Biotech: Page

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    BridgeBio sales of new heart drug outstrip expectations

    In its first full quarter, Attruby made more headway than analysts anticipated in its competition with Pfizer’s market-leading drug.

    By Kristin Jensen • April 30, 2025
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    Acelyrin should liquidate instead of merging with Alumis, investor says

    Trium Capital is the latest firm to push a biotech “zombie” to shut down, claiming in a regulatory filing there is more upside to a liquidation than Acelyrin’s planned merger. 

    By • April 29, 2025
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    Trendline

    Cell therapy

    The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases or in reprogramming cells inside the body.

    By BioPharma Dive staff
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    FDA misses approval deadline for biotech’s rare disease drug

    The delay for Stealth Biotherapeutics comes amid a heightened focus on the impact FDA job cuts might have on drug reviews.

    By • Updated April 29, 2025
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    Novavax says vaccine application still ‘approvable,’ despite FDA delay

    Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” requiring additional clinical study.

    By • April 28, 2025
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    New Akeso, Summit data stir debate on PD-1/VEGF drugs

    Interim results from a study in China suggest ivonescimab may reduce the risk of death versus Keytruda, but the difference wasn’t statistically significant.

    By • April 28, 2025
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    Biohaven stock slides on withdrawal of European marketing application

    Currently under review in the U.S. for a rare genetic disorder, the drug is seen by some investors as critical to Biohaven’s future. Shares bounced back somewhat on Monday. 

    By • April 25, 2025
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    Gilead leans on HIV drugs as oncology sales slow

    The company is looking to the highly anticipated launch of a closely watched HIV medicine to offset weakening demand for Trodelvy and its cancer cell therapies.

    By • April 25, 2025
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    Halozyme sues Merck; FDA blames cuts for Vanda delay

    Halozyme claims Merck infringed on patents in developing a subcutaneous form of Keytruda. Elsewhere, Vanda’s challenge to an FDA rejection dragged on, while Sanofi revealed an immune drug setback. 

    By BioPharma Dive staff • April 25, 2025
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    del Aguila III, Ernesto. (2018). "CRISPR Cas9" [Illustration]. Retrieved from Flickr.
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    Immune reset

    Caribou, in reversal, scraps autoimmune cell therapy and cuts staff

    The CRISPR company is laying off about a third of its employees and stopping work on an experimental lupus treatment in a bid to focus resources on a pair of cancer cell therapies.

    By • April 25, 2025
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    Startup launches

    Versant startup Granite debuts with $100M and 2 immune drugs

    The young biotech, sprung out of a Versant incubator in Switzerland, has a pair of antibody drugs it claims to have the potential to treat multiple autoimmune conditions.

    By • April 24, 2025
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    Startup launches

    Etiome, a new Flagship startup, looks to catch disease before it strikes

    The biotech is using AI and a trove of health data to better understand why certain conditions progress and intervene beforehand with a targeted medication. 

    By • April 24, 2025
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    German antibody maker valued at $1.6B in blank-check merger

    The startup, Veraxa, has $253 million in cash and is raising a crossover funding round to support a pipeline of T-cell engagers and antibody-drug conjugates for cancer. 

    By Kristin Jensen • April 23, 2025
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    Roche looks to a Flagship startup in search of new immune drugs

    Repertoire Immune Medicines will get $35 million upfront, and possibly $730 million more, in a deal to help Roche’s Genentech division unearth T-cell targeting therapies for inflammatory diseases.  

    By • April 23, 2025
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    Akeso claims another PD-1/VEGF win; FDA requests more data from Novavax

    An ivonescimab-chemotherapy combination succeeded in a study in China. Elsewhere, the FDA asked Novavax for more COVID vaccine data and Regeneron boosted its manufacturing capabilities.

    By BioPharma Dive staff • April 22, 2025
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    Trump administration

    RFK Jr. is remaking HHS. Track the changes here.

    Following an executive order from President Trump, the FDA plans to “aggressively deploy its available enforcement tools” to police direct-to-consumer drug ads.

    By BioPharma Dive staff • Updated Aug. 28, 2025
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    Former Neumora CEO to lead Galapagos spinout

    Henry Gosebruch is now chief executive of the spinout, which has roughly $2.5 billion and plans to use dealmaking to build a research pipeline targeting cancer, viruses and the immune system.

    By • April 22, 2025
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    Biotech zombies

    An investment fund sets out to free biotech’s ‘trapped capital’

    Alis Biosciences says its goal is to return to investors billions of dollars stuck on the balance sheets of “moribund” biotech companies that have suffered significant setbacks.  

    By • April 18, 2025
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    Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

    The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales potential compared to other emerging medicines for the condition.

    By • April 18, 2025
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    GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech

    U.K. regulators cleared a multiple myeloma drug GSK withdrew from market three years ago. Elsewhere, RNA editing startup Airna tapped a former Sarepta executive to oversee its pipeline.

    By BioPharma Dive staff • April 18, 2025
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    Bluebird says Ayrmid missed deadline for rival takeover bid

    The company’s board reiterated its recommendation to instead pursue an offer from SK Capital and Carlyle that’s worth about $29 million upfront.

    By • April 16, 2025
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    Leqembi finally secures EU clearance; Sandoz sues Amgen over Enbrel patents

    After a lengthy regulatory back-and-forth, Eisai and Biogen's Alzheimer's drug is on the market in Europe. Elsewhere, Sarepta will start testing a new gene therapy for limb-girdle muscular dystrophy.

    By BioPharma Dive staff • April 16, 2025
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    Startup Glycomine raises $115M to push rare disease drug deeper into testing

    The biotech is developing an experimental drug for the most common of a family of disorders all caused by errors in glycosylation.

    By • April 16, 2025
  • Third Harmonic CEO Natalie Holles
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    Third Harmonic outlines plans for dissolution

    The Atlas-backed company plans to liquidate its assets, including an experimental drug for chronic spontaneous urticaria it pursued after halting work on a different immune drug in 2022.

    By • April 14, 2025
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    Sponsored by QIAGEN Digital Insights

    The critical role of evidence-based databases in pharmacogenomics: Ensuring accuracy, consistency and relevance

    Discover how QIAGEN PGXI transforms pharmacogenomics with faster, more accurate insights!

    By QIAGEN Digital Insights • April 14, 2025
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    Amgen says Imdelltra extended survival; Parker Institute adds new leaders

    The bispecific antibody helped people with small cell lung cancer live longer, Amgen said. Elsewhere, J&J shared new autoimmune drug data and Alzheon reported an Alzheimer’s drug failure.

    By BioPharma Dive staff • April 11, 2025