Biden picks former FDA chief to lead federal vaccine efforts

Biden picks former FDA chief to lead federal vaccine efforts

cbaker_admin
Sat, 01/16/2021 – 04:30

Former FDA commissioner David Kessler, MD, will help lead the government’s COVID-19 vaccination and treatment initiative under the incoming Biden administration. The scope of his role at Operation Warp Speed will include manufacturing, distribution, and the safety and efficacy of vaccines and treatments. Kessler is taking the reins from Moncef Slaoui, who will remain on the team as a consultant, and he will co-manage the campaign alongside Gen. Gustave Perna, who is staying on as chief operating officer. Transition officials suggest Kessler was a natural choice. “Dr. Kessler became a trusted adviser to the Biden campaign and to President-elect Biden at the beginning of the pandemic, and has probably briefed Biden 50 or 60 times since March,” said Anita Dunn, co-chair of the transition team. “When staff gets asked, ‘What do the doctors say?,’ we know that David Kessler is one of the doctors that President-elect Biden expects us to have consulted.” At the helm of Operation Warp Speed, he is expected to launch a major antiviral development program for treatment of COVID-19 and build U.S. capacity for manufacturing vaccines—not only for coronavirus but also for other known pathogens.

Vaccination disarray leaves older adults confused about when they can get immunized

Vaccination disarray leaves older adults confused about when they can get immunized

cbaker_admin
Sat, 01/16/2021 – 04:30

As some states revise their vaccination rules for COVID-19, many older adults remain uncertain about how to get immunized. Older adults may check with the physician’s office, hospital, or medical clinic where they typically receive care. Many institutions are posting information about coronavirus vaccines on their websites, and some have set up phone lines. Some health systems are willing to vaccinate anyone who signs up, not just their own patients, such as Kaiser Permanente, which operates in California, Colorado, Georgia, Hawaii, Oregon, Washington state, Washington, DC, and parts of Virginia and Maryland, according to Craig Robbins, MD, MPH, co-leader of its national COVID vaccination program. Most vaccination sites require people to sign up online for appointments, but if doing so is difficult, individuals can call their county’s health department, Area Agency on Aging, or county department on aging for assistance. Every state also has a COVID-19 hotline. Older adults should also monitor local media and their county’s and state’s health department websites for updates. On Monday, for example, Washington, DC, introduced a new vaccination registration site for residents aged 65 years and older and health care workers. Most providers are not yet taking into consideration patients’ underlying medical conditions, but an exception is the Mayo Clinic Health System, which identifies patients at highest risk of getting severe infection. The health system operates in Iowa, Minnesota, and Wisconsin.

Bupropion and naltrexone in methamphetamine use disorder

Bupropion and naltrexone in methamphetamine use disorder

cbaker_admin
Sat, 01/16/2021 – 04:30

Funded in part by NIH’s National Institute on Drug Abuse, researchers explored the safety and efficacy of naltrexone plus bupropion for methamphetamine use disorder. The first leg of the study included 403 adults with moderate or severe cases, 109 of whom were randomly assigned to extended-release injectable naltrexone plus oral extended-release bupropion and 294 of whom received placebo. At followup, 16.5% of patients in the treatment group and 3.4% of controls exhibited a response, represented by at least three methamphetamine-free urine samples out of four collected at the close of the 6-week period. Participants with no response were randomized again for the second leg of the trial, which included 225 participants and also lasted for 6 weeks. This time, a response was documented in 11.4% of 114 patients assigned to naltrexone plus bupropion and in 1.8% of 111 placebo recipients. The weighted average response over 12 weeks was 13.6% for the intervention group and 2.5% for the controls, for an overall treatment effect of 11.1 percentage points. The findings indicate a response rate to naltrexone plus bupropion that was low but still greater than that of unexposed patients.

SGLT-2 inhibitors and GLP-1 receptor agonists for type 2 diabetes

SGLT-2 inhibitors and GLP-1 receptor agonists for type 2 diabetes

cbaker_admin
Sat, 01/16/2021 – 04:30

Researchers assessed the benefits and harms of adding sodium-glucose cotransporter-2 (SGLT-2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists to background treatment for type 2 diabetes. The network meta-analysis encompassed 421,346 adults with varying levels of cardiovascular and renal risk who participated in 764 randomized controlled trials comparing these medications with placebo, usual care, or other glucose-lowering therapies. High-quality evidence shows both SGLT-2 inhibitors and GLP-1 receptor agonists curtailed death for any reason, cardiovascular mortality, non-fatal myocardial infarction, and kidney failure; but there also were some differences between them in terms of risks and benefits. SGLT-2 inhibitors, for example, lowered hospitalization and mortality for heart failure more than GLP-1 receptor agonists, which curbed non-fatal stroke more than SGLT-2 inhibitors. At the same time, SGLT-2 inhibitors were strongly associated with genital infection, while GLP-1 receptor agonists were weakly linked to severe gastrointestinal events. Importantly, the investigators note that absolute benefits for cardiovascular and rental outcomes varied widely, depending on patients’ individual risk profiles. Therefore, they conclude, their findings support a risk-stratified approach to treating type 2 diabetes with SGLT-2 inhibitors and GLP-1 receptor agonists.

Overwhelmed, more states turn to National Guard for vaccine help

Overwhelmed, more states turn to National Guard for vaccine help

cbaker_admin
Sat, 01/16/2021 – 04:30

A growing number of governors are requesting assistance from the National Guard to help carry out their state’s COVID-19 vaccine programs. At least 16 states and territories are relying on doctors, nurses, medics, and other Guard members to administer injections. States are also using Guard members for logistical duties such as assembling and transporting vaccine kits, logging in patients, and controlling lines at state vaccination sites. In West Virginia, approximately 100 Guard troops statewide are assisting with distribution. Gov. Larry Hogan of Maryland has turned to 140 Maryland National Guard members to help with pop-up vaccination sites in three counties and will be adding six more next week to support county and state health officials. C.J. Karamargin, a spokesman for Gov. Doug Ducey of Arizona, says the state asked the Guard to help with personal protective equipment and testing. Claire Hannan, executive director of the Association of Immunization Managers, says: “States are naturally looking at alternative ways to get out the limited supply of vaccines. We are seeing more and more states using the National Guard and thinking bigger.” The Trump administration has so far released about 30 million doses of vaccines to states. The demand for vaccines has significantly exceeded supply, even though some people eligible for an early dose have declined to get immunized.

CVS is on a hiring spree for thousands of workers in advance of COVID vaccine rollout in stores

CVS is on a hiring spree for thousands of workers in advance of COVID vaccine rollout in stores

cbaker_admin
Sat, 01/16/2021 – 04:30

As CVS Health awaits instructions from health authorities about when to start administering COVID-19 vaccines to the general public, the company seeks to hire thousands of pharmacists, nurses, and pharmacy technicians nationwide to help administer COVID-19 vaccines. The company’s career page currently lists openings for roughly 11,300 pharmacy technicians and 1,200 pharmacists. Applicants need to complete a pre-employment assessment with the platform Modern Hire, which has worked with the pharmacy chain since 2006. Mike Hudy, chief science officer at Modern Hire, says the platform is enabling CVS to process more than 2,700 candidate assessments per day, including those for pharmacists and pharmacy technicians. It features a “virtual job tryout” that Hudy says helps reduce the time it takes to hire from several weeks to a matter of days. CVS is offering full- and part-time pharmacy technician roles, which serve as the first point of contact for customers and who are expected to work safely, promptly, and with compassion. Applicants must be at least 16 years old, licensed based on their state’s requirements, and have a high school diploma or equivalent. Staff pharmacists are responsible for pharmacy professional practice as well as quality assurance, customer service, inventory management, and workflow management.

WBA makes a majority investment in iA

WBA makes a majority investment in iA

cbaker_admin
Sat, 01/16/2021 – 04:30

Walgreens Boots Alliance (WBA) has made a majority investment in iA, which provides pharmacy automation solutions. The investment will support iA’s expansion and product development. “The role of pharmacists as an integral part of the health care system and patients’ care teams has never been more critical,” said Stefano Pessina, executive vice chairman and CEO, Walgreens Boots Alliance. “The iA mission to further modernize and automate the prescription fulfillment process aligns with our priority to create the pharmacy of the future.”

JACC expert consensus decision pathways for HF treatment

JACC expert consensus decision pathways for HF treatment

cbaker_admin
Sat, 01/16/2021 – 04:30

The American College of Cardiology (ACC) has updated its 2017 recommendations for management of heart failure with reduced ejection fraction. The 2021 revision incorporates several new guideline-directed medical therapies, including SGLT2 inhibitors and sacubitril/valsartan, an angiotensin receptor neprilysin inhibitor. The Expert Consensus Decision Pathway goes beyond simply listing recommended interventions and doses, however, according to guideline writers. Rather, the document is important for the practical strategies it proposes for stunting HFrEF progression. Widespread adoption, they believe, could empower clinicians to “make a significant difference in these patients’ length and quality of life.” The update—which addresses first-line treatments, end-of-life management, and everything in between—appears in full in the Journal of the American College of Cardiology.

Biden proposes $1.9 trillion COVID-19 relief package

Biden proposes $1.9 trillion COVID-19 relief package

cbaker_admin
Sat, 01/16/2021 – 04:30

President-elect Joe Biden on Thursday unveiled his proposal to help the country manage the COVID-19 crisis. In his speech, he outlined a $1.9 trillion relief plan that would deliver $1,400-per-person to most Americans, augment unemployment benefits with an extra $400 per week through September, boost the child tax credit to $3,000 from $2,000 this year, and extend eviction and foreclosure moratoriums, among other steps. Household assistance accounts for about one-half of the spending requested for the American Rescue Plan, with the remainder dedicated to local and state governments for vaccine testing and distribution. An estimated $160 billion, for example, would be earmarked to increase COVID-19 testing, expand the public health workforce, and otherwise support the national vaccination campaign. Biden has vowed to administer 100 million doses during the first 100 days of his term.

HHS expands access to treatment for OUD

HHS expands access to treatment for OUD

cbaker_admin
Sat, 01/16/2021 – 04:30

HHS announced Thursday new guidelines that aim to increase access to medication-assisted treatment by exempting physicians from certain certification requirements needed to prescribe buprenorphine for opioid use disorder (OUD) treatment. “The medical evidence is clear: access to medication-assisted treatment, including buprenorphine that can be prescribed in office-based settings, is the gold standard for treating individuals suffering from opioid use disorder,” said Adm. Brett P. Giroir, MD, assistant secretary for health. “Removing some of the certification requirements for an X-waiver for physicians is a step toward providing more people struggling with this chronic disease access to medication assisted treatment.” The new Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder issues an exemption from certain certification requirements under 21 U.S.C. § 823(g)(2) of the Controlled Substances Act (CSA) for physicians licensed under State law and who possess a DEA registration. HHS notes the exemption only applies to physicians who may only treat patients who are located in the states in which they are authorized to practice medicine; physicians using this exemption will be limited to treating no more than 30 patients with buprenorphine for OUD at any one time; the exemption applies only to the prescription of drugs or formulations covered under the X-waiver of the CSA, such as buprenorphine, and does not apply to the prescription, dispensation, or use of methadone for the treatment of OUD; and physicians utilizing this exemption shall place an “X” on the prescription and clearly identify that the prescription is being written for opioid use disorders. HHS also said it will establish an interagency working group to monitor the implementation and results of the guidelines and the effect on diversion. Recent provisional data from CDC indicate that more than 83,000 drug overdose deaths occurred in the United States in the 12 months ending in June 2020, the highest number of overdose deaths ever recorded in a 12-month period, and a 21% increase from the previous year.

Temporary waiver will allow qualified PA pharmacists to order, administer COVID vaccines

Temporary waiver will allow qualified PA pharmacists to order, administer COVID vaccines

cbaker_admin
Sat, 01/16/2021 – 04:30

Gov. Tom Wolf of Pennsylvania approved Thursday a temporary waiver that will enable state-licensed pharmacists to order and administer COVID-19 vaccines when the vaccines are available to the public. “Many Pennsylvanians will go to their local pharmacy for vaccination,” said Pennsylvania Secretary of State Kathy Boockvar. “This waiver will enable pharmacies to offer the COVID-19 vaccines without a physician’s order.” Pharmacists who meet certain training and other requirements can receive authorization to administer injectable medications, biologicals, and immunizations. If a pharmacist has that authorization, she or he can administer any immunization, including COVID-19, to individuals aged 18 years or older. Although some pharmacies have previously arranged with physicians to receive reimbursement for influenza and other vaccinations, even those that do “have not had time to incorporate the COVID-19 vaccination into that relationship,” state officials noted in a press release. “This waiver would allow pharmacists to order and administer COVID-19 vaccines without such a provider agreement.” State Health Secretary Rachel Levine added, “We are working on ways to increase access to the vaccine, and pharmacists already play an important role in making sure Pennsylvanians are protected.” The temporary waiver applies only to COVID-19 vaccinations.

CBP, FDA seize counterfeit, unauthorized e-cigarettes

CBP, FDA seize counterfeit, unauthorized e-cigarettes

cbaker_admin
Sat, 01/16/2021 – 04:30

U.S. Customs and Border Protection (CBP) officers, working with FDA agents, said Wednesday they have seized at Dallas Fort Worth International Airport more than 33,600 units of e-cigarettes with a Manufacturer’s Suggested Retail Price of nearly $720,000. Last December, CBP seized 42 separate shipments arriving from China on their way to a number of Texas counties. The shipments included individual disposable flavored e-cigarette cartridges resembling the Puff Bar brand. As part of an ongoing joint operation with FDA, agents were looking to intercept counterfeit or other violative e-cigarettes, including certain flavored e-cigarettes imported to the U.S. that did not meet the Federal Food, Drug, and Cosmetic Act requirements, as amended by the Family Smoking Prevention and Tobacco Control Act. “Many counterfeit, unapproved or unauthorized products are likely produced in unregulated facilities with unverified ingredients posing a serious health concern to consumers. It is especially alarming when these types of counterfeit and unauthorized products find their way into the hands of children as studies indicate,” said CBP Port Director Timothy Lemaux. “Protecting American consumers from illicit and especially harmful tobacco products, such as counterfeit or flavored e-cigarettes, is of utmost importance to the FDA,” added Judy McMeekin, PharmD, FDA Associate Commissioner for Regulatory Affairs. “We will continue to investigate and remove from the marketplace products that pose a particular danger to the public health.”

Ipca Laboratories- Openings for Officer / Executive Maintenance, Electrical- Apply Now

Ipca Laboratories- Openings for Officer / Executive Maintenance, Electrical -Apply Now

Job Description

Preparation of Plant Machine Maintenance / Preventive Maintenance Schedule and to take up the job as per schedule. To take up the plant modification work as per process requirement in consultation with maintenance Head. To update all documents like calibration records, Preventive Maintenance, DQ / IQ / OQ etc. To assist and co-ordinate EHS related issues. Overall Responsibility of Plant Machine Maintenance / Preventive maintenance & Operations of Utility.

Desired Candidate Profile: B.Tech/ B.E.-Electrical, B.Tech/ B.E.-Electronics/ Telecommunication, basic computer knowledge.

Company: Ipca Laboratories Ltd
Location: Dehradun
Position: Officer / Executive Maintenance, Electrical
Qualification: B.Tech/ B.E.- in Electrical, Mechanical
Experience:02-07 years
Vacancy: NA

Address: Ipca Laboratories Ltd. C-6, Sara Industrial Estate, Chakrata Road, Dehradun, PIN;- 248197 Ph. 7302732301, 7302732304

Ipca Laboratories- Openings for Officer / Executive Maintenance, Electrical- Apply Now

Shivalik Rasayan Ltd.- Openings for API Research Scientist / Executive -R&D

Shivalik Rasayan Ltd.- Openings for API Research Scientist / Executive -R&D

Job Description

Pharma API Experience and Organic Chemistry Qualification must. Experience in synthetic organic chemistry & multi step synthesis. Knowledge of scientific databases (Sci-finder, Reaxys and Scopus). Understand the reaction protocol & search literature.

Required Candidate profile: Ready to relocate Bhiwadi SRL R&D Center. Self Motivated and target Oriented. Ready to Join us on priority. Pharma API research experience must. Plan and execute reactions independently.

Post Name: API Research Scientist / Executive -R&D

Qualification: B.Sc/ M.Sc

Experience: 02-07 years

Location: Bhiwadi

Openings: 06

Click Here For Job Details & Apply Online

Shivalik Rasayan Ltd.- Openings for API Research Scientist / Executive -R&D

Shivalik Rasayan Ltd.- Openings for API Research Scientist / Executive -R&D

Shivalik Rasayan Ltd.- Openings for API Research Scientist / Executive -R&D

Job Description

Pharma API Experience and Organic Chemistry Qualification must. Experience in synthetic organic chemistry & multi step synthesis. Knowledge of scientific databases (Sci-finder, Reaxys and Scopus). Understand the reaction protocol & search literature.

Required Candidate profile: Ready to relocate Bhiwadi SRL R&D Center. Self Motivated and target Oriented. Ready to Join us on priority. Pharma API research experience must. Plan and execute reactions independently.

Post Name: API Research Scientist / Executive -R&D

Qualification: B.Sc/ M.Sc

Experience: 02-07 years

Location: Bhiwadi

Openings: 06

Click Here For Job Details & Apply Online

Shivalik Rasayan Ltd.- Openings for API Research Scientist / Executive -R&D

Things to Consider When You are Making Your Own Scrubs

Whenever you see physicians, nurses, or any hospital worker, there’s a good chance that they’re wearing scrubs. This sanitary clothing or uniform was originally designed for use by surgeons and their support staff while in surgery rooms. It came to be known as scrubs because surgeons typically put them on as they sterilize or scrub themselves clean before entering the operating room.  Today, scrubs are no longer just limited to surgeons and surgery staff. They have become the clothing of choice for all healthcare workers, including veterinarians. Scrubs are worn in environments that have a high risk of coming into

The post Things to Consider When You are Making Your Own Scrubs appeared first on Pharma Mirror Magazine.

Health professions ask public to take concrete actions to help safeguard underfunded COVID-affected health systems

Geneva – The presidents of all five international organisations that make up the World Health Professions Alliance (WHPA) have called for continued support for health and care workers in 2021 in a joint video message released today. International Council of Nurses president Ms Annette Kennedy, said: “As health professionals, most of us have been fighting the COVID-19 pandemic. Many of us got ill ourselves, and there is a long list of health professionals who have died because they were assisting their patients.” We got a lot of applause from our fellow citizens. We appreciated the recognition; however, what we urgently

The post Health professions ask public to take concrete actions to help safeguard underfunded COVID-affected health systems appeared first on Pharma Mirror Magazine.

The rise of the health systems

Health systems have been touted by some to be a cure to many of our health care systems ills by providing integrated, high quality care. Others claim that health systems are just a way for providers to big up prices through more bargaining power. Either way, it is not entirely clear to what extent health systems are becoming a permanent feature of medical care in the US and how this has changed over time.

To answer this question, a paper by Kimmey et al. (2021) use data from the AHRQ Compendium of US Health Systems to answer this question. They find physicians are increasingly becoming part of larger health systems.

The average change in the share of physicians in systems across MSAs from 2016 to2018 was 8.8 percentage points at the MSA level; the median change was 7.4 percentage points (data not shown). These figures are less than the national change in the share of physicians in systems from 2016 to 2018 (11 percentage points), in part because many of the largest MSAs had a change that was larger than 8.8 percentage points

The authors note that consolidation occurs most frequently in the Northeast and Midwest.

How Build Healthy Eating Habits and Make Them Stick

If you started the new year with a resolution to build healthy eating habits, know you’re in good company.

But following through may be challenging.

At the start of your health and fitness journey, let go of the urge to find and follow the perfect diet to a T.

Keep in mind that setbacks are normal, and learning to deal with them is critical for making healthy eating habits that stick.

Woman cooking at home

Why Eat Healthy

Does healthy eating matter? Absolutely. It is a form of self-care that may help you gain a better quality of life.

Proper nutrition enables you to lose and maintain weightenhance exercise performance, and improve health.

It also helps to think of the side effects of not eating healthy.

Poor nutrition might increase your risk for a number of health problems.

Can You Overdo Healthy Eating?

In a word: yes. “For some, healthy eating can turn into orthorexia or an unhealthy obsession with following the ‘perfect’ diet,” says Brittany Crump, M.P.H., R.D. at Savor Nutrition.

“It’s essentially an unrealistic goal, and those who try to follow it can damage their well-being. When an orthorexic can’t follow their diet perfectly (maybe life gets in the way), they may feel shame or self-loathing,” she explains.

Orthorexia isn’t officially recognized as an eating disorder like anorexia, but it can result in similar health consequences, namely malnutrition.

If you think you may have orthorexia, the National Eating Disorder Association has more information.

“With orthorexia, it’s more about the individual’s mindset than the diet they follow,” says Crump. “You can have orthorexia with any type of diet — vegan, gluten-free, clean eating, calorie counting, and more.”

It’s essential to have a healthy mindset, especially if you want to develop healthy habits that are sustainable.

Young woman cooking at home

Make a Healthy Eating Plan

A good plan is full of healthy habits you can maintain over time.

Here are five not-too-rigid rules to help you make healthy habits that stick:

1. Choose mostly whole, unprocessed foods

Try to eat more of these foods:

  • Fruits and vegetables — they should make up the bulk of your diet since they’re low in calories and high in fiber and other valuable vitamins and minerals. Include primarily veggies (generally lower in kcal, sugar, higher in fiber), as fruit contains naturally occurring sugar, which should not be eaten in an unlimited amount.
  • Whole grains — oats, whole grain pasta, brown rice, farro, quinoa, and popcorn are examples of fiber-licious whole grains.
  • Lean proteins — chicken, fish, eggs, yogurt, cottage cheese, nuts, seeds, beans, and legumes are examples of nutritious lean protein.
  • Healthy fats — enjoy omega-3 fats from fatty fish, walnuts, and flax seeds plus monounsaturated fats from nuts, olive oil, avocado, and peanut butter.

