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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
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Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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Boehringer Ingelheim and Zealand Pharma’s dual glucagon/GLP-1 receptor agonist elicited significant topline Phase II results in metabolic dysfunction-associated steatohepatitis.
Approved earlier this month for children and adults with one or more food allergies, Xolair in a Phase III study reduced severe allergic reactions in patients suffering from multiple food allergies.
Johnson & Johnson and Legend Biotech got a positive opinion from a European Medicines Agency panel for earlier lines of treatment, as they ready for a March FDA advisory committee meeting.
On Friday, Alvotech and Teva Pharmaceuticals finally secured the FDA’s greenlight for their Humira biosimilar Simlandi, which now has the regulator’s interchangeability designation.
GSK terminated their collaboration with Vir to research, develop and commercialize the biotech’s monoclonal antibodies for the prevention, treatment, or prophylaxis of the influenza under a 2021 agreement.
The cancer space has been aflutter with notable approvals so far this year, but there are several more candidates with significant data expected over the next four months. BioSpace takes a closer look.
Thanks to the success of outgoing CEO Richard Gonzalez, biopharma executives will be studying for years to come how AbbVie navigated the decline of blockbuster Humira.
The FDA’s target decision date is June 27, 2024, the companies announced Friday. Sanofi and Regeneron are looking to expand blockbuster Dupixent into chronic obstructive pulmonary disease.
A year after Roche returned Gavreto’s global rights to Blueprint Medicines, Rigel Pharmaceuticals has acquired the U.S. rights to the FDA-approved treatment for non-small cell lung cancer.
The biotech will use the oversubscribed Series C financing to advance its next-generation KRAS blocker FMC-376, which saw its first patient dosed in a Phase I/II clinical trial on Thursday.