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Earlier this year, Amgen refused the FDA’s request to withdraw Tavneos from the market. Now, two researchers who participated in the original study to support the drug’s approval claim they did not know the primary endpoint was readjudicated after the study was unblinded.
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The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
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Read our takes on the biggest stories happening in the industry.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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The staffing changes will focus resources on work that creates the highest impact for patients, according to Genentech. The number of employees affected is unknown, but longtime veteran Vishva Dixit is out.
Biotechs are benefitting from the AI tech frenzy and inflation, but validated pipelines and careful planning are still key to the recent record-setting IPOs, experts say.
Takeda eyes an FDA run for its investigational psoriasis pill after the drug elicited total skin clearance in more than 35% of patients at 16 weeks—more than 2.5 times that in controls taking Bristol Myers Squibb’s Sotyktu.
Instead of using viral vectors, SonoThera’s genetic medicines are delivered through an ultrasound-mediated technology that could help sidestep key safety issues with conventional delivery methods.
It’s the latest Big Pharma deal for molecular glue technology and Novartis’ second with Orionis Biosciences, after first linking up in March 2020. The backloaded agreement will see Novartis pay $40 million upfront.
In this episode of Denatured, you’ll be hearing from Hannah Franklin, associate at Biovance Capital and Pablo Gabriel Cironi Lopez, director of life science investment at Caixa Capital Risc as they discuss the rise of Southern Europe’s biotech ecosystem.
Just 23% of respondents to a BioSpace LinkedIn poll expect the biopharma job market will rebound in 2026. Three experts discuss when they see a turnaround happening and how increasing emphasis on cost efficiency is impacting hiring practices.
For the second time in 2026, the number of biopharma professionals affected by made or projected workforce reductions rose year over year. In May, layoffs spiked nearly 50%, mainly due to Takeda and BioNTech axing a combined 6,360 employees.
The discontinuation of Sanofi’s Phase 3 study for its complement inhibitor drug in chronic inflammatory demyelinating polyneuropathy delivers an ‘obviously disappointing’ blow to the broader drug class, according to William Blair.
The FDA rejected bitopertin in February amid reports of skepticism from former CBER director Vinay Prasad, who has since departed the agency.