By choosing mostly whole foods, you’ll naturally avoid the unhealthy stuff that’s mainly in processed foods such as trans fats, added sugars, preservatives, and dyes.

Plus, whole foods are a natural canvas to create exciting flavors and textures.

Read 8 Healthy Tips to Banish Borning Foods for more.

2. Plan ahead when you shop for food

Most of us eat whatever’s handy in the kitchen. Setting yourself up for success is as simple as what you put in your grocery cart.

Read 11 Grocery Shopping Tips to Make Healthy Eating Easier for more advice.

3. Mind your portions

No matter which diet you follow, food quality only gets you so far. You have to keep an eye on portion size to see results.

Over-eating healthy food is still over-eating and can lead to weight gain. So, how do you portion control?

A popular strategy is to use your hand:

  • 1 palm = 1 serving of protein
  • 1 fist = 1 serving of veggies
  • 1 cupped hand = 1 serving of complex carbohydrate (whole-grain preferred)
  • 1 thumb = a serving of fat

This is only used to demonstrate an average portion size of each food group, but depending on your daily needs, you may require larger portions.

If you struggle with fixing your portion size, our Ultimate Portion Fix containers can take the guesswork out it.

Woman eating a cookie with coffee

4. Have a balanced, healthy-ish mindset

As noted above, you don’t need to eat healthy 100% of the time. A healthy mindset leaves room for you to enjoy foods based on emotional appeal, not just nutrition.

Having this balanced mindset can help you feel less like a failure if you stray, which is totally normal.

According to Crump, “Food is for celebrating, too. You should be able to enjoy birthdays and holidays without feeling guilty about food. Even if you have a day that’s less than ideal, it’s OK. You can get back on track tomorrow.”

5. Celebrate your wins

Don’t forget that you’re making healthy eating habits for the long haul, which means you’ll need to stay motivated.

One way to do that is to reward yourself when you see progress.

Maybe you finally kicked that sugary soda habit for six straight months. Give yourself a non-food reward (like a new pair of shoes) to acknowledge the win.

What Prevents You From Eating Healthy?

Healthy eating setbacks are personal to your circumstance and lifestyle, but common hurdles include:

Not having social support

A common question that people ask is, “How can I eat healthy when no one else is healthy?”

If your friends and family are not on board with healthy eating, try to find a group of people who are.

You can join online groups to connect with like-minded individuals to help you stay on track.

Lack of time

To make healthy habits stick, you may need to front time to meal plan, grocery shop, and food prep.

You’re less likely to make impulsive food choices with healthy meals and snacks conveniently in place.

Feeling deprived

At the start, it can feel like you’re giving up the foods you like. But healthy eating doesn’t mean giving up your favorite foods forever — that would be an unhealthy mindset.

“A healthy mindset around food involves letting go of the idea that foods are ‘good’ or ‘bad.’ All foods can fit into a healthy diet. Don’t expect yourself to eat healthy 100% of the time. Maybe try 80% or 90% at most. Leave room to indulge in foods you love,” says Crump.

Losing motivation too early

Results don’t always come immediately after you adopt healthy eating habits.

Instead of fixating on numbers (e.g., pounds on the scale, body fat percentage, waist circumference), find small, promising signs of progress.

Cerner Leadership Changes, Other Key Executives Hires

Cerner announced some leadership changes promoting long-time associates Travis Dalton to Chief Client & Services Officer and Dan Devers to Chief Legal Counsel. After long, respected, meaningful careers at Cerner, John Peterzalek and Randy Sims will be departing.


Cognoa, the leading pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with autism and other behavioral health conditions appoints Eric B. Mosbrooker as Chief Operations Officer. Mosbrooker will be responsible for overseeing and leading the global commercialization of the company’s product offerings, expanding Cognoa’s operational capabilities and implementing scalable business processes.


Discovery Health Partners announced that Sameer K. Mishra has joined the company as Chief Information Officer. Leveraging his significant health payer technology experience, Mishra will lead Discovery’s dedicated IT staff and evolve the company’s technology platform.


Medical Microinstruments (MMI) SpA, hires Mark Toland as Chief Executive Officer. He brings more than 25 years of experience in the medical device industry and most recently served as President and CEO of Corindus, a vascular robotics company that Siemens Healthineers acquired for $1.1 billion in 2019. Following the CE mark of MMI’s Symani Surgical System® in 2019 and successfully completing the first human use cases in 2020, Toland will drive the company’s strategic direction from the developmental stage to broad commercialization.


Dr. Marilyn Ritholz and Dr. David Horwitz will join Chairman Eric Milledge on Dario Health’s scientific advisory board. Dr. Ritholz is a psychologist at Joslin Diabetes Center, a Harvard Medical School affiliate, and Dr. Horwitz is the former Global Chief Medical Officer of Johnson and Johnson Diabetes Institute. They will work on advancing Dario’s technical leadership and help to guide the development of its technology roadmap.


DrChrono expands its senior leadership team with two new hires joining the company. Shahram Famorzadeh will be joining as Senior Vice President of Engineering, responsible for scaling DrChrono’s platform to the next level to support its growing network of physicians and practices, and Jason Rasmussen has joined as Senior Vice President of Revenue, contributing his expertise to DrChrono’s financial operations team.


Vave Health announced two additions to its executive team and advisory board to support the company’s accelerated growth in the medical imaging market. David Garner, a long-time veteran of point-of-care ultrasound and previous vice president at Butterfly Network, brings more than 22 years of experience to Vave Health, and Terri Bresenham, founder of TruNorth Health Advisors and recognized global healthcare expert, joins as a member of the company’s advisory board.


Anang Chokshi, PT, DPT, OCS, SCS joins Include Health as Chief Clinical Officer (CCO). Chokshi joins IncludeHealth’s executive team to provide clinical and technical expertise as IncludeHealth expands its portfolio of products. 


Conversion Labs, Inc. appoints licensed personal care and wellness physician and psychiatrist, Dr. Anthony Puopolo, to the new position of chief medical officer. Dr. Puopolo will be responsible for overseeing the company’s rapidly expanding network of state-licensed physicians and ensuring that the company is delivering the highest quality of care.


BioCardia®, Inc. appoints Krisztina Zsebo, Ph.D., a 31-year veteran of the biotech industry, to its Board of Directors following her election at BioCardia’s 2020 Annual Meeting of Stockholders in December 2020.


Achiko AG appoints biotechnology research scientist and entrepreneur Dr. Morris S. Berrie to the position of President, and business leader in the life science industry Richard Lingard to the position of SVP Commercialization.

ApprioHealth announces the addition of Carl Swart as chief operating officer (COO). Prior to joining ApprioHealth, Swart served as the vice president for revenue cycle for Ensemble Health Partners. Additionally, he spent nearly a decade with Mercy Health as a market vice president.

HHS Delays Provider Relief Fund Reporting Requirements in Response to Updated Utilization Guidelines

The U.S. Department of Health and Human Services (HHS) on Friday announced it will amend the reporting timeline for the Provider Relief Fund, giving home health agencies and others more time to prepare required information. The news comes shortly after Congress clarified financial dos and don’ts of the program.

Originally, the opening date for HHS’s Provider Relief Fund reporting portal was slated for Jan. 15, with the first deadline set at Feb. 15.

The formal delay is the result of Congress passing the Federal Appropriations Act at the end of December, which authorized HHS to distribute an additional $3 billion in relief funds to health care services providers.

As of now, no new official compliance deadline has been set.

“HHS has been working to update the [Provider Relief Fund] reporting requirements to be consistent with this new law,” the health department said in a statement. “That said, as HHS has done in the past, the department wanted to give recipients ample time to familiarize themselves with the updated reporting requirements well in advance of required submission deadlines.”

For now, HHS has still opened its online reporting portal for providers starting on Friday. Providers that have received relief fund payments exceeding $10,000 should establish accounts and begin the reporting process, officials suggest.

Aside from authorizing a fresh tranche of funds, the Federal Appropriations Act included new provisions that made changes to the scope of Provider Relief Fund payments. For home health providers, especially larger ones with multiple business segments or entities, this means new flexibilities around how the funds can be utilized.

Under the new law, providers are able to transfer relief funds between their corporate parents and subsidiaries.

“Some of the prior HHS guidance had suggested that [relief funds] earned from some of the targeted distributions — which are distributions that went out to specific provider types, such as nursing facilities or hospitals — had to remain with the entity that received it,” Anil Shankar, a partner at law firm Foley & Lardner LLP, told Home Health Care News. “Congress kind of overrode that, declaring that the funds can be transferred within the corporate family.”

The recently passed appropriations legislation also reverts guidelines around calculating lost revenues back to what was previously in place as of June 2020. Updates guidelines require providers to calculate lost revenues using any “reasonable method of estimating the revenue” compared to the same period in the absence of COVID-19.

“It allows providers to run a comparison of the difference between their budgeted revenue versus their actual revenue, which is significant because the October-November guidance would not have permitted that,” Shankar said. “[It] instead required a year-over-year comparison, which in some cases, may not have been a very accurate comparison.”

Shankar noted that the previous guidance in place was a point of contention among health care organizations. Providers, generally, viewed the requirements as overly restrictive.

Still, some uncertainty around how providers should calculate budgeted versus actual revenue remains.

“Now, you can use budgeted versus actual as your comparison to identify the amount of lost revenues,” Shankar said. “But there are still questions about what counts as a budget discretion and what counts as actual.”

There are also questions around the time period, he added.

“It’s not clear to me now, with a new legal change, if they’re going back to something different or more flexible, where you can do it on a quarter-by-quarter basis, or if it’s still a full year at a time,” Shankar said.

Shankar said he believes the HHS Provider Relief Fund reporting portal being open may provide the answers to some of these lingering questions.

Provider Relief Fund distribution first began in April of last year with an initial tranche of $30 billion to Medicare-reimbursed health care providers. The federal government has since added to that with several more general and targeted relief rounds, with the latest being a $24 billion infusion in December.

The post HHS Delays Provider Relief Fund Reporting Requirements in Response to Updated Utilization Guidelines appeared first on Home Health Care News.

‘Smart pill’ company etectRx and Pear Therapeutics form CNS partnership

etectRx, Inc., a digital health company, has entered into an agreement with Pear Therapeutics, Inc., a prescription digital therapeutics (PDTs) provider.

The objective: develop up to two product candidates in the central nervous system (CNS) sector that combine PDTs and adherence sensors. The companies say that this partnership is the first to explore the use of digital pill solutions with PDTs.

etectRx’s ingestible sensor, the ID-Cap System

etectRx’s FDA-cleared ID-Cap System, a digital pill system that the company says is accurate and flexible, enhances adherence to oral medication and helps to improve patient outcomes. Specifically, FDA cleared ID-Cap System as an ingestible event marker, which has the ability to guide digital and non-digital therapeutic interventions. Once swallowed, its ID-Tag uses etectRx’s proprietary communications technology to transmit a very low power digital message from within the patient’s stomach.

The post ‘Smart pill’ company etectRx and Pear Therapeutics form CNS partnership appeared first on Pharmaceutical Commerce.

Mayo Clinic, Microsoft, Cerner join coalition to provide digital access to Covid-19 vaccine records

A group of organizations have come together to work on a solution that will provide digital access to Covid-19 vaccination records. As the country eyes a challenging transition to the new normal, a verifiable vaccine record will be necessary to ensure individual and community safety.

Step Up Your Meal Prep With the Right Freezer Containers

Freezer containers are a kitchen staple.

They keep your leftovers fresh-tasting, make it easy to meal prep in bulk, aid in portion control, and are easily stackable for total organization junkies.

But finding the right containers is essential to avoid continually cleaning up messes, wasting food, or using multiple dishes.

Here’s everything you need to know about freezer containers!

What are the Best Freezer Containers to Use?

Stick with containers made from microwave-safe BPA-free plastic or glass.

That way, you can go from freezer to microwave without dealing with multiple dishes.

According to the USDA, your leftovers and prepped meals are safe after 3-4 days in the refrigerator and 2-3 months in the freezer.

Also, don’t skimp on that leak-proof lid feature. You’ll want airtight lids to keep your food extra fresh and prevent spills and messes.

“Even if you aren’t freezing a liquid, leak-proof equals freezer burn-proof,” says Brian Casey, Chef, hunter, and founder of Knifegeeky.

“Leak-proof containers have the best seal, meaning they will keep the contents fresh and not let in any weird freezer flavors over time,” he explains.

These leak-proof containers might also save the day in an emergency.

“In case of a power outage or other situation where your freezer is unable to perform, you’ll wish you used a leak-proof container!” says Caleb Chen, a Servsafe certified food safety expert.

Vegetables in glass freezer containers

Are Plastic Freezer Containers OK?

As long as they’re BPA-free, plastic containers are OK. You’ll also want to make sure they’re microwave and dishwasher safe.

“Don’t put thin plastic (like reused takeout containers) or metal of any kind in your microwave,” says Casey. “Most containers will say on the bottom or the label if they are safe for reheating,” he adds.

When freezing contents for extended periods of time (like meat), vacuum-sealed plastic bags are your best bet, says Chen.

Leftovers in glass freezer containers

What Can I Put Inside Freezer Containers?

Anything you want to freeze! The container shape will depend on what you’re putting inside them:

  • Opt for a round container if you’re storing soups.
  • Choose a rectangular shape if you want to pre-portion meals.

“Remember that liquids will expand if frozen, so always leave a little extra room in the container. Leave an inch or so of space at the top to be safe,” advises Casey.

Can I Freeze Take Out Boxes?

“Generally, you shouldn’t freeze food that comes in a take out box because you can’t be sure if the materials used are freezer safe,” advises Chen.

Move your leftovers into your freezer containers so you can be sure your food is adequately protected.

Now that you know the basics, here are five of our favorite freezer containers.

1. Prep Naturals Food Storage Containers with Lids

This 50 pack of 25 oz freezer and microwave safe storage containers is affordable, leak-proof, and reusable.

They’re also stain-proof and BPA-free for safe, easy, and efficient stacking.

Get them on Amazon.

2. Arrow Reusable Plastic Storage Container Set

These airtight multi-use containers can do it all — freeze, reheat in the microwave, store, repeat!

Leak-proof lids will keep your spill-ables sealed (great freezer containers for soups!), and throw them in the dishwasher when they need a good rinsing.

Get them from Amazon.

3. Rubbermaid Brilliance Food Storage Containers

With over 4,000 positive Amazon reviews, you can be sure these freezer containers are legit.

These leak-proof food storage containers are BPA-free, secured with latches to prevent spills and keep food fresh, and include built-in vents under the latches to ensure splatter-free microwaving.

Get them from Amazon.

4. PrepWorks Freezer Pod

Use these dishwasher-safe freezer pods for perfectly sized portions of sauces, chicken stocks, soups, purees, and more.

They come in 1/2 cup, 1 cup, 2 tablespoon, and 2 cup options depending on your needs.

Get them from Amazon.

5. Pyrex 18pc Glass Storage Set

These dishwasher and microwave-safe glass dishes have color-coded airtight lids to keep you organized.

Made from durable Pyrex® glass, these freezer containers are stain- and odor-resistant.

The set includes one 7-cup round container, one 6-cup rectangle, one 4-cup round, two 3-cup rectangle, two 2-cup round, and two 1-cup round containers with the lids included.

Get them from Target.

UK to face short term delay in delivery of Pfizer vaccine

Overall number of doses delivered between January and March will remain the same, the firm says

The UK is set to face short-term delays in delivery of the Pfizer/BioNTech coronavirus vaccine as the pharmaceutical company upgrades its production capacity.

Pfizer is upscaling production at its plant in Puurs, Belgium, in efforts to produce more doses than originally planned for 2021 – temporarily reducing deliveries to all European countries.

Continue reading…

Thermo Fisher acquires Novasep’s viral vector manufacturing business

Thermo Fisher Scientific Inc. and Groupe Novasep SAS, a services and technologies supplier for the life sciences industry, announced that Thermo Fisher has acquired Henogen S.A., Novasep’s viral vector manufacturing business in Belgium, for approximately €725 million (about $876 million) in cash.

Henogen S.A. will be part of Thermo Fisher’s pharma services business within the laboratory products and services segment.

Between its two locations in Seneffe and Gosselies, Belgium, the business offers contract manufacturing services for both vaccines and therapies to biotech companies and large biopharma customers via approximately 75,347 square feet of capacity. The business’ estimated 2020 revenue was €80 million (approximately $97 million).

Thermo Fisher previously announced plans to construct a 67,000-sq.-ft. plasmid DNA manufacturing facility in Carlsbad, CA last month.

The post Thermo Fisher acquires Novasep’s viral vector manufacturing business appeared first on Pharmaceutical Commerce.

QGenda Acquires Automated Provider Scheduling Platform Shift Admin – M&A

QGenda acquires Shift Admin – M&A

What You Should Know:

– QGenda has acquired Shift Admin, an industry-recognized
leader for shift-based specialties including emergency medicine, urgent care,
and hospital medicine.

With the industry-leading scheduling technology for all
specialties across the healthcare delivery system, QGenda’s technology will
ensure care is available for patients when and where it is needed.


QGenda, the leading
innovator in enterprise healthcare workforce management solutions, announced
the acquisition
of Shift Admin, an industry-recognized
leader for shift-based specialties including emergency medicine, urgent care,
and hospital medicine. With the industry-leading scheduling technology for all
specialties across the healthcare delivery system, QGenda’s technology will
serve as the single source of truth for all provider schedules, ensuring care
is available for patients when and where it is needed.

Automated Provider Scheduling for All Specialties

Founded in 2007, Shift Admin offers Automated Schedule
Generation that can generate optimized schedules based on fully customizable
rules and user’s requests. The Shift Admin schedule generator contains a
world-class scheduling algorithm and features a simple but powerful user
interface. Our system is flexible enough to handle even the most complicated
schedules.

Acquisition Enables Greater Access to Data Insights for
Providers

The announcement furthers QGenda’s commitment to advancing
how healthcare organizations manage and schedule their workforce so they can
effectively use providers’ time, reduce burnout and optimize capacity. By
scheduling for all providers and specialties through QGenda, organizations have
greater access to data, details, and insights for thousands of providers
working across the system.

“With care needs fluctuating across states and even within the same area, transparency and flexibility continue to be a large need for healthcare organizations nationwide. QGenda, with the addition of Shift Admin’s shift-based provider scheduling capabilities, is helping healthcare organizations address these priorities. We are partnering with customers to deliver greater visibility into where and when providers are working and optimizing capacity to deliver quality, cohesive care across the entire organization,” stated Greg Benoit, CEO of QGenda.

By adding the leading provider in shift-based scheduling,
QGenda is enhancing capabilities for emergency medicine, hospital medicine, and
urgent care, while building upon its industry-leading scheduling solution for
providers in specialties such as anesthesia, radiology, cardiology, obstetrics
& gynecology, and pathology. The QGenda platform also includes solutions
for on-call scheduling, room management, time tracking, compensation
management, and workforce analytics.


Transitioning from Traditional to E-Fax: How Healthcare Communications are Transforming Post-COVID

Telehealth After COVID-19: What's Next for the Healthcare Industry?
Michael Morgan, CEO of Updox

The majority of industries have decreased or eliminated their use of the traditional fax machine over the past decade, including aviation, retail, and even finance. While the healthcare industry is at the forefront of disease research and treatment, however, it is still heavily reliant on this aging technology. 

Traditional fax has become ubiquitous in healthcare. It worked for health systems for many years, but the overwhelming volume of patient data and paper documents the healthcare industry is now processing makes traditional faxing more challenging. In today’s environment, fax is no longer the most convenient, safe, or secure communications format but it is still an ingrained part of practice workflows. The good news is, there is no need to “axe the fax” in order to improve office communications and alleviate paper overload. By transitioning to electronic fax, healthcare providers can maintain their workflows and the benefits of fax, while incorporating it into their overall virtual communications strategy – further simplifying the business of healthcare. 

The Traditional Fax Challenge

The challenge with traditional fax isn’t new. In fact, in 2008 the Obama administration allocated nearly $30 billion to incentivize American hospitals and doctor offices to switch from paper to electronic systems. Since then, the industry has made small steps towards a more digitized system via fax servers and virtual patient communications such as secure text and broadcast messaging. While this solved part of the problem by making documents electronic and streamlining communications, it did not address the issue of inefficiency at its core, as practices are still printing, signing, and scanning paper documents. This inefficiency is causing a bottleneck when it comes to getting information transferred quickly, creates unnecessary costs for practices, and causes a lack of integration between health technologies across our healthcare system. 

A recent poll by the Medical Group Management Association (MGMA) found that 89% of healthcare organizations still use a fax machine, primarily to: 

  • Share patient records and lab and/or test results
  • Referrals
  • Payer communication
  • Pharmacy communication

This fragmented, outdated way of communication is not only inefficient and costly, it also impacts patient privacy and safety. At the onset of the COVID-19 pandemic, one Texas health department received so many test results via fax in one day that it simply couldn’t keep up with the amount of paper being spit out – resulting in hundreds of confidential results being dumped on the floor. In addition, the vast differences between old and new technology being blended together are making it difficult to keep track of patient records, share data between practices or report to the government, and more, including important racial, ethnic and geographic data that the Trump administration required for COVID tests. In addition to these challenges, traditional fax eats up staff time that could instead be spent on patient care.  

