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… Read More »Distrusting Trump, States Plan to Vet COVID Vaccines Themselves. Bad Idea, Say Experts.
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.
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.
The company said that those who received the two-antibody cocktail REGN-COV2 showed a lower viral loads and faster alleviation of symptoms than those who received placebo.
Molina announced it will acquire the assets of Affinity Health Plan, a New York-based Medicaid managed care organization. It’s one of several Medicaid MCO purchases the insurer has announced this year.
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… Read More »They Cared for Some of New York’s Most Vulnerable Communities. Then 12 Died.
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.
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… Read More »Is Cuomo Directive to Blame for Nursing Home COVID Deaths, as US Official Claims?
The companies also said their Phase II/III study, slated to enroll about 30,000 participants, had already dosed more than 11,000.
The deal brings Roche’s considerable manufacturing heft to Regeneron’s efforts to develop the two-antibody cocktail, REGN-COV2. Regeneron will distribute the drug in the U.S., while Roche will distribute it ex-U.S.
Nearly all of the states, plus five territories and the District of Columbia, are seeking an aggregate of $2.156 trillion from the maker of the opioid painkiller OxyContin, according to documents filed in the U.S. Bankruptcy Court Monday.
Thirty Madison, which owns direct-to-consumer pharmacy brands for hair loss, migraines and acid reflux, raised $47 million in a series B round. Polaris Partners led the round, and Johnson & Johnson participated as an investor.
The company plans to train 250 new racially and ethnically diverse clinical trial investigators and extend the reach of its trials to underserved rural and urban communities.
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… Read More »‘Is This When I Drop Dead?’ Two Doctors Report From the COVID Front Lines
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.… Read More »Public Health Officials Are Quitting or Getting Fired in Throes of Pandemic
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.
Insurance startup Oscar Health plans to expand to 19 new markets next year, pending regulatory approval. The company will offer individual and family health plans in four new states, and will expand its presence in existing states.
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.
The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.
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… Read More »Last Thing Patients Need During Pandemic: Being Last to Know a Doctor Left Network
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.
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… Read More »Pfizer, BioNTech get $1.95B from HHS to supply Covid-19 vaccine
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… Read More »Digital health startup Kaia hopes to win over insurers with results of back pain study
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… Read More »Why Doctors Keep Monitoring Kids Who Recover From Mysterious COVID-Linked Illness
Medly, a New York-based digital pharmacy startup that offers same-day prescription delivery, raised $100 million in a series B round.
In exchange for a $20 million upfront payment and up to $212.5 million in milestones, Italy-based Angelini will gain exclusive development, manufacturing and commercialzation rights in Europe for OV101, a drug for Angelman syndrome.
The companies anticipate releasing more clinical data from the BNT162 messenger RNA vaccine program and potentially starting a 30,000-participant Phase IIb/III study this month.
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… Read More »MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron
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.
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.