New York

Reluctant Localities Are Being Dragged Into Court to Fix Sidewalks for People With Disabilities

From her Baltimore dining room, Susan Goodlaxson can see her neighbor gardening across the street. But while other neighbors stop to chat, Goodlaxson just watches from the window. She uses a wheelchair, and there isn’t a single curb ramp on her block. If the 66-year-old wanted to join, she’d have to jump her wheelchair down …

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NY Reaches Agreement With DOJ Over Vaccine Access for Blind People

Five New York state and local government agencies agreed to fix covid-19 vaccine websites to make them accessible for blind users following a Department of Justice investigation spurred by a KHN story. New York State’s Department of Health, the City of New York’s Department of Health, New York City Health and Hospitals Corp., Nassau County …

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Despite drug’s Phase 2 failure in ulcerative colitis, BMS keeps blockbuster hopes

Bristol Myers Squibb drug deucravacitinib missed the main and secondary goals of a Phase 2 study in ulcerative colitis. Despite the clinical trial failure, the drug previously posted positive Phase 3 results in plaque psoriasis and BMS still projects the molecule will become a blockbuster seller in multiple autoimmune conditions.

Mount Sinai, Empire BlueCross BlueShield to extend access to home-based care models

Empire members will gain access to three Mount Sinai Health System care models, which enable patients to opt for in-home care when medically appropriate. The agreement also includes a plan to improve bi-directional data exchange between the provider and payer.

Clinical trials vendor TrialSpark raises $156M to transform into a drug company

TrialSpark, a startup whose software manages various aspects of clinical trials, is becoming a drug developer. Led by CEO and cofounder Benjamine Liu, the company now plans to to acquire or partner on drug candidates, and to invest in biotech companies.

CVS sues pharmacy benefit startup Capital Rx over ‘unenforceable’ non-compete clause

After Capital Rx’s former medical director of pharmacy services got a job offer at CVS, the PBM startup claimed he couldn’t work there because of a noncompete agreement. CVS recently sued the company, saying its non-compete clause was unenforceable.

‘An Arm and a Leg’: They Turned Grief Into Action

Can’t see the audio player? Click here to listen. In 2004, 24-year-old Manny Lanza urgently needed surgery for a life-threatening brain condition. But he didn’t have insurance, so his hospital refused to schedule the treatment — until it was too late. Manny died waiting.  In the months that followed, Manny’s parents, Reynaldo Prieto and Levia Lanza, …

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Pfizer reports positive Covid-19 vaccine data in kids; FDA is filing coming

A lower-dose version of Pfizer and BioNTech’s Covid-19 vaccine showed safety and efficacy results in children 5 to 11 that were comparable to those in an older age group. With these preliminary data, the companies said they plan to seek emergency use authorization of the shots.

With $100M in new funding, Tia CEO says the ‘tide has turned’ for investing in women’s health

Tia, a concierge clinic combining primary care and OBGYN services, recently raised $100 million in funding. Amid a surge of financing into women’s health startups, CEO Carolyn Witte said investors’ perspectives are changing. 

‘Luckiest Man Alive’: Why 9/11 First Responders’ Outlooks May Improve Even as Physical Health Fails

Ray Pfeifer and Luis Alvarez’s names are on the federal 9/11 legislation that establishes benefits for first responders. Both men fought to make Congress pass it while they were dying of cancer — and they had another thing in common. In spite of it all, they were content. “I am the luckiest man alive,” Pfeifer, …

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Pfizer eczema contender beats Dupixent in study, but JAK drug class is still in limbo

Pfizer has preliminary data showing its experimental drug for atopic dermatitis beat a blockbuster drug from Regeneron Pharmaceuticals in a head-to-head clinical trial. But the future of that drug and others might depend more on an FDA review of safety data for medicines in this class of so-called JAK inhibitors.

Headed Away to School? Here’s What Students With Health Issues Need to Know

College is a time of transition, but for those managing chronic medical conditions, it may also be the first time they will be wholly responsible for their own health: setting appointments, securing supplies and pharmaceuticals, and monitoring symptoms. For those heading to schools far from home, it can be especially tricky navigating the complex world …

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Pfizer makes big move in blood cancers with $2.3B Trillium acquisition

Though Gilead Sciences leads the group of companies developing immunotherapies that target the cancer protein CD47, Pfizer contends that molecules it is getting through the Trillium Therapeutics acquisition have safety and efficacy advantages that could make them the best in this emerging drug class.