Addressing Outdated Systems and Driving Transformation 

While on the surface the solution seems simple, actually addressing this challenge at its core is not as easy as it seems. Many providers and large health systems face barriers when it comes to implementing this technology, such as: 

  • Compatibility between systems 
  • Fear of competition and/or losing patients to other health systems if e-fax enables patients to easily share data with other physicians
  • Cost considerations
  • Regulatory issues around the transfer of data between providers/EHRs through electronic fax

Despite these challenges, the pandemic has highlighted the delayed, disjointed communications that exist within our healthcare system – and underscored the need for practices and health systems to adopt electronic fax technology. For example, a CNBC survey found that due to COVID-19 tests results coming in via fax in such large amounts, almost 40% of Americans had to wait more than three days for their results, which was too late to be clinically meaningful.  

It’s time to address this challenge industry-wide. Last year’s MGMA 2020 virtual conference theme, Rise Above, focused on giving providers actionable tools to navigate through the challenges COVID-19 has presented. The importance of virtual care solutions, including communications tools like electronic fax and forms, are unprecedented. Electronic fax technology can help alleviate the bottlenecks and inefficiencies that currently exist in healthcare. These solutions can: 

  • Reduce costs spent on traditional fax hardware, such as paper, ink, toner, etc.
  • Increase accessibility, allowing providers to view documents via mobile, etc.  at their convenience 
  • Improve practice workflow and efficiency, allowing practices to edit, organize, assign and complete patient forms online

Additionally, electronic fax should integrate seamlessly with other patient management solutions that practices are leveraging, such as video chat, SMS text, electronic forms, and a virtual waiting room, ultimately streamlining the entire patient experience.

Healthcare has transformed dramatically this year and will continue to do so — there’s a new expectation of patient care post-COVID. In order to improve patient communications, practice efficiency, system interoperability, and data sharing, practices must adopt an entire virtual care strategy, including electronic fax. Offering telehealth but still communicating via traditional fax will hold your practice back. It’s time for our healthcare system to ditch outdated systems and go completely paperless. This is how we will tap into the true power of the inbox, drive practice profitability and efficiency, and better serve patients. 


About Michael Morgan, CEO of Updox
With a successful track record in helping organizations use technology to transform the way healthcare is delivered, Mike has more than 25 years of healthcare leadership within software, behavioral health, and HIT organizations. Updox was named to the Inc. 5000 list of fastest-growing companies in America for the past six consecutive years.


FCC Unveils 14 Initial Projects Selected for $100M Connected Care Pilot Program

FCC COVID-19 Telehealth Program Providers

What You Should Know:

– FCC announces initial 14 pilot project selected for $100M Connected Care Pilot Program that will support connected care service across the country and focus on low-income and veteran patients.


The Federal Communications
Commission (FCC)
today announced an initial set of 14 pilot projects with
over 150 treatment sites in 11 states that have been selected for the Connected
Care Pilot Program
.  A total of $26.6 million will be awarded to these
applicants for proposed projects to treat nearly half a million patients in
both urban and rural parts of the country. 


Connected Care Pilot Program Background

Overall, this Pilot Program will make available up to $100
million over a three-year period for selected pilot projects for qualifying
purchases necessary to provide connected care services, with a particular
emphasis on providing connected care services to low-income and veteran
patients.  

The Pilot
Program will use Universal Service Fund monies to help defray the costs of
connected care services for eligible health care providers, providing support
for 85% of the cost of eligible services and network equipment, which include:

1. patient
broadband Internet access services

2. health care
provider broadband data connections

3. other
connected care information services

4. certain
network equipment

These pilot projects will address a variety of critical
health issues such as high-risk pregnancy, mental health conditions, and opioid
dependency, among others. Here is the list initial list of healthcare providers
that were selected into the Pilot Program:

Banyan Community Health Center, Inc.,
Coral Gables, FL.
 
Banyan Community Health Center’s pilot project seeks $911,833 to provide
patient-based Internet-connected remote monitoring, video visits or consults,
and other diagnostics and services to low-income and veteran patients who are
suffering from chronic/long-term conditions, high-risk pregnancy, infectious
disease including COVID-19, mental health conditions, and opioid
dependency.  Banyan Community Health Center plans to serve an estimated
20,847 patients in Miami, Florida, 85% of which are low-income or veteran
patients.

Duke University Health System, Durham,
NC.
  Duke
University Health System’s pilot project seeks $1,464,759 to provide remote
patient monitoring and video visits or consults to a large number of low-income
patients suffering from heart failure, cancer, and infectious diseases. 
Duke University Health System’s pilot project plans to serve an estimated
16,000 patients in North Carolina, of which 25% are low-income.

Geisinger, consortium with sites in
Lewiston, PA; Danville, PA; Jersey Shore, PA; Bloomsburg, PA; Coal Township,
PA; and Wilkes-Barre, PA.
 
Geisinger’s pilot project seeks $1,739,100 in support to provide connected care
services and remote patient monitoring to low-income patients in rural
communities in Pennsylvania.  Geisinger’s pilot project would serve an
estimated 1,000 patients and would focus on chronic disease management and
high-risk pregnancies, while also treating infectious disease and behavioral
health conditions.  Through its pilot program, Geisinger plans to directly
connect all participating patients, 100% of whom are low-income, with broadband
Internet access service. 

Grady Health System, Atlanta, GA.  Grady Health System’s pilot
project seeks $635,596 to provide Internet connectivity to an estimated 1,896
primarily low-income and high-risk patients who are unable to utilize video
telemedicine services due to lack of a reliable network connection in
Atlanta.  The program will focus on using connected care services such as
patient remote monitoring and video visits/consults to treat vulnerable
patients with conditions such as congestive heart failure, COVID19,
hypertension, diabetes, heart disease, and HIV. 

Intermountain Centers for Human
Development, consortium with sites in Casa Grande, AZ; Nogales, AZ; Coolidge,
AZ; and Eloy, AZ. 
 Intermountain
Centers for Human Development’s pilot project seeks $237,150 in support to
treat mental health conditions, opioid dependency, and other substance abuse
disorders.  The pilot project plans to serve 3,400 patients in Arizona,
including rural areas, of which 90% are low-income.

MA FQHC Telehealth Consortium,
consortium with 76 sites in Massachusetts.
  MA FQHC Telehealth Consortium’s pilot project
seeks $3,121,879 in support to provide mental health and substance abuse
disorder treatment through remote patient monitoring, video visits, and other
remote treatment to patients in Massachusetts, including significant numbers of
veterans and low-income patients.  The pilot project will expand access to
these services by leveraging program funding to increase bandwidth at its
sites, and to provide patients with mobile hotspots.  This project would
serve 75,000 patients through 76 federally qualified health centers in
Massachusetts, including rural areas, with an intended patient population of
61.5% low-income or veteran patients.

Mountain Valley Health Center,
consortium with 7 sites in Northeastern California.
  Mountain Valley Health Center’s
pilot project seeks $550,800 in support to provide telehealth capabilities and
in-home monitoring of patients with hypertension and diabetes.  Mountain
Valley’s pilot project plans to serve an estimated 200 patients in rural
Northeastern California, of which at least 24% will be low-income patients and
10% will be veteran patients.

Neighborhood Healthcare – Escondido,
Escondido, CA, Neighborhood Healthcare – Valley Parkway, Escondido, CA,
Neighborhood Healthcare – El Cajon, El Cajon, CA, Neighborhood Healthcare –
Temecula, Temecula, CA, Neighborhood Healthcare – Pauma Valley, Pauma Valley,
CA.
  Neighborhood
Healthcare’s pilot project seeks $129,744 to provide patient broadband access
to primarily low-income patients suffering from chronic and long-term
conditions (e.g., diabetes and high blood pressure).  Neighborhood
Healthcare’s collective project plans to serve an estimated 339 patients, 97%
of which are low-income patients, in five sites serving Riverside and San Diego
counties.

OCHIN, Inc., consortium with 15 sites in
Ohio, 16 sites in Oregon, and 13 sites in Washington.
  OCHIN’s pilot project seeks
$5,834,620 in support to lead a consortium of 44 providers in Ohio, Oregon, and
Washington, encompassing 8 federally qualified health centers (FQHCs) serving
rural, urban, and tribal communities.  OCHIN’s pilot project will provide
patient broadband Internet access service and wireless connections directly to
an estimated 3,450 low-income patients to access connected care services,
including video visits, patient-based Internet-connected patient monitoring,
and remote treatment and will deliver care to treat high-risk pregnancy,
maternal health conditions, mental health conditions, and chronic and long-term
conditions such as diabetes, hypertension, and heart disease. 

Phoebe Worth Medical Center – Camilla
Clinic, Camilla, GA; Phoebe Physicians Group Inc – PPC of Buena Vista, Buena
Vista, GA; Phoebe Physicians Group – Ellaville Primary Medicine Center,
Ellaville, GA; Phoebe Physicians dba Phoebe Family Medicine & Sports
Medicine, Americus, GA; Phoebe Putney Memorial Hospital, Albany, GA; Phoebe
Putney Memorial Hospital dba Phoebe Family Medicine – Sylvester, Sylvester, GA.
  The Phoebe Putney Health System
projects seek $673,200 to provide patient-based Internet-connected remote
monitoring, video visits, and remote treatment for low-income patients
suffering from chronic conditions or mental health conditions.  These projects
plan to serve an estimated 4,007 patients, approximately 1,000 of which will be
low-income patients in six sites serving southwest Georgia. 

Summit Pacific Medical Center, Elma, WA.  Summit Pacific Medical Center’s
pilot program seeks $169,977 in support to provide patient-based
Internet-connected remote monitoring, other monitoring services, video visits,
diagnostic imaging, remote treatment and other services for veterans and
low-income patients suffering from chronic conditions, infectious diseases,
mental health conditions, and opioid dependency.  Summit Pacific Medical
Center’s pilot project would serve an estimated 25 patients in Elma,
Washington, 100% of which would be low-income or veteran patients.

Temple University Hospital,
Philadelphia, PA.
 
Temple University Hospital’s pilot project seeks $4,254,250 to provide
patient-based Internet connected remote monitoring and video visits to
patients, including low-income patients, suffering from chronic/long-term
conditions and mental health conditions.  This pilot project plans to
serve an estimated 100,000 patients in Philadelphia, Pennsylvania, 45% of which
are low-income patients. 

University of Mississippi Medical
Center, Jackson, MS.
 
The University of Mississippi Medical Center’s (UMMC) pilot project seeks
$2,377,875 in support to provide broadband Internet access service to patients,
enabling remote patient monitoring technologies and ambulatory telehealth
visits to low-income patients suffering from chronic conditions or illnesses
requiring long-term care.  UMMC’s pilot project would impact an estimated
237,120 patients across Mississippi and serve up to 6,000 patients
directly.  Of these patients, UMMC estimates that 52% would be low-income.

University of Virginia Health System,
Charlottesville, VA. 
 The
University of Virginia (UVA) Health System’s pilot project seeks $4,462,500 in
support to expand the deployment of remote patient monitoring and telehealth
services to an estimated 17,000 patients across Virginia, nearly 30% of whom
will be low-income.  The UVA Health System pilot project will support
patient broadband and information services, including systems to capture,
transmit, and store patient data to allow remote patient monitoring, two-way
video, and patient scheduling. 

A Mix of Pride and Doubts as Modi Launches India’s Covid-19 Vaccine Drive

One of the world’s largest inoculation programs is set to begin on Saturday, but experts have questioned the data behind one of the country’s two vaccines — and patients don’t get to pick their shot.

Covid: 5 razones para seguir usando máscara después de vacunarse

Como médica de emergencias, la doctora Eugenia South fue parte del primer grupo de personas en recibir la vacuna contra covid. Tuvo su segunda dosis a principios de enero, incluso antes que el presidente electo Joe Biden.

Así y todo, South dice que no tiene apuro por dejar de usar máscara

“Honestamente, no creo que vuelva a estar sin máscara en el trabajo”, dijo South, quien es directora del Urban Health Lab de la Universidad de Pennsylvania en Philadelphia. “No creo que me sentiría segura”.

Aunque las vacunas contra covid son altamente efectivas, South planea seguir usando máscara dentro y fuera del hospital.

Expertos en salud dicen que hay buenas razones para seguir el ejemplo de esta doctora.

“El uso de máscaras y el distanciamiento social deberán continuar en el futuro, hasta que tengamos cierto nivel de inmunidad colectiva”, dijo el doctor Preeti Malani, oficial de salud jefe de la Universidad de Michigan. “Las máscaras y el distanciamiento están aquí para quedarse”.

Malani y otros expertos en salud explican cinco razones:

  1. Ninguna vacuna es 100% efectiva

Extensos ensayos clínicos hallaron que dos dosis de las vacunas de Moderna y Pfizer-BioNTech prevenían el 95% de las enfermedades causadas por el coronavirus. Si bien esos resultados son impresionantes, 1 de cada 20 personas queda desprotegida, dijo el doctor Tom Frieden, ex director de los Centros para el Control y Prevención de Enfermedades (CDC).

Malani señala que las vacunas se probaron en ensayos clínicos controlados, en los mejores centros médicos, en condiciones óptimas.

Pero en el mundo real, las vacunas suelen ser un poco menos efectivas. Los científicos usan términos específicos para describir el fenómeno. Se refieren a la protección que ofrecen las vacunas en los ensayos clínicos como “eficacia”, mientras que la inmunidad real que se obvserva en la población vacunada es “efectividad”.

La efectividad de las vacunas contra covid podría verse afectada por la forma en que se manipulan, observó Malani. El material genético utilizado en las vacunas elaboradas con ARN mensajero del coronavirus es tán frágil que debe almacenarse y transportarse con cuidado.

Cualquier variante que no siga la guía de manejo de vacunas de los CDC podría influir en su funcionamiento, explicó Malani.

  1. Las vacunas no brindan protección inmediata

Malani explicó que ninguna vacuna ofrece protección apenas la persona se vacuna. El sistema inmunológico tarda aproximadamente dos semanas en producir anticuerpos que bloquean las infecciones virales.

Las vacunas contra covid, sin embargo, tardarán un poco más que otras porque tanto la de Pfizer como la de Moderna, requieren de dos dosis. Las dosis de Pfizer se administran con tres semanas de diferencia, las de Moderna, con cuatro semanas.

Es decir que no habrá protección completa hasta cinco o seis semanas después de la primera dosis. Una persona que se vacunó el día de Año Nuevo no estará completamente protegida hasta el día de San Valentín.

  1. Es posible que las vacunas no impidan propagar el virus

Las vacunas pueden poporcionar dos niveles de protección. Por ejemplo, la vacuna contra el sarampión previene que el virus infecte un organismo, por lo que las personas vacunadas no transmiten la infección ni desarrollan síntomas.

La mayoría de las otras vacunas, como la de la gripe, evitan que las personas se enfermen pero no que se infecten o transmitan el virus a otros, explicó el doctor Paul Offit, asesor de los Institutos Nacionales de Salud (NIH) y de la Administración de Drogas y Alimentos (FDA) sobre las vacunas contra covid.

Si bien las vacunas contra covid claramente previenen la enfermedad, los científicos necesitan más tiempo para descubrir si también previenen la transmisión, dijo Saskia Popescu, epidemióloga con sede en Phoenix y profesora asistente en el programa de biodefensa de la Escuela Schar de Gobierno y Políticas de la Universidad George Mason.

“Todavía no sabemos si la vacuna protege contra la infección o solo contra la enfermedad”, dijo Frieden, quien ahora es director ejecutivo de Resolve to Save Lives, una iniciativa mundial de salud pública. “En otras palabras, una persona vacunada podría transmitir el virus, incluso si no se siente enferma”.

Hasta que los investigadores puedan responder esta pregunta, usar cubrebocas es la forma más segura para que las personas vacunadas protejan a quienes las rodean.

  1. Las máscaras protegen a personas con sistemas inmunitarios comprometidos

Las personas con cáncer tienen un riesgo particular de contraer covid. Estudios han mostrado que son más propensos a infectarse y a morir a causa del coronavirus. Y es posible que las vacunas no los protejan dijo el doctor Gary Lyman, profesor del Centro de Investigación del Cáncer Fred Hutchinson.

Los pacientes con cáncer son vulnerables en muchos aspectos. Las personas con cáncer de pulmón son menos capaces de combatir una neumonía, y los que están bajo quimioterapia o radioterapia tienen sistemas inmunes debilitados. La leucemia y el linfoma atacan directamente las células inmunitarias, lo que dificulta que los pacientes combatan el virus.

Lyman dijo que no se sabe cómo reaccionarán a la vacuna los pacientes oncológicos, porque fueron excluidos de los ensayos clínicos. A solo unos pocos participantes se les diagnóstico cáncer después de inscribirse. En este grupo, la protección de las vacunas solo fue del 76%.

“Por ahora, debemos asumir que los pacientes con cáncer pueden no experimentar el 95% de eficacia”, completó Lyman.

También hay algunas personas alérgicas que no pueden vacunarse.

Usar máscaras también ayuda a proteger a estos grupos más vulnerables.

  1. Las máscaras protegen contra cualquier cepa del coronavirus, la original y las nuevas mutaciones

Líderes a nivel global están muy preocupados por las nuevas variantes genéticas del coronavirus, que al parecer son 50% más contagiosas.

Hasta ahora, los estudios sugieren que las vacunas protegerán contra estas cepas. Pero es claro, según explicó Frieden, que los cubrebocas, la distancia física y medidas como evitar multitudes protegen contra todas las formas del virus, y de otros virus respiratorios.

Por ejemplo, los casos de gripe bajaron dramáticamente en todo el mundo desde que se implementaron las cuarentenas y el uso de máscaras.

Lo ideal es combinar las vacunas con las máscaras y el distanciamiento, para poner fin a la pandemia, dijo Offit. “Los tres enfoques funcionan mejor en equipo”.

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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Worldwide coronavirus deaths pass 2 million

The world passed 2 million coronavirus deaths on Friday, a stunning toll that is continuing to rise as more contagious variants of the virus take hold.The United States has had, by far, the most deaths and cases of any country in the world, at more…

Listen: Coronavirus Mutations

After a new variant of the coronavirus spread throughout the United Kingdom, daily cases hit record levels and the prime minister ordered a national lockdown. Now more mutations from South Africa and Brazil have made headlines. The prospect of a more transmissible virus has many worried, but exactly how bad are these new mutations? And should you change anything you’re doing already?

Vineet Menachery, a virologist at the Galveston National Laboratory who studies coronaviruses, joins staff writer James Hamblin and executive producer Katherine Wells on the podcast Social Distance to explain.

Listen to their conversation here:

Subscribe to Social Distance on Apple Podcasts, Spotify, or another podcast platform to receive new episodes as soon as they’re published.


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

Katherine Wells: My understanding is that virus mutations happen all the time. And the lesson I learned in the early days of this pandemic was: Don’t worry about them too much because it’s normal, and it doesn’t mean it’s worse just because it’s mutated. These latest mutations in the news seem different and more worrisome, but I don’t understand why. Are they in fact different and more worrisome than all the previous evolving mutations?

Vineet Menachery: The quickest answer at this point is: We don’t know yet. The mutations that we think about are twofold: There are mutations that allow the virus to replicate or transmit better. These are worrisome because obviously that just changes how fast this virus can spread. And that’s one of the concerns for these variants. There’s the U.K. variant. There’s a South African variant. And, most recently, there’s a variant in Japan that’s been traced back to Brazil. Each of these have a mutation at a position in the spike protein that are associated with, potentially, an increase in transmission.

Wells: Can you help me visualize it? It’s like the spike is spikier and therefore stickier, or something?

Menachery: The analogy I would make is that it’s like a key. And the spike protein has to fit to its key. Now you can think about a key in a lot of different ways, but the better that key fits, the more efficient and transmissible the virus is going to be. These new variants may actually fit that key better. And that allows the virus to replicate or transmit a little bit better than the previous versions. And that’s what’s concerning.

Wells: So this particular mutation wouldn’t mean that it hangs longer in the air or that it is better at sticking to your skin or something. It just means that, once it is in your body, it is better at actually latching on to the cells that it needs to infect you. It’s not actually that it’s easier to get into your body. It just is more likely to infect you once it’s inside.

Menachery: Yeah, I think it gets back to efficiency. Now, we don’t know anything for sure, but the barriers that are in place [such as] masking and social distancing will still be effective against this. The virus hasn’t changed fundamentally. It’s a small difference in a molecular aspect of the virus that gives it a little bit of an advantage. We think, based on the math, that it does have an advantage over the original, but we don’t know the scale at which it has an advantage. Is it 10 times worse or is it two times worse?

Both viruses, the original and this version, are pretty transmissible. And so if it’s two times worse, you may not be able to see the difference. If it’s 10 times worse, you’ll see that in terms of how quickly the virus spreads.

Wells: How do we figure that out?

Menachery: There are a bunch of different ways, and none of them are particularly great. There are experimental ways. Scientists here, and around the world probably, will take the different variants and put them into animals in direct competition. We’ll take the original and the new variant, mix them together, and put them in animals to see how well they transmit [and] how well they replicate.

Wells: Is that what you’re doing now?

Menachery: People in our group are doing that experiment as we speak.

Wells: What animals?

Menachery: We’ll be doing them in hamsters. I imagine groups will try to do it in ferrets, and maybe even in mice. Each of these models are useful in their own way, but none are ideal because none of them are really human.

James Hamblin: When you hear a number, like what was widely reported out of the U.K., like “70 percent more transmissible”—which I believe made it to a push alert from The New York Times and is widely cited—do you think it’s premature to put a number like that on it, or do you think that’s an accurate ballpark [figure]?

Menachery: The number is accurate in the context of the viruses that are spreading in the U.K. So that’s just based on what they’re surveying and the total numbers. You can see that it is becoming a great part of the population very quickly. But it’s hard to gauge. You have the original virus, and you’re comparing it to this other virus. And it’s moving faster, but we can’t control for other aspects. The virus may be moving through a population faster than it was in the summer because of the temperature or the conditions or the lockdowns or how [lax] sick people are with their masking.

