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Today’s Big NewsNov 29, 2023 |
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| By Annalee Armstrong As if biotechs needed any more bad news, CAR-T therapy companies are trading down today on the news that the FDA will investigate the “serious risk” of subsequent, secondary cancers that can occur after treatment with the therapies. |
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By Annalee Armstrong Karuna Therapeutics officially has its date with the FDA. The agency will decide on the approval of KarXT for schizophrenia by September 26, 2024. |
By Nick Paul Taylor Eli Lilly has joined Prism BioLab’s stable of Big Pharma partners, striking a deal worth up to $660 million to collaborate on the discovery of oral inhibitors of protein-protein interaction targets. |
Sponsored by WCG Pediatric CGT trials have the potential to cure diseases and prolong lives. Discover steps to protect safety and enhance operations in your CGT trials. |
By Max Bayer Phenomic has inked its first partnership since emerging three years ago, signing a target identification pact with Boehringer Ingelheim worth more than $500 million. |
By Max Bayer Jazz is pausing a phase 1-stage sleep disorder med after clocking concerning side effects in healthy volunteers. Executives emphasized they were not terminating the program outright but needed time to investigate. |
By James Waldron Ascendis Pharma has pocketed $70 million in exchange for the Japanese rights to the FDA-approved long-acting growth hormone Skytrofa and two other hormone drugs. |
By Nick Paul Taylor Generation Bio is laying off 40% of its staff as part of an R&D pivot to extend the biotech’s cash runway into the second half of 2027. The layoffs, which will see the biotech's chief development and medical officers exit the building, are part of a pivot to targets beyond the liver. |
By James Waldron BioVie has blamed "protocol deviations" at a number of clinical trial sites for the failure of a potential Alzheimer’s disease drug while claiming that the evaluable data still shows the candidate improves cognitive function. |
By Annalee Armstrong Gilead’s Kite Pharma cell therapy unit is undergoing a business review that will result in layoffs to about 7% of the organization’s workforce. In a letter sent to staff this week that was obtained by Fierce Biotech, Kite Pharma Executive Vice President Cindy Perettie previewed a “refreshed business strategy” that would better align the unit’s strategic priorities. |
By Angus Liu In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. |
By Andrea Park As Philips still scrambles to wrap up its 2021 recall of more than 5.5 million home ventilators, a new issue has cropped up among another swath of its CPAP machines. |
By Andrea Park As it awaits regulatory clearance for its Tumor Treating Fields technology in non-small cell lung cancer—and in the wake of the technology’s recent trial failure in ovarian disease—Novocure is narrowing its pipeline and its workforce to conserve funds. |
Fierce podcastsDon’t miss an episode |
| This episode of "The Top Line" is dedicated to Alzheimer’s disease, spotlighting the latest treatments and what lies ahead. Fierce Pharma's Fraiser Kansteiner discusses Leqembi's full approval with Eisai's Alexander Scott. Annalee Armstrong from Fierce Biotech interviews Alzheimer's expert Howard Fillit, M.D., exploring groundbreaking research. Fierce Pharma’s Eric Sagonowsky speaks with Reisa Sperling, M.D., about Leqembi's potential in preventing Alzheimer’s progression before symptoms emerge. |
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