Pfizer, BioNTech Covid-19 vaccine is awarded full FDA approval

Full FDA approval makes the Pfizer/BioNTech Covid-19 vaccine the first to reach that milestone. But the regulatory decision also flagged a potential risk of heart inflammation, particularly in young males, and the agency has asked the companies to conduct additional clinical research.

HiberCell’s Genuity buyout brings $100M, plus alliances with Ionis and AbbVie

Startup HiberCell has acquired Genuity Science, a marriage that brings together two companies that apply AI and machine learning to drug research. HiberCell says Genuity will help the company identify and validate new pathways in how cancer starts and progresses.

UnitedHealth subsidiaries settle mental health parity allegations for $15.6M

UnitedHealthcare and United Behavioral Health agreed to the settlement to resolve allegations that they illegally denied coverage for mental health and substance use disorder treatments. The allegations are related to business practices they no longer use, parent company UnitedHealth Group said.

How a Hospital and a School District Teamed Up to Help Kids in Emotional Crisis

In 2019, the Rockville Centre school district in Long Island, New York, was shaken by a string of student deaths, including the suicides of a recent graduate and a current student. “When you get these losses, one after the other, you almost can’t get traction on normalcy,” said Noreen Leahy, an assistant superintendent at the …

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Bristol Myers pulls Opdivo for use in liver cancer amid broader FDA scrutiny of speedy approvals

Bristol Myers Squibb blockbuster drug Opdivo is being pulled from the market after failing to meet the main goal of a confirmatory study. The voluntary withdrawal comes amid broader FDA scrutiny of cancer drugs that were given accelerated approval.

Teen Volunteers Get a Foot in the Door for Nursing Home Careers

Jasmine De Moya, 17, has dreamed for years of working in the medical field, and she yearned to spend time with older people, missing her grandparents, who live in the Dominican Republic. A program sponsored by the New Jewish Home health system in New York City that combines volunteering and free training for entry-level health …

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States Step Up Push to Regulate Pharmacy Drug Brokers

Under pressure to rein in skyrocketing prescription drug costs, states are targeting companies that serve as conduits for drug manufacturers, health insurers and pharmacies. More than 100 separate bills regulating those companies, known as pharmacy benefit managers, have been introduced in 42 states this year, according to the National Academy for State Health Policy, which …

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‘Johnson & Johnson helped fuel this fire’ – now it’s out of the opioids business

Whether the pharmaceutical giant jumped or was pushed, its New York deal is a significant sign of the way the wind is blowing Johnson & Johnson said it had already jumped. New York’s attorney general suggested the pharmaceutical giant was pushed. Either way, the American drug maker is the first to formally agree to get …

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Unvaccinated, Homebound and Now Hospitalized With Covid in New York City

Dr. Leora Horwitz treats fewer and fewer covid patients at NYU Langone Medical Center in New York City. Still, she thinks there are too many. And they almost all have something in common. “I’ve only had one patient who was vaccinated, and he was being treated for cancer with chemotherapy,” she said, reflecting recent research …

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Pfizer’s Prevnar 20 wins FDA nod, getting edge in pneumococcus vax race—for now

The FDA has approved Prevnar 20, a Pfizer vaccine that protects against 20 pneumococcal strains—seven more than the company’s blockbuster Prevnar 13. But others are on Pfizer’s heels with vaccine candidates that aim to match or even beat the Pfizer pneumococcal vaccines.

Versant Ventures unveils new startup that stabilizes proteins to treat disease

Stablix Therapeutics is developing technology that uses small molecules to stabilize a protein, keeping it from going to a cell’s built-in disposal system. The startup now has $63 million in funding to further invest in the technology and advance its first molecules toward the clinic.

FDA authorizes Regeneron’s Covid drug at lower dose, and in injectable formulation

Emergency authorization of Regeneron Pharmaceuticals’ Covid-19 antibody drug now includes an injectable version, which is a more convenient option for patients. The drug developer plans to seek full FDA approval of its antibody cocktail later this summer.