There are so many factors that contribute to that. It does appear, based on just the pure mathematical numbers, that the strain is moving faster and is more transmissible. But again, we don’t have a relative scale to know how much more transmissible it is than the original.

Wells: How do I, as a person trying to just get through this, internalize this news? There are two concerns: Do I have to change my behavior? And should I be worried about vaccines?

I’ve developed an understanding of how this transmits, a way of behaving, a risk tolerance that involves mostly being very worried about being not masked with people close and kind of being aware of surfaces, but everyone tells me surfaces aren’t really how it transmits. Does this raise the stakes of any of my day-to-day behaviors?

Menachery: I don’t believe so. The precautions you’re taking should still keep you safe. The virus is not structurally different. It’s these small changes at the molecular level. But it is a situation where, if you’re unmasked, you may be at a greater risk of getting infected from that same person. We don’t know how much more, but if you’re in contact and don’t have the same level of precaution as before, you’re going to be at a greater risk with these new variants.

Hamblin: As I understand it, viruses can become more transmissible by either being more efficient—that key being better able to enter a cell—and/or increasing the viral load within a person. So when you are carrying this virus, you just have more within you and you therefore have more that’s able to infect other people. Are there possibly other effects of that? [If it causes] a higher viral load, people might develop symptoms differently or the disease might manifest differently. Could that have other good or bad consequences that would change the course of the pandemic?

Menachery: The worry would be: If you’re increasing the viral load, the virus is replicating better and that might cause more severe disease. We haven’t had any evidence that these new variants cause more severe disease. And this gets to a weird aspect of disease and transmissibility. If you get really sick, you actually don’t transmit the virus all that well because you’re really sick and you don’t interact with the same number of people, whereas a virus that causes less disease might actually be more transmissible in a sense, because, since you don’t feel as bad, you’re more likely to transmit it to other people.

So there’s a bit of a dichotomy in how viruses spread. This particular COVID-19 is kind of this Goldilocks of viruses. If it was a little bit more severe, it would be easier to control. If it was a little bit less severe, it wouldn’t be as disruptive. And so, in the same sense, these variants could push in one direction or the other. So far, we haven’t had any evidence from the human data that there’s more severe disease associated with it. But often it takes three or four weeks for that data to come in. Coronavirus doesn’t kill in three or four days. It takes three or four weeks. And so, we may be just getting some of that information now. And then the studies we’re doing in hamsters and in mice will also give us some insight. When we compare the variant to the original, we’ll see how sick those animals get and really look at how much disease and how much damage the new variant causes, relative to the original viruses.

Wells: What is your level of worry right now?

Menachery: On a scale of one to 10, I’m probably at a three or a four at this point. There are certain mutations that are more important than others. Some are related to transmission. And these variants are coming up in a population of people [where] the vast majority of people don’t have any immunity. These variants we’re seeing haven’t been pushed to evolve away from antibodies yet.

Your antibodies may be not as effective, but they’re still going to be effective. If you have 10 times the amount of antibody that you need and you lose half of that, you’re still going to be well protected. And I think that’s where these variants are. Most people will be well protected from the worst aspects of disease.

Hamblin: Is the virus going to become more transmissible and eventually infect us all but cause less severe disease? Do we have any idea of the overall arc of this narrative that’s just starting to unfold?

Menachery: It’s hard to say, obviously. What you’ve described is something that may have already happened in the natural world with common coronaviruses. There are four or five common-cold coronaviruses. Many of them have their roots in animals, whether they be bats or cows or other animal species, and then jumped into humans. None of those viruses cause severe disease. They’re all relatively transmissible, and you can get infected every two or three years with them.

There is some possibility [SARS-CoV-2] will go along that route. Once we’ve all gotten some level of baseline immunity—we’ve seen a virus like this or very similar to this—the next time you have it, it [may cause] a mild infection but, for the most part, you won’t end up in a hospital or on a respirator. That’s kind of the trajectory that you could expect, but again, we don’t know.

This event could have happened in 2002 with [SARS-CoV-1], but that virus was effectively stopped through quarantining and other procedures. We have an event now where most of the world will have seen this virus, either through a vaccine or through natural immunity, and so its trajectory in a few years is really hard to predict. I’m hopeful that it’s going to be more like a common-cold coronavirus. The best outcome would be that it’s like SARS 1 and it just disappears from the Earth.

The Evolution of the Coronavirus

In the final, darkest days of the deadliest year in U.S. history, the world received ominous news of a mutation in the SARS-CoV-2 coronavirus. Scientists in the U.K. had identified a form of the virus that was spreading rapidly throughout the nation. Then, on January 4, Prime Minister Boris Johnson announced a lockdown that began almost immediately and will last until at least the middle of February. “It’s been both frustrating and alarming to see the speed with which the new variant is spreading,” he said in an address, noting that “our scientists have confirmed this new variant is between 50 and 70 percent more transmissible” than previous strains.

Those figures, based on an early estimate by British government scientists in late December, made for terrifying push alerts and headlines. Though this strain of the virus (officially called “B.1.1.7”) quickly became known as “the U.K. variant,” it has already been found in 45 countries, suggesting that the opportunity to contain it with travel restrictions has passed. On January 8, Australia locked down Brisbane, a city of 2.3 million people, after discovering a single case.

Each day, B.1.1.7 is being found in more people in more places, including all around the United States. Experts have raised dire warnings that a 70 percent more transmissible form of the virus would overwhelm already severely stretched medical systems. Daily deaths have already tripled in recent months, and the virus is killing more than 3,000 Americans every day. From a purely mathematical perspective, considering exponential growth, a significantly more transmissible strain could theoretically lead to tens of thousands of daily deaths, with hospital beds lining sidewalks and filling parking lots.

[Read: The problem with stories about dangerous coronavirus mutations]

To make matters worse, the warnings from Britain were followed by headlines about yet another variant, B.1.351, in South Africa. Then another concerning variant was identified in Brazil. News reports speculated that these strains may resist vaccines. Some experts cautioned that the mutations could render current treatments less effective. Scott Gottlieb, the former director of the FDA, said last week: “The South Africa variant is very concerning right now because it does appear that it may obviate some of our medical countermeasures, particularly the antibody drugs.” On Tuesday, Anthony Fauci echoed that concern, calling the variant “disturbing.”

These new variants demand to be taken seriously. Skyrocketing case counts in the U.K. suggest a potential to do enormous damage, and the identification of B.1.1.7 in so many countries is noteworthy. Still, we don’t yet know whether either variant will become as dominant worldwide as they have in their respective countries. They might spread widely and cause tremendous harm. They might also do neither.

The sheer scale and capacity of this virus are challenging many things we thought we knew, but the basic laws governing its evolution are not among them. All viruses are constantly evolving and changing, just as human populations are. When a virus is spreading as widely and rapidly as SARS-CoV-2, spinning through trillions of generations each minute, adaptation is inevitable. The transmissibility of the virus will change. The severity of the disease it causes will change. Its ability to evade our immune system will change. It very well may evolve to circumvent our current vaccines.

Thanks to genetic-sequencing technology, we can watch this evolution in real time. We can see the changes in a virus’s genes before we even know what they mean for the spread of disease. Charting the course of this evolution, and assessing its significance, has quickly become a foremost challenge of the pandemic. The peril is not that the virus will suddenly change in an extraordinary way that transforms the pandemic, but that it is changing in small, ordinary ways that are playing out on a vast scale, and whose significance we may not appreciate until it’s too late.

Almost exactly a year ago, in January of 2020, a flight attendant warned the renowned Chinese virologist Zhang Yongzhen: It was time to turn off all portable electronic devices. He was sitting with his phone to his ear. On the other end of the line, his Australian collaborator Eddie Holmes was pleading with him to publish the genetic code of the novel coronavirus.

The Chinese government had forbidden this. Yongzhen was torn. The world did not yet know the cause of the rapidly spreading respiratory infection, and he seemed to have uncovered it in a sample of sputum from a severely ill person in Wuhan. Using genomic sequencing to unravel the code of the virus, he had found what appeared to be the blueprint of a new coronavirus.

He told Holmes to publish the code. When Holmes did so on Twitter, the international scientific community pounced. Within days, researchers in Thailand were able to verify that the same virus had infected patients there. Scientists at the U.S. National Institutes of Health began to work on a vaccine. The code became the backbone of the Pfizer/BioNTech and Moderna vaccines, which owe their development to the speedy identification and sharing of the genome.

[Read: The end of the pandemic is now in sight]

The exact sequence that Holmes tweeted is now a relic. The virus it represented is gone, replaced by many, many, many subsequent generations. New lineages have arisen in different parts of the world, and hundreds of thousands of slightly different sequences have been added to an international database. There are now thousands of unique SARS-CoV-2 genomes, each the result of myriad permutations of mutations in the code. There is no single, standard genetic code for this coronavirus, any more than there is a standard human genome.

“The term variant is misleading, in that it creates the idea that all the other viruses are the same,” explains Ramon Lorenzo Redondo, a genomic analyst at Northwestern University’s Feinberg School of Medicine. Technically, every version of the virus is a variant. Even within a single person, the virus changes and evolves many times. If you were to have your bodily fluids sequenced on different days, the viral strains would show new mutations. “Viruses operate as a cloud of mutants—a swarm of mutants,” Redondo told me.

This is not a flaw in the system, but rather the way viruses work. When it comes to reproduction, viruses are sloppy. The speed and scale of their replication come at the cost of accuracy; they operate like a spam email marketing scheme, favoring inundation over meticulous grammar. Insofar as a virus can be said to have a “goal,” the goal is to ensure as many future generations as possible. To that end, it fires off shotgun blasts of imperfect clones, gambling that a few will make their way to other cells and penetrate them.

Almost all of these accidental mutations are inconsequential: The virus still looks and functions just as its parent before it did. Over time, though, sets of mutations can layer on top of one another and accumulate, and the virus begins to function differently. Some of these differences confer an advantage of one sort or another—for example, increased transmissibility.

“What we’re observing is very expected,” Paul Turner, a professor of ecology and evolutionary biology at Yale, told me. “If a population can improve in its environment, evolution lets that happen. The virus population size is expanding, and mutations spontaneously occur.”

Although it’s not news that the virus has mutated, it’s extremely important to keep an eye on the general direction of the changes—and what they mean for the humans whose cells are being hijacked. “If you see a mutation that could allow the virus to escape detection by the immune system, or escape vaccine coverage, that’s very worrisome,” Turner said. “We don’t have evidence of that yet.”

The likelihood of these scenarios depends on a few factors. Some viruses mutate more readily than others: Influenza mutates so quickly that new strains spread around the world each year, requiring the creation of new vaccines. Measles, by contrast, mutates slowly, so people who were vaccinated decades ago are very likely still protected. “Coronaviruses typically don’t mutate very quickly,” Turner said. “I don’t see any evidence that this coronavirus is going to suddenly become like influenza. But right now there are so many people infected, and the virus is in a new environment [humans instead of bats], so I’m not surprised that evolution is pushing it to improve.”

In the long run, he believes, the spread of this coronavirus will more closely resemble measles than flu. Although we may need to update our vaccines occasionally, we won’t need to do so every year. But as long as rates of infection remain high, the coronavirus is likely to acquire, over months or years, the ability to at least partially bypass our immune responses. Second-time infections may be less severe, but their severity also depends on how the virus evolves. And we may develop immunity to one variant but not to another.

In anticipation of such complexities, Redondo and others have been creating and updating phylogenetic maps—essentially, family trees—for this coronavirus. Groups with a common ancestor are referred to as a “lineage.” A lineage is something like a human family: different individuals sharing a common ancestor. (B.1.1.7 and B.1.351 are separate lineages that evolved similar changes in their spike protein independently.)

Genetic commonalities can also define broader groups called “clades.” Last spring, a clade known as D614G came to dominate the world. This was attributed to a mutation in the spike protein that made this group more transmissible than previous strains. And this was just one part of a family tree that’s now more like a forest. “The two first clades that were defined have disappeared,” Redondo said. Right now five major clades are jockeying for dominance, he said, but the picture is constantly shifting.

The emergence of a new clade can be as difficult to predict as any rise to global domination. Obsolescence and dominance are determined by the qualities of the lineages, the characteristics of the host populations, and the legacies of previous microbial invaders. The fact that a lineage or clade is dominant in one place, within one group of humans, does not mean it will be in others. So far, the U.K. and South African variants are dominating local surges, but they are not expansive enough to be considered clades. The South African variant, for example, accounts for about 90 percent of the genetic sequences analyzed in the country, but remains a minor player elsewhere.

Similarly, the B.1.1.7 variant was identified in the U.K. in September, yet so far dominates only one geographic region. Although genomic testing in the U.S. is relatively sparse, “we’re doing enough sequencing that we know it’s not that common in the U.S.,” says Nathan Grubaugh, a microbial epidemiologist at the Yale School of Public Health. “This variant doesn’t seem to be more than 1 or 2 percent of cases at the moment. It’s here, and it’s very widespread, but it’s low in frequency. I think, for the most part, this is true globally.”

For now, these variants may be thought of like weeds in a garden. They have shown that they have the capacity to take over in some areas. There is a plausible mechanism that could allow them to do so elsewhere: Both the U.K. and South African variants share a mutation that manifests as a subtle change in a key site where the virus binds to human cells. But weeds take over for many reasons, and sometimes they have more to do with the garden than the weed. Human populations vary in so many ways—behaviorally, genetically, immunologically, geographically, environmentally—that the degree to which a regional surge in cases is due to a change in the virus itself is extremely difficult to discern. And that leads to some uncertainty. “We may have it wrong in the end, [and] it’s not actually more transmissible,” Grubaugh told me. “It seems to be, but we may have been fooled.”

Even if these variants are indeed as transmissible as the rising case numbers suggest, transmissibility is only one determinant of a virus’s overall potential to do harm. Sometimes viruses become more transmissible but ultimately less dangerous. And of course, each new variant is but an intermediate step toward some other form of the virus. The real challenge is understanding how any given change fits into all of these larger patterns, and what that means for us.

The plot of Michael Crichton’s 1969 novel, The Andromeda Strain, hinges on an extraterrestrial microorganism that “mutates” its way out of containment. A similar narrative device drives the film Outbreak, in which a bleed-from-the-eyes virus suddenly becomes airborne. What amounts to a lazy screenwriting cliché has loaded the word mutation with such horrifying subtext that it’s almost unusable. The process of viral evolution is much subtler, and requires a careful eye to detect. That subtlety is what makes it dangerous.

There are two basic ways that a coronavirus can become more transmissible. One is by binding more effectively to human cells. When this happens, a person who inhales viral particles becomes slightly more likely to develop an infection. The other is by replicating more efficiently, creating higher numbers of viral particles (higher “viral load”) in an infected person, so that they exhale more particles with each breath (making it statistically more likely that one of the particles will infect someone else). If a breath contains 10 percent more viral particles, it is that much more likely that one will land in someone else’s nose.

It’s unclear whether one or both of these mechanisms are at play in the U.K. and South African lineages, but we know their effects can be complex. If a person is carrying a much higher viral load, for example, they may get sick more quickly. That sounds bad—and it certainly is for that person. But a shorter asymptomatic period could ultimately make the virus easier to contain. This was the case with the first SARS coronavirus, in 2003 (SARS-CoV-1), which caused a more severe disease than SARS-CoV-2 does, but killed far fewer people in total because each case was identifiable.

By the same token, this coronavirus could evolve to cause a somewhat less severe illness—something slightly closer to that caused by the other four endemic coronaviruses. The common cold is extremely transmissible, yet rarely fatal. This makes sense from an evolutionary perspective: Viruses that kill their hosts are less likely to become dominant than those that don’t. “It could be that transmissibility correlates with being ‘kinder’ to your host,” Turner said. “We’ve observed that in other realms of virus evolution.” Natural selection would, hypothetically, favor the versions that leave people feeling well enough to be out and about, spreading the virus to other hosts.

Major changes in the severity of the disease—in either direction—are unlikely, but the scale at which this virus is operating means that small differences in things like transmissibility are amplified, and can manifest as significant changes in how many people get sick. Experts widely agree that playing it safe in the coming weeks is prudent. Oliver Pybus, a professor of evolution and infectious diseases at the University of Oxford, emphasizes that understanding why B.1.1.7 took over the U.K. “is extremely scientifically difficult.” He has been at the forefront of identifying and tracking the variant, but says huge questions remain unanswered. “There’s still considerable uncertainty as to the long-term consequences” of B.1.1.7, Pybus told me. “We don’t even know whether this lineage truly originated in the U.K., with so many countries not doing this surveillance.”

Though much of the world is now on alert for this particular variant, Pybus said that very few places are sequencing genomes as comprehensively as the U.K. is. In some places, institutions are sampling but not sharing findings in the public domain. Both elements are crucial. Testing with PCR or antigen tests alone is no longer sufficient. Positive tests must be followed by analyses of the genomes of the virus. The more genomes we have, the more effectively we can identify anomalous patterns, both to raise alarms early and to avoid raising false ones.

The U.S. is especially far behind the U.K. in this regard. Without a baseline level of genomic surveillance, Yale’s Grubaugh told me, we do not know if a city like New York would be as devastated by B.1.1.7 as London has been. The forecast for any given variant depends on context that we lack. “I don’t think any one state is doing enough sequencing yet,” Grubaugh said. “Sequencing is the most important thing. We don’t have a big organized project like in the U.K. What we have is a bunch of individual labs, mostly at academic medical centers.” Sporadic sequencing is arguably as bad as none at all, in that it can fail to represent how and why variants are spreading. And focusing too narrowly on hunting one particular variant can mean failing to notice other, possibly more consequential warning signs.

The hunt for any one variant also introduces selection bias, making it hard to know if the variant is truly spreading more readily than others, or if we are just looking harder for it. After finding a person carrying  B.1.1.7 in New York last week, for example, state health officials sequenced the genomes of nearby cases—an approach that is likely to find a disproportionate number of B.1.1.7 cases. Without constant, widespread surveillance testing, Pybus said, it’s difficult to discern an accurate overall picture.

“The field of genomic epidemiology is going through its adolescence in public, developing in full view of the most extraordinary event of the century,” Pybus told me. The ability to identify new viral lineages before we even understand how they will affect people may allow epidemiologists to warn of consequential variants—but may undermine their credibility when strains don’t prove as dangerous as headlines predict.

Even if we cannot contain this particular variant, we’re learning from its spread. Preventing more virulent strains from becoming dominant—when they inevitably do arise—may be possible if we can track genomic patterns more widely, so that we have the context needed to determine whether a strain is indeed uniquely dangerous. If we can take steps to contain a new threat early enough, it may never become widespread. If we miss these opportunities, we risk repeating the kind of mistake that allowed the original SARS-CoV-2 strain to escape China in the first place.

Last week, Eddie Holmes reflected on the fateful moment when he tweeted the virus’s original genetic code. It was a moment of triumph for collaborative science, but the work was just beginning. The triumph must be repeated daily. “What worries me most of all is if politics gets in the way of data sharing and science,” he told Medscape. “Step one has to be immediate, rapid, open data sharing. Speed is of the essence in a pandemic. Any barrier to working together makes this a much less safe world. That should be the lesson of this outbreak.”

The changing genetic code of the coronavirus will not nullify our fundamental strategies for ending the pandemic. With better data, we can keep our vaccines and antibody treatments up to date and our shutdown measures as minimal as possible, and we can sever any ominous new chains of transmission. The spread of new variants is a stark reminder that we all have an immediate part to play in this. If you carry the virus, it will mutate within you. You could be the person in whom a new, even more threatening variant emerges. You could seed the entire world with it. But no matter how the virus mutates, the same basic preventive measures—the unglamorous ones we’ve been lectured about for nearly a year—will still have the power to ensure that you don’t.

2nd Manufacturing Assets & Facility Management in Pharma (MAFM) Summit

Twenty-twenty has demonstrated the need for a 24/7reliable manufacturing environment. Emulating on the first edition in 2020, the 2nd Manufacturing Assets & Facility Management in Pharma (MAFM) Summit will return in May, dedicated to aiding Engineering, Maintenance & Manufacturing Facilities leaders to collaborate. This exclusive, industry-led community will enable you to reduce COGs and maximize efficiency over just 3 days!

Join this cutting-edge discussion with 80+ senior colleagues, including J&J, AstraZeneca, Merck KGaA to advance your predictive asset maintenance strategies, progress facilities to the next generation of manufacturing, and ensure sustainability.

Why is this Community for You? 

  • Understand how to plan and manage the next generation of biomanufacturing facilities. Accounting for sustainabilityflexibility and reliability
  • Revamp your asset management strategies to minimize downtime and extend asset lifespans
  • Implement smart asset solutions to reduce COGs such as lean manufacturing and total productive maintenance
  • Leverage industry 4.0 to utilize predictive maintenance programs
  • Hear best-in-class management for excellent capital engineering and maintaining operational readiness

Visit our website here to view the full agenda: https://ter.li/z9tcq7

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Interstitial Lung Disease (ILD) Drug Development Summit

Network with over 50 other industry pioneers including Ionis Pharmaceuticals, Genentech, Vicore, and AnaMar to hear first-hand how the latest scientific research is innovating and upgrading ILD therapeutics at this trailblazing new meeting.

The 1st Interstitial Lung Disease Drug Development Summit is a ground-breaking new conference dedicated to helping you drive forward the development of effective therapies for chronic fibrosing ILDs and achieve success in anti-fibrotic drug development beyond IPF.

Join the world’s top ILD specialists as they guide you through the seminal research and insights you need to confidently define, understand, and develop clinically effective antifibrotic therapies against connective tissue disease, rheumatoid arthritis, hypersensitivity pneumonitis, Goodpasture’s syndrome, and much more.

