391 million, an increase of $52.4 million, or 15.5%, over the prior year. The company’s home health and hospice services segment brought in $253.7 million on the year, an increase of $47 million, or 22.8%, compared to 2019.

In Q4 of last year, Pennant’s total revenue checked in at $108 million, an increase of $18.5 million, or 20.6%, compared to the prior year’s fourth quarter. The company’s home health and hospice services segment revenue was $74.5 million, an increase of $19.4 million, or 35.2%, compared to Q4 2019.

Total home health admissions for Pennant in Q4 increased by 44.1% over the prior year’s quarter. Home health admissions for all of 2020 increased by 17.8% compared to 2019.

Walker noted that the company cared for nearly 13,000 patients and residents across its home health, hospice and senior living operations over the course of 2020.

“Our first year as a public company was eventful, challenging and ultimately rewarding,” Walker said. “We navigated the complexities and dynamics of a new reimbursement methodology in [the Patient-Driven Groupings Model]. We completed the successful transition of key enterprise, financial, human capital and IT systems related to our spinoff from The Ensign Group. And we dealt with — and continue to deal with — the impact of an unprecedented pandemic. I am proud of our collective efforts on each of these fronts.”

The post Pennant Plans to ‘Put Capital to Work’ in Its Home Health Business appeared first on Home Health Care News.

How UCSF created a data platform that leverages 150+ social determinants variables

UCSF’s interactive data platform allows users to drill down into 150 social determinants of health variables. This data, layered with EHR data, can give researchers and clinicians invaluable insights into the nexus of social factors and health.

How representative are clinical trials of the US population?

Diversity in clinical trials

Recently, the FDA’s Center for Drug Evaluation and Research’s (CDER’s) released its 2020 Drug Trials Snapshots Summary Report. Part of the report examines the demographics of participants in clinical trials for the 53 drugs that FDA approved in 2020 either as new molecular entities (NMEs) under new drug applications (NDAs) or as new therapeutic biologics under biologics license applications (BLAs). More than 32,000 patients participated in these trials. Were they representative of the overall US population?

In the figure below, I compare the FDA figures against the data from the 2019 US Census population estimates. We see that there are more females patients in clinical trials (56%) compared to the US population. Likely these numbers are skewed by the fact that there were clinical trials for 7 approved breast cancer drugs (with generally >99% of participants being female in the trial) compared to only 3 prostate cancer drugs (with generally 0% of trial participants being female). Unsurprisingly, there are more elderly individuals (30%) compared to the US as a whole (60%).

The racial composition is a bit more complex to disentangle. At first glance, it seems like the trials population (with 75% white individuals) has more minority individuals than the U.S. as a whole (with 79% White individuals). However, the 79% figure includes Hispanics as well. Once Hispanics (who make up 18.5% of the US population) are taken out of the Census estimates, the clinical trials appear disproportionately white (75% in trial vs. 62% in the US).

So are the trial populations ignoring minorities? I would say likely no. Although the Census has 79% of the population as White (including Hispanics), this figure rises to 84% among Americans aged 65 and older. Since most of the disease of interest from the clinical trials disproportionately affect the elderly, there are bound to be a higher percentage of White than for the population in general. Additionally, 46% of all clinical trial participants came from outside the US.

Although these data do not provide conclusive evidence, at first glance it appears that the life sciences industry is doing a good job insuring that clinical trials are representative of diverse US populations.

Generic approvals

The FDA’s Office of Generic Drugs also released their 2020 Annual Report. While generics are often ignored in policy debates, they couldn’t be more important. Citing the Association for Accessible Medicines’ 2020 Report, the Office of Generic Drugs writes:

Right now, 9 out of 10 prescriptions in the United States are filled by generic drugs. Generic drugs have saved the health care system $2.2 trillion dollars in the past decade.

In 2020, FDA approved 948 Abbreviated New Drug Applications (ANDAs) including 72 first generics. A visual summary of these approvals is below.

https://www.fda.gov/drugs/generic-drugs/office-generic-drugs-2020-annual-report

Note: A tentative approval does not allow the applicant to market the generic drug product and postpones the final approval until all patent/exclusivity issues have been resolved.

Everything You Ever Wanted to Know About Blueberries

Blueberries may be tiny, but they pack quite the nutritional punch.

Juicy, sweet, and tart, blueberries are a good source of fiber and packed with flavor. Fresh or frozen, they’re super easy to add to your daily routine.

Read on to find out why these small but mighty berries are included on lists like the best good mood foods.

Plus, discover the blueberry nutrition benefits you can reap from eating them on the regular, and get expert-approved ways to include more blueberries in your diet.

Oatmeal topped with blueberries

Blueberry Nutrition Facts

1 cup of blueberries provides:

84 calories
21 g carbs
1 g protein
0.5 g fat
4 g fiber

16% of men’s daily recommended intake for vitamin C (and 19% of women’s), which is important for supporting normal skin health and immune function.

32% of women’s daily recommended intake for vitamin K (and 24% of men’s), which may benefit bone health and is essential for normal blood clotting.

Bowl of blueberries

3 Health-Supporting Benefits of Blueberries

1. Provide antioxidant properties

Blueberries provide plant compounds like anthocyanins, quercetin, and myricetin, which all have antioxidant properties and other health benefits.

In fact, compared to other fruits, blueberries have one of the highest antioxidant activity levels. Antioxidants help neutralize free radicals in your body.

2. May support brain function

Blueberries may also help support normal brain function! They contain antioxidant vitamins that may play a role in supporting healthy brain function as we age.

A large, six-year study of older adults found that consuming blueberries and strawberries supported age-related cognitive function.

3. May support health as we age

A 2020 research study done at Cornell University shows promising results that blueberry consumption may support muscle cell growth.

How to Incorporate Blueberries in Your Diet

Want to eat more blueberries?

While there’s no magic number to aim for each day, Jamie Mok, M.S., R.D., R.Y.T., a dietitian nutritionist and yoga teacher based in Santa Monica, California, says that “eating blueberries regularly is certainly encouraged from a nutrition standpoint.”

A good portion is about ¼ cup to 1 cup, “depending on how you’re using them, says Krista Maguire, R.D., C.S.S.D., Nutrition Manager at Beachbody.

Shakeology ultracremoso de arándanos y moras

Here are 11 of our favorite ways to incorporate blueberries (and all that blueberry nutrition) into your snacks or meals:

1. Snack on them plain — fresh or frozen!

2. Blend some into a Limitless Blueberry Blackberry Shakeology smoothie.

3. Add them to your morning oatmeal or cereal.

4. Toss into yogurt or chia pudding.

5. Add to your favorite muffins, waffles, or pancakes

6. Throw fresh blueberries onto a salad.

7. Blend thawed frozen blueberries into salad dressing.

8. Pair still-frozen berries with vanilla Greek yogurt for a sweet treat.

9. Use them in desserts like these Blueberry Chocolate Truffle Balls.

10. Whip up baked oatmeal cups with blueberries for easy breakfasts.

11. Cut them in half or quarters for your tiny toddler or serve whole for the bigger kids, says Maguire. “It’s never too early to start introducing healthful foods to your little ones,” she says.

Is It Possible to Eat Too Many Blueberries?

While it would be pretty tough to eat too many blueberries, it is always possible to overdo it.

“The benefits mentioned can also be drawbacks depending on the person,” explains Maguire.

“For example, excessive fiber may cause digestive issues for some, so be sure to eat blueberries in moderation, especially if a high-fiber diet is new to you. Also, because of their high vitamin K content, those who are taking blood thinners or have blood clotting issues will want to keep a line of communication with their doctor about their typical diet,” she explains.

A Golden Rule for a Semi-Vaccinated World

The past 11 months have been a crash course in a million concepts that you probably wish you knew a whole lot less about. Particle filtration. Ventilation. Epidemiological variables. And, perhaps above all else, interdependence. In forming quarantine bubbles, in donning protective gear just to buy groceries, in boiling our days down to only our most essential interactions, people around the world have been shown exactly how linked their lives and health are. Now, as COVID-19 vaccines rewrite the rules of pandemic life once more, we are due for a new lesson in how each person’s well-being is inextricably tangled with others’.

This odd (and hopefully brief) chapter in which some Americans are fully vaccinated, but not enough of us to shield the wider population against the coronavirus’s spread, brings with it a whole new set of practical and ethical questions. If I’m vaccinated, can I travel freely? Can two vaccinated people from different households eat lunch together? If your parents are vaccinated but you’re not, can you see them inside? What if only one of them got both shots? What if one of them is a nurse on a COVID-19 ward?

After asking four experts what the vaccinated can do in as many ways as I could come up with, I’m sorry to report that there are no one-size-fits-all guides to what new freedoms the newly vaccinated should enjoy. Still, there is one principle—if not a black-and-white rule—that can help both the vaccinated and the unvaccinated navigate our once again unfamiliar world: When deciding what you can and can’t do, you should think less about your own vaccination status, and more about whether your neighbors, family, grocery clerks, delivery drivers, and friends are still vulnerable to the virus.

The COVID-19 vaccines are fantastic. The shots that are currently available are tremendously effective at protecting the people who get them from severe illness, hospitalization, and death—all the things we want to avoid if we have any hope of fully reopening society. Even so, advice on what people can do once vaccinated gets complicated. Those who are vaccinated can still be infected by, and test positive for, SARS-CoV-2; they’re just way, way less likely to get sick as a result. The sticky element is whether not-sick-but-still-infected vaccinated people can spread the virus to others and get them sick. So far, the early data have been promising, showing that the vaccines stop at least some transmission, but the matter is not scientifically settled.

[Read: The one area where the U.S. COVID-19 strategy seems to be working]

This leaves us in an awkward situation. Getting vaccinated means that your choices no longer endanger you much, but they still might make you a risk to everyone else. To put this in more concrete terms: If a vaccinated person goes out to eat, they can’t yet be sure that they’re not carrying the virus and spreading it to their unvaccinated fellow diners and the restaurant staff, or that they won’t pick up the virus at the restaurant and bring it home to their unvaccinated family.

So, first, a very broad guideline for navigating a world in which vaccinations are rising and infections are dropping: Whether you’re vaccinated or not, how much you can safely branch out in your activities and social life depends on the baseline level of virus in your community. You can imagine that, in pandemic life, each of us has been dealt a certain number of risk points that we can spend on seeing friends outside, going to work, sending the kids to day care, and so on. If you or someone you live with is especially vulnerable to the virus, you might choose to spend fewer points by getting groceries delivered; if you live alone in an area where very few people are sick, you might choose to spend more points by forming a bubble with friends. The vaccine delivers you a huge number of bonus points, if you’re lucky enough to get one. And when spread of the virus is low, everyone gets more points.

Saskia Popescu, an infectious-disease epidemiologist at George Mason University, told me that everyone, vaccinated or not, should try to keep track of three metrics in your area: The number of new daily cases per 100,000 people, the rate at which people transmit the virus to one another, and the rate at which people test positive for the virus. Popescu said that there are no magic numbers that would immediately bring the country back to pre-COVID life, but she’ll feel better about reopening when we hit daily case rates of just one to two per 100,000, transmission rates of .5 or less, and test-positivity rates at or below 2 percent. (As of last week, no U.S. state had reached the trifecta, and the country as a whole is still far from it.) Many local public-health departments regularly provide these numbers.

[Read: A simple rule of thumb for knowing when the pandemic is over]

You might be tempted to factor vaccination rates into your safety equation too, but Whitney Robinson, an epidemiologist at the University of North Carolina, told me that those numbers shouldn’t be anyone’s main safety indicator. That’s because vaccine distribution so far has been concentrated in particular social networks (for instance, health-care workers) and demographic groups (notably the white and wealthy), so an entire community won’t necessarily reap the benefits that a local vaccination rate of 15, or even 50, percent might imply.

Knowing the overall risk of infection in your area is at least a first step toward making better decisions about whether you should host that birthday party or take Grandpa out to lunch. Even for people who are vaccinated, all of the public-health experts I spoke with emphasized, it’s still important to not throw caution to the wind. If vaccinated people flock to indoor restaurants or go unmasked in a crowd, they’re not just risking infecting others if they can indeed spread the virus, Popescu said. They’re contributing to a sense that life as we knew it before March 2020 is back, despite the fact that more than 65,000 people are still contracting the virus each day. Simply returning to our old habits would be deadly.

That doesn’t mean that any loosening up is off the table for the vaccinated. Far from it—plenty of public-health experts have argued that vaccinated people safely seeing relatives or returning to the office can benefit everyone, because seeing how much the shot improves life will persuade more people to take it. Downplaying the vaccines’ success could discourage people from getting them, because if it won’t change their lives, they have no incentive.

The best way forward for us all is for vaccinated people to spend their extra risk points in ways that don’t put unvaccinated people in danger. As you consider whether you should do things that you wouldn’t have done before the vaccine, think creatively about how you can make those things safer for everyone involved. “Grandparents really want to be able to go hug their grandchildren,” Tara Kirk Sell, a senior scholar at the Johns Hopkins Center for Health Security, told me. “I don’t have a problem with that.” But consider asking Grandma and Grandpa to wear masks during that hug, or meet you outside, or avoid sleeping over. Throughout the pandemic, we’ve developed an arsenal of strategies to make particular settings and activities safer. The vaccine is an extra-strong weapon against transmission that some people can deploy, but that doesn’t mean they need to discard all of the other ones to use it.

[Julia Marcus: Vaccinated people are going to hug each other]

How many of those methods you choose should depend on how many vulnerable people you regularly come into contact with. A vaccinated oncologist who lives with her immunocompromised sister is going to behave differently from a vaccinated retiree who lives alone. That said, there are plenty of settings, such as restaurants and stores, where you don’t know or can’t control how many vulnerable people are around you. For that reason, small private gatherings where you can adjust your anti-spread tactics to accommodate everyone’s risk factors are a safer first step toward normalcy than activities such as concerts, indoor dining, or big weddings. Travel in small groups might be a nearer goal, too: Popescu said she hopes that by the end of the year, she can take a vacation in another state with her husband without worrying that she’s “being a bad steward of public health.”

Playing it safe, even as you loosen up a little, is the best way to ensure that someday, you will again live in a world with bars and birthday parties and movie theaters. It’s also the best way to keep yourself from getting sick with COVID-19 in the future—regardless of whether you’re already vaccinated. No one knows exactly how long you’ll be protected against serious illness if you get a vaccine (or were previously infected), simply because no one has been vaccinated for more than seven months yet. Given what we do know so far, the most likely way for a vaccinated person to get seriously ill from the coronavirus would be if they encounter a variant that the vaccine they received doesn’t effectively protect against. Such variants are much more likely to emerge if the virus is allowed to rage in particular places or groups before the overwhelming majority of the world’s people can be vaccinated.

As Gregg Gonsalves, an epidemiologist at the Yale School of Public Health, put it, “In the context of epidemiology, we’re all in the same boat.”

Openly available toolkit to help lab-based coronavirus research

During the SARS-CoV-2 outbreak, laboratories worldwide have pivoted from their usual research to working to identify new COVID-19 drug and vaccine candidates. This experimental work requires access to clinical isolates and systems that allow genetic manipulation of SARS-CoV-2. A new paper reports an openly available SARS-CoV-2 laboratory research toolkit aimed at increasing availability of these materials.

What Is the “Green” Mediterranean Diet Plan?

It’s hard to beat the heart-healthy benefits of the Mediterranean diet plan, which emphasizes whole foods like fruit, veggies, legumes, seafood, and lean meats.

But the new “green” Mediterranean diet plan has been getting a lot of buzz lately — and it may offer even greater benefits than the original diet.

The green Mediterranean diet plan follows many of the same basic principles as the original.

However, the green version incorporates more plants and fewer animal products (though it’s still not 100 percent vegetarian or vegan).

Here’s what you need to know about the latest plant-based diet plan.

Woman eating Mediterranean food

What Foods Are Allowed on the Green Mediterranean Diet?

The green Mediterranean diet is based around many of the same foods as the original version, including:

  • fruits and vegetables
  • whole grains
  • legumes
  • nuts and seeds
  • olive oil
  • lean proteins like fish, eggs, and dairy

However, there are a few tweaks.

The green Mediterranean diet is rooted in a recent study on the effects of a Mediterranean diet that incorporates more plant-based foods and fewer animal products.

Researchers placed participants into three groups. Over a period of six months, one group followed healthy dietary guidance; one followed the original Mediterranean diet, and one followed a “green” Mediterranean diet, which made the following changes to the original:

  • Add 1 ounce of walnuts and 3 to 4 cups of green tea per day.
  • Replace animal protein at dinner each day with a plant-based protein shake containing 100 grams of frozen cubed Wolffia globosa (a.k.a. duckweed).
  • Limit poultry.
  • Avoid red meat and processed meats (such as hot dogs and salami).

Woman eating Mediterranean food

What Are the Benefits of the Green Mediterranean Diet Plan?

Research suggests the original Mediterranean diet is a healthy eating pattern that may benefit cardiovascular health and help to maintain a healthy weight.

The green Mediterranean diet seemed to amplify some of those health benefits.

In the study above, participants who followed the green Mediterranean diet plan experienced greater improvement in their Framingham Risk Score (which assesses cardiovascular risk) than the other groups.

The green Mediterranean diet group also experienced greater decreases in “bad” LDL cholesterol, blood pressure, and C-reactive protein (a marker of inflammation) compared to those on the traditional Mediterranean diet (who also saw these vitals improve).

Certain components of the green Mediterranean diet may contribute to these additional benefits.

For example:

  • Researchers believe the compounds in plants called polyphenols — as well as the fiber, plant protein, and unsaturated fats — may help to promote heart health.
  • Fiber is an important part of a healthy diets and helps to support digestive health.
  • Research suggests Wolffia globosa, a.k.a. duckweed, is a high-quality source of protein that contains nine essential amino acids and provides fiber.

Plus, research suggests red meat consumption (which is banned on the green version of the diet) may be linked with an increased risk of certain cardiovascular risks, says Shannon Henry, RD, of EZCare Clinic.

Woman eating a green salad

Can You Lose Weight on the Green Mediterranean Diet?

“The green Mediterranean can be effective for weight loss, so long as you do not go over your daily caloric needs on a normal basis,” says Trista Best, M.P.H., R.D., L.D.

In the study, participants on the green Mediterranean diet lost an average of 13.66 pounds in six months.

The group that followed the original Mediterranean diet lost an average of 11.9 pounds, while the healthy dietary guidance group lost an average of 3.3 pounds.

(Both the green and original Mediterranean diet groups were on calorie-restricted diets, and all diets were combined with physical activity.)

Participants who followed the green Mediterranean diet also experience a greater reduction in waist circumference than the other groups.

“Because of the satiating nature of higher-fiber foods present in the diet, some people may lose weight as they transition to the green Mediterranean eating style,” says Jen Bruning, RDN, spokesperson for the Academy of Nutrition and Dietetics.

The Bottom Line

While the results of this study are promising, so far this is the only published peer-review study on the green Mediterranean diet, and the study participants were predominantly men (88 percent).

More research is necessary to confirm the results of this study.

With that said, “the components of green Mediterranean that are different — less red meat, more veggies, green tea — have their own evidence as being health-promoting,” Bruning says. “The combination would be likely to have those benefits as well, though more evidence is needed to look at the whole diet.”

CDC urges masks, better ventilation in gyms

Gym users should wear masks when exercising, even if they are more than six feet apart, and the facilities need to improve ventilation, the Centers for Disease Control and Prevention recommended.The CDC cited multiple outbreaks at gyms in Chicago…

Buoy Health Wins Over Three Health Plans, Turns Symptom Checking into Patient Decision-Making

By JESSICA DaMASSA, WTF HEALTH

Symptom checker startup Buoy Health’s $37.5M Series C caught a lot of attention among health tech market watchers because of the collaborative support the funding round garnered from health plans. THREE payor orgs – UnitedHealth’s Optum, Humana, and Cigna – participated in the round, and co-founder and CEO Andrew Le is here to tell us why.