Bristol Myers “dual immunotherapy” beats Opdivo alone in melanoma study

Bristol Myers Squibb reported Phase 3 data that show its experimental cancer immunotherapy relatlimab, combined with the company’s blockbuster drug Opdivo, was better at stopping melanoma from progressing. BMS will present the data at the upcoming annual meeting of the American Society of Clinical Oncology.

Perceptive Advisors closes $515M fund to fuel more early-stage biotech startups

Perceptive Advisors has $515 million for its second fund investing in biotech startups. Portfolio Manager Chris Garabedian says Perceptive Xontogeny Ventures Fund II is looking to make Series A investments in early-stage companies with assets that can show a path to clinical testing.

Roivant’s move to go public reveals just how much its drug strategy has changed

Founded by former hedge fund manager Vivek Ramawamy, Roivant Sciences set out to redefine drug development by acquiring overlooked drugs and advancing their development. The merger deal that will take it public reveals how much new technology changed the company’s vision and its strategy.

INVEST Pitch Perfect winner spotlight: Oshi builds digital approach for oft-overlooked GI conditions

As awareness grows around GI conditions, startup Oshi Health is building a platform to connect people to teams of clinicians and health coaches to better manage their symptoms. Judges picked the startup as the health services winner for MedCity INVEST’s Pitch Perfect contest. 

With new funding, digital physical therapy startup Kaia strikes partnerships with clinicians  

Kaia Health, a startup providing app-based programs for musculoskeletal conditions and COPD, recently raised $75 million in funding. As competitors look to round out their platforms with other services, Kaia is looking to strike partnerships with clinicians. 

Regulatory progress for two biotechs stalls as FDA requests more information

The FDA placed a clinical hold on a KalVista Pharmaceuticals drug being readied for mid-stage studies in a rare, inherited disorder. Meanwhile, the FDA has some questions about the historical data Y-mAbs used as the control in a clinical trial for its antibody cancer drug.

Regeneron, Roche injectable antibody drug shows efficacy in preventing Covid-19

A Regeneron Pharmaceuticals antibody cocktail currently authorized for treating Covid-19 now has additional clinical data showing it reduces the risk of infection spread. The drug developer, along with partner Roche, plan to ask regulators to expand the drug’s authorization to include disease prevention.

The key IT decisions that helped providers survive April 2020

As Covid-19 cases started escalating last April, providers in hotspot states, like New York, California and Washington, had to quickly pivot their IT plans. These are some of the decisions that five health IT leaders made — aside from expanding telehealth — that helped their health systems survive the first wave of the pandemic and …

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Can Cell Phone Radiation Damage Your DNA?

Do mobile phones cause brain tumors? Whenever a trillion-dollar industry is involved—whether it’s Big Food, Big Tobacco, Big Pharma, or Big Telecom—there’s so much money that the science can get manipulated. When it comes to the potential human health effects of cell phone use, certainly, you might end up with a crick in your neck …

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Cityblock nets another $192M, plans to expand into maternity and pediatrics

The startup, which provides primary care services to Medicaid patients, plans to use the funds to expand into new states and add maternity and pediatrics services lines. It also recently launched a vaccination site in conjunction with the New York Department of Health.

Some Dream — Others Scheme — To Find a Vaccine Before Spring Break

Hawaii, Florida, Seattle and the South of France are on the minds of New York City college students. Those are some of the destinations that undergrads mentioned when asked where they’d go for spring break, if they weren’t grounded by covid-19. This story also ran on NPR. It can be republished for free. “I’d be …

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FDA calls out Brainstorm’s ALS stem cell therapy, says data don’t show benefit

A Brainstorm Cell Therapeutics therapy for Lou Gehrig’s disease failed a pivotal study, but the company points to better results in a subgroup. The FDA took the unusual step of publicly stating that study’s results do not show the stem cell therapy helps patients.

Sorting Out How Politics, Policies Figure in Flap Over New York Nursing Home Covid Death Rates

The plaudits have faded for New York Gov. Andrew Cuomo. Once hailed as a paragon of pandemic governing, he’s since come under scorching criticism for undercounting the state’s covid deaths among nursing home residents by as much as half. The tallying flap drew attention to another misstep: a policy last March that directed nursing homes …

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Roivant extends AI drug discovery reach with $450M Silicon Therapeutics buyout

Roivant Sciences is expanding its drug discovery and design capabilities via a stock deal to acquire Silicon Therapeutics. The Boston startup uses physics-based modeling to simulate proteins and the small molecules that bind to them.

