ODAC to debate Roche's Polivy in first-line DLBCL following 2019 … – Endpoints News

Once again the FDA’s panel of outside oncology experts will have to weigh in on whether or not to grant another indication for Roche’s potential blockbuster cancer drug Polivy, which some analysts have said could reap $2.4 billion in peak annual sales.
Approved in June 2019 under the accelerated pathway, the antibody drug conjugate Polivy was OK’d in combo with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies.
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George Scangos, one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time.
The 74-year-old biotech legend spent close to three decades in a CEO post. The first was at Exelixis — which is still heavily focused on a drug Scangos advanced in the clinic. The second “retirement” was at Biogen, where he and his team were credited with a big turnaround with the now fading MS blockbuster Tecfidera. And the third comes at Vir, where he traded in his Big Biotech credentials for a marquee founder’s role back on the West Coast, hammering out a Covid-19 alliance with Hal Barron — then R&D chief at GSK — and breaking new ground on infectious diseases with some high-powered venture players.
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Last July, Jeanne Loring stood on a dirt road surrounded by Florida swampland and watched as a nearby SpaceX rocket blasted into the sky. The payload included a very personal belonging: cell clusters mimicking parts of her brain.
For more than two decades, Loring has been at the forefront of a stem cell field that always seems on the brink of becoming the next thing in medicine, but has been slow to lift off.
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An institutional review board (IRB) for a hospital in South Florida has been hit with a warning letter from the FDA over concerns raised during an inspection late in 2021.
The letter, sent earlier this month to Sima Marzban, the VP of research and academic affairs for the Larkin Community Hospital Institutional Review Board, states that an inspection was conducted in November to see if the hospital’s human studies complied with FDA requirements. The site was issued a Form ‘483, however, investigators noticed after reviewing the IRB’s response that it “did not adhere to applicable statutory requirements” that govern the protection of human subjects.
Gene editing and artificial intelligence were the top trending topics on social media among industry experts at the JP Morgan Healthcare Conference this year, according to The Harris Poll.
Among leading CEOs, JPM Chase’s own Jamie Dimon, along with Flagship’s Noubar Afeyan, Sage Therapeutics’ Barry Greene, Biogen’s Chris Viehbacher and Moderna’s Stéphane Bancel were the most discussed chief executives among Harris’ JPM expert network.
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Merck is slamming the brakes on a late-stage Keytruda study in prostate cancer after an interim analysis showed no improvement in survival, the company announced on Wednesday. However, the pharma giant cushioned the blow with a positive look at a separate study in biliary tract cancer.
An independent data monitoring committee reviewing the Phase III KEYNOTE-991 trial saw no improvement in overall survival or radiographic progression-free survival in a Keytruda combination group compared to the control group, Merck said in a news release. The trial was conducted in more than 1,200 patients with metastatic hormone-sensitive prostate cancer (mHSPC), or those whose cancer is controlled by keeping testosterone levels as low as would be expected after castration.
Pharma marketers are known for recruiting both doctors and celebrities for ad campaigns. But Novartis has both in one person for its dry eye disease medicine Xiidra.
Actor Ken Jeong is no longer a practicing physician, but he is still a celebrity Novartis spokesperson for the past 18 months, and he’s now turning up the celebrity for the brand.
Novartis’ latest TV commercial for Xiidra is a movie trailer spoof with Jeong squinting and rubbing his eyes as he walks through a park, while a loud, ominous voiceover intones: “In a world where dry eye symptoms keep coming back … one man learns the truth.”
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One of the generic manufacturers of a drug used to end early pregnancies sued West Virginia’s attorney general today, claiming that federal law and the FDA’s regulations supersede West Virginia’s law banning the drug.
The case will likely be closely followed, given the fact that medication abortions are now the majority of all abortions, and as the Supreme Court last September revoked the right to abortion, paving the way for bans in almost all cases. And if West Virginia’s restrictions are overturned, as GenBioPro claims they “functionally displace FDA’s judgment in approving mifepristone and imposing a REMS,” this might be a test case for other states.
The European Medicines Agency said yesterday that it’s changing how it signs off on orphan designations for drugs targeting inherited retinal dystrophies (IRD) in order to make sure that patients are not left out because of the limitations of the previous orphan designation terms.
Inherited retinal dystrophies are a group of genetic and progressive blinding diseases.
The Committee for Orphan Medicinal Products for the EMA announced the changed policy, which the organization said was supported by input from experts and patients of IRD, as well as a review of scientific literature and 64 active orphan designations in the specific eye diseases in the EU.
What happens when you combine a country music star with a trending health issue and throw in a good measure of TikTok and Instagram?
For Sanofi’s “Knowing RSV” campaign, it’s meant broader awareness for a common virus that many parents don’t know much about. One common misconception, for example, is that respiratory syncytia virus (RSV) only affects infants who are born prematurely or have other health issues. However, 72% of infants hospitalized with RSV are healthy, full-term babies, said Ayanna Santos, head of Sanofi’s RSV franchise in the US.
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The University of Kansas
Lawrence, Kansas
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