What’s interesting is how the health tech startup’s model has evolved past “symptom checking” and into patient decision-making to better solve the underlying uncertainty that typically causes a patient to “shotgun into care” that’s often a poor fit clinically AND financially. “If you don’t solve the clinical uncertainty first,” says Andrew, “then nothing else matters.” Health plans, though, are likely also seeing the potential of making sure that their members are routed to the right kind of “covered” care. And Buoy’s big plan is to help that along with a full-on marketplace of curated solutions – think telehealth, digital health apps, digital therapeutics, and so on – that round out the benefit design of a traditional health plan. Suddenly, symptom checking seems a means to a very different end…

Altimmune begins trial of nasal vaccine for COVID-19

Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle.

Maryland, US-based company Altimmune is among the biotechs and research labs trying to find more convenient alternatives and believes a nasal vaccine spray that is stable at room temperature could be the answer.

A nasal delivery method will also produce an immune response at the point where the virus enters the body.

While traditional vaccines delivered by an intramuscular injection can stimulate systemic immunity in the blood, they have not been shown to cause mucosal immunity in the nasal cavity, which may be critical for blocking transmission of the virus, Altimmune said.

The company announced a phase 1 trial is beginning of its nasal spray vaccine just as scientists in the UK said they are considering a similar approach.

Professor Sarah Gilbert, who formed the University of Oxford team that developed the vaccine marketed by AstraZeneca, pointed out to the UK’s Commons Science and Technology Committee that there is already a nasal vaccine for flu.

AZ already markets a nasal flu vaccine called FluMist, so the precedent is there, and the Oxford team is thinking of going down this route with its own research.

Altimmune’s AdCOVID is an adenovirus-vector vaccine designed to stimulate a broad immune response including both antibody and T-cell responses in the nasal cavity and respiratory tract, the point of entry for the virus.

The phase 1 clinical trial will test the safety and immune response of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55.

Subjects will receive AdCOVID at one of three dose levels administered as a nasal spray.

In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses.

Altimmune expects a full data readout from this phase 1 study in Q2 2021.

The post Altimmune begins trial of nasal vaccine for COVID-19 appeared first on .

Moderna forecasts $18bn in sales of Covid vaccine this year

Better than expected revenues will push US firm founded in 2010 into profit for first time

Moderna expects to rake in $18.4bn (£13bn) of sales from its coronavirus vaccine this year, marking a huge turnaround in the fortunes of the US biotech firm.

The expected revenue is far higher than the $11.2bn predicted by analysts, and exceeds the $15bn in sales that its US rival Pfizer expects for the Covid-19 vaccine that it developed with Germany’s BioNTech.

Continue reading…

Vetiver

In my experience, most organic and medicinal chemists are always ready to hear about the latest results in two branches of the science: things that explode and things with weird smells. Maybe we are in our way “singularly in touch with the primitive promptings of humanity”, as Captain Grimes says in Decline and Fall (although let it be noted that he had something very different in mind). So let’s do a bit of solid, 100% odoriferous chemistry today as a brief change of pace from vaccine work. Ever heard of vetiver? It’s a tropical grass, very large and sturdy, with an extremely deep, dense root system that’s led to the plant’s use in soil stabilization. But those roots have long been used for something else entirely: perfume.

There are a lot of plants in that category – not just flowers, but thing like sandalwood and patchouli. The problem is that in many cases it’s just not possible to grow enough of some of these to meet the fragrance industry’s needs. True sandalwood, for example, has been ferociously overharvested over the decades and is now a protected species. This C&E News article is a nice look at the problem, and at the balance between supply chain needs, cost of ingredients and many consumer’s stated preference for “all-natural” formulations. This can be an opportunity for organic synthesis to step in with larger-scale production, either from other chemical feedstocks or from natural products that can be harvested from more easily grown plants. Medicinal chemists will immediately recall the situation with the natural product taxol, whose use in chemotherapy threatened to make the Pacific yew extinct at one point (the inner bark of the tree had to be stripped). A semisynthetic route was developed at Bristol-Myers Squibb from a related intermediate that could be harvested from pine needles, and now there is even commercial production from plant cell culture.

Now, you don’t hear too much demand from oncologists for all-natural paclitaxel, but all of these techniques do raise questions about what can be called natural and what can’t. It should go without saying that (for example) pure vanillin made in an industrial reactor is exactly the same as pure vanillin isolated from the tropical bean. But it should also go without saying that the extract from the plant will likely contain all sorts of other constituents (some of them at very low levels) that add depth and complexity to an aroma or flavor. Isoamyl acetate, for example, is by far the dominant note in the smell and taste of a banana. But by itself, it smells like banana candy more than it smells like a fresh banana, thanks to all the other components. (Note: I’ve heard the story about how isoamyl acetate was marketed to mimic an earlier variety of banana, but that doesn’t quite hold up). Similarly, ethyl methylphenylglycidate is a big part of the smell of a strawberry, but definitely comes across as artificial and cheap-candy-like on its own.

Most natural extracts have been investigated to the point that we know their “principle”, as the perfume industry calls it. Instead of trying to source original sandalwood oil (not easy on a commercial scale) or deal with the various other oils from related trees and shrubs, you can go get some santalols made by fermentation processes, or buy some sandalore or brahmanol, or try “Dreamwood“, a macrocyclic lactone in a totally different structural class that also recreates much of the effect. Vetiver, though, has been a tough one.

Vetiver itself is a lot easier to cultivate than sandalwood, but harvesting and distilling tons of vetiver root is still something that might be improved on just a bit. But despite decades of effort, no one has quite pinned down which of the hundreds of compounds in vetiver oil really carries the bulk of its distinctive character. Until now, apparently. This new paper seems to have tracked it down, and it took a fair amount of synthetic chemistry to confirm it.

You can see some of those components above (graphic from Angewandte Chemie/Wiley). And you’ll notice that some of these things are pretty easy to smell, like beta-vetivone with a threshold of 0.3 nanograms/liter of air. But it smells more like grapefruit than it does vetiver oil itself, so that can’t be the principle (rather, it’s one of the “top notes” of the overall scent). You may be surprised to see geosmin in there – now that’s a compound with a low detection threshold, and you’ve certainly smelled it, whether you know it or not. It’s the smell of fresh dirt, or the smell you get as a rainstorm starts to wet the ground. There’s a tiny bit of that in the overall vetiver profile, too. But there’s a unique-to-vetiver part of that profile that people have been trying to track down all these years. As the paper details, khusimone (lower left) has long been thought to be that principle, but although its in the right ballpark, its odor detection threshold is just too high for it to be the real candidate.

The paper is a joint effort from the Max Planck Institute in Mülheim and from Givaudan (a big player in the fragrance industry), and it mentions an effort at the latter company to carefully distill 800g of vetiver oil through a Sulzer column and then a Spaltrohr. Even a lot of synthetic organic chemists will be saying “Through a what and a which?” to that one. Sulzer is a Swiss company that makes all sorts of fluid-handling equipment, including many high-end distillation column systems. A look through their material will take you into a whole new world of chemical engineering for such hardware, if you’ve never had to worry about such things. (I haven’t myself – the most hardcore distillation I’ve ever done was with a spinning band column back in 1985 or so, and that was a one time event!) A Spaltrohr distillation (the second step in the Givaudan work) is a tube-within-a-tube column with only a very small separation between the tube surfaces. It’s typically used for small scale vacuum distillation work, although I don’t think “typical” is the right word for what’s a rather uncommon piece of equipment. You’ve got to take those things up very slowly, but you can get some pretty amazing separations if you have the patience.

Now, if you put vetiver oil into a gas chromatograph system, you get hundreds of peaks for different compounds, so isolating things through fractional distillation is not something you’d undertake lightly. A mere 155 of those peaks, by the way, have ever been firmly identified. But you can narrow things down with an interesting GC accessory called a “nose port”, which is exactly what it sounds like: you sniff the separated eluent from the column and use the human nose (which can be a startlingly good detector) to figure out where your compounds of interest like. Not recommended for ordinary use in the lab, but for flavor-and-fragance work it’s just the thing. That showed a key region eluting at between 45 and 46 minutes with the sought-after aroma, but there were still a number of different peaks in there. And the problem with all research on olfaction is that trace constituents, things that you would hardly even notice in such a forest of GC peaks, can have enormous impacts on smell.

So the only way to be sure was to synthesize some of these things, and that’s what the team in Mülheim did. An earlier attempt to deconvolute both vetiver oil and the vetiver oil literature, which was hardly in better shape due to such trace-component problems, suggested the ziza‐6(13)en‐3‐on skeleton compounds as candidates, but no one had ever prepared these in enough quantity to see if they came at the right spot in the GC smell traces. The Givaudan work agreed with this, pointing especially to compound 10 in the graphic above as a likely winner. Chemistry time! The synthesis (which gives three stereoisomers that are then separated) is about ten steps from cyclopentenone, and involves a tricky intramolecular Pauson-Khand for ring formation. The double bond left from the starting material turned out to be a real pain to reduce selectively in the presence of the exo-alkene left over from the Pauson-Khand, and as you can see from the structure above, that latter one needs to be in the final product. You can tell that this is not what the team was looking to be fighting ten steps into the synthesis, but they got around the problem by epoxidizing the exo-alkene. Hydrogenation then knocks down the enone double bond while converting the epoxide into a hydroxymethyl, which is then eliminated.

And sure enough, compound 10 had a unique odor that hit the elusive “transparent woody-amber” note of vetiver. It’s at least 150 times more detectable to the nose than khusimone, down to 0.03 ng/l of air or below. The authors noted that its scent is rather similar to arborone, which is the active component of a well-known fragrance ingredient called Iso E Super (and other other names as various mixtures of stereoisomers). Those compounds don’t look a heck of a lot alike at first glance, but are quite similar stereoelectronically in a 3-D overlay, which makes sense. Iso E Super has been described as “remarkably pleasant”, and apparently compound 10 is as well. You can bet that the fragrance chemists are modeling the two of them as we speak to figure out some other interesting molecules that might share the same property!

Cotiviti achieves 20 years of HEDIS® certification amid expanding quality landscape

BrankaSusticTo build a successful quality improvement program, health plans not only must stay ahead of annual changes to HEDIS® reporting requirements, but also a continually expanding list of state and other custom measures to track as well. Amid all this change, Cotiviti’s Quality Intelligence solution recently earned full certification for its Quality Engine application from National Committee for Quality Assurance (NCQA) for all HEDIS Measurement Year (MY) 2020 measures—marking the 20th consecutive year that Cotiviti has earned this certification. The solution was also certified for 22 California AMP measures. To mark the occasion, we spoke with Cotiviti’s Branka Sustic, vice president of data operations program management, who reflected on the continuous evolution of Cotiviti’s quality measurement solutions as well as health plans’ changing needs and goals.

You’ve been with our organization yourself for 20 years. Tell us about your current role on Cotiviti’s quality team and what keeps you busy from day to day.

Ultimately I am responsible for the day-to-day operational delivery of our HEDIS solution as well as HEDIS retrieval and abstraction to our client base. This includes everything from supporting the implementation process all the way through HEDIS submission. My responsibilities also include ensuring that the data analysts are providing the necessary knowledge to our clients around the value of certain data elements that are necessary to feed our engine and being able to explain to our customers how we implemented HEDIS measure logic.

I’m also responsible for our program management support services for HEDIS retrieval and abstraction. My team serves as an intermediary between our retrieval and abstraction operations and our clients; they are the client-facing team updating the clients on the status of where they are in the season, how far along we are with the project, and when they expect the project to complete. Finally, I oversee our HEDIS program managers, those who are responsible to work with our clients and help guide them through the HEDIS season. So, it really spans a number of different responsibilities, but if you’re thinking of the overall HEDIS project, my team is really the day-to-day support for our clients to help them be successful during the HEDIS season.

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How has quality reporting gotten more difficult for health plans in the past several years, and what is Cotiviti doing to help them with those problems?

When I started working on HEDIS, we had very few clients who really performed HEDIS year-round, treating it as a regulatory task to perform once per year. It has gotten much more complex because a lot of plans are now using that HEDIS data throughout the entire year to feed different components of their programs, whether it’s provider pay-for-performance, or submitting measure results to different states, or feeding different internal dashboards projects that the plans have.

We have seen a tremendous shift in that focus on just the HEDIS season to using HEDIS data around the clock to feed different health plan initiatives. We have continually supported our clients in these initiatives. So, instead of running the data once a year or four times a year, just for HEDIS purposes, we have seen a big uptick on helping our clients do year-round activities.

We have regular touchpoints with NCQA’s audit and measures teams to discuss trends in market and topics relevant to our client base. This is something we look forward to continuing and building upon in the future. One other major way we help our clients be successful is through our partnership with the auditor firms. In the HEDIS world, every plan has an auditor and goes through the audit process every year before submission. What we have done is hold two annual auditor open houses, where we have gotten great participation and feedback. It’s an opportunity for us to share information about our products with the auditors so that they can have a better understanding of our tools—so that once the audit time comes, they can better service our joint clients.

Clients often request HEDIS data to use for downstream reporting in their own reporting environment. As a result, we have developed a standard extract offering that meets the needs of the majority of our clients. For clients who need more than the standard extract, we have developed a structured custom request intake process. Sometimes the custom work is a fairly quick task, other times it’s a longer-term initiative requiring custom development, but either way we work collaboratively with the client to get it done. We make sure we understand the underlying business need to help the client arrive at the most effective solution.

In 2020, we also formed a new partnership with Health Data Decisions (HDD) to help clients who could benefit from additional service, particularly when there is high turnover or limited resources within their quality department. Some examples include offering education about what HEDIS is and its importance to a health plan or looking at the client’s internal data warehouse(s) and making sure the client is mapping all of the fields that it should be mapping. HDD can help clients take full advantage of the data streams and elements that they have in their possession but might not be passing through to Cotiviti today. It could have an increase on your rates if you are passing more data, or better data. If plans are lacking IT knowledge or data knowledge, this is where the HDD team can step in and provide that assistance.

How have Cotiviti’s solutions evolved in the time that you’ve been with the quality team?

What stands out to me the most is how we have really adapted to the requirements of the quality improvement business and the regulatory requirements of NCQA. Some of the things that I have seen us enhance specifically have been state and custom measures, expanding our library and offering—that really is driven by our customers’ needs to report for different Medicare or Medicaid requirements.

I have also seen us, as an organization, become much more effective with our processes and servicing our clients in a more efficient manner. We have continually improved our teams’ skills to be able to meet the demands of our customers and the market in order to serve our clients better. One of our most important core values is customer success and we are a strategic partner in helping clients have successful HEDIS seasons. Industry-wide, Cotiviti’s Quality Engine is used to process the most lives annually for HEDIS submission purposes. It’s something we are proud of, and I strongly believe this is a result of hard work done by all our teams. We have the strongest development organization in the industry that consistently delivers a product with the lowest recertification rates and coupling that with our extraordinary service delivery teams creates a best-in-class HEDIS offering for our client base.

By listening to our customers, we have also made great strides in product development. One of the things that we are very proud of this past year, and are continuing to do in 2021, is upgrading our customers to our Quality Reporter Web solution. This will help our clients do a better job with their own abstraction activities, offering real-time reporting of their hybrid measures.

In developing Quality Reporter Web, we worked very closely with our product advisory board, which is really a quorum of select clients who provide feedback, offering us early insights into the development areas and serving as our testing ground for different types of ideas. We have gotten great feedback from clients who have already implemented this new solution. It’s really one of our flagship items that we are very proud of, and it has definitely contributed to the evolution of our product line.

Looking toward the future of quality improvement, what excites you the most?

Quality in and of itself is very regulatory in some ways—health plans have to do it. However, what I find exciting is that health plans are taking on new initiatives not because they have to, but because they want to better feed their other downstream processes.

NCQA is pushing a technology initiative for health plans and quality vendors. This includes the incorporation of FHIR and interoperability, which Cotiviti is excited to tackle. The ability to receive a standard format of measure code in the clinical quality language (CQL) from NCQA is another item that we are eager to implement.

Cotiviti’s Quality Intelligence reduces quality measurement and reporting workflow to its most efficient and effective point, easing the burdens of seasonal HEDIS reporting and enabling year-round quality improvement that significantly improves health plan rankings. Download our fact sheet or reach out to our team at [email protected] to connect with one of our specialists.

Read the fact sheet

About Branka Sustic

Branka Sustic has led the data operations team for Cotiviti’s Quality Intelligence client base since 2016. She has over 18 years of industry experience working with health plans, third-party administrators, self-funded employers, reinsurance companies, and brokers.

HEDIS® is a registered trademark of the National Committee for Quality Assurance (NCQA).

 

Merck takes on Lilly/Nektar in IL-2 with $1.85bn Pandion buy

Merck & Co/MSD has agreed to buy Pandion for $1.85 billion, bolting on a pipeline of drugs for autoimmune and other immunological disorders headed by interleukin-2 (IL-2) based therapy PT-101. 

The $60 per share is a handsome, more than 100% premium on Pandion’s closing share price yesterday, and gives Merck a foothold in the hot area of treating disease by modifying the activity of regulatory T cells, or Tregs.

Pandion’s lead candidate PT101 has completed a phase 1a clinical trial backing its safety and tolerability, and is due to start a phase 1a/2b study in ulcerative colitis and a phase 2 trial in systemic lupus erythematosus before the end of the year.

The first trial showed that it could increase levels of Treg cells thought to be involved in dampening down immune responses.

PT101 is an engineered IL-2 mutein fused to a protein backbone, and is vying to come to market along with other IL-2-based therapies, notably Eli Lilly and Nektar Therapeutics’ phase 2 candidate LY3471851 (also known as NKTR-358).

LY3471851 – a long-acting, pegylated IL-2 formulation – is already in clinical trials for psoriasis, atopic dermatitis and SLE, with studies planned to get underway in ulcerative colitis shortly, according to the clinicaltrials.gov database.

Data from a phase 1b study in patients with mild to moderate SLE reported last November showed that LY3471851 produced a dose-dependent increase in expression of Treg activation markers, backing up its proposed mode of action.

A little further behind in development are other IL-2 candidates including Amgen’s AMG-592, in phase 1/2 trials in SLE and graft versus host disease (GvHD), Roche’s RG 7835, which is in phase 1, and SAR444245 from Sanofi’s Synthorx unit, due to start clinical testing later this year.

Nektar and Bristol-Myers Squibb also have a pegylated IL-2 drug heading for a phase 3 readout, but that candidate – bempegaldesleukin (NKTR-214) – is being developed as a cancer therapy. Nektar and Merck are also working on the combination of NKTR-214 with its Keytruda (pembrolizumab) cancer blockbuster.

There are in fact dozens of companies trying to harness IL-2 to defeat cancer’s ability to avoid surveillance and attack from the immune system, but Pandion is one of a select few that are trying to flip that on its head and try to use the cytokine to protect organs from autoimmune reactions.

Merck’s swoop on four-year-old Pandion comes just a few months after the company listed on the Nasdaq via an upsized IPO that raised $135 million, earmarked for the clinical development of PT101 as well as two PD-1 agonist candidates codenamed PT627 and PT001.

Merck meanwhile has been steadily adding to its immunological disease pipeline in the last few years via a series of acquisitions. That includes deals to buy OncoImmune and its COVID-19 and GvHD candidate CD24Fc and COVID-19 vaccine developer Themis last year, and the $773 million takeover of Tilos Therapeutics in 2019.

The post Merck takes on Lilly/Nektar in IL-2 with $1.85bn Pandion buy appeared first on .

#Healthin2Point00, Episode 187 | Redox, Nanit, Innovacer & MindMed

Today on Health in 2 Point 00, Jess makes me pronounce some impossible words while we cover lots of funding deals. Redox has raised $45 million in a Series D, bringing their total up to $95 million. Nanit, another baby monitoring company, raises $25 million in a Series C, Innovaccer raises a $105 million D round, and psychedelic biotech company MindMed acquires digital health company HealthMode. —Matthew Holt

How Do Patients View Virtual Care?

The digital transformation sweeping through healthcare has had a profound impact on the way consumers expect technology to improve their care experience.
Two surveys from Deloitte, conducted in 2020 and focused on U.S. healthcare consumers, show that patients are more comfortable with technology-enabled services such as virtual care and remote monitoring — but they aren’t always satisfied with the process or the information they receive.
Healthcare organizations must understand patient expectations if they hope to deploy digital experiences in meaningful ways. Such services could range from…

Drug Delivery Devices Symposium

Drug Delivery Devices Symposium
10 March 2021 | GMT (UTC+0)

We have the distinct privilege of unveiling Oxford Global’s Drug Delivery Devices Symposium, taking place on the 10th of March, 2021.