To view the full agenda, visit our website here: https://ter.li/8ug2my

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Maithri Drugs Pvt. Ltd-Walk-In Drive for Senior Positions in Quality Control Dept. On 18th Jan’ 2021

Maithri Drugs Pvt. Ltd-Walk-In Drive for Senior Positions in Quality Control Dept. On 18th Jan’ 2021

Job Description

Walk-In Drive On 9th Dec’ 2020 for Engineering Services (API) @ Maithri Drugs Pvt. Ltd, Bonthapally.

Walk-In Drive On 18th January 2021 @ MDPL, Bonthapally

Vacancies:  Assistant Manager/ Deputy Manager/ Manager

Eligibility Criteria: M.Sc with minimum 10-15 years of work experience.

Job Responsibilities: Need to plan & complete method validations and forced degradation Studies. Need to handle QC department as per regulatory guidelines and also analytical method validations. Need to face regulatory audits.

Documents to Be Carried:  Candidates are requested to carry Recent passport size photograph (MUST), Updated resume, Photostat copies of Educational Certificates, Latest Increment Letter, Last 3 Months Pay Slips, Last 6 Months Bank Statement and Photostat copy of Aadhar Card…

Timings: Only Men Candidates may Walk-In From 09:00 AM to 01:00 PM

Interview Venue & Work Location : Maithri Drugs Pvt. Ltd, Bonthapally. Landmark: Bonthapally Kamaan, Inside Bharat Petroleum Bunk Lane.

Google Map: https://goo.gl/maps/vV9L5cG9vadJVZS87

Contact:  040 30438366, 08452334101

Maithri Drugs Pvt. Ltd-Walk-In Drive for Senior Positions in Quality Control Dept. On 18th Jan’ 2021

Research shows gene therapies can offer cost savings potential of up to $1.8M over five years for patients with certain blood diseases

A recent analysis by Health Advances looks at two particularly burdensome hematological (or blood) diseases — beta thalassemia and hemophilia A — and finds that potential gene therapies in the pipeline could reduce per patient costs by as much as 41% and 90%, respectively, over five years. Research-based knowledge gained in recent years about the genetic foundation for these diseases has facilitated the pursuit of several promising gene therapy approaches.

ViewPoints Interview: Vigeo Therapeutics’ Dr. Lou Vaickus and Dr. Jing Watnick Share Insights on VT1021 Data Presented at SITC 2020

In a recent interview with PharmaShots, Dr. Jing Watnick, Co-Founder and Chief Executive Officer, and Dr. Lou Vaickus, Interim Chief Medical Officer at Vigeo shared their views on the data findings presented at the SITC 2020 Annual Meeting that demonstrated VT1021 as a single-agent has a favorable safety profile and shows early signals of clinical activity across a wide variety of solid tumors, including pancreatic cancer and glioblastoma.

Shots:

  • VT1021 is a first-in-class, dual-modulating therapy that blocks the CD47 immune checkpoint and activates CD36, stimulating cytotoxic T-cell functions, inducing apoptosis in tumor and endothelial cells, and increasing the phagocytosis of the tumor by M1 macrophages by stimulating the production of Tsp-1
  • The compound initially targets pancreatic cancer, glioblastoma multiforme (GBM) and ovarian cancer
  • Vigeo Therapeutics is open for collaborations to advance its clinical program and build pipeline

Tuba:  Can we have a glimpse of the poster presented at the Society for Immunotherapy of Cancer’s (SITC) 2020 Annual Meeting?

Tuba:  Highlight the key points of the VT1021 development program and its mechanism of action. 

Lou: VT1021 is a first-in-class, dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, stimulating cytotoxic T-cell functions, inducing apoptosis in tumor and endothelial cells, and increasing the phagocytosis of the tumor by M1 macrophages by stimulating the production of thrombospondin-1 (Tsp-1). Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.

Source: Vigeo

Tuba:  Describe in brief about the specific disease targets of VT1021. 

Lou: Currently the target indications for VT1021 are pancreatic cancer, glioblastoma multiforme (GBM) and ovarian cancer.  Vigeo is also targeting patients with tumors that express high levels of both CD47 and CD36 as a biomarker based/indication agnostic strategy.

Tuba:  Discuss the key findings from the interim clinical data from the P-I/II study of VT1021. 

Lou: Dual modulation of CD47 and CD36 promotes complementary anti-tumor activity as 75% of patients who achieved a PR or SD had high expression of both CD47 and CD36 prior to entering the study.

Tuba:  When can we expect the complete results of the P-I/II study and initiation of P-II study?

Lou: Escalation has been completed and expansion is expected to be completed by 2Q of 2021. We expect to initiate combination studies in 2Q of 2021.

Tuba:  What are the unique attributes about Vigeo’s lead candidate VT1021? 

Lou: Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis and increases the M1:M2 macrophage ratio.  VT1021 achieves this through stimulation of thrombospondin-1 (Tsp-1).  The goal of these dual-modulating effects is conversion of immuno-suppressive, or “cold,” tumors that don’t respond to immuno-oncology agents, to immuno-stimulated, or “hot,” tumors that are potentially more receptive to immuno-oncology agents. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. Pre-clinical results have demonstrated that single-agent VT1021 causes tumor regression at both the primary and metastatic sites.

Tuba:  What were the major highlights about the dose escalation portion of first in human trial with VT1021? 

Lou: The dose escalation study was marked by a very clean safety profile, an expected and dose dependent pharmacokinetic profile, and the attainment of changes in desired biomarkers in patients that were predicted in nonhuman animal models.  As such the recommended Phase 2 dose was determined based on a combination of safety, pharmacokinetic, and pharmacodynamic parameters.  Additionally, there was a very overall high disease control rate (SD+PR) of 43% (12/28). When analyzing patients with high levels of both CD36 and CD47, the disease control rate increased to 80% (8/10).  

Tuba:  How do you feel about the development status of VT1021 so far?

Lou: We are very encouraged by the development of the biomarker-based strategy and feel that this will significantly impact the clinical development of VT1021.  Early results in the indication expansion cohorts are promising and we are cautiously optimistic. In addition, the clean safety profile allows for combinability with other immunomodulatory and chemotherapy drugs.

Tuba:  What are the other programs that we can expect to escalate further from Vigeo’s pipeline? 

Lou: There are several preclinical-stage programs in the pipeline focusing on TME modulation.

Tuba:  Do you plan for any partnerships for the commercialization strategies of VT1021? 

Lou: We are continuously evaluating potential partnerships and remain open to any number of possibilities as we work to advance our clinical program and build out our pipeline. 

About Authors:

Dr. Jing Watnick is a co-founder of Vigeo and leads the company as its CEO. She has over 20 years of experience in the pharmaceutical industry, including roles in program and portfolio management, strategic planning, business development, alliance management, and preclinical and clinical research.

Lou Vaickus serves as Interim CMO of Vigeo. He has over 30 years of experience that began as an academic scientist, then practicing physician, then spanned into the industry with preclinical, clinical, and globally marketed pharmaceutical products.

Related Post: ViewPoints Interview: Janssen’s Kiran Patel Shares Insights on Amivantamab for Metastatic EGFR Exon 20+ NSCLC

The post ViewPoints Interview: Vigeo Therapeutics’ Dr. Lou Vaickus and Dr. Jing Watnick Share Insights on VT1021 Data Presented at SITC 2020 first appeared on PharmaShots.

More opioids for U.S. surgery patients than for those in other countries

More opioids for U.S. surgery patients than for those in other countries

mcathers_editor
Fri, 01/15/2021 – 08:46

The study, published in the December 1, 2020, issue of the Journal of the American College of Surgeons, involved a post-hoc analysis of the data from the International Patterns of Opioid Prescribing multicenter study.

Hetero Labs Limited-Walk-In Interview for ITI Freshers On 19th Jan’ 2021

Hetero Labs Limited-Walk-In Interview for ITI Freshers On 19th Jan’ 2021

Job Description

Greetings From Hetero Labs Limited….!

Urgent Requirement for Maintenance Department.
Qualification: ITI Fitter
Experience: Freshers
Eligibility : Should be age below 27 years
Work Location: Kazipally (Hyderabad)

Time And Venue Details: Walk-In On 19th Jan’ 2021 @ 9:30 AM at Govt ITI college, BC Colony, near mahila pranganam, Vizianagaram, Andhra Pradesh 535001. ( 50k.m far from Vizag).

Interested Candidates can attend the walk-ins with updated resume & ITI pass certificate mandatory.

Regards,
Team HR
Hetero Corporate

Hetero Labs Limited-Walk-In Interview for ITI Freshers On 19th Jan’ 2021

Prednisone could help prevent episodic cluster headache

Prednisone could help prevent episodic cluster headache

mcathers_editor
Fri, 01/15/2021 – 08:39

The multicenter, randomized, double-blind, placebo-controlled trial enrolled patients between 18 and 65 years old at 10 specialized headache centers in Germany who experienced episodic cluster headaches. Patients received either 100-mg oral prednisone for 5 days followed by tapering by 20 mg every 3 days or matching placebo. All patients received oral verapamil for long-term prevention, starting with 40 mg three times daily and increasing to 120 mg three times daily by day 19.

PharmaShots Weekly Snapshots (Jan 11 – 15, 2021)

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Published: Jan 15, 2020 | Tags: Novartis’, Ligelizumab (QGE031), Receives ,US FDA’s, Breakthrough Designation for Patients , Chronic Spontaneous Urticaria

Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment

Published: Jan 15, 2020 | Tags: Philips, Collaborates, Merck KGaA, Advance Personalized Fertility Treatment

Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Published: Jan 15, 2020 | Tags: Henlius’, HLX15 (biosimilar, daratumumab), Receives, IND, Approval, Multiple Myeloma in China

Abbott to Launch NeuroSphere myPath App to Record Pain Relief in Chronic Pain Patients

Published: Jan 15, 2020 | Tags: Abbott, Launch, NeuroSphere myPath App, to Record Pain Relief in Chronic Pain Patients

Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma in Children And Young Adult

Published: Jan 15, 2020 | Tags: Pfizer’s, Xalkori (crizotinib), Receives, US FDA’s, Approval, ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

 Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Published: Jan 15, 2020 | Tags: Takeda, KSQ, Collaborate, Develop, Commercialize, Novel Immuno-Oncology Therapies

BeiGene’s Tislelizumab (BGB-A317) + CT Receive NMPA’s Approval as 1L Therapy for Advanced Squamous NSCLC

Published: Jan 14, 2020 | Tags: BeiGene, Tislelizumab, (BGB-A317), CT, Receive ,NMPA, Approval ,1L Therapy, Advanced Squamous NSCLC

Sanofi Signs a License Agreement with Biond for BND-22

Published: Jan 14, 2020 | Tags: Sanofi, Signs, License Agreement, Biond, BND-22

Celltrion Report Results of CT-P59 in P-II/III Study for COVID-19

Published: Jan 14, 2020 | Tags: Celltrion, Report, Results, CT-P59, P-II/III, Study, COVID-19

ViiV Healthcare’s Tivicay (dolutegravir, dispersible tablets) Receives the EMA’s Approval for Children with HIV

Published: Jan 14, 2020 | Tags: ViiV Healthcare, Tivicay, dolutegravir, dispersible tablets, Receives, EMA, Approval, Children, HIV

Amgen Collaborates with Evoq to Develop Novel Therapies for Autoimmune Disorders

Published: Jan 14, 2020 | Tags: Amgen, Collaborates, Evoq, Develop, Novel Therapies, Autoimmune Disorders

Kamada to Commercialize Three Biosimilar Products in Israel

Published: Jan 14, 2020 | Tags: Kamada, Commercialize, Three Biosimilar, Israel

The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19

Published: Jan 13, 2020 | Tags: US, Government, Purchase, Additional Doses, Regeneron, Casirivimab, Imdevimab, COVID-19

Teladoc Health and Dexcom Offers CGM-Powered Insight for T2D

Published: Jan 13, 2020 | Tags: Teladoc Health, Dexcom, Offers, CGM-Powered, T2D

UCB Launches Nile AI as a Digital Health Company to Transform the Course of Epilepsy

Published: Jan 13, 2020 | Tags: UCB, Launches, Nile AI, Digital Health Company, Transform, Course of Epilepsy

Bayer Reports the US FDA’s Acceptance of NDA and Grants Priority Review for Finerenone (BAY 94-8862) to Treat CKD and T2D
Published: Jan 13, 2020 | Tags: Bayer, Reports, US, FDA, Acceptance, NDA, Priority Review , Finerenone, (BAY 94-8862), CKD, T2D

Gilead Collaborates with VIR to Evaluate Combination Therapy for Chronic Hepatitis B Virus

Published: Jan 13, 2020 | Tags: Gilead, Collaborates, VIR, Evaluate, Combination Therapy, Chronic Hepatitis B Virus

GSK and VIR Biotechnology to Evaluate VIR-7832 in the Early Treatment of COVID-19

Published: Jan 12, 2020 | Tags: GSK and VIR, Biotechnology, Evaluate, VIR-7832, Early Treatment, COVID-19

Roche Reports Updated OS Data of Tecentriq + Avastin in P-III IMbrave150 Study for Unresectable HCC

Published: Jan 12, 2020 | Tags: Roche, Reports, Updated OS Data, Tecentriq, Avastin, P-III, IMbrave150 Study, Unresectable HCC

AstraZeneca Collaborates with Adaptive on Mapping Immune Response in Cancer

Published: Jan 12, 2020 | Tags: AstraZeneca, Collaborates, Adaptive, Mapping, Immune Response, Cancer

Bluebird bio to Spin Off its Oncology Business into Independent Company

Published: Jan 12, 2020 | Tags: Bluebird bio, Spin Off, Oncology Business, Independent Company

Novartis In-Licenses BieGene’s Tislelizumab to Expand its Oncology Portfolio

Published: Jan 12, 2020 | Tags: Novartis, In-Licenses, BieGene, Tislelizumab, Oncology Portfolio

 Biogen and Apple Collaborate to Launch Virtual Study on Cognitive Decline

Published: Jan 12, 2020 | Tags: Biogen, Apple, Collaborate, Launch, Virtual Study, Cognitive Decline

BMS Collaborates with ArsenalBio to Advance Next-Generation T cell Therapies for Solid Tumors

Published: Jan 11, 2020 | Tags: BMS, Collaborates, ArsenalBio, Advance, Next-Generation, T cell Therapies,  Solid Tumors

Chi-Med and Inmagene Collaborate to Develop Therapies for Immunological Diseases

Published: Jan 11, 2020 | Tags: Chi-Med, Inmagene, Collaborate, Immunological Diseases

Sanofi to Acquire Kymab for ~$1.45B

Published: Jan 11, 2020 | Tags: Sanofi, Acquire, Kymab, ~$1.45B

BioMarin Reports Results of Valoctocogene Roxaparvovec in P-III GENEr8-1 Study for Hemophilia A

Published: Jan 11, 2020 | Tags: BioMarin, Reports, Results, Valoctocogene Roxaparvovec, P-III, GENEr8-1 Study, Hemophilia A

Roche’s Xofluza Receives the EC’s Approval for the Treatment of Influenza

Published: Jan 11, 2020 | Tags: Roche, Xofluza, Receives, EC, Approval, Treatment, Influenza

AbbVie Reports Results of Skyrizi (risankizumab) in P-III Induction Studies for Crohn’s Disease

Published: Jan 11, 2020 | Tags: AbbVie, Reports, Results, Skyrizi, (risankizumab), P-III, Induction Studies, Crohn’s Disease

Related Post: PharmaShots Weekly Snapshot (Jan 4-8, 2020)

The post PharmaShots Weekly Snapshots (Jan 11 – 15, 2021) first appeared on PharmaShots.

Cabozantinib reduces tumour burden in Phase II neurofibromatosis trial

black cells dividing on orange background - idea of tumour/cancerCabozantinib, a tyrosine kinase inhibitor, was shown to reduce tumour volume and pain in patients with the genetic disorder neurofibromatosis type 1 (NF1). Because of the promising response rate, the Neurofibromatosis Clinical Trials Consortium has opened and fully enrolled a paediatric cohort (patients ages 3 to 15).

NF1 is a rare tumour predisposition syndrome which affects approximately 1 in 3000 people worldwide. The condition involves the proliferation of tumours throughout the central and peripheral nervous system. One of the most prevalent type of tumours in NF1 are plexiform neurofibromas (PN), multicellular tumours composed of tumorigenic Schwann cells, fibroblasts, perineural cells, macrophages, mast cells and secreted collagen. These PN tumors arise within nerves and affect almost 50 percent of patients with NF1. They grow rapidly during childhood and can lead to motor and sensory dysfunction, pain and disfigurement. When the tumors impinge on vital structures like the airway or the spinal cord, they can be life-threatening. While they are benign, PN tumours can become malignant over time.

Surgery is the current standard of care because chemo- and radiotherapies are ineffective. However, given that the tumours can be intertwined with nerves and other vital structures, surgery is often not possible. Recent studies have shown that a MEK inhibitor called selumetinib can be an effective treatment in some children with NF1-related PNs, but not all patients respond to this treatment, so there is a need for more treatment options.

Based on preclinical studies of cabozantinib, an investigational drug that targets both the tumorigenic Schwann cells in PNs as well as the complex tumor microenvironment, researchers at Children’s Hospital of Philadelphia (CHOP), US, enrolled patients in a single arm, multicentre Phase II clinical trial. The results of the trial were published in Nature Medicine.

Twenty-three patients aged 16 to 34 enrolled in the trial; twenty-one were evaluable for drug toxicity and 19 were evaluable for their response to the treatment. Of the 19 patients studied for response, eight (42 percent) had a greater than a 20 percent decrease in tumour volume (partial response) and 11 had stable disease after 12 rounds of treatment. No patient had disease progression while participating in the trial. Those with a partial response to cabozantinib also reported a significant reduction in tumour pain intensity and pain interference in daily life.

The adverse events reported by participants included diarrhoea, nausea, asymptomatic hypothyroidism, fatigue and palmar plantar erythrodysesthesia, a condition that causes redness, swelling and pain on the palms of the hands and/or the soles of the feet. None of these effects were reported as being severe.

“This is the second class of drugs to demonstrate a very promising response rate for NF1 patients with these tumours,” said first author Dr Michael Fisher, Chief of the Section of Neuro-Oncology and Director of the Neurofibromatosis Program at CHOP, and Group Chair for the NF Clinical Trials Consortium, which includes 25 sites developing innovative biologically-based clinical trials for complications of NF. “Collectively, the data presented in this study illustrate a true bench-to-bedside approach, coordinating translational and clinical efforts to advance targeted therapies for a rare disease like NF1.”

He added: “It’s incredibly exciting that we now have two classes of drugs that result in tumor responses, given that we had no promising agents only a few years ago. However, despite this excitement, neither cabozantinib nor MEK inhibitors shrink all tumours or make them go away completely. Therefore, we are building on these results as well as ongoing laboratory studies and are planning future exploration of combination therapies, so that we can further improve outcomes for these patients with these debilitating and life-threatening tumours.”

The post Cabozantinib reduces tumour burden in Phase II neurofibromatosis trial appeared first on European Pharmaceutical Review.

Valneva may provide Europe with the only inactivated virus vaccine for COVID-19

vials labelled 'SARS-CoV-2 Vaccine' - idea of COVID-19 vaccine supplyValneva SE is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe.

The VLA2001 vaccine candidate consists of inactivated whole virus particles of SARS-CoV-2 with high Spike (S) protein density, in combination with two adjuvants – alum and CpG 1018. Its potential benefits, aside from being manufactured by the same platform the company uses for its US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Japanese encephalitis vaccine, is that the efficacy of inactivated virus vaccines is well established and the vaccine is expected to conform with standard cold chain requirements (2-8°C).

VLA2001 entered Phase I/II clinical studies in December 2020 and Valneva expects to report initial safety and immunogenicity data in April 2021. Upon analysis of the data, the company said it will select the best dose and commence the second part of the Phase I/II clinical development. If clinical development is successful, an initial approval may be granted in the second half of 2021.

Thomas Lingelbach, Chief Executive Officer of Valneva, said: “Today’s announcement helps to ensure that millions of Europeans potentially have access to a proven and well-established inactivated vaccine approach, upon approval of VLA2001. We are grateful to the European Commission for their support and eager to partner with them to address the ongoing pandemic. We are deeply committed to providing broad access to our inactivated SARS-CoV-2 vaccine candidate and, as we proceed with clinical development, we will simultaneously continue working with partners, including the European Commission and the UK Government, to help us reach that goal. We increasingly see wider recognition that our vaccine will be one that the world cannot do without.”

In September 2020, the company signed an agreement with the UK government for the supply of up to 190 million doses of VLA2001. Under the agreement, if vaccine development is successful, the enterprise will provide the UK government with 60 million doses in the second half of 2021.

About VLA2001-201

VLA2001-201 is the first-in-human, randomised, double-blind, multicentre Phase I/II study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra-muscular vaccinations three weeks apart. Overall, 150 healthy young adults aged 18 to 55 years will be recruited.

The post Valneva may provide Europe with the only inactivated virus vaccine for COVID-19 appeared first on European Pharmaceutical Review.

Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria

Shots:

  • The US FDA has granted BTD for Ligelizumab for the treatment of CSU in patients with an inadequate response to H1-antihistamine treatment
  • The therapy is currently being evaluated in ongoing P-III program including PEARL 1 & -2 that assess Ligelizumab vs Xolair (omalizumab) in ~2000 patients across the globe with its anticipated results in H2’21
  • Ligelizumab is a next generation monoclonal anti-IgE Ab, that demonstrated more patients experienced complete resolution of wheals (hives) in a P-IIb dose-finding trial. The company is anticipating the US regulatory submission in 2022

Click here ­to­ read full press release/ article | Ref: Novartis | Image: Medical, Marketing and Media

The post Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria first appeared on PharmaShots.

J&J single-shot COVID-19 vaccine shows early promise

J&J has announced early trial results that suggest its single-shot coronavirus vaccine provides a sustained response against the virus ahead of a phase 3 trial readout due later this month.

