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Brazilian authorities said the death was unlikely to have been caused by Elevidys and was instead more in line with severe infection exacerbated by immunosuppression.
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J.P. Morgan kicked off with a flurry of deals, with Eli Lilly, GSK and Gilead all announcing deals potentially worth more than $1 billion while J&J committed $14.6 billion to buy Intra-Cellular. These moves have reinvigorated sentiment across the biopharma industry.
An FDA committee’s September 2024 vote to limit the use of Merck’s Keytruda and BMS’ Opdivo in stomach and esophageal cancers based on PD-L1 expression levels reflects an emerging trend that leverages ever-maturing datasets.
Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.
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Eli Lilly and Company announced that the U.S. NRC has issued its consent for the indirect transfer of control of POINT Biopharma Global Inc.'s radioactive materials license, which will occur following the completion of Lilly’s previously announced tender offer to acquire all of the issued and outstanding shares of common stock of POINT, for a purchase price of $12.50 per share in cash, without interest and less any applicable tax withholding.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care.
The deal helps revitalize the TREM2 target after the high-profile failure of AbbVie and Alector’s candidate last year.
After discussions with the FDA, Moderna has withdrawn its application for a combination shot, which had demonstrated efficacy in eliciting antibodies in data announced earlier this month.
BioSpace’s NextGen companies are rising in one of the most confounding biotech markets ever experienced. Executives sounded off on how to keep your head above water during our webinar, Are We There Yet?
BioSpace sits down with four NextGen companies that are thriving despite a multi-year down period. You will hear about ways they are defying the odds to churn out clinical data that may finally provide the industry with a ladder out. Watch now.
Roche, along with Bristol Myers Squibb, Novo Nordisk, AbbVie, Eli Lilly and others, is making inroads into molecular glues to use in cancer, immunology and other applications.
After a tense exchange, Senator Patty Murray (D-WA) told Kennedy that by implementing sweeping cuts to the HHS, he is “enacting his budget,” which “Congress has not passed.”
The ODAC cited concerns with patient populations in clinical trials used to support the proposed expansion. Johnson & Johnson fared better, with the FDA’s cancer advisors voting to recommend Darzalex in patients with a certain type of multiple myeloma.
China continues to be a source of innovation as Pfizer strikes biggest pact yet; HHS provides more info on Trump’s Most Favored Nation executive order; FDA Commissioner Marty Makary and CBER director Vinay Prasad reveal new COVID-19 vaccine strategy following Novavax approval; ODAC underway after chaotic planning; more.
BioSpace examines the busiest corporate venture capital arms in the pharmaceutical industry. Novo Holdings, which made headlines last year with its $16.5 billion Catalent buy, topped the list.