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The company’s FcRn inhibitor Vyvgart grew 17% quarter-over-quarter, reigniting confidence it will hit its ambitious goals despite a string of clinical setbacks in recent months.
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As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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23andMe Holding Co. reported its financial results for the fourth quarter and full year of fiscal year 2022, which ended March 31, 2022.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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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.
Carl Icahn is seeking to get rid of “legacy conflicted directors” on Illumina’s board following the announcement that GRAIL will be divested after a drawn out antitrust battle with regulators.