The UK has caused controversy in recent weeks by tinkering with the dosing regimens for coronavirus vaccines from AstraZeneca and Pfizer/BioNTech, which are being rolled as part of the country’s mass vaccination programme.

Both of these vaccines require two doses, as does the most recently approved shot from Moderna, which is due to arrive in the UK in the spring.

In order to make the best use of scarce vaccine resources the UK has opted to extend the time between doses to up to 12 weeks, a strategy that has been criticised by some scientists who are fearful that it could cause vaccine-tolerant strains of the virus to emerge.

Johnson & Johnson’s Janssen pharma unit is further behind in the development of its vaccine, which has the crucial advantage of being administered in a single shot.

The UK government has an order of 30 million doses of the vaccine from J&J and an option for an additional 22 million doses in an agreement signed last summer.

Latest data give hope that the vaccine could be added to the campaign after phase 1/2a data showed that the shot provided an immune response that lasted for at least 71 days, the duration of time measured in the study involving patients aged 18-55 years.

The phase 1/2a interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants.

Data demonstrated that, after a single vaccination, neutralising antibodies against COVID-19 were detected in over 90% of study participants at day 29 and 100% of participants aged 18-55 years at day 57.

These neutralising antibodies remained stable through day 71, currently the latest timepoint available in this ongoing study.

Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned.

Top line data from a phase 3 study is due later this month, although this timing may change due to disease events.

J&J expects to file with the FDA first, followed by other regulators. The European Medicines Agency is conducting a rolling review of the vaccine to speed up the process.

The post J&J single-shot COVID-19 vaccine shows early promise appeared first on .

CVS and Walgreens Under Fire for Slow Pace of Vaccination in Nursing Homes

The effort to vaccinate some of the country’s most vulnerable residents against covid-19 has been slowed by a federal program that sends retail pharmacists into nursing homes — accompanied by layers of bureaucracy and logistical snafus.

As of Thursday, more than 4.7 million doses of the Pfizer-BioNTech and Moderna covid vaccines had been allocated to the federal pharmacy partnership, which has deputized pharmacy teams from Walgreens and CVS to vaccinate nursing home residents and workers. Since the program started in some states on Dec. 21, however, they have administered about one-quarter of the doses, according to the Centers for Disease Control and Prevention.

Across the country, some nursing home directors and health care officials say the partnership is actually hampering the vaccination process by imposing paperwork and cumbersome corporate policies on facilities that are thinly staffed and reeling from the devastating effects of the coronavirus. They argue that nursing homes are unique medical facilities that would be better served by medical workers who already understand how they operate.

Mississippi’s state health officer, Dr. Thomas Dobbs, said the partnership “has been a fiasco.”

The state has committed 90,000 vaccine doses to the effort, but the pharmacies had administered only 5% of those shots as of Thursday, Dobbs said. Pharmacy officials told him they’re having trouble finding enough people to staff the program.

Dobbs pointed to neighboring Alabama and Louisiana, which he says are vaccinating long-term care residents at four times the rate of Mississippi.

“We’re getting a lot of angry people because it’s going so slowly, and we’re unhappy too,” he said.

Many of the nursing homes that have successfully vaccinated willing residents and staff members are doing so without federal help.

For instance, Los Angeles Jewish Home, with roughly 1,650 staff members and 1,100 residents on four campuses, started vaccinating Dec. 30. By Jan. 11, the home’s medical staff had administered its 1,640th dose. Even the facility’s chief medical director, Noah Marco, helped vaccinate.

The home is in Los Angeles County, which declined to participate in the CVS/Walgreens program. Instead, it has tasked nursing homes with administering vaccines themselves, and is using only Moderna’s easier-to-handle product, which doesn’t need to be stored at ultracold temperatures, like the Pfizer vaccine. (Both vaccines require two doses to offer full protection, spaced 21 to 28 days apart.)

By contrast, Mariner Health Central, which operates 20 nursing homes in California, is relying on the federal partnership for its homes outside of L.A. County. One of them won’t be getting its first doses until next week.

“It’s been so much worse than anybody expected,” said the chain’s chief medical officer, Dr. Karl Steinberg. “That light at the end of the tunnel is dim.”

Nursing homes have experienced some of the worst outbreaks of the pandemic. Though they house less than 1% of the nation’s population, nursing homes have accounted for 37% of deaths, according to the COVID Tracking Project.

Facilities participating in the federal partnership typically schedule three vaccine clinics over the course of nine to 12 weeks. Ideally, those who are eligible and want a vaccine will get the first dose at the first clinic and the second dose three to four weeks later. The third clinic is considered a makeup day for anyone who missed the others. Before administering the vaccines, the pharmacies require the nursing homes to obtain consent from residents and staffers.

Despite the complaints of a slow rollout, CVS and Walgreens said they’re on track to finish giving the first doses by Jan. 25, as promised.

“Everything has gone as planned, save for a few instances where we’ve been challenged or had difficulties making contact with long-term care facilities to schedule clinics,” said Joe Goode, a spokesperson for CVS Health.

Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials, acknowledged some delays through the partnership, but said that’s to be expected because this kind of effort has never before been attempted.

“There’s a feeling they’ll get up to speed with it and it will be helpful, as health departments are pretty overstretched,” Plescia said.

But any delay puts lives at risk, said Dr. Michael Wasserman, the immediate past president of the California Association of Long Term Care Medicine.

“I’m about to go nuclear on this,” he said. “There should never be an excuse about people not getting vaccinated. There’s no excuse for delays.”

Bringing in Vaccinators

Nursing homes are equipped with resources that could have helped the vaccination effort — but often aren’t being used.

Most already work with specialized pharmacists who understand the needs of nursing homes and administer medications and yearly vaccinations. These pharmacists know the patients and their medical histories, and are familiar with the apparatus of nursing homes, said Linda Taetz, chief compliance officer for Mariner Health Central.

“It’s not that they aren’t capable,” Taetz said of the retail pharmacists. “They just aren’t embedded in our buildings.”

If a facility participates in the federal program, it can’t use these or any other pharmacists or staffers to vaccinate, said Nicole Howell, executive director for Ombudsman Services of Contra Costa, Solano and Alameda counties.

But many nursing homes would like the flexibility to do so because they believe it would speed the process, help build trust and get more people to say yes to the vaccine, she said.

Howell pointed to West Virginia, which relied primarily on local, independent pharmacies instead of the federal program to vaccinate its nursing home residents.

The state opted against the partnership largely because CVS/Walgreens would have taken weeks to begin shots and Republican Gov. Jim Justice wanted them to start immediately, said Marty Wright, CEO of the West Virginia Health Care Association, which represents the state’s long-term care facilities.

The bulk of the work is being done by more than 60 pharmacies, giving the state greater control over how the doses were distributed, Wright said. The pharmacies were joined by Walgreens in the second week, he said, though not as part of the federal partnership.

“We had more interest from local pharmacies than facilities we could partner them up with,” Wright said. Preliminary estimates show that more than 80% of residents and 60% of staffers in more than 200 homes got a first dose by the end of December, he said.

Goode from CVS said his company’s participation in the program is being led by its long-term care division, which has deep experience with nursing homes. He noted that tens of thousands of nursing homes — about 85% nationally, according to the CDC — have found that reassuring enough to participate.

“That underscores the trust the long-term care community has in CVS and Walgreens,” he said.

Vaccine recipients don’t pay anything out-of-pocket for the shots. The costs of purchasing and administering them are covered by the federal government and health insurance, which means CVS and Walgreens stand to make a lot of money: Medicare is reimbursing $16.94 for the first shot and $28.39 for the second.

Bureaucratic Delays

Technically, federal law doesn’t require nursing homes to obtain written consent for vaccinations.

But CVS and Walgreens require them to get verbal or written consent from residents or family members, which must be documented on forms supplied by the pharmacies.

Goode said consent hasn’t been an impediment so far, but many people on the ground disagree. The requirements have slowed the process as nursing homes collect paper forms and Medicare numbers from residents, said Tracy Greene Mintz, a social worker who owns Senior Care Training, which trains and deploys social workers in more than 100 facilities around California.

In some cases, social workers have mailed paper consent forms to families and waited to get them back, she said.

“The facilities are busy trying to keep residents alive,” Greene Mintz said. “If you want to get paid from Medicare, do your own paperwork,” she suggested to CVS and Walgreens.

Scheduling has also been a challenge for some nursing homes, partly because people who are actively sick with covid shouldn’t be vaccinated, the CDC advises.

“If something comes up — say, an entire building becomes covid-positive — you don’t want the pharmacists coming because nobody is going to get the vaccine,” said Taetz of Mariner Health.

Both pharmacy companies say they work with facilities to reschedule when necessary. That happened at Windsor Chico Creek Care and Rehabilitation in Chico, California, where a clinic was pushed back a day because the facility was awaiting covid test results for residents. Melissa Cabrera, who manages the facility’s infection control, described the process as streamlined and professional.

In Illinois, about 12,000 of the state’s roughly 55,000 nursing home residents had received their first dose by Sunday, mostly through the CVS/Walgreens partnership, said Matt Hartman, executive director of the Illinois Health Care Association.

While Hartman hopes the pharmacies will finish administering the first round by the end of the month, he noted that there’s a lot of “headache” around scheduling the clinics, especially when homes have outbreaks.

“Are we happy that we haven’t gotten through round one and West Virginia is done?” he asked. “Absolutely not.”

KHN correspondent Rachana Pradhan contributed to this report.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

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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Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment

Shots:

  • The companies have launched a multi-year collaboration to bring digital technologies to fertility treatments integrating informatics, mobile ultrasound diagnostics and more
  • The collaboration build on Philips’ expertise in maternal & fetal monitoring, Pregnancy+, Baby+ consumer engagement apps, which provide information on diet and exercise along with updates on the baby’s development
  • The companies will utilize remote patient monitoring, cloud-based platform services and mobile, AI-enabled ultrasound diagnostics to support improved access to care and better outcomes in fertility treatment

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

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NICE recommends interim funding for GSK’s Zejula in ovarian cancer

Women with newly-diagnosed advanced ovarian cancer have a new treatment option in England after NICE recommend interim funding for GlaxoSmithKline’s Zejula (niraparib) in final guidance.

Zejula competes with AstraZeneca/Merck & Co’s PARP inhibitor class rival Lynparza (olaparib) but in this case it has an advantage in this maintenance therapy use as it can be used regardless of whether the BRCA mutation is present.

GSK estimates that around 3,000 people could benefit annually from the decision covering advanced high-grade epithelial ovarian cancer, fallopian tube or primary peritoneal cancer, who have completed and shown a response to platinum-based chemotherapy.

The drug will be paid for by the Cancer Drugs Fund, which provides interim funding until further data can be gathered that can help NICE with its cost-effectiveness calculations.

This indication is supported by data from the phase 3 PRIMA study, which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status.

The primary endpoint in PRIMA was progression-free survival (PFS) analysed sequentially first in patients with BRCA-like mutations, then in the overall population.

Results showed Zejula significantly improved PFS regardless of biomarker status – in patients with homologous recombination deficiency (HRd) mutations, Zejula resulted in a 57% reduction in risk of disease progression versus placebo. 

In the overall population there was a 38% reduction in the risk of disease progression or death compared with placebo.

However NICE usually requires overall survival data before making decisions on long-term funding NHS funding.

As a result, the cost-effectiveness body has decided to use the CDF until GSK has the required survival data, it said in the guidance document.

In a managed access agreement with NICE, GSK has agreed an confidential discount to the list price of £4,500 for 56 100mg capsules, excluding VAT. Zejula pills are taken three times daily.

Poly-(ADP-ribose) polymerase (PARP) inhibitors are targeted therapies that work by exploiting cancer cells’ tendency to use a back-up system to keep control of mutations in their DNA.

By interfering with this process PARP inhibitors cause cancer cells to self-destruct as genetic defects mount, while leaving healthy tissue unaffected.

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A new approach to COVID-19 treatment

While pharma has raced to develop COVID-19 vaccines, US-based company NeuroRx is taking a different approach to treating the virus. CEO Dr. Jonathan Javitt tells pharmaphorum about the science behind the company’s Zyesami, which targets the alveolar type II cells in the lung that are critical for transmission of oxygen.

Zyesami was developed in conjunction with partner Relief Therapeutics, and NeuroRx is currently awaiting results from a Phase 2b/3 trial (COVID-AIV) evaluating the therapeutic for the treatment of respiratory failure in COVID-19 patients.

Based on years of research by Professor Sami Said at New York’s Stony Brook University, the drug is a synthetic formulation of Vasoactive Intestinal Peptide (VIP), a naturally occurring peptide that is highly concentrated in the lungs. VIP is known to have potent anti-inflammatory effects and can inhibit coronavirus replication and block the formation of inflammatory cytokines.

“Every air-breathing warm-blooded animal makes this peptide to protect the lungs from the toxic effects of breathing air,” NeuroRx CEO, Jonathan Javitt, MD, MPH, told pharmaphorum. “It protects the lungs against all injuries and turns out it has some extraordinarily valuable properties for patients with COVID-19.”

“The cytokine storm story became popular, but it was mostly popularised by companies who already had drugs against cytokines. They created the story and then threw their monoclonal antibodies against COVID-19 but there is real scepticism now about whether COVID-19 is really a cytokine storm problem”

‘A fish out of water’

When SARS-CoV-2 invades the body, it attacks the alveolar type II (ATII) cell in the lining of the lung which shuts down the production of surfactant and stimulates a cytokine response.

“This is how you go from somebody who is infected by the virus but not particularly sick to somebody who’s on a ventilator dying of COVID-19,” explained Dr. Javitt.

“For example – when a fish swims through water, seawater goes across its gills and oxygen is then absorbed from the seawater. The fish derives enough oxygen from that to carry out all the functions it needs to live. However, the minute you put that fish on the land, the fish dies. But why? There is more oxygen in the air than there is in the sea, so why would the fish die?”

The problem, he says, is due to the fact the atmosphere is toxic to the fish’s epithelial cells.

“In humans it is the same. The mixture of gases that we breathe all the time are toxic if it touches the lung’s cell, so the lung is covered by this layer of fluid that creates a barrier between the atmosphere, the air, and the cell membrane.”

The minute the ATII cells die due to the SARS-CoV-2 virus, the lung is no longer capable of oxygenation and the patient dies as well.

“It is like a fish out of water.”

Zyesami works by binding to receptors on ATII cells in the lung and protecting the surrounding pulmonary epithelium by blocking cytokines, preventing apoptosis, and upregulating the production of surfactant.

By targeting the vulnerable ATII, NeuroRx and Relief Therapeutics believe they can help the most critically ill COVID-19 patients.  “Until we focus on the specific lesion associated with this virus, we’re not going to have any real cures,” concluded Dr. Javitt.

While other COVID-19 therapeutics, such as Gilead’s Veklury (remdesivir) have focused on controlling the cytokine storm triggered by COVID-19, Dr. Javitt believes this is only one piece of the puzzle.

“The cytokine storm story became popular, but it was mostly popularised by companies who already had drugs against cytokines. They created the story and then threw their monoclonal antibodies against COVID-19 but there is real scepticism now about whether COVID-19 is really a cytokine storm problem.

“Personally, I don’t think it is. I think cytokine storms are a secondary problem and until we really face the lesion that occurs when the SARS-CoV-2 virus infects the lungs and causes COVID-19, we’re not going to have a solution.”

The next steps

Top line data from Zyesami’s Phase 2b/3 trial is expected by the end of January/beginning of February and if successful, the drug could quickly receive emergency use authorisation from the FDA.

The multicenter, randomised trial was initially conducted at a single centre and expanded to 196 patients at 12 study sites. Patients were administered with escalating doses of Zyesami by intravenous infusion and compared to a placebo control group.

Early data from trials were encouraging, with results from a study at Houston Methodist hospital in Texas showing approximately 81% of the patients who received the drug survived beyond 60 days, compared to just 17% of control patients. Those who had the treatment also demonstrated a nine-fold increased probability of survival and recovery from respiratory failure.

“These patients included in our study are those who were too sick to be admitted to any other clinical trial,” said Dr. Javitt. “There were extremely ill patients who had had lung transplants, severe lung disease, heart disease, renal failure and kidney transplants so the results we have seen bring a lot of hope for how we can treat COVID-19 in future.”

Although the arrival of COVID-19 vaccines is providing hope for people, there is still a need for effective treatments. “We hope that the vaccine will reduce the number of COVID-19 cases.  However, we believe it likely that population wide vaccination will be slow in coming and the vaccine is not 100% effective,” said Dr. Javitt.

NeuroRx is also gearing up for a phase of rapid expansion after closing a deal in December to combine with investment firm Big Rock Partners. The merger created a company with an estimated post-transaction equity value of more than $500 million.

The deal is expected to complete in the first quarter of 2021 and will increase NeuroRx’s access to capital for Zyesami and spur development of its other drug pipeline targeting treatment of bipolar depression.

The company is also looking at advancing trials for Zyesami in other countries around the world, with a Phase 2b/3 trial set to begin in Europe.

“One thing about our drug compared to all of these monoclonal antibodies is we can make it at enormous scale relatively inexpensively and it’s within the cost range that works for the rest of the world,” said Dr. Javitt.

About the interviewee

Dr. Jonathan Javitt is founder, chairman and CEO of NeuroRx. He is a physician with a background in information technology, health economics, and public health. His scientific publications have been cited by more than 17,000 people and he is ranked among the top 1% of quoted scientists worldwide.

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GSK’s Neale Belson on building trust with employees and society

Pharma’s reputation is currently riding high as the industry comes together to tackle COVID-19, but GSK’s UK general manager Neale Belson says there is always more companies can do to build their culture and make sure employees and customers trust they are doing the right thing.

When we spoke with Belson about the GSK’s response to COVID-19, he pointed out how the pandemic has allowed him to get to know his colleagues even better than he anticipated. Now, speaking to him as the first vaccines are deployed in the UK, he highlights the importance of GSK’s employees and culture to the future of the company post-COVID.

Despite becoming UK GM at a difficult time – right before lockdowns came into effect in March – Belson says he was excited to start the role, which he describes as his “dream job”.

“It’s an incredibly humbling experience. When I was young, I had a strong desire to make a difference, and making a difference is right at the heart of GSK’s mission.”

As GSK’s UK lead, Belson is responsible for promoting and implementing the company’s three core priorities – Innovation, Trust and Performance – in the country. He believes the most important aspect of doing this is to develop the business by building its people.

“Our employees’ friends and colleagues understand the great work we’re doing, which has changed how they feel about working for GSK and how they are engaged in our mission”

“To me that’s all about the environment we create,” he says. “We want people to enjoy working for GSK in the UK, to feel valuable, and to feel excited about being part of something.

“What we do as an industry is really special, and it’s important to me that people feel proud of what we do and see that we can achieve an awful lot together.”

The COVID-19 pandemic, he says, has been a key catalyst in helping people both outside and inside the company understand its purpose and build on the Trust agenda.

“People now recognise what the industry has done to help tackle COVID. Our employees’ friends and colleagues understand the great work we’re doing, which has changed how they feel about working for GSK and how they are engaged in our mission. It’s been lovely to see that.

“There’s never been a better time to be in pharma. If we build on that, our Trust agenda can have a very strong future.”

Trust and Performance

Building this trust among employees involves improving a company’s culture from the ground up, Belson says.

“We are looking to build a purpose-led, performance-driven culture to enable us to make the biggest difference possible. To us, that means making a difference to what matters to people.

“We want to focus on things like development, diversity, health and wellbeing – and all of that underpins our goal to be one of the most innovative, high-performing, and trusted companies in the healthcare space.”

The same is true for the company’s Performance agenda.

“Our performance agenda is all about investing in our people and our capabilities,” Belson says. “At the beginning of the pandemic we ramped up our training, and our capabilities developed significantly as a result. We wanted to get people match-fit, and they really enjoyed and appreciated that.

“As part of that we also sought to understand the challenges people were having and how we could help them. This is not only good for health and wellbeing, but also for overall performance.”

Sustainability and joint working

But Belson notes that building trust must go beyond internal projects and involve external efforts as well.

He highlights GSK’s recently announced sustainability ambitions as an example of how the company is aiming to “do the right thing” for wider society.

With the new goals, GSK aims to have a net zero impact on climate and a net positive impact on nature by 2030.

Underpinning these goals, the company has set new targets across its different businesses, including: 100% renewable electricity usage and good water stewardship at all GSK sites; 100% of materials sustainably sourced and deforestation free and transitioning to 100% usage of electric vehicles by sales reps worldwide.

“We’re investing in restoration projects where we can and are looking to put back into nature more than we take out,” Belson explains.

“We don’t have all the answers yet, but I’m proud of the agenda and the ambition.”

Similarly, Belson believes it is important to make sure that GSK is “part of the solution” in addressing patient needs in the UK through joint working initiatives with the NHS.

Some examples where GSK have done this include a collaboration with Health Innovation Manchester to deliver asthma care to patients within a pharmacy community setting, and an initiative with the Federation of Family Practices in Belfast to help improve the care of COPD patients who remain symptomatic.

“It’s also important that we continue to learn and understand what patients need throughout the ecosystem, from early drug development all the way through to how patients are diagnosed and treated and their journey through these processes.”

Overall, Belson says the Trust agenda is about making sure people genuinely feel that GSK is doing the right thing.

“I think people are proud to work for a company that has that as one of the core pillars of its strategy. Fundamentally, I want to lead an organisation where people genuinely feel they are connected with our purpose.”

He says he would like to see employees become even more connected to this purpose in the future.

“We’re trying to drive a culture where people feel valued and respected, and where they’re genuinely part of the solutions we’re providing.

“That involves listening, understanding and making sure they have a voice and feel confident about speaking up – as well as making sure they can feel part of where we’re going as an organisation.”

