President Biden’s nominee to be the next FDA commissioner officially has his Senate confirmation hearing set for next Tuesday. Rob Califf, who’s prepping for his second run as FDA commish, will be peppered with questions by senators ahead of an up or down vote that will likely go Califf’s way.
At least four Democrats, including Bernie Sanders and West Virginia’s Joe Manchin, have already said they won’t vote for Califf, as they did during Califf’s first confirmation (89-4 was the final vote on that one). While Califf’s industry ties and views on the pandemic will likely be the focus of the hearing, all eyes will be on the Republicans (given the tight R-D split in the Senate), and whether they’re willing to back a Biden nominee.
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Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.
Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.
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Members of the public disembark a train at King Cross Station in London, on the day that extra measures are put in place to fight the spread of the Omicron variant of Covid-19. Since Nov. 30, it’s been mandatory for people in England to wear face coverings in shops and on public transport. (Ben Cawthra/Sipa USA/Sipa via AP Images)
Like hundreds of other virologists and epidemiologists, Benjamin tenOever’s Thanksgiving weekend was interrupted with emails about an emergency Omicron meeting.
But when he logged onto a WHO conference call 9 a.m. Monday morning, officials had a surprisingly upbeat spin on the little-understood variant that had already prompted leaders around the world, fearful the strain could evade vaccines, to close their borders to broad swaths of Southern Africa.
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KEY POINTS
Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients. The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers. A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.
Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.
Please signup to continue — it’s fast and free. This article is sponsored by Catalent and produced by Endpoints Studio. Myelodysplastic syndrome is not only hard to say, it’s also hard to explain. So Novartis hired Noma Bar, an artist and illustrator well-known for his simple and striking imagery to create a video that explains the rare blood cancer.
The 2-minute video uses bold colors and seamless graphics that morph from image to image. A white blood cell, for instance, turns into a Pacman-like character gobbling infection, while a drop of blood turns into a dial pointer and then an exclamation point.
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Stephen Hahn (AP Photo/Alex Brandon, File)
Since leaving the FDA’s top post last January, Steve Hahn has been busy, jumping between multiple industry positions thanks to Flagship Pioneering, and most recently taking the helm at a startup focused on the detection of early cancer with a simple blood test.
Hahn’s new company, known as Harbinger Health, will receive $50 million from Flagship to use a proprietary platform combining AI and machine learning to potentially create an entirely new paradigm for cancer diagnosis, enabling early therapeutic interventions or prevention. Hahn’s prior work as chief medical executive of the University of Texas MD Anderson Cancer Center will likely inform his new role, where he’s serving as a Flagship CEO-partner as well as CEO of Harbinger.
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Geoffrey Porges (SVB Leerink)
All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.
So is all that about to change, big time?
SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.
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The team at OncoMyx is trying to leverage one therapeutic to treat several forms of cancer, using the Myxoma virus. Wednesday, it announced the closing of a $50 million Series B financing to take it a step closer to that goal.
The round was co-led by Lumira Ventures and B Capital Group with participation from LYZZ Capital and its Series A investors Boehringer Ingelheim Venture Fund, Delos Capital, Xeraya Capital, Korea Investment Partners, City Hill Ventures, and Madison Partners. Beni Rovinski, the managing director at Lumira Ventures, and Widya Mulyasasmita, the senior principal of healthcare at B Capital Group, will join the companies board of directors.
Ugur Sahin, BioNTech CEO (Frank Rumpenhorst/dpa via AP Images)
The first substantial evidence for how mRNA vaccines will hold up against the new Omicron variant was released Tuesday night from scientists in South Africa.
The study, conducted by mixing sera from vaccinated individuals with live Omicron virus, showed that the variant could largely — but not entirely — dodge antibodies elicited by the Pfizer-BioNTech vaccine.
The result suggests that the vaccines will be less effective at preventing infection by Omicron. But because many antibodies do still bind to the virus, experts say, boosters should help stem the decline. And efficacy will likely hold up against the most important metric for vaccines: preventing severe disease.
When prominent biotech founder David Sabatini was ousted by the Whitehead Institute and the Howard Hughes Medical Institute this summer over sexual harassment allegations, he fought back with a lawsuit claiming he was falsely accused.
On Monday, a main defendant in that case — one of Sabatini’s accusers — filed a counterclaim maintaining that Sabatini condoned a ‘toxic and sexually charged lab environment,’ and that he coerced her into a non-consenual sexual relationship.
https://endpts.com/fda-roundup-republicans-will-be-key-for-rob-califfs-confirmation-janet-woodcock-and-margaret-hamburg-talk-fda-and-the-pandemic/