Free Passes Now Available: https://bit.ly/2YoWrId

This one-of-a-kind event brings together global leaders in the Drug Delivery Technology and Medical Devices field for an intensive one-day meeting on the latest updates and innovations for device developers.

✔ Learn about the Latest Advances in Connected Devices and Smart Technologies/AI with Matthew James Clemente, VP of Device Development, Sanofi and Mark Milton-Edwards, Head of Digital Health, Teva Pharmaceuticals

✔ Discuss Combination Product Development & Engineering with leading experts such as Andrew Yum, United Therapeutics and Ning Yu, Biogen

✔ Discuss Regulatory Guidance and Safety for combination products with Mike Wallenstein, Novartis, John Barlow Weiner, FDA and Khaudeja Bano, Amgen

Attendees should not miss out on panel discussions on critical topic areas such as International Perspectives on Regulatory Pathways & Device Design and Engineering.

This event is for professionals working across the drug delivery device industry seeking to broaden their knowledge and engage in interactive discussions with like-minded experts.

For more information visit the website: https://bit.ly/2Ym3IIT

Download the full agenda: https://bit.ly/2M5apg6

#FDDSeries21

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OBGYNs and the Provision of Sexual and Reproductive Health Care: Key Findings from a National Survey

This report highlights key findings from the 2020 KFF National Physician Survey on Reproductive Health that asked a nationally representative sample of OBGYNs practicing in the United States about a wide range of issues, including their provision of contraception, abortion, and STI care.

Survey: OBGYNs Report That the Affordable Care Act Has Increased Use of Contraceptives Among Patients, but the Cost of Reproductive Health Care Still a Burden for Their Low-Income Patients

This report highlights key findings from the 2020 KFF National Physician Survey on Reproductive Health that asked a nationally representative sample of OBGYNs practicing in the United States about a wide range of issues, including their provision of contraception, abortion, and STI care.

Wiping the Sleep From Our Eyes: The Pandemic Plan Trump Ignored

By MIKE MAGEE

When awakening from a long sleep, there is a transition period, when the brain struggles momentarily to become oriented, to “think straight.” When the sleep has extended four years, as with the Trump reign, it takes longer to clear the sleepy lies from your eyes.

We are emerging, but it will take time and guidance. This week President Biden and our First Lady showed us the way. As we together observed the startling passage of a half million dead, many needlessly, from the pandemic, the President gave us a crash course on grief. He compared it to entering a “black hole”, and acknowledged that whether you “held the hand” as your loved one passed on, or were unable (by logistics or regulation) to be there to offer comfort, time would heal. “You have to believe me, honey!”, as he is so prone to say.

As important, we saw the First Lady, without fanfare or concious need for attention, at one moment, draw close to him, as she sensed that he was about to be overcome by his own sadness, and place her hand simply on his back, patting him gently, knowing that this was enough to get him through. She, by then, had done this many times before.

And we saw the Vice President and her husband, across from the first couple, there only for support. This was neither a speaking role or super-ceremonial. It was humble. It was supportive. It was human, and far away from a predecessor who for four years had to fawn, and lie, and grovel to satisfy his Commander-in-Chief.

As these four lead us back to sanity, we as a body politic are fast at work doing three things as once:

1. We are addressing this pandemic with vaccines and good public health processes, and managing our emotional and economic grief and shock.

2. We are beginning to address all the other challenges left unaddressed that demand “good government” whether they be getting kids back to school, or reforming police practice, or turning on the electricity in Houston.

3. We are relearning how to respect the truth, tell the truth, and demand the truth. As Mandela taught the world in 1995, this is not as easy as it sounds. It requires that we reconcile with our past, reform our present, and resolve together to build a better future.

A simple example of these processes at work is addressing the lie that the Obama Administration had never created a pandemic plan, or warned the incoming Trump administration of the threat. This was a false narrative surfaced in May, 2020 by Trump administration officials, and reinforced by David Popp, Majority Leader McConell’s spokesperson, to aid Republican candidates.

Ronald Klain, Obama’s man-in-charge of the Ebola respose (and now Chief of Staff to Biden) then produced the actual plan, and multiple witnesses to the transition. These included  Jeremy Konyndyk, who directed USAID’s Office of U.S. Foreign Disaster Assistance, who said, “They were extensively briefed, to the extent that they paid attention to these things during the transition.” Then there was  Lisa Monaco, former homeland security adviser to President Obama, who affirmed, “We absolutely did leave a plan. It was called a playbook.”

Four days later, White House  press secretary Kayleigh McEnany was forced to acknowledge the existence of the Obama pandemic playbook, but then obfuscated with a discussion of what constituted a “game plan.”

This was a tricky proposition since the Appendix Materials in the 69 page document included: I. Declaration and Mitigation Options, II. Key Department and Agencies: International and Domestic, III. Sample Exercises, IV. Communications, V. Concept of Operations for Domestic Response.

But as we have tragically witnessed, setting the past record straight alone is inadeqaute absent power and control over the levers of government.  It took an election, and 5 dead from an insurrection at our Capitol on January 6th, to reclaim the present, and hopefully alter our future.

As difficult as that was, it leaves the critical third step ahead of us. Those who knowingly lied, who dishonored and spoiled the truth, must accept responsibility, apologize, and be held accountable. As Mandela taught us, this need not be punitive, but must be public, if trust and confidence in our Democracy is to be reestablished. Otherwise, history will repeat.

Mike Magee, MD is a Medical Historian and Health Economist and author of “Code Blue: Inside the Medical Industrial Complex.”

Novel anti-psychotic shows promise in Phase II schizophrenia trial

MRI images of human brain in various orientationsIn a Phase II trial KarXT was shown to significantly reduce the positive and negative symptoms of schizophrenia, compared to placebo, over five weeks.

KarXT is an oral modulator of muscarinic cholinergic receptors. It combines xanomeline, a novel muscarinic agonist, with trospium, a US Food and Drug Administration (FDA)-approved muscarinic antagonist that does not appreciably cross the blood-brain-barrier, to preferentially stimulate muscarinic receptors in the central nervous system. Current treatments in clinic, known as atypicals, primarily target the D2 dopaminergic receptors and serotonin receptors; therefore, if approved for clinical use, this therapy could usher in a new treatment paradigm and dramatically impact patients with schizophrenia and other psychotic disorders.

The results of the double-blind, placebo-controlled, five-week inpatient EMERGENT-1 Phase II trial were published in The New England Journal of Medicine. In the trial, 182 adults with an acute exacerbation of schizophrenia were randomised to receive a twice-daily, flexible-dose of KarXT or placebo.

Treatment with KarXT demonstrated a statistically significant and clinically meaningful 11.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at week five – the primary endpoint of the study. Additionally, the treatment resulted in statistically significant reductions in PANSS positive symptom subscore, PANSS negative symptom subscore, PANSS Marder negative symptom subscore and Clinical Global Impression – Severity frequency counts, compared to placebo. These were four of the trial’s five pre-specified secondary endpoints.

According to investigators, KarXT was generally well-tolerated. They reported similar discontinuation rates between KarXT and placebo arms – 20 percent and 21 percent, respectively. In each arm there was a two percent discontinuation due to treatment-emergent adverse events. The most common adverse events associated with KarXT were mild-to-moderate and not associated with treatment discontinuation, they included constipation, nausea, dry mouth, dyspepsia and vomiting. Rates of nausea, vomiting and dry mouth decreased over the course of the trial, while rates of constipation remained essentially constant. Incidences of somnolence, weight gain and extrapyramidal symptoms, which are common problematic side effects of current antipsychotic therapies, were similar in the placebo and KarXT treatment groups.

Dr Steve Brannan, chief medical officer of Karuna Therapeutics and lead author of the study, commented: “These findings support the potential for KarXT to treat symptoms of psychosis in schizophrenia without producing the common problematic side effects of current therapies, such as weight gain and extrapyramidal symptoms. Given these encouraging results, we have advanced KarXT into Phase III clinical development in our efforts to provide a meaningful, new, non-dopaminergic treatment option for this serious neuropsychiatric disorder affecting more than 21 million people worldwide.”

Dr Jeffrey Lieberman, professor and chairman of the Department of Psychiatry at Columbia University’s College of Physicians and Surgeons, a member of Karuna’s scientific advisory board and co-author of the manuscript, added: “The clinical trial results with KarXT highlight its potential to be a differentiated treatment option with a completely new mechanism of action for people living with schizophrenia, offering relief from acute psychotic symptoms without the debilitating side effects associated with the current standard of care.”

The post Novel anti-psychotic shows promise in Phase II schizophrenia trial appeared first on European Pharmaceutical Review.

New variant-specific mRNA COVID-19 vaccine to enter clinical trials

Vials labelled 'SARS-CoV-2 Coronavirus Vaccine'Moderna has completed manufacturing and shipped the first doses of its variant-specific COVID-19 vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 B.1.351 variant, to the US National Institutes of Health (NIH) for a Phase I clinical trial.

While initial data confirms that the emergency use authorised Moderna COVID-19 Vaccine (mRNA-1273) targeting ancestral strains provides neutralising activity against variants of concern, out of an abundance of caution, Moderna is pursuing two new strategies to combat these variants, subject to U.S. Food and Drug Administration (FDA) review.

The first strategy is to use booster doses of vaccine to increase immunity against the variants. The company plans to evaluate three approaches to boosting, including:

  • A variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant first identified in the Republic of South Africa, at the 50µg dose level and lower.
  • A multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273, Moderna’s authorised vaccine against ancestral strains, and mRNA-1273.351 in a single vaccine at the 50µg dose level and lower.
  • A third dose of mRNA-1273 as a booster, at the 50µg dose level. The company has already begun dosing this cohort with the booster.

Second, the company plans to evaluate mRNA-1273.351 and mRNA-1273.211 as a primary vaccination series for those who are seronegative. These candidates will be evaluated in a two-dose series at the 100µg dose level and lower.

In accordance with the new FDA guidelines, Moderna said it intends to evaluate the immunogenicity and safety in participants who are naïve (have not received a COVID-19 vaccine) as well as participants who previously received the mRNA-1273 vaccine.

The Phase I trial evaluating whether mRNA-1273.351 can boost immunity against variants of concern will be conducted by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). In parallel, the company will be conducting its own clinical studies to support regulatory filings for any booster vaccine or updated primary vaccine.

Stéphane Bancel, Chief Executive Officer of Moderna, commented: “As we seek to defeat COVID-19, we must be vigilant and proactive as new variants of SARS-CoV-2 emerge. Leveraging the flexibility of our mRNA platform, we are moving quickly to test updates to the vaccines that address emerging variants of the virus in the clinic. Moderna is committed to making as many updates to our vaccine as necessary until the pandemic is under control. We hope to demonstrate that booster doses, if necessary, can be done at lower dose levels, which will allow us to provide many more doses to the global community in late 2021 and 2022 if necessary.”

These studies will inform the Company’s regulatory strategy with the US FDA and regulatory agencies outside of the U.S. The current Moderna COVID-19 Vaccine protocol calls for two 100 µg doses.

Increasing manufacturing capacity

Additionally, Moderna announced it is making new capital investments to increase capacity at its owned and partnered manufacturing facilities. In a statement, the company said it expects to increase the global manufacturing capacity to approximately 1.4 billion 100μg doses of its COVID-19 vaccine in 2022. However, said that the 2022 output will depend on the effective dose of the booster and the mix of the authorised COVID-19 vaccine at 100μg versus the dose level authorised for a booster. If the effective dose for a booster is 50μg, then the 2022 supply could be significantly higher than 1.4 billion doses.

The company has already begun adding this capacity at its owned and partnered manufacturing facilities and is increasing its expected 2021 manufacturing from 600 million doses to 700 million doses globally. It is also exploring other approaches to potentially improve throughput and further optimise its operations to potentially deliver up to one billion doses in fiscal year 2021.

To date, the enterprise has shipped approximately 60 million doses globally, including approximately 55 million to the US and roughly four million doses from its ex-US supply chain.

An additional approximately 33 million doses have been produced in the US and are filled in vials and in the final stages of production and testing before release. Moderna expects to complete delivery of the first 100 million doses to the U. Government by the end of the first quarter 2021, the second 100 million doses by the end of May 2021 and the third 100 million doses by the end of July 2021.

The post New variant-specific mRNA COVID-19 vaccine to enter clinical trials appeared first on European Pharmaceutical Review.

ViewPoints Interview: Legend’s Ying Huang Shares Insight on ASH 2020 Data and Initiation of BLA Rolling Submission for Cilta-cel

In an interview with PharmaShots, Ying Huang, Ph.D., CEO and CFO of Legend Biotech shed light on the clinical data following the rolling submission of BLA for Cilta-cel. He also shared insight on Legends’ collaboration with Janssen.

Shots:

  • The submission of BLA was based on results from the P-Ib/II CARTITUDE-1 study of cilta-cel, which were recently presented at the 62nd ASH Meeting
  • The data demonstrated a 97% ORR and 67% stringent CRR, as well as a unique, predictable profile for cytokine release syndrome. The mDOR and PFS still have not been reached in the P-Ib/II data, suggesting a significant durable response
  • Janssen is developing cilta-cel in partnership with Legend Biotech. The FDA previously granted BTD for cilta-cel and has agreed to a rolling review of the application

Tuba:  Discuss the clinical data that follows the rolling submission of the Biologics License Application to the U.S. FDA for cilta-cel.

Ying Huang: The submission was based on results from the Phase 1b/2 CARTITUDE-1 study, which evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapsed and/or refractory multiple myeloma. The latest data from the study presented at the 62nd ASH annual meeting demonstrated a 97 percent overall response rate and 12-month progression-free survival rate of 77 percent at a median follow-up of 12.4 months with a manageable safety profile.

Tuba:  Can we have a glance at your collaboration with Janssen? Also, discuss the deal terms and milestones achieved to date.

Ying Huang: In December 2017, Legend entered an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel.

Legend Biotech received $75M as the fifth milestone payment under its collaboration agreement with Janssen in the clinical development of cilta-cel. Also, the Company recently announced the initiation of a BLA submission for cilta-cel to the FDA for the treatment of relapsed/refractory multiple myeloma.

Tuba:  How do you think the approval of ciltacabtagene autoleucel (cilta-cel) will improve the lives of patients with R/R MM?

Ying Huang: Cilta-cel has the potential to be a transformative treatment option for patients living with R/R MM. Patients with R/R MM have received previous lines of treatment and yet their disease has returned, is non-responsive or is still progressing. Patients who have received prior therapies, including proteasome inhibitors (PIs), immunomodulatory agents (IMiDs) and anti-CD38 therapies, have poor prognoses and few treatment options. Data from the CARTITUDE-1 study showed a very high overall response rate (ORR) that deepened over time, with 97 percent of patients achieving a response and 67 percent of patients achieving a stringent complete response (sCR) at a median follow-up of 12.4 months with a manageable safety profile.

Tuba:  Can you discuss the working of cilta-cel?

Ying Huang: Cilta-cel is a structurally differentiated chimeric antigen receptor T-cell (CAR-T) therapy with two BCMA-targeting single domain antibodies. BCMA is a protein that is highly expressed on myeloma cells. Cilta-cel is delivered in a single intravenous infusion at a target dose of 0.75×106 CAR+ viable T cells/kg.  

Tuba:  When can we expect the launch of the therapy in the U.S.?

Ying Huang: The FDA previously granted Breakthrough Therapy Designation (BTD) for cilta-cel and has agreed to a rolling review of the BLA in which completed portions of the application will be submitted and reviewed on an ongoing basis. Initiation of the BLA submission was announced on December 21, 2020.

Tuba:  After the U.S., which would be the targeted countries for seeking approvals?

Ying Huang: Legend and Janssen are also preparing for regulatory submissions for cilta-cel in the European Union and China. In addition to a U.S. Breakthrough Designation granted in December 2019, cilta-cel received a PRIority MEdicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020.

Tuba:  Briefly discuss Multiple Myeloma. What is the cause and how does it work in the body?

Ying Huang: Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. Although treatment may result in remission, unfortunately, patients will most likely relapse. Relapsed myeloma is when the disease has returned after a period of initial, partial, or complete remission and does not meet the definition of being refractory. Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy. While some patients with multiple myeloma have no symptoms until later stages of the disease, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems, or infections. Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options.

Tuba:  Are you planning to explore the potential of cilta-cel in other indications?

Ying Huang: Cilta-cel is an investigational CAR-T cell therapy being studied in a comprehensive clinical development program with Janssen for the treatment of patients with relapsed/refractory multiple myeloma and in earlier lines of treatment. We are also evaluating the potential for outpatient administration of cilta-cel.

For additional information:

  • CARTITUDE-2: The global, multi-cohort Phase 2 CARTITUDE-2 (MMY2003, NCT04133636) study of cilta-cel is actively recruiting patients with multiple myeloma in various clinical settings. This study is being conducted to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive cilta-cel to further explore efficacy and safety in earlier patient populations.
  • CARTITUDE-4: The global, Phase 3 CARTITUDE-4 (MMY3002, NCT04181827) study of cilta-cel is actively recruiting patients with multiple myeloma who have received 1-3 prior lines of therapy including a PI and IMiD and are refractory to lenalidomide. The study is being conducted to evaluate the efficacy of cilta-cel compared to standard therapies including daratumumab, pomalidomide and low-dose dexamethasone (DPd) or pomalidomide, bortezomib, and low-dose dexamethasone (PVd)

Tuba:  What can you tell us about Legend’s pipeline beyond cilta-cel?

Ying Huang: Legend Biotech is working to explore the potential of cell therapy to treat diseases with high unmet needs, such as hematologic malignancies and solid tumors. We recently announced the Investigational New Drug Application submission for our anti-CD4 CAR-T cell therapy candidate for T-cell lymphoma and have several other early-stage clinical trials underway investigating potential treatments for AML, NHL, MM, and gastric, pancreatic, and ovarian cancers.

Image Source: WebMD 

About Author:

Dr. Ying Huang was named Chief Executive Officer of Legend Biotech on November 6, 2020.  He also has served as Chief Financial Officer since July 2019. He has over 9 years of experience in research and development at major multi-national pharmaceutical companies and 12 years of experience as a biotechnology analyst on Wall Street.

Related Post: ViewPoints Interview: GSK’s Steve Bradford Shares Insight on Benlysta

The post ViewPoints Interview: Legend’s Ying Huang Shares Insight on ASH 2020 Data and Initiation of BLA Rolling Submission for Cilta-cel first appeared on PharmaShots.

Key Takeaways on Organic Food

I’m frequently asked for summaries on many different topics of interest. Your wish is my command. We have topic pages on more than a thousand subjects! Each provides links to many of its related videos and may include a brief summary of the information.

Allow me to highlight some of these pages, starting with one of our most requested topics: organic food. Is it safer and more nutritious? You can learn everything you need to know about organic food on its topic page, which has information on key takeaways and all related videos.

 

New Volume Covers Cultivated Meat, IBD, and Thyroid Function

Vol-53-Download-Artwork (1)My new DVD is out today and available as a streaming video so you can start watching it immediately. You can see the full list of topics here. Eventually, all of these videos will be available online for free over the next few months. If you don’t want to wait for them to roll out, though, you can stream them all right now

If you are a $25+ monthly supporter and opted in to our donor rewards, you’ve already received a complimentary link to the new download, so you’re likely an expert on these new topics by now. If you’d like early access, too, please consider becoming a monthly supporter. Sign up on the donation page to become a $25+ monthly contributor, and, as long as your contributions are current, you’ll get an opportunity to receive the newest downloads for free before they’re available to the public.

And, remember: If you watch the videos on NutritionFacts.org or YouTube, you can access captions in several different languages. To find yours, click on the settings wheel in the lower-right corner of the video and then select “Subtitles/CC.” 
 
 

Upcoming Webinar on Thyroid Function

Thyroid Webinar PromoOne of the most common questions I’m asked is for a natural treatment for Hashimoto’s disease, also known as autoimmune thyroiditis, the leading cause of hypothyroidism. I’m excited to say I found one!