‘It Doesn’t Feel Worth It’: Covid Is Pushing New York’s EMTs to the Brink

This story also ran on The Guardian. It can be republished for free. In his 17 years as an emergency medical provider, Anthony Almojera thought he had seen it all. “Shootings, stabbings, people on fire, you name it,” he said. Then came covid-19. Before the pandemic, Almojera said it was normal to respond to one …

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FDA approves Regeneron drug for rare, inherited form of high cholesterol

The FDA approval clears Regeneron’s drug, Evkeeza, as a treatment for the rarer of two forms of an inherited disease that causes high cholesterol levels. The company already markets Praluent, which treats the more common form of familial cholesterolemia.

Estados permiten contratar profesionales de salud extranjeros por la pandemia

Cuando los hospitales de todo el país luchan contra la nueva ola de la pandemia, no son camas ni ventiladores lo que escasean. Son las personas que cuidan de los enfermos. Pero existe mano de obra altamente calificada de médicos, enfermeras y otros trabajadores de salud, con formación en el extranjero, que no se aprovecha …

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States threaten to crackdown on providers amid Covid-19 vaccine distribution

In an effort to ensure the efficient and orderly distribution of the Covid-19 vaccine, governors from New York, California and Florida are warning that they will take action against providers who are conducting vaccinations too slowly or healthcare workers who undercut priority guidelines.

INVEST Precision Medicine Pitch Perfect winner spotlight: TrialSpark

Judges picked TrialSpark as the winner on the life sciences track of the pitch competition at MedCity’s virtual precision medicine conference. While the company is focused on improving clinical trials for others, it hopes eventually to bring drugs of its own to market.

As the Terror of COVID Struck, Health Care Workers Struggled to Survive. Thousands Lost the Fight.

This story also ran on The Guardian. It can be republished for free. Workers at Garfield Medical Center in suburban Los Angeles were on edge as the pandemic ramped up in March and April. Staffers in a 30-patient unit were rationing a single tub of sanitizing wipes all day. A May memo from the CEO …

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NYC Hospital Workers, Knowing How Bad It Can Get, Brace for COVID 2nd Wave

No single municipality in the country suffered more in the first wave of the pandemic than New York City, which saw more than 24,000 deaths, mainly in the spring. Medical staff in New York know precisely how difficult and dangerous overwhelmed hospitals can be and are braced warily as infections begin to rise again.  Around …

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Trump’s Lame-Duck Status Leaves Governors to Wing It on COVID

Not long after the world learned that President Donald Trump had lost his reelection bid, states began issuing a new round of crackdowns and emergency declarations against the surging coronavirus. Taking action this time were Republican governors who had resisted doing so during the spring and summer. Now they face an increasingly out-of-control virus and …

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Patients Struggle to Find Prescription Opioids After NY Tax Drives Out Suppliers

NEW YORK — Mike Angevine lives in constant pain. For a decade the 37-year-old has relied on opioids to manage his chronic pancreatitis, a disease with no known cure. But in January, Angevine’s pharmacy on Long Island ran out of oxymorphone and he couldn’t find it at other drugstores. He fell into withdrawal and had …

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Lions and Tigers and Anteaters? US Scientists Scan the Menagerie for COVID

As COVID-19 cases surge in the U.S., one Texas veterinarian has been quietly tracking the spread of the disease — not in people, but in their pets. Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and …

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Distrusting Trump, States Plan to Vet COVID Vaccines Themselves. Bad Idea, Say Experts.

As trust in the Food and Drug Administration wavers, several states have vowed to conduct independent reviews of any COVID-19 vaccine the federal agency authorizes. But top health experts say such vetting may be misguided, even if it reflects a well-founded lack of confidence in the Trump administration — especially now that the FDA has …

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BMS acquires MyoKardia, maker of drugs for cardiovascular disease, for $13.1B

The companies expect the deal to close in the fourth quarter. MyoKardia’s lead drug candidate is mavacamten, which it is developing for hypertrophic cardiomyopathy and plans to submit to the FDA in the first quarter of next year.

