FDA commissioner Hahn ousts agency’s new chief spokesperson as plasma controversy continues to smolder

Stephen Hahn, FDA commissioner (Alex Brandon/AP Images)

August 28, 2020 02:05 PM EDT

FDA commissioner Hahn ousts agency’s new chief spokesperson as plasma controversy continues to smolder

Jason Mast

Editor

FDA commissioner Stephen Hahn capped a week of controversy over a fiasco revolving around his misleading comments on a Covid-19 treatment by ousting the agency’s newly-hired chief spokesperson, Emily Miller.

Miller had worked at the right-wing cable news network One America News — a favorite of President Trump’s — as well as for the campaign of Senator Ted Cruz before she was placed at the FDA just 11 days ago, according to the New York Times, which broke the story. Her appointment raised eyebrows at an agency that has long hired civil servants for such positions and worked to maintain its independence from political winds.

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At the Inflection Point for the Next Generation of Cancer Immunotherapy

Willem Overwijk, Ph.D.

Vice President, Oncology Research, Nektar Therapeutics

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

December 4, 2021 06:00 AM EST

Weekly

All about Omicron; We need more Covid antivirals; GSK snags Pfizer’s vaccine exec; Janet Woodcock’s future at FDA; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

December 2, 2021 09:02 AM ESTUpdated 13 hours ago

Pharma

Coronavirus

As Omicron spread looms, oral antivirals appear to be one of the best defenses — now we just need more

Paul Schloesser

Associate Editor

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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ENDPOINTS CAREERS

Lead Manager / Associate Director of Statistical Genetics

Deep Genomics

Boston, MA, USA

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December 3, 2021 10:04 AM EST

Discovery

Coronavirus

Researchers move closer to deciphering blood clots from AstraZeneca, J&J's Covid-19 vaccines

Jason Mast

Editor

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Lisa Deschamps, AviadoBio CEO

December 2, 2021 11:07 AM ESTUpdated December 3, 02:00 AM

Financing

Startups

Cell/Gene Tx

Ex-Novartis business head hops over to a gene therapy startup — and she's reeled in $80M for a dash to the clinic

Nicole DeFeudis

Editor

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News.

Incorporating External Data into Clinical Trials: Comparing Digital Twins to External Control Arms

Unlearn.AI

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

December 1, 2021 03:59 PM ESTUpdated December 2, 07:08 AM

Coronavirus

As first Omicron case in US crops up, researchers wonder: Which antibodies, vaccines will hold up?

Zachary Brennan

Senior Editor

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

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ENDPOINTS CAREERS

Executive Director - Data Analysis - Science & Technology

Alexandria Real Estate Equities

Pasadena, CA

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December 1, 2021 10:34 AM ESTUpdated 04:28 PM

Coronavirus

Moderna loses latest battle in key vaccine delivery patent fight as federal appeal falls flat

Zachary Brennan

Senior Editor

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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December 3, 2021 04:55 PM EST

Marketing

AbbVie tacks on a new warning to Rinvoq label as safety frets crimp JAK class

John Carroll

Editor & Founder

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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