In my upcoming webinar, I will cover the best diet for both hypothyroidism and hyperthyroidism, as well as the healthiest natural source of iodine. All of these videos will eventually be available on NutritionFacts.org over the course of the next year, but you can see them all and get your questions answered by joining me for an hour-long live event on March 5. 

Make a donation of any amount using this form, and we will send you a link to register for the webinar as a donor reward. Our payment processor requires a minimum donation of $5.

Webinar Date & Time: Friday, March 5, 3-4pm ET

(Please note: Registration closes March 3, so don’t delay!)

 

Now Hiring!

We are growing our team with two positions here at NutritionFacts.org: 

  • Web Developer (Full-time)
  • Digital Marketing Assistant (Part-time)

Job descriptions and applications for both can be found on our employment page. Please share these job openings with anyone who would be a good fit!

 

Podcast Available on YouTube 

Podcast announcementMy audio podcast, which comes out every Thursday, is available on most podcast apps, and I’m excited to share that it’s also now on YouTube! Putting the podcast on YouTube not only expands the listening options, but it also gives us the ability to caption them, which we’ve done in both English and Spanish. You can find them on NutritionFacts.org’s YouTube channel

 

 

Top 3 Videos of the Month

 

Why Does Forest Bathing Boost Natural Killer Cell Activity?Why Does Forest Bathing Boost Natural Killer Cell Function?

Can the aroma of wood essential oils replicate the immune-boosting effects of walking in a forest?

 

 

 

Are Beyond Meat and the Impossible Burger Healthy?Are Beyond Meat and the Impossible Burger Healthful?

What happens when you compare the trans fat, saturated fat, sodium, and cholesterol levels in plant-based burgers versus animal-based burgers?

 

 

Plant-Based Protein: Are Pea and Soy Isolates Harmful?Plant-Based Protein: Are Pea and Soy Protein Isolates Harmful?

What are the different impacts of plant protein versus animal protein, and do the benefits of plant proteins translate to plant protein isolates?

 

 

Volunteer Spotlight: George Jacobs 

I get a lot of satisfaction from being a part of the ever-more-mighty NutritionFacts.org team. I do proofreading, which lets me read the latest from the greatest in advance. I enjoy the challenge of trying to live up to the NF team’s high standards.  Steven Litrov, the NF volunteer coordinator, is so efficient and so pleasant to interact with. I always look forward to his next assignment. I also promote the NF team’s work as part of the activism I do, and I’m proud to tell people about my small role in that work.

My favorite food is the No Bread – Peanut Butter and Banana Sandwich. Peel a very ripe banana. Cut it in half length-wise. Spread no-salt, no-sugar, no-added oil peanut butter on one half. Reunite the halves and enjoy! Here’s a video of the process that I made for a European Union project that teaches language and cuisine.

 

Next Live Q&A on February 25

Live Q&AEvery month, I do a live Q&A directly from my treadmill, and Thursday, February 25 is the day.

Join on our Facebook page or YouTube channel at 3pm ET.  I’ll be streaming to both at the same time!

You can find links to past live Q&As here on NutritionFacts.org. If that’s not enough, don’t forget I have an audio podcast to keep you company.

 

In health,
Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live, year-in-review presentations:

Ide-cel provides lasting remissions in multiply-relapsed myeloma

CAR therapiesPhase II trial results published today reveal that idecabtagene vicleucel (ide-cel, bb2121), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell immunotherapy, induced a response in almost three quarters of relapsed and refractory multiple myeloma (RRMM) patients treated and, for some, provided remissions lasting more than two years.

The KarMMa study enrolled 140 participants with active myeloma after receiving at least three previous therapies. These included members of several high-risk subgroups, such as those with high-risk cytogenetics, triple- or penta-refractory disease, high tumour burden at baseline and extramedullary disease.

In the trial, 128 patients were treated with a single dose of ide-cel (different doses were tested in different patients). At a median follow-up of 13.3 months, 73 percent of patients had responded and 33 percent had a complete response or better. The median progression-free survival (PFS) was eight to nine months, but some have reportedly not relapsed more than two years after treatment. The researchers also reported clinically meaningful improvements for median duration of response and overall survival in treated patients across all dose levels and several high-risk subgroups.

According to the investigators, ide-cel outshone standard treatments for RRMM, as the current therapies, including selinexor, panobinostat and isatuximab, have a response rate of 25-30 percent and a PFS of three to four months.

The most common side effects with ide-cel were neutropenia (91 percent), anaemia (70 percent) and thrombocytopenia (63 percent). Cytokine release syndrome was also reported in 84 percent, including seven patients who had events of grade 3 or higher. Neurotoxic effects of developed in 23 patients (18 percent) and were of grade 3 in four participants.

Based on these results, a Biologics License Application (BLA) has been submitted to the US Food and Drug Administration (FDA) for approval of ide-cel as a standard therapy for patients with relapsed or treatment-resistant myeloma. A decision on the application is expected by the end of March 2021.

The success of ide-cel in patients who had undergone several previous treatments has also prompted investigators to launch trials of the therapy in patients in earlier stages of the disease.

“Despite the progress made in the treatment of multiple myeloma over the past decade, long-term disease-free survival is uncommon and relapses are inevitable. Currently, the patients who have progressed through the three main classes of therapy [immunomodulatory drugs, proteasome inhibitors and anti-CD38 antibodies] do not have very effective therapeutic options and their outcomes are often poor,” said Dr Nikhil Munshi, lead author of the study and Associate Director of The Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute, US. “The deep and durable responses observed in a large majority of patients in the KarMMa study published today in The New England Journal of Medicine demonstrate the potential of ide-cel to address a high unmet need for patients with heavily pre-treated and highly refractory multiple myeloma.”

Ide-cel is being developed by Bluebird bio and Bristol Myer-Squibb.

The post Ide-cel provides lasting remissions in multiply-relapsed myeloma appeared first on European Pharmaceutical Review.

Intra-Cellular Reports the Expansion of Pipeline with the Addition of ITI-1284

Shots:

  • Following the completion of a P-I program, the company plans to initiate P- II studies to evaluate ITI-1284 ODT-SL for the treatment of behavioral disturbances in dementia, dementia-related psychosis and certain depressive disorders in the elderly
  • The P-I single and multiple ascending dose studies in healthy volunteers including elderly subjects aged >65yrs. evaluated the safety, tolerability and PK of ITI-1284 and reported no SAEs in either age group
  • TI-1284 is a deuterated form of lumateperone, delivered sublingually as an ODT-SL and offer pharmacologic benefits and ease of use for patients, particularly in elderly populations

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: The Science of Parkinson’s

The post Intra-Cellular Reports the Expansion of Pipeline with the Addition of ITI-1284 first appeared on PharmaShots.

FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac™

Close up photo of adult female deer tick crawling on piece of strawThe US Food and Drug Administration (FDA) has granted Priority Review to Pfizer’s Biologics License Application (BLA) for TicoVac™, a vaccine for active immunisation against tick-borne encephalitis (TBE) in individuals aged one year and older. If approved, TicoVac would be the first vaccine in the US to help protect adults and children who are visiting or living in TBE endemic areas.

Under the Priority Review designation pathway, the FDA will target an action within six months of the application submission date, therefore the Prescription Drug User Fee Act (PDUFA) action is anticipated for August 2021.

TBE is a viral infection of the brain and spine transmitted via the bite of an infected tick. Whit not endemic in the US, thus far, ticks infected with the TBE virus have been identified in more than 35 countries across Europe and Asia. In a third of cases TBE can have long-term effects that last months or years including cognitive changes, muscle weakness or permanent paralysis. On rare occasions it may also cause death. As a result, the European Centre for Disease Prevention and Control (ECDC) currently recommends TBE vaccination for people who live in or are traveling to these risk areas.

“For many years, our TBE vaccine has helped protect millions of people in Europe from this potentially serious disease. We are proud that today’s US FDA Priority Review acceptance acknowledges the potential value that our vaccine candidate can bring,” commented Dr Nanette Cocero, Global President of Vaccines at Pfizer Inc. “If approved in the US, we hope this vaccine will help protect those traveling to or residing temporarily in at-risk locations, potentially including military personnel who are serving overseas.”

The BLA includes more than 40 years of evidence from outside the US. In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (one to 15 years of age and 16 to 65 years of age). In these studies, pooled seropositivity rates were 99-100 percent in one to 15 year olds and 94-99 percent in adults >15 years following three doses. Subsequent real-world studies have shown that the vaccine is 96-99 percent effective in people who have received at least two doses of the vaccine and that two to three doses of the vaccine are sufficient for a long-lasting immune memory.

In the trials the inactivated whole virus vaccine was well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed.

The post FDA grants Priority Review to Pfizer’s tick-borne encephalitis vaccine TicoVac<sup>™</sup> appeared first on European Pharmaceutical Review.

Beam makes USD 120M bet; GRAIL and Quest announce the collaboration; Brain organoids mimic infant’s brains; Improvement in T cells to kill cancer

Beam adds to drug delivery stable with USD 120 Million GuideTx buy

Beam Therapeutics has taken over a startup whose technology could proffer the biotech’s genetic medicines to more tissues in the body, widening the potential to approach more diseases.

Beam announced that it paid USD 120 million upfront to acquire Guide Therapeutics in an all-stock agreement.

The gene-editing technologies, which have reached the clinic, CRISPR, zinc finger nucleases, and TALENs, make their edits by nicking DNA at the target site. Cambridge, Massachusetts-based Beam aims to make more precise edits with genetic medicines, which employ base-editing. Instead of snipping the genome, base editing lets for edits of individual letters in a genetic sequence.

Beam employs three approaches to deliver its genetic medicines to cells. Electroporation is used for ex vivo delivery of therapies to blood and immune cells. The company’s in vivo therapies reach the eye and central nervous system via adeno-associated viruses, while its liver therapies employ lipid nanoparticles (LNPs).

GuideTx will aid Beam in developing LNP-based medicines. The startup spun out of Georgia Tech in 2018 and is based on James Dahlman’s research, a professor in the university’s department of biomedical engineering and school of medicine. The GuideTx technology screens for lipid nanoparticles inside the body that can be used to deliver RNA to cells throughout the body. 

GRAIL and Quest collaborate for the cancer blood test

Cancer detection company GRAIL has announced a collaboration with Quest Diagnostics that sees Quest proffering phlebotomy services to bolster GRAIL’s multi-cancer early detection blood test Galleri™.

Quest runs 2,200 patient service centers and recruits 5,000 mobile phlebotomists who have experience and expertise in offering phlebotomy services for at-home visits. Through this pact with GRAIL, Quest’s phlebotomy network will benefit the Galleri test in blood specimen collection throughout the U.S. once Galleri becomes accessible in the second quarter of 2021. Earlier, the prescription-only blood test will only be available through partner health systems, medical practices, and self-insured employers.

Dr. Joshua Ofman, GRAIL’s chief medical officer and head of external affairs, said in a statement that the majority of cancers go undetected until too late when outcomes are often deadly, and they believe Galleri could offer a unique and potentially life-saving solution by finding multiple types of cancers earlier. Working with Quest will help them support convenient access to blood collection for patients and healthcare providers.

A study published in Cancer Epidemiology, Biomarkers & Prevention last year, December, estimated that the annual use of Galleri, among other multi-cancer early detection blood tests, could decrease late-stage cancer diagnoses by more than 50% in people aged 50 to 79 in the U.S. The study hints that this reduction could translate to a 39% reduction in five-year cancer deaths for patients who had their cancer detected earlier. Overall, this could result in a 26% overall reduction in all five-year cancer deaths.

Brain organoids grown in the lab mimic infant’s brains

A new study from UCLA and Stanford University researchers observes that three-dimensional human stem cell-derived brain organoids can mature in a strikingly similar way to human brain development.

The senior authors, Dr. Daniel Geschwind of UCLA and Dr. Sergiu Pasca of Stanford University, conducted an extensive genetic analysis of organoids grown for up to 20 months in a lab dish per the new study, which was published in Nature Neuroscience. They discovered that these 3D organoids follow an internal clock that controls their maturation in sync with the human development timeline.

Human brain organoids are developed using induced pluripotent stem cells, aka iPS cells derived from skin or blood cells, which have been reprogrammed back to an embryonic stem cell-like state, enabling scientists to develop any cell type.

These iPS cells are then subjected to a specialized mix of chemicals, which influences them to develop a certain brain region. With time and the appropriate conditions, the cells self-organize to develop 3D structures that faithfully replicate various human brain development aspects.

Human stem cell-derived organoids have the potential to transform the practice of medicine by conferring researchers unprecedented insights into how complex organs, including the brain, develop and respond to disease.

Increasing the immune system’s T cells to enhance cancer-destroying capabilities

Combining immuno-oncology treatments such as checkpoint inhibitors with other cancer-killing drugs is considered a remarkable strategy for enhancing the response rate to immunotherapy. A team of Canadian researchers is suggesting a new combination strategy for enhancing the response of the immune system’s T cells to immuno-oncology drugs, and it comprises epigenetics.

A team led by the Princess Margaret Cancer Centre in Toronto found that chemotherapy drugs known as DNA hypomethylating agents directly influenced the anti-tumor response of a specific type of T cell in samples from patients with several tumor types. Two genes were activated to improve the T cells’ ability to eradicate cancer cells, as reported in the journal Molecular Cell.

DNA hypomethylating agents are epigenetic drugs that eliminate specific chemical tags on DNA, hence turning specific genes on and off and changing the cells’ function.

The researchers had previously discovered that when mouse tumors were treated with epigenetic drugs, there was an increase in T cells infiltrating cancer. If they eliminated the T cells, the therapy stopped working.

They decided to evaluate the phenomenon further using samples from healthy people and patients with melanoma and breast, ovarian, or colon cancer. Again they discovered that DNA hypomethylating agents improved the ability of T cells to eliminate cancer.

The post Beam makes USD 120M bet; GRAIL and Quest announce the collaboration; Brain organoids mimic infant’s brains; Improvement in T cells to kill cancer appeared first on DelveInsight Business Research.

Otsuka, Click trial digital depression therapy with Google

Otsuka and Click Therapeutics are working with Verily, the healthcare subsidiary of Google owners Alphabet, on a fully remote clinical trial testing a digital therapy as an add-on in adults with severe depression.

Otsuka is on a mission to develop digital technology to treat mental illness and broke new ground by marketed Abilify Mycite (aripiprazole) a “digital pill” for schizophrenia with Proteus Therapeutics that failed to capture the imagination of payers in the US and proved to be a commercial flop.

That project, which used an ingestible sensor to track whether patients had taken doses of the medication, ended with the demise of Proteus.

After buying what was left of Proteus in a fire-sale last year, Otsuka is continuing its digital odyssey with a new approach, adding both digital technology and a remote clinical trial.

The pivotal, randomised, controlled trial will enrol up to 540 US patients with Major Depressive Disorder.

Trial participation will be 10 weeks and efficacy will be evaluated as a change from baseline using a standard score.

Otsuka and digital health firm Click will collaborate with Verily, a subsidiary of Alphabet, to run the completely remote trial.

Verily will provide electronic trial tools and technology to engage patients and clinicians, in order to increase the pace of studies and collect comprehensive data in a more naturalistic setting.

The collaboration also enables the trial to proceed efficiently and safely during the COVID-19 pandemic.

Otsuka and Click have been working together since 2019 to develop and market prescription digital therapeutics.

Click is developing its own suite of digital therapies and is also working with Germany’s Boehringer Ingelheim on a digital therapy for schizophrenia in a partnership worth up to $500 million.

That deal, signed in September, is based around a digital therapeutic (DTx) app called CT-155.

The companies hope CT-155 will be prescribed either as a standalone treatment or in combination with pharmaceuticals.

The post Otsuka, Click trial digital depression therapy with Google appeared first on .

Qiagen Expand its Collaboration with Inovio to Develop Liquid Biopsy Based CDx for VGX-3100 to Treat Advanced Cervical Dysplasia

Shots:

  • The companies collaborated to develop liquid biopsy-based CDx based on NGS technology to complement Inovio’s therapies. The collaboration initially focuses on the co-development of a diagnostic test that identifies women who are most likely to benefit from VGX-3100
  • QIAGEN’s bioinformatic expertise will raise the predictive biomarker power in Inovio’s patient selection. The assay will now be developed for use on the Illumina NextSeq 550Dx platform
  • VGX-3100 is a late-stage DNA immunotherapy, currently in two P-III trials (REVEAL 1 & 2) and has the potential to become the first non-surgical treatment for advanced pre-cancerous cervical lesions associated with the virus

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: NBC 7 San Diego

The post Qiagen Expand its Collaboration with Inovio to Develop Liquid Biopsy Based CDx for VGX-3100 to Treat Advanced Cervical Dysplasia first appeared on PharmaShots.

Switch data back Chiesi/Protalix long-acting Fabry drug

Chiesi and Protalix have built the case for their long-acting enzyme replacement therapy (ERT) for Fabry disease PRX-102, as the FDA’s review of the drug continues towards a decision due by 27 April. 

New data from the phase 3 BRIGHT study of PRX-102 (pegunigalsidase alfa) shows that patients can be switched to the new drug from their current ERT – either Takeda’s Replagal (agalsidase alfa) or Sanofi Genzyme’s Fabrazyme (agalsidase beta) – with no safety issues and continued disease control.

PRX-102 is a chemically modified version of alpha galactosidase, the enzyme that is deficient in people with Fabry disease, which may require less frequent infusions than existing ERTs.

Earlier this month Chiesi and Protalix reported results from another trial called BRIDGE which showed a decrease in patients with moderately or fast progressing kidney disease following the switch from Replagal.

With currently available ERTs, some patients can continue to lose kidney function despite ongoing treatment, according to the partners.

The readout comes ahead of Rare Disease Day on Sunday, an event that places a spotlight on the 7,000 or so rare diseases, the majority of which have no or limited treatments available, according to Giacomo Chiesi, head of Chiesi’s recently formed Global Rare Diseases unit.

It’s an annual reminder of the challenges and unmet needs in the rare disease community, he told pharmaphorum, adding that Chiesi is however “committed to patients and families every single day. We continue to let the patient voice shape who we are as a company and make patients the centre of everything we do.”

The 30-patient BRIGHT data demonstrated that PRX-102 was able to maintain control of Fabry disease with an infusion delivered every four weeks, rather than dosing every two weeks with Fabrazyme and Replagal.

All told, 80% of the patients have now been treated with this less frequent treatment regimen for more than two years with the efficacy maintained, according to the partners, and no new patients have developed antibodies against the drug – a perennial concern with ERT and something that can reduce its effectiveness.

Chiesi told pharmaphorum that the data reinforces the view that PRX-102 could be “an effective and important treatment option for Fabry patients”. Final results from the study are due before the end of the year.

The current marketing application for the drug in the US is for two-weekly dosing, but Chiesi and Protalix hope that can be extended once the full BRIGHT dataset is in. Meanwhile a third study – called BALANCE – is pitting PRX-102 head-to-head against Fabrazyme to see if it can maintain kidney function more effectively.

Among the new drug’s potential benefits are “improved control over the course of the disease, increased bioavailability, reduced immunogenicity to therapy, reduced infusion time, lower risk of infusion reactions, reduced need for premedication before infusion, and an improved dosing schedule with an at-home dosing option,” said Chiesi.

PRX-102 would compete against Fabrazyme and Amicus Therapeutics’ Galafold (migalastat) if approved by the FDA, as Takeda does not sell Replagal in the US market.

The post Switch data back Chiesi/Protalix long-acting Fabry drug appeared first on .

Building a better future for people with rare diseases in all four UK nations

How has rare disease care changed over the last few years? And what might we expect from the next five? We attended the Rare Disease Day Virtual Parliamentary Event to find out.

The rare disease community has a golden opportunity to transform the way care is delivered across all four UK nations – that’s according to speakers at a parliamentary reception held to mark 2021’s Rare Disease Day.

Chaired by the Genetic Alliance, the virtual meeting saw representatives from Scotland, England, Wales, and Northern Ireland discuss the implementation of the UK Government’s Rare Disease Framework.

Published in January, the document replaces 2013’s UK Strategy for Rare Diseases and sets out four priorities for the next five years: faster diagnosis, increasing awareness among healthcare professionals, the better coordination of care, and improving access to specialist care, treatments, and drugs.