About the interviewee

Neale Belson is senior vice president and general manager UK and Ireland at GSK, and leader of the GSK Pharmaceuticals affiliate in the UK. Neale has performed several significant leadership roles encompassing many therapeutic areas working in the United States, Europe and most recently as vice president and area director GSK Nordic and Baltic Cluster, based in Copenhagen, Denmark. Prior to GSK, Neale held senior commercial roles at AstraZeneca.

About the author

George Underwood is pharmaphorum’s Deep Dive magazine editor, leading the content for the bi-monthly magazine. He has been reporting on the industry for seven years and has worked at a number of leading publications in the UK.

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Henlius’ HLX15 (biosimilar, daratumumab) Receives IND Approval for Multiple Myeloma in China

Shots:

  • Henlius reported that NMPA has approved the IND application of HLX15 for the treatment of multiple myeloma
  • The company has compared HLX15 in a head to head study with reference daratumumab via analytical & preclinical studies. The results demostrated that HLX15 is highly similar to reference daratumumab
  • The company has developed the HLX15 in accordance with the Technical Guidelines of Development and Evaluation of Biosimilar Drugs & EMA Guideline on Similar Biological Medicinal Products

Click here ­to­ read full press release/ article | Ref: Henlius | Image: BioSpectrum Asia

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UCB backs epilepsy-focused digital heath startup Nile AI

Belgian drugmaker UCB has been steadily building its digital health expertise for several years, and that includes nurturing new projects. One of those is now being launched as a new company – Nile AI – that aims to improve the care of people with epilepsy.

UCB is bankrolling Los Angeles-based Nile with €25 million (around $29 million) in startup cash and will be a majority shareholder, with a presence on the company’s board as well as options on acquiring “data and insights” from its platform.

Nile is being formed to develop a digital health platform – consisting of a patient app that links to a portal for healthcare professionals – that can use data from patients’ past epileptic seizures to try to predict future attacks.

The patient app connects individuals with their care team, and provides information about their treatment and progress, while the portal shows the status of patients, maintains support between consultations, and allows data-driven decisions on treatment and care, according to UCB.

The digital tools are being piloted at Massachusetts General Hospital and Michigan State University Healthcare, and the aim is to have it ready for a commercial launch before the end of this year.

“We know that patients suffering from epilepsy struggle with the unpredictable nature of their lives,” said Dr Leo Petrossian, Nile AI’s CEO.

“Every single day they awake uncertain of what they can expect. At Nile, we believe that all of the data to predict the path of an epilepsy patient exists, though it is fragmented and disconnected.”

Nile’s software operates as a care management system, and cam be used to address this uncertainty, he continued, with the ultimate goal of shortening the time it takes for people with epilepsy to be on the best care available.

It’s a mission that dovetails with UCB’s position as a well-established player in the epilepsy category. Medicines like Vimpat (lacosamide), Keppra (levetiracetam), Briviact (brivaracetam) and recent launch Nayzilam (midazolam) nasal spray collectively make upwards of €2.3 billion a year and account for almost half of its net sales.

UCB added to its range last June with the $270 million acquisition of Engage Therapeutics and its Staccato Alprazolam product for the rapid termination of seizures.

“UCB has a deep understanding of epilepsy and the challenges that people living with the disease face every day, including how patients communicate with their healthcare providers,” said the Belgian firm’s head of neurology Charl Van Zyl.

“We think Nile’s platform can provide valuable insights and foster a better care management experience for people living with epilepsy.”

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Journalists Examine How Covid Polarizes Communities

California Healthline senior correspondent Anna Maria Barry-Jester discussed public health backlash on WABE’s “Did You Wash Your Hands?” on Jan. 5.

KHN Colorado correspondent Rae Ellen Bichell dissected how covid-19 exacerbates tensions between counties in Colorado on NPR’s “Weekend Edition” on Jan. 9.

KHN chief Washington correspondent Julie Rovner talked about mental health care and the pandemic on WAMU/NPR’s “1A” on Jan. 11.

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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When Covid Deaths Aren’t Counted, Families Pay the Price


This story also ran on The Guardian. It can be republished for free.

On Sundays, Bishop Bruce Davis preached love. Through his Pentecostal ministry, he organized youth parades and gave computers, bicycles and food to families in need.

During the week, Bruce practiced what he preached, caring for prisoners at a Georgia hospital. On March 27 he began coughing, and on April 1 he was hospitalized. He’d tested positive for covid-19. The virus swept through his household, infecting his wife and daughter and hospitalizing their disabled son. Ten days after landing in the hospital, Bruce died.

But when Gwendolyn Davis received her husband’s death certificate, she was taken aback. The causes of death? Sepsis and renal failure. No mention of covid-19.

“He wouldn’t have had kidney failure if he didn’t have covid,” Gwendolyn said.

After Bruce died, his wife applied to two pandemic relief programs seeking help with $1,500 in missed payments on a truck and an electricity bill. But, she said, she was denied because his death certificate didn’t mention covid-19.

“I think it’s wrong,” Gwendolyn said. “It’s almost like we didn’t count.”

The count has profound implications for families and the country. Omitting covid-19 on death certificates threatens to undercount the toll of the pandemic nationwide. For Davis’ family and others, it can pile financial hardship onto emotional despair, as death benefits and other covid-19 relief programs are withheld. Interviews with families across the U.S. shed light on reasons covid deaths are being undercounted — and the consequences loved ones have endured.

When covid patients die, the “immediate” cause of death is always something else, such as respiratory failure or cardiac arrest. Residents, doctors, medical examiners and coroners make the call on whether covid was an underlying factor, or “contributory cause.” If so, the diagnosis should be included on the death certificate, according to the Centers for Disease Control and Prevention.

Even beyond the pandemic, there is wide variation in how certifiers describe causes of death: “There’s just no such thing as an objective measure of cause of death,” said Lee Anne Flagg, a statistician at the CDC’s National Center for Health Statistics.

Partly because of a lack of training in how to fill them out, “the quality of the death certificates is not good,” said Dr. James Gill, vice president of the National Association of Medical Examiners. And in cases in which people had other chronic conditions, it can be difficult to determine whether covid was a contributing cause of death, he said. That was especially true early on, when reliable testing was not widely available.

Since early in the pandemic, the CDC has encouraged certifiers who suspect covid as a cause of death to list it on the death certificate as “probable” or “likely.”

Still, some clinicians are “reluctant to certify a death as a covid death without a test in hand,” Gill said.

It’s not clear how Bruce Davis’ case slipped under the radar. His death was certified by William Ken Garland, deputy coroner in Baldwin County. Reached by phone, Garland said the causes of death were provided by Dr. Joseph Coppiano, a medical resident who pronounced Davis dead at Augusta University Medical Center, about 90 miles away. No autopsy was done.

“I did certify the record, but that’s about all I did,” Garland said.

Hospital spokesperson Danielle Harris declined to comment on the case, citing patient privacy. She said the hospital follows Georgia Department of Public Health guidelines.

In the absence of certainty, the CDC has encouraged coroners to document the virus. “We’re not worried that we’re overcounting the number of [covid-19] deaths,” Farida Ahmad, epidemiologist and mortality surveillance team leader at NCHS, said in April.

Missed cases are one reason that experts agree covid deaths are being undercounted nationwide. As evidence for that, they point to the vast number of excess deaths — additional deaths compared to what would be expected based on prior-year numbers and demographic trends.

Over the past year, the U.S. had endured up to 431,792 excess deaths as of Jan. 6, with 68% directly attributed to covid, according to the CDC.

These excess deaths “tend to track pretty closely with covid cases, trailing by a couple of weeks,” said Daniel Weinberger, an epidemiologist at Yale School of Public Health who has published on this topic. “This strongly suggests that a large proportion of these uncounted deaths are due to covid but not recorded as such.”

We may never know how many covid deaths went uncounted: Postmortem tests can detect the virus, but it’s “unlikely that this type of testing will be performed at a [sufficient] scale,” Weinberger said. Early in the pandemic, especially in the Northeast, many of those who were treated clinically for covid and then died were not tested for the virus — so they never made it into the statistics.

Testing Troubles Affect Lawsuits, Hospital Bills

Inaccurate death certificates can make it harder to pursue a lawsuit or win a workers’ compensation case when a loved one dies after contracting covid on the job. Gwendolyn Davis did win workers’ compensation death benefits from Bruce’s employer, a state psychiatric facility in Milledgeville, by providing medical records. But problems with covid testing can complicate the process.

Bruce’s supervisor at work, Mark DeLong, also died after contracting covid, but it did not appear on his death certificate with the other causes: cardiopulmonary arrest, respiratory failure and diabetes.

The omission on DeLong’s certificate seemed to stem from a delay in test results: His covid-positive results didn’t arrive until three days after he died, according to his widow, Jan DeLong. She has asked the local coroner to correct the record.

In New Jersey, attorney Paul da Costa represents 75 family members who lost loved ones at veterans homes in Menlo Park and Paramus in April and May. He said he knows of at least five patients whose death certificates did not list covid-19 despite evidence suggesting it killed them.

The root problem, he said, was a “complete dearth of testing.” Patients were transferred to hospitals, or dying in the veterans facilities, without ever being tested, he said.

The gap between excess deaths and confirmed covid deaths has “narrowed over time as testing has increased,” Weinberger said.

Early testing inaccuracy may also have led to undercounting, which creates a different burden: hospital bills. Without a diagnosis, families can be on the hook for thousands of dollars in charges that otherwise would have been covered under the CARES Act.

Correcting the Record

In some cases, families have sought to have death certificates changed to reflect covid. Dorothy Payton, 95, who lived in the ManorCare nursing home in Denver, first showed covid symptoms April 5. Five days later, Payton — known as “Nana Dee” — tested positive for it. And on April 13, her husband, Edward Benjamin, received a call that she had died.

The death certificate offered a litany of causes: vascular dementia, atrial fibrillation, congestive heart failure, gait instability, difficulty swallowing and “failure to thrive.”

But not covid-19. So it “seemed logical to fight for listing her cause of death under her cause of death,” Benjamin said.

After a few calls, her husband was able to get the certificate amended. ManorCare could not be reached for comment.

For Benjamin, it wasn’t about public health statistics or financial considerations. It simply offers a sense of closure.

“I want her life and death remembered the way it was, and I’m glad we set the record straight,” he said. “It’s the first step towards moving on.”

This story is part of “Lost on the Frontline,” an ongoing project from The Guardian and Kaiser Health News that aims to document the lives of health care workers in the U.S. who die from COVID-19, and to investigate why so many are victims of the disease. If you have a colleague or loved one we should include, please share their story.

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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5 Reasons to Wear a Mask Even After You’re Vaccinated

As an emergency physician, Dr. Eugenia South was in the first group of people to receive a covid vaccine. She received her second dose last week  — even before President-elect Joe Biden.

Yet South said she’s in no rush to throw away her face mask.

“I honestly don’t think I’ll ever go without a mask at work again,” said South, faculty director of the Urban Health Lab at the University of Pennsylvania in Philadelphia. “I don’t think I’ll ever feel safe doing that.”

And although covid vaccines are highly effective, South plans to continue wearing her mask outside the hospital as well.

Health experts say there are good reasons to follow her example.

“Masks and social distancing will need to continue into the foreseeable future — until we have some level of herd immunity,” said Dr. Preeti Malani, chief health officer at the University of Michigan. “Masks and distancing are here to stay.”

Malani and other health experts explained five reasons Americans should hold on to their masks:

1. No vaccine is 100% effective.

Large clinical trials found that two doses of the Moderna and Pfizer-BioNTech vaccines prevented 95% of illnesses caused by the coronavirus. While those results are impressive, 1 in 20 people are left unprotected, said Dr. Tom Frieden, a former director of the Centers for Disease Control and Prevention.

Malani notes that vaccines were tested in controlled clinical trials at top medical centers, under optimal conditions.

In the real world, vaccines are usually slightly less effective. Scientists use specific terms to describe the phenomenon. They refer to the protection offered by vaccines in clinical trials as “efficacy,” while the actual immunity seen in a vaccinated population is “effectiveness.”

The effectiveness of covid vaccines could be affected by the way they’re handled, Malani said. The genetic material used in mRNA vaccines — made with messenger RNA from the coronavirus — is so fragile that it has to be carefully stored and transported.

Any variation from the CDC’s strict guidance could influence how well vaccines work, Malani said.

2. Vaccines don’t provide immediate protection.

No vaccine is effective right away, Malani said. It takes about two weeks for the immune system to make the antibodies that block viral infections.

Covid vaccines will take a little longer than other inoculations, such as the flu shot, because both the Moderna and Pfizer products require two doses. The Pfizer shots are given three weeks apart; the  Moderna shots, four weeks apart.

In other words, full protection won’t arrive until five or six weeks after the first shot. So, a person vaccinated on New Year’s Day won’t be fully protected until Valentine’s Day.

3. Covid vaccines may not prevent you from spreading the virus.

Vaccines can provide two levels of protection. The measles vaccine prevents viruses from causing infection, so vaccinated people don’t spread the infection or develop symptoms.

Most other vaccines — including flu shots — prevent people from becoming sick but not from becoming infected or passing the virus to others, said Dr. Paul Offit, who advises the National Institutes of Health and Food and Drug Administration on covid vaccines.

While covid vaccines clearly prevent illness, researchers need more time to figure out whether they prevent transmission, too, said Phoenix-based epidemiologist Saskia Popescu, an assistant professor in the biodefense program at George Mason University’s Schar School of Policy and Government.

“We don’t yet know if the vaccine protects against infection, or only against illness,” said Frieden, now CEO of Resolve to Save Lives, a global public health initiative. “In other words, a vaccinated person might still be able to spread the virus, even if they don’t feel sick.”

Until researchers can answer that question, Frieden said, wearing masks is the safest way for vaccinated people to protect those around them.

4. Masks protect people with compromised immune systems.

People with cancer are at particular risk from covid. Studies show they’re more likely  than others to become infected and die from the virus, but may not be protected by vaccines, said Dr. Gary Lyman, a professor at Fred Hutchinson Cancer Research Center.

Cancer patients are vulnerable in multiple ways. People with lung cancer are less able to fight off pneumonia, while those undergoing chemotherapy or radiation treatment have weakened immune systems. Leukemia and lymphoma attack immune cells directly, which makes it harder for patients to fight off the virus.

Doctors don’t know much about how people with cancer will respond to vaccines, because they were excluded from randomized trials, Lyman said. Only a handful of study participants were diagnosed with cancer after enrolling. Among those people, covid vaccines protected only 76%.

Although the vaccines appear safe, “prior studies with other vaccines raise concerns that immunosuppressed patients, including cancer patients, may not mount as great an immune response as healthy patients,” Lyman said. “For now, we should assume that patients with cancer may not experience the 95% efficacy.”

Some people aren’t able to be vaccinated.

While most people with allergies can receive covid vaccines safely, the CDC advises those who have had severe allergic reactions to vaccine ingredients, including polyethylene glycol, to avoid vaccination. The agency also warns people who have had dangerous allergic reactions to a first vaccine dose to skip the second.

Lyman encourages people to continue wearing masks to protect those with cancer and others who won’t be fully protected.

5. Masks protect against any strain of the coronavirus, in spite of genetic mutations.

Global health leaders are extremely concerned about new genetic variants of the coronavirus, which appear to be at least 50% more contagious than the original.

So far, studies suggest vaccines will still work against these new strains.

One thing is clear: Public health measures — such as avoiding crowds, physical distancing and masks — reduce the risk of contracting all strains of the coronavirus, as well as other respiratory diseases, Frieden said. For example, the number of flu cases worldwide has been dramatically lower since countries began asking citizens to stay home and wear masks.

“Masks will remain effective,” Malani said. “But careful and consistent use will be essential.”

The best hope for ending the pandemic isn’t to choose between masks, physical distancing and vaccines, Offit said, but to combine them. “The three approaches work best as a team,” 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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Geography Is Destiny: Dentists’ Access to Covid Shots Depends on Where They Live

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Dr. Monte Junker, an Oregon dentist, is waiting for his turn to get vaccinated for covid even though he considers himself a front-line health worker.

“If they offered it to me today, I would be there,” he said.

In December, just before the first vaccines were cleared for emergency use, the Centers for Disease Control and Prevention immunization advisory board recommended that health care workers — as well as nursing home residents and staff members — be the first to be inoculated because of their high risks of infection.

But Oregon is one of a handful of states, including Colorado, North Carolina and Texas, that have put dentists lower in priority order than other health professionals who treat patients — even though they have their hands in people’s mouths and are exposed to aerosols that spray germs in their faces during procedures.

As a result, dentists in those states must wait while many of their peers got their shots in December.

Dr. Tam Le, president of the Connecticut State Dental Association, was vaccinated in December along with employees at his practice in Cheshire. He said he lobbied the state to include dentists with other front-line hospital and health workers.

“In Connecticut, we are doing really well,” he said, noting that the state set up an online registration system for eligible health workers and then contacted them about when and where they could get the vaccine. Le said he and his staff went to a nearby community health center for their shots.

Dentists gained goodwill from state officials last spring by donating gloves and masks to hospitals, Le said. They also offered to help administer the shots since they have experience with that.

States are increasingly diverging from CDC guidance in their vaccination plans, according to an analysis by KFF. “Timelines vary significantly across states, regardless of priority group, resulting in a vaccine rollout labyrinth across the country,” the report said. (KHN is an editorially independent program of KFF.)

The American Dental Association said it’s aware that the lack of a national immunization strategy has meant that dentists and their staffs are not being treated equally across the country.

The CDC advisory board included dentists when it recommended that front-line health workers get priority.

“Each state government’s approach to vaccination will be different based on populations and need, but all dental team members should be prioritized in the first-tier distribution as the vaccines roll out by the different state and county public health departments,” said Daniel Klemmedson, the ADA president. An oral surgeon in Arizona, he has been vaccinated.

In Florida, dentists and their staffs are included among front-line workers eligible for vaccines in the first wave, but a lack of supply has hindered some from getting their shots, according to Drew Eason, CEO of the Florida Dental Association. Some county health departments have also incorrectly turned dentists away, he added.

Dr. Cindy Roark, a Boca Raton dentist and chief clinical officer of Sage Dental, which has 15 offices in Florida and Georgia, said she has no idea when she’ll get vaccinated. She said Georgia dentists in her company have been vaccinated, while those in Florida must wait. The only exceptions appear to be the relatively few dentists affiliated with hospitals. “We are equally vulnerable,” she said.

Still, Roark said she is not upset. “I know I can protect myself,” she said, adding that her office staffers wear N95 masks, face shields and gloves to protect themselves and patients. “Most dentists feel completely safe running their practice and preventing transmission.”

Junker, regional dental director at Advantage Dental in The Dalles, Oregon, said he understands that intensive care staff members, emergency department workers and the elderly in nursing homes need the vaccine first.

“But we are definitely up there for the copious quantities of aerosol in our faces each day,” he said. “The atmosphere is highly concentrated” with virus.

He’s upset at the poor planning and coordination between states and the federal government to make dentists a priority.

In cases where hospital staffers are declining the vaccine because they don’t trust it, Junker said, hospitals should offer shots to dentists and others who are eager for them.

“I don’t think it’s fair for them to sit on the vaccine for a month or two. It needs to get used, and if the hospital workers later decide to get vaccinated, they can get back in line,” he said.

Dr. Stan Hardesty, a Raleigh, North Carolina, dentist and president of the state dental society, said it’s disappointing to see dentists in other states get the vaccine while he and his colleagues have been told to wait.

“We have been advocating on behalf of our members to have dentists and our team members included in phase 1a as recommended by the CDC,” he said. “Unfortunately, the decision-makers [in the state government] have decided to utilize a different prioritization in their vaccine implementation.”

North Carolina dentists will be in “phase 1b,” which includes adults 75 and older, essential workers such as police officers and firefighters.

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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Celltrion closes in on COVID-19 antibody market after trial success

South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease.

Several other companies are also working on antibody therapies and Eli Lilly’s bamlanivimab gained an FDA Emergency Use Authorization in November last year, shortly after Regeneron’s cocktail of casirivimab and imdevimab.

There are doubts over efficacy of Lilly’s antibody, which failed to produce benefits in hospitalised patients in a phase 3 trial last month.

AstraZeneca is developing an antibody therapy and so is its UK rival GlaxoSmithKline, which this week announced a deal with VIR Biotechnology to trial VIR-7832 in mild to moderate COVID-19 patients.

Until COVID-19 hit Celltrion was best known for producing biosimilars, which are near-copies of biologic drugs that have been shown to be as safe and effective in rigorous trials and tests.

But the company is using its expertise to develop an antibody therapy, CT-P59, to help the effort against the pandemic.

Celltrion filed the therapy with the Korean regulator at the end of December and plans to submit data to regulators in Europe and the US in the coming months.

A spokesperson said in an email that company is “working closely with the regulatory agencies to accelerate the regulatory procedures”.

Part I of the trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups (40mg/kg, 80mg/kg and placebo), in which approximately 60% of patients with moderate symptoms suffered from COVID-19 related pneumonia.

This data analysis has demonstrated that at day 28, CT-P59 treated patients presented with a significantly reduced risk of COVID-19 related hospitalisation and oxygenation without mortality.

When compared to placebo, CT-P59 treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderate patients and 68% for moderate patients aged 50 years and over.

CT-P59 treatment groups also reported with significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo.

Patients treated with CT-P59 recovered 3.4 days earlier than those in a placebo group, while patients with pneumonia reported that their recovery time was 5.1 days shorter compared with placebo.

A group of patients with moderate disease aged 50 years and over treated with CR-P59 reported that their recovery time was 6.4 days shorter than placebo, the company said.

CT-P59 treated patients rapidly and significantly reduced viral load through Day 7 compared to placebo. Top-line results from the trial shows CT-P59 to have a positive safety profile, comparable to that of the placebo group, with no serious adverse advents reported.