Ovid drug reduces seizure frequency in two rare forms of epilepsy, according to early Phase II data

The data from a Phase II pilot and an extension study of soticlestat, also known as OV935 or TAK-935, showed short- and long-term reductions of seizure frequency in patients with CDKL5 deficiency disorder and Dup15q syndrome.

They Cared for Some of New York’s Most Vulnerable Communities. Then 12 Died.

Dr. Reza Chowdhury didn’t charge copays when his patients were low on cash. He gave them his home phone number and answered their medical questions at all hours. Once, when Chowdhury’s daughter, Nikita Rahman, struck up a conversation with a New York taxi driver, it turned out that he was from Bangladesh and knew her …

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Aetion completes $82M Series B round with $19M extension

The healthcare analytics company said it had raised the extension funding from three new investors and would use it to accelerate development of its real-world evidence technology.

Is Cuomo Directive to Blame for Nursing Home COVID Deaths, as US Official Claims?

On the first night of the Democratic National Convention, New York Gov. Andrew Cuomo was among the first in a weeklong parade of speakers to issue scathing critiques of the Trump administration’s coronavirus response. Cuomo’s criticisms drew a quick reply in a tweet from Michael Caputo, an assistant secretary for public affairs at the Department …

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‘Is This When I Drop Dead?’ Two Doctors Report From the COVID Front Lines

Health workers across the country looked on in horror when New York became the global epicenter of the coronavirus. Now, as physicians in cities such as Houston, Phoenix and Miami face their own COVID-19 crises, they are looking to New York, where the caseload has since abated, for guidance. The Guardian sat in on a …

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Public Health Officials Are Quitting or Getting Fired in Throes of Pandemic

Vilified, threatened with violence or in some cases suffering from burnout, dozens of state and local public health officials around the U.S. have resigned or have been fired amid the coronavirus outbreak, a testament to how politically combustible masks, lockdowns and infection data have become. One of the latest departures came Sunday, when California’s public …

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Big Pharma plays CMO as Pfizer signs on to produce Covid-19 drug remdesivir for Gilead

Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.

BMS, bluebird refile FDA approval application for CAR-T therapy in myeloma

The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.

Last Thing Patients Need During Pandemic: Being Last to Know a Doctor Left Network

NEW YORK — As the coronavirus spread silently through New York City early this year, Deborah Koeppel had an appointment with her cardiologist and two visits with her primary care doctor. Both physicians are members of Concorde Medical Group, a practice in Manhattan with an office conveniently located a few blocks from where Koeppel works. …

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How are VCs performing due diligence when they can’t meet startups in person?

In a panel discussion during MedCity INVEST Thursday, investors discussed how the Covid-19 pandemic and social distancing requirements have impacted the way they interact with companies.

Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine

The companies will supply 100 million doses of the vaccine by the end of the year, and the government will have the option to acquire 500 million more. However, the FDA must grant an authorization based on its safety and efficacy, for which there are only preliminary data so far.

Digital health startup Kaia hopes to win over insurers with results of back pain study

Kaia Health, a startup making an app to help users manage back pain, touted the results of a large, randomized controlled trial using its app. The company currently markets its system to employers, but hopes to make it available as a covered benefit in the future.

Why Doctors Keep Monitoring Kids Who Recover From Mysterious COVID-Linked Illness

Israel Shippy doesn’t remember much about having COVID-19 — or the unusual auto-immune disease it triggered — other than being groggy and uncomfortable for a bunch of days. He’s a 5-year-old, and would much rather talk about cartoons, or the ideas for inventions that constantly pop into his head. “Hold your horses, I think I …

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MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron

Bari Kowal, vice president of global clinical operations at Regeneron Pharmaceuticals, gives an update on the clinical trials ongoing to develop drugs to fight Covid-19 and provides insights on how the clinical trials landscape and pharma overall must change in the next episode of MedCity Pivot Podcast.

BARDA, DoD give Regeneron $450M contract for Covid-19 antiviral drug

The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.

Regeneron starts late-stage trials of antiviral antibody cocktail in Covid-19

The company also said that the Phase III study of the autoimmune disease drug Kevzara that it was running with Sanofi failed to meet either its primary or key secondary endpoints among critically ill Covid-19 patients.