Nick Meade, director of policy at Genetic Alliance UK, said the framework, based on a survey of more than 6,000 people with rare diseases, their families, advocates, and healthcare professionals, represented an opportunity.

“The challenge now is to get the most out of this opportunity. The framework is a UK-wide commitment from the four nations to make progress on these priorities. The detail remains to be written,” he said, explaining that all four nations would now develop their own action plans for the implementation of the framework.

“We need action plans to be comprehensive and ambitious. We want to see measurable commitments because we need to be able to see progress being made.”

“We need action plans to be comprehensive and ambitious. We want to see measurable commitments because we need to be able to see progress being made.”

Scotland

Mairi Gougeon MSP, minister for public health, sport and wellbeing in Scotland said the country had seen “great advances” in the diagnosis, treatment, and care of rare disease since adopting the UK Strategy for Rare Diseases in 2013.

The Congenital Anomalies and Rare Diseases Registration and Information Service for Scotland (CARDRISS) is in the process of establishing a register of all babies affected by a major structural or chromosomal anomaly, or recognised syndrome, for example.

Although it is not yet complete the dataset is already informing the planning of services. In the future, Gourgeon went on, the data will help NHS Scotland to understand the impact of antenatal screening and to better support research.

“The Scottish Government has supported the transition of genomic testing for inherited rare disease from the research setting into routine care,” she went on.

“As a result of that investment, more families have been able to get the right genetic test and receive an often-long-awaited diagnosis, enabling them to get the support and the treatment they need.”

In terms of next steps, Gougeon said Scotland would establish a Rare Disease Framework Implementation Board to “help oversee” the action plan, which will “take account of the population needs and health systems that we have here in Scotland”.

The board, which will work closely with patient organisations, will hold a series of virtual patient engagement workshops over the summer, she said.

England

In building their action plans, said minister for innovation Lord Bethell of Romford, teams will strive to use digital tools and data technology, while also striving to maximise collaboration and ensure the patient voice is always heard.

“Beyond the framework we are also currently developing proposals for an innovative medicines fund,” said Lord Bethell, describing it as an extension of the Cancer Drugs Fund.

“It will enable doctors to use highly advanced, life-saving treatments for a range of conditions while NICE, which sets NHS clinical guidelines, will continue to review methods so that the guidance can keep pace with developments.”

On genomics, he added, the country is going “further and faster”, and ensuring synergy between the Rare Disease Framework and the UK Genomic Healthcare Strategy.

“We now know that 80% of rare diseases have a genetic origin. Genomic technology, therefore, has a key role to play in our work,” he said.

“The NHS genomic medicine service, launched in 2018, is leading the drive for more personalised treatment, making genomic sequencing a routine part of diagnosis and treatment, and giving all patients the chance to participate in research.

“When fully rolled out the NHS will be the only integrated healthcare system in the world to routinely offer whole genome sequencing. That is a remarkable feat and I’m extremely proud of it.”

Wales

The framework is about giving people with rare diseases a fair and level playing field, said Angela Burns MS, chair of Wales’ CPG on Rare, Genetic and Undiagnosed Conditions.

“Our role is to ensure that those living with a rare disease or an unknown syndrome have a voice, that their voice is heard, and that we raise the bar in ensuring equitable and fair treatment,” she said.

Burns added that a CPG repot had highlighted several priorities for people with rare diseases, including mental health, access to medicines, and the impact of COVID-19. These, she said, would help inform Wales’ action plan.

Dr Graham Shortland, chair of the country’s Rare Diseases Implementation Group, said his team had achieved much since its inception in 2013. Projects have focused on access to medicines, newborn screening and research, he said.

“We are continuing to work with the Welsh government, and we would very much like to see funding for a ‘syndrome without a name’ (SWAN) clinic. I’m seeing lots of good practice with specialist centres being set up, but there is a danger of fragmentation,” he said, adding that a “detailed proposal” was currently being considered by the government.

“It has been strengthened hugely by the Genetic Alliance securing funding from the charitable sector for a SWAN co-ordinator in Wales. We need to push forward on that and confirm the process and timescales by which Wales will develop and publish the action plan.”

Northern Ireland

Rare Diseases Day is an opportunity to “pause and reflect on the achievements” of the rare disease strategy, before “setting our sights” on the framework, said Robin Swann, minister of health.

Northern Ireland’s participation in the 100,000 Genomes Project has been very successful, he said. “Firstly, we recruited patients from all five of our health trusts and sequenced around 1,700 samples from patients and relatives. So far, we have returned a diagnosis to over 50 families who would otherwise not have had one.”

The country has also improved access to new medicines by introducing clinically-led, regional scrutiny committees to the individual patient request process. This enables rapid assessment and decision making for requests that fall outside commissioned services, including off-label treatment.

Swann also spoke about Northern Ireland’s health IT infrastructure replacement project, which will “empower patients through an enhanced and fully integrated electronic healthcare record”.

In turn, he went on, the new infrastructure will facilitate the “long overdue development” of a Northern Ireland Rare Disease and Cogenetic Anomaly Register.

Education and awareness have also been high on the team’s priority list, said Swann.

“We know one of the main challenges is the basic lack of awareness, and the frustration this can cause when people have to repeat their story at every step.

“Therefore, we have started to develop rare disease teaching sessions for our undergraduate medical, nursing, and biomedical university curriculum,” he said.

About the author

Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.

The post Building a better future for people with rare diseases in all four UK nations appeared first on .

AbbVie’s Humira (adalimumab) Receives the US FDA’s Approval to Treat Pediatric Patients with Ulcerative Colitis

Shots:

  • The approval is based on P-III ENVISION I study that involves assessing Humira (SC) vs PBO in pediatric patients aged 4-17yrs. with mod. to sev. UC
  • The study demonstrated that 60% of patients taking the higher dosage achieved clinical remission per PMS @8wks induction period and 45% of patients who responded @8wks, achieved remission per FMS @52wks.
  • Humira is the 1st and only SC biologic treatment option for pediatric patients with the mod. to sev. active UC. The approval marks the 11 indication in the US which includes 5 approval in pediatric populations

Click here ­to­ read full press release/ article | Ref: Abbvie | Image: Abbvie

The post AbbVie’s Humira (adalimumab) Receives the US FDA’s Approval to Treat Pediatric Patients with Ulcerative Colitis first appeared on PharmaShots.

Workplace challenges and risk factors call for new approaches in MSDs prevention

© EU-OSHA / Zahare Astrida

25/02/2021
The prevalence of musculoskeletal disorders (MSDs) remains high among EU workers due to a combination of elements. These include the impact of changing ways of working, an ageing workforce, and psychosocial factors. New approaches to prevention can…See more

Rare disease insights from the patient community

To help pharma companies understand what life is really like for patients with a rare disease, a new resource has been released to coincide with Rare Disease Day 2021.

A series of stakeholder interviews have been collected in a new video from Bedrock Healthcare Communications and Origins Insights that explores the underappreciated challenges of living with a rare disease.

As part of this it asks the question: Are we looking at rare diseases in the wrong way?

“We believe it’s critical that these voices are heard to raise awareness of this incredible community,” the creators of the video say. “We started our conversations with ‘what one thing…?’ and the answers provided us with a story of challenge, hope for the future and community.”

Interviewees share how their conditions impact their lives, what misconceptions they face and what they want to see from the future of research and treatment.

In addition to the patients who provide their perspectives, the video also hears from a range of other stakeholders, including the Cambridge Rare Disease Network, the Nova Scotia Fabry Disease Program, CRISPR Therapeutics and Kyowa Kirin.

For pharmaceutical firms working on new orphan drugs the video will bring new insights to feed into their efforts to improve the lives of people with a rare disease and their carers.

While rare can mean unusual, uncommon and unfamiliar, for those living with a rare disease this couldn’t be further from the truth. One in 17 people will be affected by a rare disease at some point in their life – that’s more than 350 million people across the world.

Consequently, there is a pressing need for healthcare systems, life science companies and the general public to start looking at these conditions in a different way.

The observations that Bedrock and Origins have gathered from people in the rare disease community into a video that aims to raise awareness of and understanding of authentic patient experiences.

Watch video Rare disease insights from the patient community

 

About Bedrock

 

 

Bedrock is a privately-owned communications and healthcare experience research agency group that utilises an absolute audience focus to provide creative solutions for client’s communication needs. Consisting of two separate companies, Bedrock Healthcare Communications and Origins Insights, Bedrock Group has grown from a small UK based start-up consultancy in 2011, to an award-winning leading player in health experience research, international strategic medical communications and creative medical education in 2019.

The post Rare disease insights from the patient community appeared first on .

Covid Vaccine Websites Violate Disability Laws, Create Inequity for the Blind

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Many covid vaccination registration and information websites at the federal, state and local levels violate disability rights laws, hindering the ability of blind people to sign up for a potentially lifesaving vaccine, a KHN investigation has found.

Across the country, people who use special software to make the web accessible have been unable to sign up for the vaccines or obtain vital information about covid-19 because many government websites lack required accessibility features. At least 7.6 million people in the U.S. over age 16 have a visual disability.

WebAIM, a nonprofit web accessibility organization, checked covid vaccine websites gathered by KHN from all 50 states and the District of Columbia. On Jan. 27, it found accessibility issues on nearly all of 94 webpages, which included general vaccine information, lists of vaccine providers and registration forms.

In at least seven states, blind residents said they were unable to register for the vaccine through their state or local governments without help. Phone alternatives, when available, have been beset with their own issues, such as long hold times and not being available at all hours like websites.

Even the federal Centers for Disease Control and Prevention’s Vaccine Administration Management System, which a small number of states and counties opted to use after its rocky rollout, has been inaccessible for blind users.

Those problems violate the Rehabilitation Act of 1973, which established the right to communications in an accessible format, multiple legal experts and disability advocates said. The federal Americans with Disabilities Act, a civil rights law that prohibits governments and private businesses from discriminating based on disability, further enshrined this protection in 1990.

Doris Ray, 72, who is blind and has a significant hearing impairment, ran into such issues when she tried to sign up for a vaccine last month with the CDC’s system, used by Arlington County in Virginia. As the outreach director for the ENDependence Center of Northern Virginia, an advocacy center run by and for people with disabilities, she had qualified for the vaccine because of her in-person work with clients.

When she used screen-reading technology, which reads a website’s text aloud, the drop-down field to identify her county did not work. She was unable to register for over two weeks, until a colleague helped her.

“This is outrageous in the time of a public health emergency, that blind people aren’t able to access something to get vaccinated,” Ray said.

Mark Riccobono, president of the National Federation of the Blind, wrote to the U.S. Health and Human Services Department in early December, laying out his concerns on vaccine accessibility.

“A national emergency does not exempt federal, state, and local governments from providing equal access,” he wrote.

Dr. Robert Redfield, who was then leading the CDC, responded that the interim vaccine playbook for health departments included a reminder of the legal requirements for accessible information.

CDC spokesperson Jasmine Reed said in an email that VAMS is compliant with federal accessibility laws and that the agency requires testing of its services.

But more than two months into a national vaccine campaign, those on the ground report problems at all levels.

Some local officials who use VAMS are aware of the ongoing problems and blame the federal government. Arlington Assistant County Manager Bryna Helfer said that because VAMS is run by the federal government the county cannot access the internal workings to troubleshoot the system for blind residents.

Connecticut Department of Public Health spokesperson Maura Fitzgerald said the state was aware of “many accessibility issues” with VAMS. She said it had staffed up its call center to handle the problems and was working with the federal government “to improve VAMS and enable the functionality that was promised.”

Deanna O’Brien, president of the National Federation of the Blind of New Hampshire, said she had heard from blind people unable to use the system. New Hampshire’s health department did not answer KHN questions about the problems.

Blind people are particularly vulnerable to contracting the covid virus because they often cannot physically distance themselves from others.

“When I go to the grocery store, I do not have the option of walking around and not being near a person,” said Albert Elia, a blind attorney who works with the San Francisco-based TRE Legal Practice on accessibility cases. “I need a person at the store to assist me in shopping.”

There is no standardized way to register for a covid vaccine nationwide — or fix the online accessibility problems. Some states use VAMS; some states have centralized online vaccination registration sites; others have a mix of state-run and locally run websites, or leave it all to local health departments or hospitals. Ultimately, state and local governments are responsible for making their vaccination systems accessible, whether they use the VAMS system or not.

“Once those portals open, it’s a race to see who can click the fastest,” Riccobono said. “We don’t have time to do things like file a lawsuit, because, at the end of the day, we need to fix it today.”

Common programming failures that make sites hard to use for the visually impaired included text without enough contrast to distinguish words from the page’s background and images without alternative text explaining what they showed, the WebAIM survey showed. Even worse, portions of the forms on 19 states’ pages were built so that screen readers couldn’t decipher what information a user should enter on search bars or vaccine registration forms.

The new vaccine pages had more errors than states’ main coronavirus pages but slightly fewer than state government websites in general, said WebAIM Associate Director Jared Smith.

In Alameda County, California, when Bryan Bashin, 65, who is blind and CEO of the LightHouse for the Blind and Visually Impaired in San Francisco, tried to sign up on Feb. 9 for his vaccine appointment, he encountered multiple hurdles. The appointments slipped away. That night he received an email from the city of Berkeley offering vaccinations. But after two hours struggling with its inaccessible website, all the slots were again taken, he said in an email.

He was only able to get an appointment after his sighted sister signed him up and has since received his first shot.

“It’s an awful bit of discrimination, one as stinging as anything I’ve experienced,” Bashin said.

Susan Jones, a blind 69-year-old in Indianapolis, had to rely on the Aira app, which allows a sighted person to operate her computer remotely, when she tried to register for her vaccine appointment.

“I resent that the assumption is that a sighted fairy godmother ought to be there at all times,” said Sheela Gunn-Cushman, a 49-year-old also in Alameda County, who also had to rely on Aira to complete preregistration for a vaccine.

Emily Creasy, 23, a visually impaired woman in Polk County, Oregon, said she tried unsuccessfully for a month to make the scheduling apparatus work with her screen reader. She finally received her first shot after her mother and roommate helped her.

Even Sachin Dev Pavithran, 43, who is blind and executive director of the U.S. Access Board, an independent agency of the federal government that works to increase accessibility, said he struggled to access vaccine registration information in Logan, Utah.

The Indiana Health Department, Public Health Division of Berkeley and Oregon’s Polk County Public Health did not respond to requests for comment. Utah’s Bear River Health Department did not answer questions on the issue.

After Alameda County received complaints from users that its site was not compatible with screen readers, officials decided to move away from its preregistration technology, Health Department spokesperson Neetu Balram said in mid-February. The county has since switched to a new form.

If vaccine accessibility issues are not fixed across the country, though, lawsuits could come next, Elia said. Members of the blind community recently won landmark lawsuits against Domino’s Pizza and the Winn-Dixie grocery chain after being unable to order online.

And, Elia said, “this is not ordering a pizza — this is being able to get a potentially lifesaving vaccine.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Have a Case of a Covid Variant? No One Is Going to Tell You


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Covid-19 infections from variant strains are quickly spreading across the U.S., but there’s one big problem: Lab officials say they can’t tell patients or their doctors whether someone has been infected by a variant.

Federal rules around who can be told about the variant cases are so confusing that public health officials may merely know the county where a case has emerged but can’t do the kind of investigation and deliver the notifications needed to slow the spread, according to Janet Hamilton, executive director of the Council of State and Territorial Epidemiologists.

“It could be associated with a person in a high-risk congregate setting or it might not be, but without patient information, we don’t know what we don’t know,” Hamilton said. The group has asked federal officials to waive the rules. “Time is ticking.”

The problem is that the tests in question for detecting variants have not been approved as a diagnostic tool either by the Food and Drug Administration or under federal rules governing university labs ― meaning that the testing being used right now for genomic sequencing is being done as high-level lab research with no communication back to patients and their doctors.

Amid limited testing to identify different strains, more than 1,900 cases of three key variants have been detected in 46 states, according to the Centers for Disease Control and Prevention. That’s worrisome because of early reports that some may spread faster, prove deadlier or potentially thwart existing treatments and vaccines.

Officials representing public health labs and epidemiologists have warned the federal government that limiting information about the variants ― in accordance with arcane regulations governing clinical labs ― could hamper efforts to investigate pressing questions about the variants.

The Association of Public Health Laboratories and the Council of State and Territorial Epidemiologists earlier this month jointly pressed federal officials to “urgently” relax certain rules that apply to clinical labs.

Washington state officials detected the first case of the variant discovered in South Africa this week, but the infected person didn’t provide a good phone number and could not be contacted about the positive result. Even if health officials do track down the patient, “legally we can’t” tell him or her about the variant because the test is not yet federally approved, Teresa McCallion, a spokesperson for the state department of health, said in an email.

“However, we are actively looking into what we can do,” she said.

Lab testing experts describe the situation as a Catch-22: Scientists need enough case data to make sure their genome-sequencing tests, which are used to detect variants, are accurate. But while they wait for results to come in and undergo thorough reviews, variant cases are surging. The lag reminds some of the situation a year ago. Amid regulatory missteps, approval for a covid-19 diagnostic test was delayed while the virus spread undetected.

The limitations also put lab professionals and epidemiologists in a bind as public health officials attempt to trace contacts of those infected with more contagious strains, said Scott Becker, CEO of the Association of Public Health Laboratories. “You want to be able to tell [patients] a variant was detected,” he said.

Complying with the lab rules “is not feasible in the timeline that a rapidly evolving virus and responsive public health system requires,” the organizations wrote.

Hamilton also said telling patients they have a novel strain could be another tool to encourage cooperation ― which is waning ― with efforts to trace and sample their contacts. She said notifications might also further encourage patients to take the advice to remain isolated seriously.

“Can our investigations be better if we can disclose that information to the patient?” she said. “I think the answer is yes.”

Public health experts have predicted that the B117 variant, first found in the United Kingdom, could be the predominant variant strain of the coronavirus in the U.S. by March.

As of Tuesday, the CDC had identified nearly 1,900 cases of the B117 variant in 45 states; 46 cases of B1351, which was first identified in South Africa, in 14 states; and five cases of the P.1 variant initially detected in Brazil in four states, Dr. Rochelle Walensky, the CDC director, told reporters Wednesday.

A Feb. 12 memo from North Carolina public health officials to clinicians stated that because genome sequencing at the CDC is done for surveillance purposes and is not an approved test under the Clinical Laboratory Improvement Amendments program ― which is overseen by the U.S. Centers for Medicare & Medicaid Services ― “results from sequencing will not be communicated back to the provider.”

Earlier this week, the topic came up in Illinois as well. Notifying patients that they are positive for a covid variant is “not allowed currently” because the test is not CLIA-approved, said Judy Kauerauf, section chief of the Illinois Department of Public Health communicable disease program, according to a record obtained by the Documenting COVID-19 project of Columbia University’s Brown Institute for Media Innovation.

The CDC has scaled up its genomic sequencing in recent weeks, with Walensky saying the agency was conducting it on only 400 samples weekly when she began as director compared with more than 9,000 samples the week of Feb. 20.

The Biden administration has committed nearly $200 million to expand the federal government’s genomic sequencing capacity in hopes it will be able to test 25,000 samples per week.

“We’ll identify covid variants sooner and better target our efforts to stop the spread. We’re quickly infusing targeted resources here because the time is critical when it comes to these fast-moving variants,” Carole Johnson, testing coordinator for President Joe Biden’s covid-19 response team, said on a call with reporters this month.

Hospitals get high-level information about whether a sample submitted for sequencing tested positive for a variant, said Dr. Nick Gilpin, director of infection prevention at Beaumont Health in Michigan, where 210 cases of the B117 variant have been detected. Yet patients and their doctors will remain in the dark about who exactly was infected.

“It’s relevant from a systems-based perspective,” Gilpin said. “If we have a bunch of B117 in my backyard, that’s going to make me think a little differently about how we do business.”

It’s the same in Washington state, McCallion said. Health officials may share general numbers, such as 14 out of 16 outbreak specimens at a facility were identified as B117 ― but not who those 14 patients were.

There are arguments for and against notifying patients. On one hand, being infected with a variant won’t affect patient care, public health officials and clinicians say. And individuals who test positive would still be advised to take the same precautions of isolation, mask-wearing and hand-washing regardless of which strain they carried.

