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In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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A court in Germany on Tuesday nullified one of CureVac’s intellectual property rights in a patent case against BioNTech. However, court proceedings involving seven other patent rights will continue.
With an upfront payment of $185 million, GSK on Wednesday added another exclusive antibody-drug conjugate license agreement with China-based Hansoh Pharma.
Continued fallout from the IRA, heightened antitrust enforcement and the rise of AI will all shape the first wave of biotech mergers and acquisitions coming this year, experts tell BioSpace.
Argenx’s subcutaneous Fc receptor blocker efgartigimod was unable to induce a significantly higher rate of complete remission than placebo in the skin autoimmune disease. The company’s stock plummeted in response to the news.
Also called an umbrella or basket trial, the master trial allows for a more targeted approach to cancer treatment, faster patient enrollment and the flexibility to pivot.
Chiesi Global Rare Diseases gained access to the Filsuvez topical gel in January 2023, when it bought Amryt Pharma. Tuesday’s approval comes nearly two years after an initial rejection by the regulator.
The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.
Companies and patients alike are questioning the Federal Trade Commission’s challenges to various biopharma agreements.
Shares of several biopharma companies in the CAR-T space dropped after the FDA’s announcement, but analysts remain optimistic about the sector’s future.