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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 limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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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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Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for which few treatment options exist.
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute liver failure, the same complication responsible for the deaths of two boys taking Sarepta’s Duchenne muscular dystrophy treatment Elevidys.
In advance of CMS’ negotiated price for the blood thinner taking effect next year, partners Bristol Myers Squibb and Pfizer pitched the direct-to-consumer program as a way to allow uninsured, underinsured and self-pay patients to pay less out of pocket.
Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.
The life sciences job market continues to shift. BioSpace’s Q2 2025 U.S. Life Sciences Job Market Report is now available, offering exclusive insights into the latest hiring trends, layoffs, and workforce dynamics across the life sciences industry.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the evolving role of local qualified persons for pharmacovigilance with Ana Pedro Jesuíno, global head local QPPV network at IQVIA.
In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO Vas Narasimhan told reporters that for most medicines, it typically takes three to four years to completely relocate production.
In the first six months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under 130 staff during the same period last year.
FDA reviewers flag “discordant results” in a briefing document published ahead of Friday’s advisory committee meeting for the partners’ application for the antipsychotic in post-traumatic stress disorder.