“There wouldn’t be any difference in medical treatment whether they have the variant,” said Mark Pandori, director of the Nevada State Public Health Laboratory. However, he added that “in a public health emergency it’s really important for doctors to know this information.”

Pandori estimated there may be only 10 or 20 labs in the U.S. capable of validating their laboratory-based variant tests. One of them doing so is the lab at the University of Washington in Seattle.

Dr. Alex Greninger, assistant director of the clinical virology laboratories there, who co-created one of the first tests to detect SARS-CoV-2, said his lab began work to validate the sequencing tests last fall.

Within the next few weeks, he said, he anticipates having a federally authorized test for whole-genome sequencing of covid. “So all the issues you note on notifying patients and using [the] results will not be a problem,” he said in an email.

Companies including San Diego-based Illumina have approved covid-testing machines that can also detect a variant. However, since the add-on sequencing capability wasn’t specifically approved by the FDA, the results can be shared with public health officials ― but not patients and their doctors, said Dr. Phil Febbo, Illumina’s chief medical officer.

He said they haven’t asked the FDA for further approval but could if variants start to pose greater concern, like escaping vaccine protection.

“I think right now there’s no need for individuals to know their strains,” he said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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With GOP Back at Helm, Montana Renews Push to Sniff Out Welfare Fraud

Montana is considering becoming the latest state to intensify its hunt for welfare overpayments and fraud, a move expected to remove more than 1,500 enrollees from low-income health coverage at a time when the pandemic has left more people needing help.

With Republicans now controlling both chambers of the Montana legislature and the governor’s office, a lawmaker is reviving an effort to both broaden and increase the frequency of eligibility checks to search for welfare fraud, waste and abuse. Proponents say it’s about what’s fair — weeding out people who don’t qualify, protecting safety nets for those who do, and saving the state millions. But advocates for low-income people who rely on such services and some policy analysts say such changes would unfairly drop eligible people who need the aid.

“We’re not looking to do anything mean. We’re taking the emotion out of it,” state Sen. Cary Smith, a Republican, said during a Jan. 20 hearing on his bill, the Provide for the Welfare Fraud Prevention Act. “If you don’t qualify, then you shouldn’t be participating in that program.”

The Montana bill, and measures underway in Ohio and Utah, are similar to earlier efforts undertaken to cut costs in states such as Illinois and Michigan. But this year’s bills come even as Congress offers states more Medicaid dollars if they ensure people have continuous coverage through the pandemic because of its economic shock waves.

The Montana proposal would create a system potentially run by third-party vendors that would mine a large swath of data to see if someone, for example, has assets like a boat, has won the lottery or has filed for benefits in another state. The vendor could earn a bonus for flagging more cases than the state projected. State employees would have the final say in cutting someone from Medicaid, the Children’s Health Insurance Program, food stamps or other aid programs.

The state estimates the measure could save Montana’s treasury between $1.4 million and $2.3 million each year over the next four years by dropping more than 1,500 people on Medicaid and 277 children covered by CHIP.

This isn’t Smith’s first effort to create such a law. He sponsored a similar bill in 2015 that was vetoed by the state’s then-governor, Democrat Steve Bullock. In the veto letter, Bullock said the measure duplicated steps the state already took and unfairly stigmatized Montanans who are poor. Opponents of Smith’s latest proposal have repeated those concerns. Smith didn’t respond to several requests for an interview.

But this time, the potential legislation has a clearer path. The state has a new governor, Greg Gianforte, a Republican who called for heightened Medicaid eligibility checks throughout his 2020 campaign.

During Montana’s first hearing for the renewed effort, Scott Centorino of Opportunities Solutions Project was the sole person to testify in support of the bill.

“I’ve seen this play out in state after state,” Centorino said. “Turns out, the less you look for welfare, fraud and waste, the less you find.”

Opportunity Solutions Project, the lobbying wing of the Foundation for Government Accountability, a right-leaning think tank, has backed similar efforts elsewhere that followed FGA model legislation. The organizations have also been major forces in trying to link food assistance to work requirements and block states from expanding Medicaid.

Opportunity Solutions Project’s attempts to influence laws at the federal level, too, appear to be growing. The nonprofit spent $25,500 lobbying the federal government in 2017 and $420,000 last year, according to the Center for Responsive Politics.

Opponents of the Montana bill have said the focus on welfare recipients is misplaced. Nationally, most Medicaid payments deemed improper last year were tied to states not collecting information that federal standards already call for, not necessarily for covering ineligible enrollees, according to a U.S. Department of Health and Human Services financial report.

Michele Gilman, a University of Baltimore law professor, said the potential bonus Montana would pay a company finding more savings than expected is especially concerning.

“The goal should not be to create some bounty hunter system to find alleged cheats that don’t exist,” Gilman said. “This is built on an unfounded mistrust of poor people and undermines public support for social programs.”

If states do move to undertake broad data searches, she said, they need to start with a pilot program to test for errors in its design. Gilman called Michigan the ultimate cautionary tale. The state, which had used a new computer program to spot cheaters, ended up mired in lawsuits after it falsely charged thousands with unemployment fraud between 2013 and 2015.

The Trump administration and federal agencies encouraged states to increase eligibility checks. According to a KFF analysis, as of January 2019 more than half of states were conducting checks more often than during annual renewals, with some doing so quarterly. (KHN is an editorially independent program of KFF.)

Robin Rudowitz, co-director of KFF’s Program on Medicaid and the Uninsured, said Medicaid and CHIP enrollment dropped across the nation from late 2017 through 2019. Rudowitz said it’s hard to untangle all the reasons the enrollment declines occurred, but increased verification efforts that add to administrative hurdles create barriers to coverage.

Jennifer Wagner, with the left-leaning Center on Budget and Policy Priorities, said people may not realize they’re still eligible when notified that their benefits are in question or may not even receive the notice. She said a search for benefits filed in a separate state may flag aid that can cross states, such as food stamps, and such searches can pull up property someone no longer owns. Frequent wage checks may not take into account inconsistent jobs. The onus would fall to the aid recipient to prove they are still eligible in each scenario, she said.

One state that Opportunity Solutions Project points to as a success is Illinois, which in 2012 hired a company to identify Medicaid recipients who might not be eligible. Wagner, who was an associate director with the Illinois Department of Human Services at the time of the change, said Illinois is unique because the state knew it had a backlog of status checks. Within a year, Illinois had canceled benefits for nearly 150,000 people. But the state reported that more than 75% of cancellations were due to clients’ failure to respond to a state letter asking for more information. Wagner said similar issues have occurred in other states.

“In many cases, those individuals remain eligible, but they have a gap in coverage and they have to reapply and do what they can to get back on the program,” said Wagner. “There’s a large cohort of people who never get that done.”

Of all the people Illinois dropped, nearly 20% had reenrolled by the end of the year. That issue — people getting knocked off when they’re eligible — already happens in annual renewals. But Wagner said more checks means more people losing benefits, and more work for states to bring those people back onboard.

Centorino, with Opportunity Solutions Project, said systems that remove qualified people aren’t being implemented properly, but added it’s not too heavy of a lift to respond to an eligibility question.

“The alternative is not is not resolving the discrepancy at all and just assuming that there is no discrepancy and continuing to fund benefits for somebody who may be ineligible,” he said.

In Montana, even with the bill’s clearer shot at becoming law, some elements that opponents criticized were rolled back after the state estimated it would need to hire 42 employees to run the new system. Smith reduced how many programs would fall under its scrutiny and pulled back eligibility checks to twice a year instead of quarterly. He removed a rule that the system pay for itself, and he cut a section that would have disenrolled people who don’t respond to eligibility questions or notices within 10 business days.

Nonetheless, if a new system flags issues in people’s enrollment, the state will have to go out searching for why. The bill is under consideration in the Senate and must also pass the House before it goes to Gianforte for signing.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Pfizer files tick-borne encephalitis shot with FDA

Pfizer may have been making headlines with the COVID vaccine it developed with BioNTech, but it’s not the only infectious disease the big pharma is targeting.

In a statement, Pfizer said the FDA has granted a fast review for TicoVac tick-borne encephalitis (TBE) vaccine, to prevent the disease in individuals one year of age or older.

If approved TicoVac would be the first shot to help protect adults and children who are visiting or living in areas where TBE is endemic.

The FDA has granted a Priority Review, where the regulator aims to make a decision within six months instead of the standard 10 month period.

Pfizer anticipates a decision in August this year.

TBE is a viral infection of the brain and spine, which is transmitted to humans through the bite of an infected tick.

Ticks infected with the TBE virus have been identified in more than 35 countries across Europe and Asia.

The European Centre for Disease Prevention and Control (ECDC) currently recommends TBE vaccination for people who live in or are travelling to these risk areas.

Already marketed in Europe under the brand names TicoVac and FSME-Immun, the shot is based around an inactivated whole virus vaccine.

It was developed using a master “seed” virus that is similar to the TBE virus found in nature but does not cause symptoms.

The vaccine causes the body to make neutralising antibodies against the natural TBE virus as it looks almost identical biologically to the one that causes the disease.

Pfizer said the vaccine helps provide protection against all known strains of the TBE virus in both children and adults, including European, Siberian and Far Eastern subtypes.

The filing is based on clinical trial evidence showing 99-100% of 1-15 years olds and 84-99% of adults produced antibodies following three doses.

Clinical studies showed TicoVac was well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed.

Real-world studies have shown that the vaccine is 96-99% effective in people who have received at least two doses of the vaccine and two to three doses of the vaccine were shown to be sufficient to provide a long-lasting immune memory.

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COVAX vaccine-sharing scheme delivers first COVID shots to Ghana

The first deliveries of vaccines from the World Health Organization-backed COVAX initiative, which aims to ensure access in low income countries,  has arrived.

A shipment of 600,000 doses of the AstraZeneca/Oxford University vaccine to Accra in Ghana is seen as milestone for a scheme.

It aims to address the imbalance that has seen the world’s high income nations snap up the first approved vaccines.

COVAX is co-led by the global vaccine alliance Gavi and is the vaccines pillar of the global Access to COVID-19 Tools (ACT) Accelerator. Along with Gavi it is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO with support from UNICEF.

The programme plans to deliver about two billion vaccine doses globally by the end of the year.

Aside from AstraZeneca, Novavax is a major partner in the scheme and has agreed to supply 1.1 billion COVID shots to the scheme.

Ghana, which has a population of more than 30 million was chosen to receive the first free vaccines under the scheme after promising quick distribution.

Doses being sent to low-income countries such as Ghana are funded by donations.

COVAX procures and delivers the jabs and works with countries to support vaccination schemes.

While many high income countries have been criticised for buying or ordering more than they need, they did so before they knew whether the vaccines would work in trials.

This could lead to a surplus in some countries and the UK has already promises to donate most of its surplus vaccine supply to low income countries after ordering more than 400 million shots – more than enough to cover its population of nearly 67 million.

In a joint statement, WHO and UNICEF said: “After a year of disruptions due to the COVID-19 pandemic, with more than 80,700 Ghanaians getting infected with the virus and over 580 lost lives, the path to recovery for the people of Ghana can finally begin.

“This is a momentous occasion, as the arrival of the COVID-19 vaccines into Ghana is critical in bringing the pandemic to an end.

“The only way out of this crisis is to ensure that vaccinations are available for all.

“We thank all partners that are supporting the COVAX Facility to deliver safe and effective COVID-19 vaccines to all countries quickly and fairly.”

Feature image courtesy of Francis Kokoroco/COVAX

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Roche Report Results of Evrysdi (risdiplam) in FIREFISH Study for Infants with Type 1 SMA

Shots:

  • Roche has reported the data from the dose-finding Part 1 of the FIREFISH study assessing Evrysdi in patients aged 1-7mos. with Type 1 SMA. Part 1 evaluated several doses of Evrysdi and determined the therapeutic dose of 0.2 mg/kg for Part 2
  • Part 1 data demonstrated that 99% of infants survive without permanent ventilation @12 mos. & 33% sit without support for at least 5sec. In an exploratory analysis, 41% received high dose, 53% achieved upright head control, and 6% were able to stand as assessed by the HINE-2., 86% were able to feed orally
  • The researcher also assessed motor function with CHOP-INTEND & demonstrated that 52% achieved a CHOP-INTEND score of ≥40 points

Click here ­to­ read full press release/ article | Ref: Roche | Image: Forbes

The post Roche Report Results of Evrysdi (risdiplam) in FIREFISH Study for Infants with Type 1 SMA first appeared on PharmaShots.

FDA reviewer backs J&J COVID jab for emergency OK

Johnson & Johnson’s one-shot coronavirus vaccine is due to be reviewed by an FDA advisory committee on Friday, and according to the regulator meets the requirements for emergency use authorisation.

In a briefing document published ahead of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, the FDA says the Ad26.COV2.S vaccine – developed by J&J’s Janssen Biotech unit – is “consistent” with recommendations in its EUA guidance for COVID-19 vaccines.

According to the document, clinical trials filed to support the EUA show that Ad26.COV2.S (JNJ-78436735) was 66.9% effective at preventing COVID-19 14 days after dosing, and 66.1% effective 28 days later, with “no specific safety concerns identified that would preclude issuance of an EUA.”

The safety of the vaccine was consistent across patients of different age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection.

The FDA also says that the clinical data show that Ad26.COV2.S is 85% effective at preventing severe COVID-19 at 28 days, and retained good activity against some emerging strains including the South African and Brazilian variants which are more transmissible.

Although it has been shown to be less effective against these, the FDA analysis puts its efficacy at preventing moderate or severe COVID-19 at 64% for the South African variant, which is higher than the 57% reported by the company in a recent analysis.

It also notes interesting if preliminary data on asymptomatic infections at 29 days, pointing to a 66% efficacy, although that should be “interpreted with caution”, according to the agency, and the early signs are that it is protective in people aged over 60.

If the EUA is granted, Ad26.COV2.S will be the third shot cleared for use in the US after the Pfizer/BioNTech and Moderna mRNA-based vaccines.

While its top-line efficacy is lower than the 90%-plus for the first two vaccines, expectations are high for J&J’s candidate because it only requires one dose rather than two, so limited supplies will be stretched further.

Moreover, it only needs regular refrigeration temperatures to remain stable, so will be easier to distribute than the mRNA jabs that need to be stored at very low temperatures.

Last year, the US ordered 100 million doses of the Janssen vaccine, with an option for a further 200 million doses, and the company has agreed to supply them at cost as the federal government contributed $1 billion towards its development.

J&J says it has 4 million doses of the vaccine ready to ship if and when the EUA comes three, and should have 20 million ready by the end of March.

At last count, 65 million doses of the Pfizer/BioNTech and Moderna vaccines doses have been administered in the US, with the daily average now running at more than 1.2 million. Almost 14% of the population has now received one dose, and 6% have had two.

The post FDA reviewer backs J&J COVID jab for emergency OK appeared first on .

Novavax nears COVID-19 vaccine game changer–After years of failure

Novavax nears COVID-19 vaccine game changer–After years of failure

cbaker_admin
Thu, 02/25/2021 – 03:00

As it rebounds from the brink of insolvency, Novavax’s future hinges on the success of its COVID-19 vaccine. Scientists are bullish on the prospects, given that the company’s approach is similar to that of other proven vaccines. Findings from late-stage U.S. trials may not be ready for another month, but preliminary data suggest the product could be a game-changer. Not only would it possibly offer longer-lasting protection against the virus than other vaccines, but it could be the first to prevent asymptomatic transmissions. Moreover, the Novavax vaccine works without super-cold storage, making it appealing for pharmacies, clinics, and hospitals that do not have freezer capacity. The company is also reformulating the vaccine for better efficacy against new mutations of coronavirus that are emerging. If it wins FDA authorization, producing and distributing large amounts of product will likely prove a challenge for the company, which was forced to unload some manufacturing assets for cash in 2019. However, it estimates that it could produce a couple billion doses over the next year, starting this spring.

FDA to release review of J&J’s single-dose vaccine

FDA to release review of J&J’s single-dose vaccine

cbaker_admin
Thu, 02/25/2021 – 03:00

FDA is set to release Wednesday its comprehensive analysis of Johnson & Johnson’s COVID-19 vaccine ahead of an advisory committee’s review for emergency use authorization on Friday. The agency has been reviewing data from a late-stage trial that found the vaccine was overall 66% effective in protecting people from COVID-19 and 85% effective against severe disease, according to J&J. On Friday, a panel of outside medical experts will evaluate the analyses from both FDA and the company. The advisory committee is expected to recommend authorization of the J&J vaccine, and FDA is expected to make its decision soon after. J&J has said that if approved, it would deliver some 20 million doses to the United States by the end of March, which could help ease the frustration of people who have been unable to sign up for vaccination due to a lack of available doses. Whereas the Pfizer-BioNTech and Moderna vaccines each require two doses, the J&J vaccine only requires one dose. The late-stage study of the J&J vaccine involved more than 43,000 volunteers in a number of countries. The vaccine was 72% effective in the United States alone, but just 57% effective in South Africa alone, where a new and more transmissible variant of the virus is spreading.

Schools may see a burst of the common cold when they reopen, research suggests

Schools may see a burst of the common cold when they reopen, research suggests

cbaker_admin
Thu, 02/25/2021 – 03:00

After Hong Kong reopened schools in October, large numbers of children became ill, despite mask mandates and other measures to reduce the spread of the novel coronavirus. The children were infected with rhinoviruses, which are associated with the common cold. Researchers believe the surge in illness was a consequence of children congregating after several months of social distancing, making them more vulnerable to respiratory viruses. The children likely had fewer exposures to people outside their households and as a result fewer chances to contract them and build up immunity. The findings are published in Emerging Infectious Diseases. Ben Cowling, a professor of infectious diseases epidemiology at the University of Hong Kong and the report’s senior author, says: “I can imagine places where schools have been closed for a long time are going to have the same experience as Hong Kong. That when the schools go back there’s suddenly going to be a lot of rhinoviruses going around, a lot of kids getting sick with colds, and then their parents getting it off them and then panicking that it could be COVID.” In all, there were 482 rhinovirus outbreaks reported by schools over about a 1 month period from late October to late November. Most outbreaks occurred in primary schools, kindergartens, nursery schools, and child care centers. The authors noted that a similar phenomenon had been observed by UK researchers, who reported a notable increase in rhinovirus infections in adults starting about 2 weeks after children returned to school in the United Kingdom last September.

Researchers halt trials of promising sickle cell treatment

Researchers halt trials of promising sickle cell treatment

cbaker_admin
Thu, 02/25/2021 – 03:00

Bluebird Bio, which developed a new gene therapy for sickle cell disease, has halted its trial for the treatment after two patients contracted cancer. The company reported that a patient who was treated 5.5 years ago developed myelodysplastic syndrome, which is often a precursor to leukemia, while another has developed acute myeloid leukemia. It is unclear if the cancers are related to the experimental gene therapy. It is possible that the disabled virus used to deliver the gene therapy treatment damaged the DNA in blood-forming cells in the patients’ bone marrows. That would be the worst-case scenario, says John F. Tisdale, MD, head of the cellular and molecular therapeutics branch at the National Heart, Lung and Blood Institute of NIH. The cause of both cancers could also potentially be a drug called busulfan, which is used to clear bone marrow to make space for new cells modified by gene therapy. Busulfan is known to confer a blood cancer risk, Tisdale notes. Bluebird is conducting an analysis to determine whether the gene inserted into the patients’ DNA ended up near a gene associated with the new cancers. If that is not the case, busulfan may be the likely suspect. A further complication is that people with sickle cell disease are known to have an increased risk of leukemia.