Infusion related reactions were mild and transient, with the CT-P59 treatment group having reported 0.5%, compared to 1.8% reported with placebo.

Feature image courtesy of Rocky Mountain Laboratories/NIH

 

 

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Enabling new models of care: pursuing pharma’s partnership potential

There is a huge, ongoing shift in how health and wellness is approached in the UK, and the changes will have important implications for NHS-industry partnerships.

Transformative change is coming to the NHS and is set to radically alter how the UK’s health service cares for people at a population level.

The NHS Long Term Plan signposted this change, with its emphasis on preventative health, and the forthcoming expansion of the Integrated Care Systems programme continues this direction of travel on a path towards the long-cherished hope of joining up health and social care.

As new approaches to healthcare attainment take hold there will be some degree of uncertainty among pharmaceutical companies about where they fit into the new structures and the holistic care they seek to provide.

But they’re not the only stakeholders working to map out how to enable new models of care and what their role should be.

 

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Extra COVID-19 shots pose quandary for vaccination sites

Extra COVID-19 shots pose quandary for vaccination sites

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Fri, 01/15/2021 – 04:00

While the nation’s supply of COVID-19 vaccine is limited, hospitals and pharmacies sometimes are left with a surplus when people miss immunization appointments, freezers malfunction, or vials contain more doses than normal. Given the cold-storage requirements and limited shelf life, however, already-thawed doses must be discarded if people cannot be found quickly to take them. A directive from HHS this week for all Americans aged 65 years and older or with medical comorbidities to start getting vaccinating will give administration sites a bigger pool of potential recipients when doses are in danger of expiring. Pharmacists for Giant Food in Washington, DC, for example, are giving extra doses to store associates first before offering them to older people, followed by anyone older than age 18 years. Still, even with takers on standby, hospitals and pharmacies cannot take advantage of the extra product if, for example, a vial that mistakenly includes seven doses only includes enough syringes and needles for the five doses it is supposed to contain.

COVID-19 vaccine distribution changes draw concern at local level

COVID-19 vaccine distribution changes draw concern at local level

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Fri, 01/15/2021 – 04:00

HHS officials on Tuesday ordered a shift in the nation’s COVID-19 vaccination campaign, changes that some say will make more vaccine available but not necessarily rev up the rollout. States have been told to begin immunizing people aged 65 years and older as well as individuals with underlying health problems weeks earlier than planned. To provide supply for those populations, the government will release doses that it had been keeping in reserve for booster injections. Observers worry that state and local health departments, already overwhelmed by a winter surge in COVID cases, will buckle under the pressure to administer more vaccine more quickly. Help could be on the way via an estimated $8 million in vaccination funding included in a stimulus bill, but delivery of those dollars is uncertain. Also frustrating is Washington’s plan to change in 2 weeks how it allocates doses, which threatens to confuse planning with hospitals and health officials unsure when and how much vaccine they should expect. Taken together, these scenarios—along with logistical snarls seen in states that began vaccinating older adults earlier than the rest of the country—has some worried that the new distribution scheme could do more harm than good.

WHO team in Wuhan to trace coronavirus

WHO team in Wuhan to trace coronavirus

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Fri, 01/15/2021 – 04:00

A team of experts from the World Health Organization (WHO) on Thursday arrived in Wuhan, China, to begin searching for the source of the novel coronavirus. However, two researchers were unable to enter China and remained in Singapore after testing positive for coronavirus antibodies, according to a Twitter post by WHO. Authorities in China required the remaining 13 WHO employees and scientists to complete 2 weeks of quarantine in Wuhan. While the investigation seeks to identify how the virus transferred from animals to humans, the Chinese government has created hurdles, making it likely that a full inquiry could exceed the typical time frame of several months. The researchers come from the United Kingdom, Germany, Japan, Russia, the United States, and other countries. The team is expected to examine the earliest reported cases of the virus in China and data gathered by China’s Center for Disease Control, “including contact tracing, environmental sampling, genetic sequences, and identification of patient zero,” says Raina MacIntyre, head of the biosecurity program at the Kirby Institute of the University of New South Wales in Sydney, Australia. Marion Koopmans, a virologist with WHO from the Netherlands, says the investigation was a “long-term project.” She adds: “We will put all the scientific information that has already been collected by our colleagues in China together and discuss, ‘What does that tell us?'”

Johnson & Johnson expects vaccine results soon but lags in production

Johnson & Johnson expects vaccine results soon but lags in production

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Fri, 01/15/2021 – 04:00

Johnson & Johnson could potentially unveil the results of its COVID-19 vaccine trial within as little as 2 weeks, but it likely will be unable to provide as many doses this spring as it pledged to the federal government because of manufacturing delays. The company’s vaccine would require only a single dose and can stay stable in a refrigerator for months. Johnson & Johnson in August signed a $1 billion contract with the federal government to have 12 million doses of its vaccine ready by the end of February, rising to a total of 100 million doses by the end of June. However, sources say the company has fallen behind schedule by as much as 2 months and would not be able to catch up until the end of April. Paul Stoffels, MD, Johnson & Johnson’s chief scientific officer, said he anticipates by late January or early February to have to clinical trial data showing whether the company’s vaccine is safe and effective, but he would not provide details about the company’s production capacity. If the data is positive and FDA authorizes the vaccine for emergency use, “hopefully somewhere in March we’ll be able to contribute” to the nation’s vaccination drive, he said.

Recovered coronavirus patients should still get the vaccine, experts say

Recovered coronavirus patients should still get the vaccine, experts say

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Fri, 01/15/2021 – 04:00

Researchers have found that roughly 90% of patients show residual immunity to the coronavirus 8 months after they recover from COVID-19. However, most epidemiologists recommend that recovered individuals still receive the vaccine. Former CDC director Thomas Frieden noted on Twitter that at least one health system is asking workers who recovered to let others go first when it comes to getting immunized. Meanwhile, researchers at the University of Colorado Boulder found that New York needs to vaccinate 1 in 5 older adults in order to bring death rates down by 73%. That same result would be achievable by immunizing 1 in 6 people if priority is given to people who do not already have antibodies to the virus, according to Kate Bubar, a PhD student in applied mathematics and quantitative biology, who co-authored the study. Some experts are reluctant to discourage anyone from getting the vaccine if they are eligible, especially because of some people’s reluctance to get vaccinated. In Santa Rosa County, FL, only about 40% of emergency responders who are eligible to receive the vaccine have been immunized or signed up to do so, and in New York, roughly 30% of health care workers have declined the vaccine.

Effect of oral moxifloxacin vs. I.V. ertapenem plus oral levofloxacin for treatment of uncomplicated acute appendicitis

Effect of oral moxifloxacin vs. I.V. ertapenem plus oral levofloxacin for treatment of uncomplicated acute appendicitis

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Fri, 01/15/2021 – 04:00

Finnish researchers explored whether a course of oral antibiotics by itself works as well as a combination of oral and I.V. antibiotics to treat uncomplicated acute appendicitis. For the Appendicitis Acuta (APPAC) II study, investigators randomly assigned 295 adults to 7 days of monotherapy with oral moxifloxacin. Another 288 participants were randomized to I.V. ertapenem for 2 days followed by oral levofloxacin and metronidazole for another 5 days. The primary outcome was treatment success, as indicated by hospital discharge without the need for surgery and the absence of recurrent appendicitis for at least 1 year. The co-outcome was noninferiority of the oral-only regimen compared with the combination therapy. At 12-month followup, 70.2% of patients in the oral group met the parameters for treatment success, as did 73.8% of patients in the combination group. With a prespecified noninferiority margin of 6%, however, researchers could not demonstrate noninferiority of oral antibiotics compared with oral and I.V. antibiotics combined.

FDA extends immunodeficiency drug’s shelf life as pandemic exacerbates shortages

FDA extends immunodeficiency drug’s shelf life as pandemic exacerbates shortages

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Fri, 01/15/2021 – 04:00

FDA extended the potency period of 42 existing lots of Octapharma’s subcutaneous immune deficiency drug cutaquig, and also granted a 12-month shelf life extension on future lots stored at 36 degrees to 46 degrees Fahrenheit. Previously, cutaquig was cleared to last 24 months when refrigerated. The drug’s 6-month shelf life at room temperature remains unchanged, according to Octapharma. The current lots were made and shipped in 2019 and 2020, and are already in the distribution chain. Octapharma believes the delayed expiration dates will be beneficial for primary immune disease patients who use its immunoglobulin solution. Flemming Nielsen, president of Octapharma USA, said: “As the supply of immunoglobulin products faces challenges in the near future, the longer shelf life of cutaquig is an important consideration.” He adds that over the last year, Octapharma expanded production of its immunoglobulin products by more than 45%. In November, the Plasma Protein Therapeutics Association alerted the public to the need for plasma donations and called on U.S. authorities to ease the plasma collection process in certain states. The association said, “Considering the complex manufacturing of plasma-derived therapies can take 7-12 months, any decline in plasma donations could impact patients’ ability to access their lifesaving therapies.”

Meijer will administer COVID vaccines at its Michigan pharmacies

Meijer will administer COVID vaccines at its Michigan pharmacies

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Fri, 01/15/2021 – 04:00

Meijer will serve as a pharmacy partner with the state of Michigan to administer COVID-19 vaccines. The company has 120 pharmacies statewide and more than 250 pharmacies across its six-state footprint. Meijer President and CEO Rick Keyes said, “We are proud to be chosen by the State of Michigan as a partner to help administer these critical vaccines and we look forward to our expanded role in helping communities throughout the Midwest defeat this pandemic.” The state government selected Meijer to directly receive and administer COVID-19 vaccines under the Federal Retail Pharmacy Partnership Program. Starting the week of January 18, Meijer pharmacies will begin administering the first doses of COVID-19 vaccine doses at select stores in Wayne County, to patients aged 65 years and older. As more doses become available, Meijer said it will widen its immunization program to more stores throughout the state.

CVS Health to provide in-home chemotherapy via CTCA collaboration

CVS Health to provide in-home chemotherapy via CTCA collaboration

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Fri, 01/15/2021 – 04:00

CVS Health is working with the Cancer Treatment Centers of America (CTCA) to increase access to chemotherapy at home for eligible, fully insured patients. Together, the companies are focused on minimizing patient exposure to COVID-19 from inpatient or hospital outpatient settings during the pandemic while ensuring continuity of critical cancer care. The program gives patients who may have delayed their care due to COVID-19 the flexibility to receive treatment from home, using Coram’s home infusion capabilities, along with training in chemotherapy administration based on Oncology Nursing Society guidelines, using CTCA’s expertise as a top oncology care provider. In collaboration with CTCA and their approach to quality, safe care, Coram has the ability to reach 97% of the U.S. population, according to the company. The program is being piloted in the Atlanta market and will expand to other areas over the next few months. Clinically eligible and fully insured CTCA patients with a range of cancers will begin their first cycles of infused chemotherapy in the hospital or outpatient care center, and, if tolerated over a number of months, can be transitioned home for continued infusions. Once home, patients will receive in-home Coram nurse visits to administer the therapy, paired with regular telehealth visits with their CTCA clinician and care team.

Neonatal abstinence syndrome and maternal opioid-related diagnoses in the US

Neonatal abstinence syndrome and maternal opioid-related diagnoses in the US

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Fri, 01/15/2021 – 04:00

Researchers with HHS, CDC, and other institutions worked together to gauge the prevalence of neonatal abstinence syndrome (NAS) and maternal opioid-related diagnoses (MOD) in the United States during 2010–17. The team drew on data from the Healthcare Cost and Utilization’s National Inpatient Sample and State Inpatient Databases. Analysis revealed that NAS and MOD rates registered a substantial increase across the nation and in most states during the study period, particularly for non-Hispanic White, Medicaid-billed Americans. The incidence varied widely state by state, ranging from 1.3–53.5 cases per 1,000 birth hospitalizations for NAS and from 1.7–47.3 cases per 1,000 delivery hospitalizations for MOD. In particular, MOD rates went up markedly when new International Classification of Disease, 10th Revision, Clinical Modification codes took effect in 2016, the researchers noted. The change included additional codes for long-term and unspecified opioid consumption.

Publix to provide COVID-19 vaccine at 22 store pharmacies

Publix to provide COVID-19 vaccine at 22 store pharmacies

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Fri, 01/15/2021 – 04:00

Publix is partnering with the Florida Department of Health to distribute 15,000 doses of the Moderna COVID-19 vaccine to individuals age 65 years and older. “We’re grateful to play a role in helping to protect the health and well-being of people at risk of serious complications from the coronavirus,” said Publix vice president of pharmacy, Dain Rusk. “We look forward to a time when everyone who wants a vaccination is able to receive one.” Vaccines will initially be available at 22 stores throughout the Citrus, Hernando and Marion communities. Stores will be able to schedule approximately 120 vaccinations per day, by appointment only, beginning January 7.

PBM lobby sues to block HHS rule denying PBMs drugmaker rebates

PBM lobby sues to block HHS rule denying PBMs drugmaker rebates

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Fri, 01/15/2021 – 04:00

A new lawsuit from the Pharmaceutical Care Management Association (PCMA) seeks to block a rebate rule passed by HHS in November 2020. The rule, which ends rebates drug companies pay to PBMs, was intended by HHS to simplify the drug-pricing system and to pass discounts on to consumers. However, PCMA asserts the rule will substantially increase Medicare Part D premiums and costs for taxpayers. “[HHS] failed to consider the significant impacts on beneficiaries and government costs that were articulated in thousands of public comments opposing the rule when it was originally proposed. The rebate rule cannot be implemented and should be invalidated,” said PCMA president and CEO J.C. Scott. PCMA also argued that rebates reduce Medicare expenses, the rebate rule would cost taxpayers $177 billion over a decade, and that the rule does not address prescription drug list prices.

Abbott to Launch NeuroSphere myPath App to Record Pain Relief in Chronic Pain Patients

Shots:

  • The app will record pain relief during the device trial period with SCS or DRG therapy, simplifying reporting outcomes & connect patients to physicians who have real-time access to the data
  • The app will be compatible with Abbott’s Proclaim XR SCS system for patients living with chronic pain in the trunk & limbs and Proclaim DRG neurostimulation system for patients with chronic pain in the lower limbs
  • The app will allow patients to use their Apple phone to connect with Abbott support, access educational resources & track the progress of their trial pain relief journey. The app will be available on the Apple app store in the coming weeks and is expected to be available on android devices in Q2’21

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

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Pfizer’s Xalkori (crizotinib) Receives the US FDA’s Approval for ALK-Positive Anaplastic Large Cell Lymphoma In Children And Young Adult

Shots:

  • The approval is based on the ADVL0912 study assessing Xalkori in 121 patients aged 1-21yrs. that included 26 patients with r/r, systemic ALK+ ALCL prior treated with at least one systemic treatment
  • The study showed 88% ORR. Among 23 patients, who achieved a response, 39% maintained their response for at least 6mos. and 22% maintained their response for at least 12mos.
  • Xalkori is a TKI and has received the FDA’s BTD for ALK+ ALCL in May’2018. Additionally, EMA has agreed to a PIP for the therapy to treat pediatric patients with r/r systemic ALK+ ALCL

Click here ­to­ read full press release/ article | Ref: Pfizer | Image: The Bangkok Post

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A Need for Curative Treatment Expected to Attract the Pharma Players in the Hallux Valgus Market Landscape

Hallux Valgus, also know as Bunion, is the most common forefoot problem in adults. It is the most common pathologic entity of the big toe. It refers to the progressive swelling of the soft tissue. 

Hallux valgus has been reported to affect approximately 23% of the adult population aged 18 to 65 years globally. As per DelveInsight epidemiological estimates, the total Hallux Valgus prevalent cases are estimated to be around 180,658,286 in the 7MM (the U.S., EU5, and Japan) in 2020 and the United States accounted for nearly 41% of the total prevalent cases of Hallux Valgus. Furthermore, it was estimated that the condition is more prevalent in women than in men. It could be due to the choice of footwear as wearing narrow-toed shoes, and high heels are known to exacerbate the problem; thus bunions are more common in women.

A bunion is nothing but a “bump” or an abnormal angulation of the metatarsophalangeal (MTP) joint of the big toe, which consists of two joints. The larger of the two is the MTP, where the first long bone of the foot (metatarsal) meets the first bone of the toe (phalanx). The primary symptom is the appearance of the bump on the inside of the foot accompanied by pain, tenderness, redness, inflammation and ultimately difficulty in walking. Clinically, bunions can be classified into three types, mild, moderate, and severe. The severity of the condition decides the choice of therapy. The treatments comprise self-care, numerous pain-relieving medications, medical devices, and the most important one, surgery

Non-operative or non-surgical treatment helps in relieving symptoms rather than correcting the deformity. It should be considered in patients with general hypermobility, ligamentous laxity or neuromuscular disorders because of the high recurrence rate or in cases with serious contraindications to surgical corrections. However, if the pain persists, the patient is advised to go for the surgery. More than 100 different operative techniques have been described for the correction of hallux valgus. The appearance and the degree of the deformity determine surgical treatment strategies. Common types of surgery include Osteotomy, Arthrodesis/Fusion Surgery, Exostectomy and Resection Arthroplasty. Various devices are used for these surgical procedures including low profile screw set, an approved device from Arthrex used in the osteotomy, Magnezix compression screws, used as bone screws in children / young people and adults almost anywhere in the body and PROstep MIS Bunionette, designed to help get patients back on their feet faster with less pain due to smaller incisions and less soft tissue disruption. 

Other Hallux Valgus marketed devices includes Lapidus Plating System (LPSTM), which is approved for the correction of mild to extreme forefoot H.V., subsequent bunions and related instability. Lapiplasty is the first and only procedure potential enough to correct all 3-dimensions of the bunion deformity, at the root of the problem. Contours LPSTM has been available commercially in the U.S. while recently in May 2019, Lapiplasty 3D Bunion Correction System received the green signal from the US FDA to treat pediatric patients greater than 12 years of age after it has clinically demonstrated high success rates in adults. Lapiplasty 3-Dimensional Bunion Correction, developed by Treace Medical Concepts, is a novel, advanced technology used to correct bunions surgically. Besides Treace, Wright Medical Technology is also a major contender in the Hallux Valgus market. The company has developed PROstep that is a minimally invasive surgical (MIS) technique. PROstep Minimally-Invasive Foot and Ankle system and MICA are manufactured, keeping in mind all the “current” procedures that can be performed through a smaller, minimally invasive, incision, with a focus on preserving the soft tissues. 

Syntellix’s Magnezix is the world’s first bio-absorbable metallic material for implants. Made with magnesium alloy (MgYREZr) with stable metallic properties, it can be completely bio-resorbed in the body and replaced by endogenous tissue. The device has been available in the E.U. Hallux Valgus market for years now. Recently, Syntellix received C.E. approval for one more new product, Magnezix StarFuse as well as approval for Magnezix CS 4.8. 

However, even with so many surgical procedures available in the Hallux Valgus treatment market, there is a serious need for a comprehensive understanding of the radiologic criteria behind the analysis of the deformities so as to help in choosing better surgical method. At present, surgery is the only viable option in severe cases; however, post-surgery complications are a major concern. Complications following H.V. surgery have been reported to be as high as 50%, with one of the most common complications being recurrent H.V.

Sadly, the market outlook has no promising news to offer. DelveInsight estimates a serious lack of novel and sophisticated technologies in the pipeline. According to the market analysis, Hallux Valgus market size in the 7MM is expected to rise during the study period (2018–2030), at a CAGR of 1.7%. However, a few pharmaceutical companies are developing pain relief medications for post-surgical bunionectomy pain relief. Companies like Concentric Analgesics (CA-008), Taiwan Liposome Company (TLC590), Ipsen (Dysport) and others being the key players for pain relief and are not focusing on the actual underlying cause. However, medicines such as NSAIDs and other analgesics are abundantly available in the market for pain relief.

Thus, the Hallux Valgus market is nothing short of a bright opportunity for pharmaceutical and biotech players to try their hands and reap the benefits. Since the average cost of the bunion surgery ranges from approximately USD 3,500 to 12,000, it puts pressure on the patients and their caretakers. Thus, entry of pocket-friendly, new-generation medical devices, with faster healing time, bio-compatibility and without the need to be removed again, are expected to grab the maximum chunk of the Hallux Valgus market share. Additionally, there is also a requirement to ponder over the recurrence rates in the bunion patients; therefore, products that effectively and safely tackle the issue of recurrence are also expected to be a major hit. Thus, the Hallux Valgus market landscape is expected to experience a shift from conservative therapies to new generation minimal invasive options in the pipeline; however, there is still a long way to go. 

The post A Need for Curative Treatment Expected to Attract the Pharma Players in the Hallux Valgus Market Landscape appeared first on DelveInsight Business Research.

Takeda and KSQ Collaborate to Develop and Commercialize Novel Immuno-Oncology Therapies

Shots:

  • KSQ to receive $100M+ as up front and preclinical milestones and up to $400M+/ program in option payment and development & commercialization milestones along with royalties on sales of each approved products
  • The deal includes two KSQ’s previously identified & validated T-cell targets with the potential to introduce two additional targets to the collaboration
  • Takeda will lead to funding for all development & commercialization activities. KSQ to get an option to participate in cost/profit sharing on one of the two products based on the T-cell targets previously identified and validated by KSQ, in the US and retain royalties on all ex-US sales for that product

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

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Top Four Stories of 2020

By Donald Zuhn –- After reflecting upon the events of the past twelve months, Patent Docs presents its 14th annual list of top patent stories. For 2020, we identified eight stories that were covered on Patent Docs last year that we believe had (or are likely to have) a significant impact on patent practitioners and applicants. On Monday, we counted down stories #8 to #5, and today we count down the top four stories of 2020. As with our other lists (2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012, 2011, 2010, 2009, 2008, and 2007), links to our coverage of…