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Right after reporting a major Phase 3 LAG-3 miss that has rattled analysts, Regeneron Pharmaceuticals revealed a back-loaded partnership with Parabilis Medicines aimed at adding a new drug class to its early-stage pipeline.
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The recent approval of Regeneron’s Otarmeni underscores the maturation of gene therapies across a range of diseases. Here, BioSpace reviews genetic medicines in development for the central nervous system, retinal, cardiac and neuromuscular diseases.
The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
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Read our takes on the biggest stories happening in the industry.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Shockwave Medical bolsters medical device portfolio with acquisition of Neovasc.
Edesa Biotech’s EBO1, a monotherapy for moderate-to-severe chronic Allergic Contact Dermatitis (ACD), showed mixed results compared to placebo in Phase II, the company announced Tuesday.
TC BioPharm and MD Anderson signed a three-year collaboration to better understand the role of gamma delta T cells in cancer treatment.
Massachusetts-based biotech Leap Therapeutics announced Tuesday that it had entered into a merger deal with the privately-held Flame Biosciences, Inc.
Elicio Therapeutics entered into a merger agreement as a wholly-owned subsidiary of Angion Biomedica Co. on Tuesday, becoming a Nasdaq-listed company.
If the letter of intent to acquire your company has been signed, you might be asking what happens next. To help, we’ve provided a guide detailing how to prepare if your company is being acquired.
A novel base editing approach shows a cardioprotective effect in a preclinical study.
The FDA approved Novo Nordisk’s Rybelsus as a first-line treatment option for adults with type 2 diabetes, signaling a shift from its previous indication as a second-line approach.
Cambrian Biopharma announced that its latest pipeline company, Isterian Biotech, has emerged from stealth to develop first-in-class medicines to tackle aging.
Oramed, a clinical-stage company developing orally available versions of biologic drugs, reported disappointing news regarding its lead candidate, ORMD-0801.