Headaches, fatigue among most common vaccine adverse effects, latest CDC report finds

Headaches, fatigue among most common vaccine adverse effects, latest CDC report finds

cbaker_admin
Thu, 02/25/2021 – 03:00

A recent study in CDC’s Morbidity and Mortality Weekly Report revealed that headache, fatigue, and dizziness were the most commonly reported adverse effects among people receiving the COVID-19 vaccine. Researchers analyzed safety data from December 14 to January 13. During that period, the first and second doses of the Pfizer-BioNTech COVID-19 vaccine were administered, in addition to the first doses of the Moderna vaccine. CDC used data from the Vaccine Adverse Event Reporting System (VAERS) and v-safe, a text message system CDC developed to track COVID-19 safety. Among more than 13.9 million doses administered during the first month of the nationwide COVID-19 vaccination program, 6,994 adverse events were reported to VAERS. Of those, 90.8% were deemed nonserious, while 9.2% were serious. Women represented nearly 78% of adverse event reports. There were 62 confirmed cases of anaphylaxis, while the most frequently reported adverse effects were headache, fatigue, and dizziness, followed by chills and nausea. Data from v-safe indicated that reactions occurred more often following the second dose of the Pfizer vaccine compared with the first, with the reported rate of fever and chills more than four times higher. A total of 113 deaths were reported during the analysis period, including 78 among individuals staying at long-term care facilities. CDC said, “Counseling vaccine recipients to expect transient local and systemic reactions might ease concerns and encourage competition of the 2-dose vaccination series.”

Pharmacists say ‘pooling’ COVID vaccines could save thousands of doses

Pharmacists say ‘pooling’ COVID vaccines could save thousands of doses

cbaker_admin
Thu, 02/25/2021 – 03:00

With demand for COVID-19 vaccination outstripping supply, pharmacists say “pooling” product would allow thousands more Americans to get immunized each week. The longstanding practice entails combining the remnants of multiple drug vials to create a full dose, and pharmacists have applied this methodology to everything from influenza vaccines to antibiotics. “It doesn’t look like a lot at the bottom of the bottle,” admits Stephen Jones, MD, CEO of Inova Health System in Falls Church, VA. “But ultimately, in aggregate, that adds up to a lot of doses that end up being wasted.” An informal experiment by Inova pharmacists illustrated how the pooling strategy could help. They presented 100 vials, all of which contained residual COVID-19 vaccine. Eighty of the vials held significant leftover amounts. The pharmacists found that putting them together created another 40 full doses. In the context of a typical vaccination day, when the hospital administers more than 4,000 doses, that would mean protecting 400 more people using the same supply. While pooling is a simple and effective solution, FDA rules prohibit it. Any extra vaccine, the regulator stipulates, must be discarded for infection-control purposes. The agency explains that Moderna’s and Pfizer’s vaccines do not contain preservatives, which help halt microbial growth in the event the vaccine becomes tainted with bacteria or other germs. Pharmacy experts counter that the benefits easily eclipse the risks.

To make more COVID-19 vaccines, rival drugmakers team up

To make more COVID-19 vaccines, rival drugmakers team up

cbaker_admin
Thu, 02/25/2021 – 03:00

The global demand for COVID-19 vaccines is spurring competitors to cooperate in manufacturing them. Starting in June, Sanofi will perform fill-finish for Pfizer and its partner BioNTech to make 125 million doses. Thomas Triomphe, Sanofi’s executive vice president for vaccines, says the company has 6 months before giving priority to its own COVID-19 vaccine. Sanofi had to purchase machines to accommodate Pfizer’s vials in addition to freezers to store vaccines at subzero temperatures. Sanofi also said Monday it would assist with fill-finish for Johnson & Johnson’s vaccine. Meanwhile, Novartis agreed to do fill-finishing work for Pfizer and BioNTech, and Novartis’ plant in Switzerland is expected to deliver doses as early as July, according to Steffen Lang, who oversees Novartis’ manufacturing and supply operations. Lang says the company is making adjustments to its plant’s production line, hiring more employees, and shifting production of other products to accommodate the work. Baxter International and Endo International have also agreed to help Novavax produce its vaccine. These collaborations could help significantly boost global output. In the United States, the companies are supplying enough doses in February to vaccinate 20 million people, but output is predicted to increase to 65 million people in June, according to analysts from Evercore ISI.

Walgreens launches partnership with Instacart in Illinois

Walgreens launches partnership with Instacart in Illinois

cbaker_admin
Thu, 02/25/2021 – 03:00

Walgreens has launched a partnership with Instacart in Illinois. It aims to introduce the service nationwide to nearly 8,000 of its stores in coming weeks. Under the agreement, consumers will be able to order from Walgreens with delivery through Instacart OTC medications and health, wellness, beauty, personal care, and household products, with more items to be added over time. Prescription medications will not be available. Walgreens also has delivery partnerships with DoorDash and Postmates.

CVS builds on community-based strategy to address COVID-19 vaccine education and equity

CVS builds on community-based strategy to address COVID-19 vaccine education and equity

cbaker_admin
Thu, 02/25/2021 – 03:00

CVS Health recently unveiled a community-based strategy to address potential inequities related to COVID-19 vaccine access in vulnerable communities. There are nearly 10,000 CVS Pharmacy locations nationwide, with almost one-half located in communities ranked high or very high by the CDC Social Vulnerability Index. Karen Lynch, president and CEO, CVS Health, noted: “Our presence in communities across the country uniquely positions CVS Health to educate vulnerable populations and connect them with vaccine administration services.” Last week, select CVS Pharmacy locations in 11 states began offering COVID-19 vaccinations to eligible populations as part of the federal pharmacy partnership program. As more supply becomes available, the company will continue to prioritize these measures as it expands to additional states while increasing the number of stores offering vaccinations. In areas where COVID-19 vaccines are currently available at CVS Pharmacy locations, the company is working to help ensure Black and Hispanic patients have equitable access to appointments. CVS Health will reach out to CVS Pharmacy patients, Aetna members, and CVS Caremark members in vulnerable communities to help them make an appointment and to answer questions or concerns they may have about being vaccinated. CVS will also use mobile vaccination vans and launch community-based clinics in March and April, working closely with nonprofit groups to distribute the vaccine. Additionally, CVS Health will conduct outreach to patients in vulnerable communities with text messages and emails featuring messages from pharmacists to encourage vaccination and address hesitancy. CVS Health has also joined the Ad Council’s COVID-19 Vaccine Education Initiative as a founding partner. This extensive communications effort will educate the public about the importance of, and work to build confidence in, COVID-19 vaccines with the goal of increasing vaccination uptake.

Biden to order sweeping review of U.S. supply chain weak spots

Biden to order sweeping review of U.S. supply chain weak spots

cbaker_admin
Thu, 02/25/2021 – 03:00

President Biden plans to sign on Wednesday an executive order calling for a 100-day government review of potential vulnerabilities in the U.S. supply chain for critical materials, including medical gear, computer chips, and rare-earth minerals. The executive order comes as U.S. auto makers deal with a severe shortage of semiconductors but is also aimed at avoiding a repeat of the personal protective equipment shortages that were so prevalent last year. The directive will set in motion comprehensive studies of the supply needs of the defense, public health, information technology, transportation, energy, and food production sectors.

COVID vaccine makers to Congress: Expect steady rise in US supply

COVID vaccine makers to Congress: Expect steady rise in US supply

cbaker_admin
Thu, 02/25/2021 – 03:00

Speaking before a House Energy and Commerce Subcommittee on Tuesday, pharmaceutical executives told lawmakers that the United States could potentially have surplus COVID-19 vaccines later this year as production increases and new vaccines seek emergency clearances. The investigations and oversight panel called executives from five companies as witnesses: Johnson & Johnson, AstraZeneca, Novavax, Pfizer, and Moderna. Stephen Hoge, MD, president of Moderna, said: “We have doubled our monthly deliveries since late 2020, and we are aiming to double them again by April to more than 40 million doses per month.” John Young, chief business officer for Pfizer, said: “We anticipate all 300 million contracted doses will be made available for shipment by the end of July, enabling the vaccination of up to 150 million Americans.” Johnson & Johnson executives gave best-case projections for their COVID-19 vaccines, saying it has doses ready to ship quickly if FDA clears its vaccine for emergency use. Novavax executives similarly told the House subcommittee that it would be ready to deliver 110 million doses included in its current agreements with the federal government later this year, if it secures FDA’s clearance.

Assessment of coverage in England of cancer drugs qualifying for US FDA accelerated approval

Assessment of coverage in England of cancer drugs qualifying for US FDA accelerated approval

cbaker_admin
Thu, 02/25/2021 – 03:00

A retrospective cohort study examined whether cancer drugs that win accelerated approval in the United States also typically receive regulatory sanction in England. FDA grants this designation to certain medications that have not met the criteria typically required for traditional approval, but it was unclear whether the U.K.-based National Institute for Health and Care Excellence (NICE) usually recommends these same medications for coverage by the National Health Service (NHS) despite the lack of supporting data. The researchers scrutinized cancer drug indication pairs that won FDA accelerated approval from December 1992 through May 2017, comparing them with the same set of drug indication pairs in England through August 2019. During the study period, 42 drug indications out of 93 receiving FDA accelerated approval were not routinely available through the NHS. The overseas regulator did not review 30 of the drug indications and rejected the remaining 12 due to insufficient evidence of safety, efficacy, and cost efficiency. Another six were withdrawn from the U.S. market. When it did back products receiving FDA accelerated approval, NHS generally did so only after negotiating additional price concessions, requiring further data collection, or limiting drug indications to specific patient populations. The discordance between the two countries on the evaluation of cancer drugs contrasts with a highly concordant relationship between FDA and the European Medicines Agency on these drugs.

Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids

Shots:

  • The companies collaborated to develop improved tissue-selective AAV vectors to realize effective gene therapy treatments for multiple life-threatening disorders
  • The focus of this agreement is to develop new and modified AAV capsids that exhibit a safe product profile with improved specificity and higher gene delivery efficiency
  • The collaboration comes two years after Sirion signed a similar pact with Denali Therapeutics, with other partners including Acucela and Orchard Therapeutics

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

The post Sanofi Collaborates with Sirion to Develop Gene Therapy Treatment with Improved AAV Capsids first appeared on PharmaShots.

THCB Gang Episode 44, Thursday Feb 25, 1pm PT – 4pm ET

This weeks THCB Gang will be held live on Thurs Feb 24 at 1pm PT -4pm ET.

Joining me, Matthew Holt (@boltyboy), will be consultant/author Rosemarie Day @Rosemarie_Day1),  Suntra Modern Recovery CEO JL Neptune (@JeanLucNeptune), and health futurist Jeff Goldsmith (@JeffcGoldsmith). We will also have a special guest who is possibly the most successful corporate venture capitalist in health tech–Merck’s Bill Taranto. He had a decent run last year — you may have heard of Livongo which he was a big investor in! We’ll look forward to talking with Bill about the future of investing, the drug business and what he’s expecting in the big health care realignment. He may decide to give us a cut of all those winnings (or he may not!)

You can see the video below live and the audio will be on our podcast channel (Apple/Spotify) from Friday

Zydus Cadila- Walk-In Interviews for Freshers & Experienced On 26th & 27th Feb’ 2021

Zydus Cadila- Walk-In Interviews for Freshers & Experienced On 26th & 27th Feb’ 2021

Job Description

We are Recruiting “All Women Team” for our Moraiya Unit.

For OSD Production & Packing, We seek applications for the following positions.

Apprentice / Operator/ Technical Assistant

ITI/ Diploma/ B.Sc having 0-6 years of experience to operate production machines of Dispensing, Granulation, Compression, Coating and Packing.

Apprentice/ Officer/ Executive

B.Pharm with 0-4 years of experience in supervising OSD manufacturing areas like Dispensing, Granulation, Compression, Coating and Packing area.

Position: OSD Production & Packing,
Qualification: B.Pharm, ITI / B.Sc/ Diploma
Experience: 0-05 years
Openings: NA
Salary: NA
Location: Ahmedabad

Time And Venue Details: Walk-In Interview On 26th & 27th Feb’ 2021 from 9:00 AM onwards at Zydus cadila, Sarkhej – bavla NH No 8A, Moraiya, Near Modern Denims Dist: Ahmedabad 382210

Candidates who can’t come to attend interview can share their CV on [email protected]

Zydus Cadila- Walk-In Interviews for Freshers & Experienced On 26th & 27th Feb’ 2021

UCB Collaborates with Microsoft to Accelerate Drug Discovery and Development

Shots:

  • The collaboration will merge Microsoft’s computational services, cloud and AI with UCB’s drug discovery and development capabilities
  • The companies intend to discover and develop medicines for people living with severe diseases in immunology and neurology. The collaboration follows UCB and Microsoft’s collaboration around COVID-19
  • Microsoft will provide AI technology and applied scientists to work alongside UCB’s scientist and data specialist that will allow UCB to discover new correlations and patterns critical to find new and highly individualized medicines

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

The post UCB Collaborates with Microsoft to Accelerate Drug Discovery and Development first appeared on PharmaShots.

Alrosa Pharma

Alrosa Pharma Address : SCF-289, 1st Floor Motor Market Manimajra Chandigarh   Alrosa Pharmaceuticals is one of the best renowned and well-established pcd pharma company in Chandigarh Pharma PCD Company | PCD Pharma Franchise Company| PCD Franchise products | Pharma … Continue reading

The post Alrosa Pharma appeared first on Pharmafranchiseeidia.

WeylChem

WeylChem Group of Companies is the fine chemicals platform of International Chemicals Investors Group.
Posted in US

These 7 Technical SEO Problems Can Cripple Your Website’s Visibility on Google

Technical SEO mistakes can throttle the effectiveness of your healthcare website and its visibility on Google. What’s more, technical missteps can often invisibly impair the health of your entire website, not just a few pages.

Computer will illustrated rocked ship taking of with the words SEO underneath

Over the years, we’ve conducted hundreds if not thousands of technical SEO audits and in-depth analyses. We’ve observed many commonalities among healthcare websites, and today we’ll be sharing seven of the most common SEO mistakes we see.

Understanding these mistakes will help you address these problems and put out severe website fires.

To get a better sense of what’s going on behind the scenes of healthcare websites today, I spoke to our Senior SEO specialist Naghmeh Jafarzadeh.

Naghmeh performs our in-depth website audits for enterprise-level healthcare businesses and multilocation practices.

Here, she outlines the most common blunders in order of importance.

Common Technical SEO Mistakes in Order of Priority

According to Naghmeh, there are seven common technical SEO issues found on healthcare websites.

Issue 1: Lack of Site Architecture

How is the content on your website organized? Can people quickly find what they need? Optimizing a website for organic search starts with good site architecture – the way information is organized on a site.

Many healthcare sites lack proper site architecture. People and search engines should navigate your site easily, which includes the flow of buttons and links. Without this foundational step, your website can’t achieve maximum organic results.

Issue 2: Missing Key Landing Pages

Once a website audit is conducted, and it’s clear that the site lacks proper architecture, we often find that the site is also missing important landing pages. According to Naghmeh, it’s not uncommon for major healthcare brands to have missing pages, including location pages, service pages, and about us pages.

From a user experience (UX) and SEO perspective, missing these key pages can harm your SEO and business growth. A proper technical SEO audit can identify these key missing pages and provide suggestions on what you need on your site.

We recommend that all healthcare industry websites include (at a minimum):

  • A homepage
  • Service pages to describe services, treatments, and programs.
  • Location pages (if applicable)
  • A Blog
  • Contact Us
  • About Us page: On this page, you can profile doctors and staff and feature your company values and mission statement.

Issue 3: Lack of Supporting Content for Main Topics

Another common SEO issue in healthcare marketing is thin content. Thin content often refers to content that offers little or no value for your patients or target audience. In this case, we often see a lack of supporting pages for a website’s main topics.

With your site organized and your key pages created, the next focus should be to develop supporting content for your site’s main topics. For example, if you are a specialty practice, you might need blog posts or child landing pages that explore the treatment options offered at your practice. With enough of the right content on your site, search engines can examine and hopefully reward your site’s authority, relevance, and trust.

Issue 4: Over-optimizing Blog and Website

While lack of content can hurt your SEO, so can too much of it. Over-optimizing your blog or website can mean many things, including keyword stuffing and link spamming. Today, over-optimization also includes using non-relevant words on your site and using one too many H1s on a page.

But in healthcare websites, Naghmeh often finds websites with multiple pages on the same topic. This means more than one page is trying to rank for the same set of keywords or keyword phrases. When this happens, you harm your site’s ability to rank in Google.

Issue 5: URL Structure Problems

Technical SEO covers nearly every aspect of a site, including the URL structure of a page. Just like other SEO elements, the URL structure must be user-friendly for both people and search engines. According to Naghmeh, she often finds many URL issues. One of the most common? When deeper pages on a website lose a path to the parent page.

Issue 6: Site Performance (Page Speed)

Patients and search engines want and reward fast websites. However, many healthcare sites have slow page speeds. This means that the content on the page loads slowly. Unfortunately, slow page speeds can negatively affect the patient experience and SEO.

Today, page speed is a Google algorithm factor. A faster page speed can help your site rank higher in search engines, increase conversions and reduce bounce rates.

Curious to find your website page speed? Google has a handy tool for that.

Issue 7: Medical Related Schema Markup

Finally, one of the most common technical SEO issues with healthcare sites is the lack of health and medical schema or structured data markup.

What is schema? Schema markup is a piece of snippet added to HTML code to improve the way search engines read your webpages. According to Schema.org, schema is available for “both consumer- and professionally-targeted health and medical web content.”

“Proper schema allows search engines to return more informative results,” says Naghmeh. “It also helps populate rich snippets, carousel results and the knowledge graph.”

“Schema markup is not a ranking factor. However, rich snippets have shown to attract users’ attention, increase click-through rates, decrease bounces, and potentially improve rankings from metrics around engagement.”

With these most common issues out in the open, how does your site compare with the competition? If you are looking for some expert help, we invite you to contact us for an exploratory discussion. Creating a solid foundation will help you optimize your site and set it up for success.

The post These 7 Technical SEO Problems Can Cripple Your Website’s Visibility on Google appeared first on Healthcare Success.

Bharat Serums and Vaccines Ltd-Openings for Regulatory Affairs Officer-Apply Now

Bharat Serums and Vaccines Ltd-Openings for Regulatory Affairs Officer-Apply Now

Job Description

DCGI Submission Hard Copy & though Sugam Portal for : Import and registration. Marketing Authorizations. Clinical Trial. Applications. Import Licenses. Test License. Import NOC. Post Approval Submissions. Artwork Checking. Legalization of Legal documents for Submission. Query Responses. Variation Filing.

Position: Regulatory Affairs Officer
Qualification: B.Pharm/ M.Pharm/ M.Sc Biotech candidate can apply
Experience: 01-02 years
Openings: 2
Salary: NA
Location: Navi Mumbai

Contact Details: 

Company: Bharat Serums and Vaccines Ltd

Please send your profile On [email protected]

Bharat Serums and Vaccines Ltd-Openings for Regulatory Affairs Officer-Apply Now

HY-GRO Chemicals -Walk-In Drive for QC Department On 27th Feb’ 2021

HY-GRO Chemicals -Walk-In Drive for QC Department On 27th Feb’ 2021

Job Description

Position: QC
Qualification: M.Sc (Any Chemistry)
Experience: 02-06 years
Openings: NA
Salary: NA
Location: Hyderabad

Time And Venue Details: Walk-In Interview On 27th Feb’ 2021 from 9:30 AM to 2:00 PM Ashoka Bhopal Chambers, Flat No.203 & 204 2nd Floor, Sardar Patel Rd, Secunderabad, Telangana 500003. Contact – HR Department (9010366684).

Contact Details: 

Company: HY-GRO Chemicals Pharmtek Pvt. Ltd.

Contact: HR Department (9010366684).

HY-GRO Chemicals -Walk-In Drive for QC Department On 27th Feb’ 2021

HY-GRO Chemicals -Walk-In Drive for Freshers & Experienced On 28th Feb’ 2021

HY-GRO Chemicals -Walk-In Drive for Freshers & Experienced On 28th Feb’ 2021

Job Description

Position: Chemists / Associates-R&D
Qualification: M.Sc (Organic Chemistry)
Experience: 0-5 years
Openings: 12
Salary: NA
Location: Hyderabad

Required Candidate Profile: Candidate having Experience in API or Intermediates or Bulk Drug Industries in R&D Dept. 0 to 5 yrs Experience. Troubleshoot API and intermediates, Develops product /process specifications for products in R&D.

Time And Venue Details: Walk-In Interview On 28th Feb’ 2021 from 9:30 AM to 2:00 PM Ashoka Bhopal Chambers, Flat No.203 & 204 2nd Floor, Sardar Patel Rd, Secunderabad, Telangana 500003. Contact – HR Department (9010366684).

