GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.
Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.
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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.
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Stéphane Bancel, Moderna CEO
Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.
Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?
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Tillman Gerngross (Adagio)
Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.
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Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.
The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.
Younger teens could be eligible for the Pfizer-BioNTech Covid-19 booster shots as early as next week, the Wall Street Journal reported Monday.
The companies will apply for regulatory approval for a booster shot in 16- and 17-year-olds this week, according to a source. The move comes as the Omicron variant has brought new cause for concern, and days after US President Joe Biden stood before the country and assured that it’s ‘not a cause for panic.’
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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.
Sean Bohen, Olema Oncology CEO
Olema Oncology had been preparing to present the first clinical data from its lead program at a conference next week, but the biotech’s poster supposedly leaked online Monday. In response, Olema issued a statement saying the image was falsified, and published topline results in a press release Tuesday morning.
The leaked poster ostensibly came from a patient in the Phase I portion of the study, who posted on a discussion forum after saying they completed treatment and received a summary. Originally written on the advocacy website Inspire.com, the forum now leads to a 404 page, but some social media users managed to screenshot the post.
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Ken Song, Ablaze chairman and RayzeBio CEO
Thanks in part to interest from Big Pharma players like Bayer and Novartis over the last decade, there’s been no shortage in cash for new companies looking to slay tumor cells with targeted radioisotopes. Now a transpacific upstart has hooked $75 million to bring the increasingly popular drugs to China.
Ablaze Pharmaceuticals emerged from stealth on Monday with a Vivo Capital and AdvanTech Capital-led Series A round and a licensing pact with Versant-backed RayzeBio. The goal? Introduce targeted radiopharmaceutical therapies (TRTs) to the Chinese market.
https://endpts.com/glaxosmithkline-poaches-pfizers-viral-vaccines-lead-in-rush-to-capitalize-on-future-of-mrna/