Contact Details: 

Company: HY-GRO Chemicals Pharmtek Pvt. Ltd.

Contact: HR Department (9010366684).

HY-GRO Chemicals -Walk-In Drive for Freshers & Experienced On 28th Feb’ 2021

EU-OSHA participates in experts’ hearing on the Carcinogens and Mutagens Directive at the EP EMPL Committee

25/02/2021

© Vector by www.freepik.es

On 23 February, the European Parliament Committee on Employment and Social Affairs held an exchange of views with experts on the 4 th revision of the Directive 2004/37/EC ‘Protection of workers from exposure to carcinogens or mutagens at work’…

Innovaccer Reaches $1.3B Valuation, Launches Health Cloud Platform

What You Should Know:

– Innovaccer closes Series D round of growth capital bringing Innovaccer at a total valuation of $1.3 billion.

– In addition, the company has launched the Innovaccer Health Cloud, a platform as a service that combines the company’s Data Activation Platform and application suite with an extensive set of platform services and tools that allow customers and partners to easily develop interoperable applications that improve patient outcomes and lower costs.


Innovaccer Inc., a Silicon Valley-based healthcare data platform company, announced today it has closed a new round of growth funding at a $1.3 billion post-money valuation. The latest round of funding was led by Tiger Global Management. Existing investors Steadview Capital, Dragoneer, B-Capital, Mubadala and M12 (Microsoft’s Venture Fund) participated in the round as well as new investor OMERS Growth Equity.

Founded in 2014, Innovaccer Inc. is on a mission to drive efficiency in healthcare by unleashing the power of data. Its leading healthcare data platform, InData, already ingests, normalizes, and manages millions of patient records and actionable insights that result in better patient outcomes and lower costs. The company’s platform improves efficiencies for providers, payers, and others across the care ecosystem and helps them deliver whole-person care.

Its solutions have been deployed across more than 1,000 locations in the U.S., enabling more than 37,000 providers to transform care delivery and work collaboratively with payers, employers, and life sciences companies. By using the connected care framework, Innovaccer has helped healthcare organizations unify records for more than 24 million people and generate more than $600M in savings for the healthcare ecosystem. 

Innovaccer Health Cloud

With its additional funding, Innovaccer is launching the Innovaccer Health Cloud. The platform-as-a-service offering combines the company’s Data Activation Platform and application suite with an extensive set of platform services and tools that allow customers and partners to develop interoperable applications that improve patient engagement and operational performance. With the Innovaccer Health Cloud, Innovaccer is building the platform that will power the future of health.

“Healthcare is on the brink of a massive transformation. Over the last ten years, we have spent billions of dollars digitizing healthcare information with great success,” said Abhinav Shashank, Co-founder and Chief Executive Officer at Innovaccer. “That was step #1 of the journey. Now, we have troves of information on our health locked in electronic silos. We need to bring this information together using a cloud platform that not only unlocks the power of the data but also provides a platform on which new digital services and solutions can be built with native interoperability. This is exactly what Innovaccer is doing with the launch of Innovaccer Health Cloud.”

Why Patients, Not EHRs, Deserve our Undivided Attention

Prayus Tailor, MD, FASN

We cannot earn patients’ trust and respect if we are tethered to a computer in the exam room, navigating the EHR concurrent to a visit or otherwise in a hurry to finish so we can return to our office where data entry to the EHR awaits us.

______________________________________________________

I am a physician married to a physician, and for years, our evenings consisted of putting the kids to bed, then sitting next to each other, laptops open, finishing our charting. If you are a physician, you likely know the drill. There is even a name for it: “pajama time” in the EHR, and it usually consumes two or more hours.

This scenario, which plays out in physicians’ homes all across the country, is not just robbing us of work-life balance, it is robbing our patients of the undivided attention they deserve. We cannot earn patients’ trust and respect if we are tethered to a computer in the exam room, navigating the EHR concurrent to a visit or otherwise in a hurry to finish so we can return to our office where data entry to the EHR awaits us.

We have become slaves to computer data entry for the sake of insurance billing and regulatory requirements

These administrative burdens have driven some of my colleagues to retire early and others to simply quit practice and take a different direction with their careers. This is not why we went to medical school and certainly not an effective use of our license. It is a national crisis, an assault on our profession.

Artificial intelligence can do much of this for us

Not long ago, during one of those long evenings of charting, I thought to myself, if I can use Alexa to place an order for my favorite shaving cream and have it delivered the next day, surely there has to be a better, easier way of doing this. I searched Google for “artificial intelligence (AI)” and “physician charting” and came across a product that claimed to be a voice assistant designed expressly to automate the creation of clinical notes.

I signed up for a free trial. I figured I had nothing to lose and everything to gain. Client testimonials made reference to numerous benefits, not only eliminating after-hours charting and restoring work-life balance but improving the patient experience. The company instilled confidence they would be able to tailor the product to my specific style and preferences, and the artificial intelligence would learn and become more adept with continued use.

A voice assistant that listens to physician-patient conversations via an iPhone app

This voice assistant doesn’t require a separate device like an Amazon Echo. I am able to access it from an app on my iPhone, which I take into the exam room with me. I don’t have to use instructional commands, I just talk naturally. It listens to my conversations with patients, constructs clinical notes, then populates both narrative and structured data directly to the EHR.

A win-win for physicians and patients alike

I find that patients really like this, especially when I summarize what I’ve heard them say and what I intend to include in their record, which gives them an opportunity to either confirm that I have it right or correct me if I’ve misstated something. It also helps reinforce what they need to do before their next visit.

After using this voice assistant for the duration of the free trial, I ended up purchasing a subscription. Now, several other physicians in my group are adopting it as well. It has been life-changing, and I say that in the literal sense, not with hyperbole. I spend more time listening to my patients, I no longer spend my evenings charting, and the accuracy of my notes is amazing. 

This is how practicing medicine is meant to be 

We need technology that helps physicians rather than hinders them, and I believe technology like this is going to make a huge difference in the lives of physicians and their patients.


About Dr. Prayus Tailor
Dr. Prayus Tailor is a board-certified nephrologist and internist who specializes in the care of patients with kidney disease and hypertension. He is an attending physician with Nephrology Associates, P.A. (Newark, Delaware) as well as the medical director of Fresenius Medical Care Brandywine Home Therapies. He does not have any affiliation with nor a financial interest in the company that develops and markets the voice assistant mentioned. You may reach him on Twitter at @PrayusTailor or on LinkedIn.


NAHC’s Dombi: Home Care Opportunities Are on the Rise, Despite Ongoing Operational Challenges

Home care agencies have been through a turbulent year. But they’re coming out of it under a new light from the perspective of clients and potential partners.

That spotlight continues to grow brighter with each passing day, too, though COVID-19 cases within home care have fluctuated as of late. Far more agencies are dealing with COVID-19 patients now than early on, and nearly 63% have served actively infected patients, according to National Association for Home Care & Hospice (NAHC) data.

Overall, close to 10% of all home care admissions are currently tied to the virus, reportsNAHC, which shared those figures during a Tuesday virtual event.

Similar to cases, personal protective equipment (PPE) costs have also fluctuated as of late. Access continues to be a concern, but the days of scrambling desperately for any sort of equipment to keep workers and clients safe is likely in the rearview mirror.

Despite all of the hardships, home care agencies have absorbed the blows and survived, according to NAHC President William A. Dombi. This experience, he said at Tuesday’s event, is likely to pay off in the long run.

“We have seen — and this is coming by way of agencies’ good deeds — media attention as well as kind of a cultural change in health care,” Dombi said. “Public awareness and health care sector awareness of home care’s value has exponentially increased. [It’s seen] as a viable alternative to other care settings.”

Home care demand took a dip at the beginning of the public health emergency, but it has since stabilized and even increased in some areas. Likewise, the perceived worth of home care has skyrocketed — and that has presented new opportunities.

Payers had already begun recognizing the benefits of home care services, especially when it comes to managing social determinants of health.

But the value of home care — and its ability to provide both pre- and post-acute care — has really become evident during the COVID-19 crisis.

“We are also in the midst of an earlier integration of care at home,” Dombi said “If anybody ever talks to you about post-acute care as the way of defining home care services, they’re off base. Now, others are realizing that home care can be pre- and post-acute, and can also be a very successful way of dealing with individuals with chronic multiple comorbidities.”

Home-based care advocates have been touting the industry’s ability to take on greater challenges, reduce costs and improve care for a long time now.

It’s not a silver lining, per se, that this was recognized in the midst of a deadly pandemic. But it could mean more business for operators long after the public health emergency has subsided.

“Payers, like managed care organizations, are learning more and more about the value of home care services,” Dombi said. “For decades, we’ve had a real hard time convincing payers that the value of home care is something even better than other [means of care] and that it offers a dynamic value. But now that knowledge is starting to take hold, and other health care providers are also appreciating home care across the country.”

In the home care world, this type of realization is represented by the increased interest in palliative care. In some ways, palliative care is a parallel to traditional home care. It takes on patients’ basic needs outside of brick-and-mortar facilities.

“With private-duty home care services, agencies and the physicians make natural partners on this,” Dombi said. “So ultimately, we’re going to see policy building on the growing perception that home care is a total positive, which will translate to totally positive health care policy actions.”

PPE procurement

PPE procurement remains a struggle, according to Dombi. Home care agencies are not on PPE priority lists, nor have they been benefiting from direct government funding that helps pay for these increased costs.

“Back in March of 2020, I received numerous phone calls from the mass media,” Dombi said. “And they were all focused on how unsafe home care must be because there wasn’t PPE. And while it’s still difficult to acquire that, agencies have found ways to continue to keep your patients and staff safe. So that insecurity has somewhat faded away.”

The darker days of PPE may be gone, but the unit prices have also gone up as demand persists.

While private-duty agencies are finally eligible to receive governmental support from the Provider Relief Fund, it is a requirement that agencies also provide some sort of services under Medicare or Medicaid programs.

“We still have those PPE concerns that are persisting, but are we not at that stage where you’re cutting open empty soda bottles to make face masks or knocking on the doors of tattoo parlors to see if they have any spare gloves or masks,” Dombi said. “So I think the current environment overall has a real positive to it.”

Campaign promises

Politicians tend to make campaign promises, just as current President Joe Biden did when he announced a $775 billion plan to boost the caregiver economy in July.

The 10-year proposal would seek to dramatically change the way older adults are cared for in the United States. Specifically, it would expand home- and community-based services, for Medicaid providers and others, and also offer support for both agency caregivers and family caregivers.

Promises aren’t always kept, but Dombi said that NAHC and other industry advocates are determined to hold President Biden and his administration to this one.

“We do not expect this to surface in the near-term of 2021,” Dombi said. “But keep this one in mind, because we’re going to do everything we can to make the president honor that campaign promise to put this program out there. And I know you’re rolling your eyes, … but we believe that President Biden is at least somewhat serious about this.”

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Innovaccer gains unicorn status, plans to launch cloud platform

The health technology company’s valuation skyrocketed to $1.3 billion following its latest funding round. It plans to use the new funds to launch Innovaccer Health Cloud, which will aggregate and normalize data from different systems and support the development of interoperable apps.

BrightSpring Reportedly Acquires Abode in $775M Deal

BrightSpring Health Services has reportedly brokered a deal to acquire Abode Hospice and Home Health, according to PE Hub.

Based in Louisville, Kentucky, BrightSpring provides a diverse array of home- and community-based services, serving more than 350,000 patients across 50 states.

In 2019, BrightSpring was acquired by global investment firm KKR, with Walgreens Boots Alliance Inc. (Nasdaq: WBA) a minority owner. As part of the deal, the company merged with pharmacy giant PharMerica.

KKR’s acquisition of BrightSpring was valued at $1.32 billion.

Abode is a Durango, Colorado-based home health and hospice provider that also offers palliative care and support services. Abode operates in 12 states and is valued at $775 million, PE Hub reports.

For BrightSpring, the potential move falls in line with the company’s “three legs of the stool” strategy, which combines pharmacy services, day-to-day caregiving and clinical services. 

“We certainly have a unique platform, and we’re hopeful that it will be beneficial in the future” BrightSpring CEO and President Jon Rousseau previously told Home Health Care News. “Our platform is centered around offering multiple essential services that we think are all required to optimally and holistically treat an individual with high needs, somebody with significant acute and/or chronic needs.”

Abode has been involved in a number of private equity transactions over the past few years. Summit Partners purchased Abode from Tailwind Capital Partners in 2019, with Tailwind purchasing Abode from Frazier Healthcare Partners the year before.

Combined, BrightSpring and Abode would check in at $6 billion in revenue, according to PE Hub. Upon receiving regulatory approval for the reported acquisition, the combined companies would become one of the largest home-based care providers in the U.S.

“We are absolutely convinced that we have a suite of services that — when combined together the right way, working with the right partners — absolutely results in positive, innovative outcomes,” Rousseau told HHCN last March.

The rumored deal between BrightSpring and Abode reflects larger trends in health care.

In the past couple of years, a number of providers have made strategic moves in an attempt to position their organizations as one-stop-shops for care needs. Overall, the goal of these organizations is to deliver various services that will help keep patients in the home and out of institutionalized settings.

Through a possible acquisition of Abode, BrightSpring would gain a stronger foothold in the home health space, an area that has been a priority for Rousseau since he joined the company in 2016. 

“We’ve had a strategic focus on the service lines in which we want to participate and grow, and which are complementary to optimize care,” he previously told HHCN. “We’ve focused on building out more of a clinical capability set, whether that be through pharmacy, through home health and hospice, or through rehab.”

Rousseau believes that as the home continues to gain prominence as a health care setting, the ability to be multifaceted in terms of care delivery will become more important for providers.

Almost a year ago exactly, BrightSpring purchased the home health and specialty infusion businesses of Advanced Home Care, an organization that operated in Georgia, North Carolina, South Carolina, Tennessee and Virginia.

Both BrightSpring and Abode declined to comment on the transaction, which has not been formally announced.

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BrightSpring Reportedly Acquires Adobe Healthcare in $775M Deal

BrightSpring Health Services has reportedly brokered a deal to acquire home health provider Abode Healthcare, according to PE Hub.

Based in Louisville, Kentucky, BrightSpring provides a diverse array of home- and community-based services, serving more than 350,000 patients across 50 states.

In 2019, BrightSpring was acquired by global investment firm KKR, with Walgreens Boots Alliance Inc. (Nasdaq: WBA) a minority owner. As part of the deal, the company merged with pharmacy giant PharMerica.

KKR’s acquisition of BrightSpring was valued at $1.32 billion.

Abode Healthcare is a Durango, Colorado-based home health and hospice provider that also offers palliative care and support services. Abode operates in 12 states and is valued at $775 million, PE Hub reports.

For BrightSpring, the move falls in line with the company’s “three legs of the stool” strategy, which combines pharmacy services, day-to-day caregiving and clinical services.

“We certainly have a unique platform, and we’re hopeful that it will be beneficial in the future” BrightSpring CEO and President Jon Rousseau previously told Home Health Care News. “Our platform is centered around offering multiple essential services that we think are all required to optimally and holistically treat an individual with high needs, somebody with significant acute and/or chronic needs.”

Abode has been involved in a number of private equity transactions over the past few years. Summit Partners purchased Abode from Tailwind Capital Partners in 2019, with Tailwind purchasing Abode from Frazier Healthcare Partners the year before.

Combined, BrightSpring and Abode check in at $6 billion in revenue, according to PE Hub. Upon receiving regulatory approval for the acquisition, the combined companies will become one of the largest home-based care providers in the U.S.

“We are absolutely convinced that we have a suite of services that — when combined together the right way, working with the right partners — absolutely results in positive, innovative outcomes,” Rousseau told HHCN last March.

The rumored deal between BrightSpring and Adobe reflects larger trends in health care.

In the past couple of years, a number of providers have made strategic moves in an attempt to position their organizations as one-stop-shops for care needs. Overall, the goal of these organizations is to deliver various services that will help keep patients in the home and out of institutionalized settings.

Through its acquisition of Abode, BrightSpring will gain a stronger foothold in the home health space, an area that has been a priority for Rousseau since he joined the company in 2016.

“We’ve had a strategic focus on the service lines in which we want to participate and grow, and which are complementary to optimize care,” he previously told HHCN. “We’ve focused on building out more of a clinical capability set, whether that be through pharmacy, through home health and hospice, or through rehab.”

Rousseau believes that as the home continues to gain prominence as a health care setting, the ability to be multifaceted in terms of care delivery will become more important for providers.

Almost a year ago exactly, BrightSpring purchased the home health and specialty infusion businesses of Advanced Home Care, an organization that operated in Georgia, North Carolina, South Carolina, Tennessee and Virginia.

Both BrightSpring and Abode Healthcare declined to comment on the transaction, which has not been formally announced.

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Brookdale Selling Majority Stake in Home Health Business to HCA Healthcare

Brookdale Senior Living Inc. (NYSE: BKD) announced Wednesday it has entered into a definitive agreement to sell a majority stake in its home health, hospice and outpatient therapy business.

As part of the transaction, the Brentwood, Tennessee-based Brookdale will partner with HCA Healthcare (NYSE: HCA), a for-profit operator of health care facilities that has more than 2,000 sites of care nationwide.

“The health and wellbeing of our residents is at the core of Brookdale’s mission,” Lucinda Baier, Brookdale’s president and CEO, said in a statement issued with the company’s Q4 earnings results. “Today’s partnership with HCA Healthcare will continue the high quality services delivered to our residents and patients, strengthen our liquidity position and provide meaningful opportunities for growth through better integration of services across the entire care continuum.”

Brookdale has agreed to sell 80% of the equity in Brookdale Health Services to the Nasheville, Tennessee-based HCA Healthcare for a purchase price of $400 million. That total implies a $500 million value for the segment, according to Brookdale.

One of the nation’s largest operators of senior living communities, Brookdale will retain a 20% equity interest in the venture with HCA Healthcare.

This is a developing story. Please check back shortly for additional information.

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Why R&D expenses rising and productivity falling could be a good thing

A few facts:

  • Pharma is increasingly a key driver of US R&D. Pharmaceutical firms share of R&D increased from <10% in the early 1970s to 24% in 2018 (among firms in Compustat data). Moreover, 5 out of top 10 largest R&D spenders in Compustat in 2010 were pharmaceutical firms.
  • A majority of drugs are targeted at the elderly. This is not surprising as the elderly are often have multiple comorbidities requiring medication. Between 1995 and 2013, drugs targeting indications with a majority of elderly individuals represented over half new drug development entry for preclinical projects.
  • In the US economy at large, R&D spending is rising, but productivity is not.

Based on these facts, an NBER working paper by Benmelechet al. (2021) aims to solve the conundrum posed by fact #3. The authors write:

…we have shown that a significant share of intangible investment, specifically R&D expenditure, is geared towards treating medical conditions afflicting the elderly. To the extent that these seniors remain out of the labor force, their increased quality of life and life expectancy will not directly increase labor supply and output (via a supply mechanism). Hence, output metrics may not benefit from this type of R&D investment.

While these R&D investments may not increase the productivity of the economy, these investments are likely still well worth the money. As the authors conclude in their abstract:

Increased life expectancy and quality of life among the elderly increases welfare but may not be reflected in estimates of total factor productivity


Methods detail:

The first fact listed above the authors arrive at through Compustat data. The second fact the authors get by using Cortellis Investigational Drugs and Medical Expenditure Panel Survey (MEPS) data. The Cortellis data is used to identify the drug pipeline and relevant indications. Then the authors map the indications to ICD-9 diagnosis codes and then map ICD9 to Clinical Classification Codes (CCC) available in MEPS data. The authors then classify a drug as elderly if the majority of patients in the CCC in MEPS were aged 65 years or older.

Source:

Patient perspectives on the state of patient access

How has the pandemic affected consumer attitudes around patient access? What do consumers want when it comes to accessing care? These are the questions providers must answer if they are to survive the pandemic and lay the groundwork for future financial success.

Experian Health’s recent patient access survey offers a glimpse of what patients hope the digital front door will look like in 2021 and beyond.

Wherever you are in the digital patient access journey, there’s an opportunity to improve the experience for patients to one that will not only survive the tumult of the pandemic, but also thrive in the years ahead.

Learn more.

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