The Latest

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    Adeline Kon/BioPharma Dive
    Deep Dive

    Biotech M&A, despite big expectations, has yet to pick back up. Here are the latest deals.

    Innoviva is acquiring the rest of Entasis Therapeutics that it doesn't own in a deal valuing the AstraZeneca spinout and its antibiotic pipeline at $113 million.

    Updated May 23, 2022
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    Editas Medicines

    Former Editas CEO Bosley joins UK venture capital firm

    Bosley, who once led the CRISPR gene editing biotech, will become a venture partner at Advent Life Sciences, which backs a range of early-stage drug companies.

  • Pfizer pledges not-for-profit sale of medicines in low-income countries

    The pharma has been criticized for not doing enough to make its COVID-19 vaccine and pill available globally. The new initiative commits Pfizer to supplying current and future branded medicines at lower cost to 45 countries.

  • A cash-strapped biotech winds down operations

    With the market for biotech stocks constrained, Genocea Biosciences plans to delist from Nasdaq and lay off the its remaining employees.

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    ismagilov via Getty Images

    FDA starts clock on review of CSL, UniQure gene therapy

    The regulator agreed to assess the companies' data under priority review, setting up a decision on approval of the hemophilia B treatment in six months.

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    Adeline Kon/BioPharma Dive
    Deep Dive

    After a record run, fewer biotechs are going public. Here's how they're performing.

    Only a handful of biotechs that IPO'd since 2021 trade above their original offering price, while more than 100 are underwater as the sector's market downturn endures.

    Updated May 19, 2022
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    Moderna

    Responding to outbreak, Moderna starts early work on monkeypox vaccine

    One day after the U.S. began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus.

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    Jeenah Moon via Getty Images

    Pfizer, Lilly bolster cases for experimental ulcerative colitis drugs

    The two companies are each developing new types of medicines that they hope can soon win FDA approval for treating the autoimmune disease.

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    Getty Images

    Springworks shares fall despite drug trial's success

    The biotech plans to seek FDA approval for its soft-tissue tumor treatment after positive study results. But investors still sent the stock down by nearly 10%.

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    Permission granted by Biohaven Pharmaceuticals

    Biohaven hits setback as it moves beyond migraine

    The company's experimental treatment for spinocerebellar ataxia is one of several drugs meant to form the pipeline of the "New Biohaven" that will be spun out after Pfizer's planned acquisition.

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    Courtesy of Pfizer

    Pfizer says 3 doses of its COVID-19 vaccine works in youngest children

    The drugmaker, along with partner BioNTech, plans to submit the new data to the FDA this week. The agency has scheduled a meeting for outside experts to review the data in mid-June.

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    Elizabeth Regan / Industry Dive

    Concert drug helps regrow hair in study, boosting shares

    There are no treatments specifically approved for alopecia areata. Concert follows Pfizer and Eli Lilly in reporting positive late-stage results for drugs the companies are developing for the autoimmune disorder.

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    Getty / Edited by BioPharma Dive

    PTC's first gene therapy gains European regulator's backing

    The brain-infused treatment for a rare neurological disease would be one of only three gene therapies commercially available in the EU. PTC plans to ask for FDA approval later this year.

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    AbbVie

    AbbVie asks FDA to approve Parkinson's treatment

    The company believes the treatment, which uses prodrug versions of two commonly used Parkinson's medications, could be a longer-lasting option for patients and blockbuster product for AbbVie.

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    Bayer AG

    Bayer backs out of Atara cell therapy deal

    The German drugmaker will hand back rights to two CAR-T cell therapies it was developing with Atara, which said it would reassess its strategy for the programs.

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    National Institute of Allergy and Infectious Diseases. (2017). "Human Respiratory Syncytial Virus" [Micrograph]. Retrieved from Flickr.

    Trial setback casts doubt on a biotech's respiratory virus drug

    As vaccines for respiratory syncytial virus progressed, Enanta used its hepatitis C know-how to develop an antiviral pill. Yet data in lower-risk patients raise questions of whether it can work.

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    Permission granted by Odyssey Therapeutics

    Cancer drug startup draws former Vertex CEO to board

    Jeffrey Leiden will team up again with biotech entrepreneur Gary Glick, this time as board chairman of Glick's new company, the recently launched Odyssey Therapeutics.

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    Courtesy of Vertex Pharmaceuticals

    Vertex adds to Boston expansion with plans for new site

    The addition, which will be located next to the company's newly dedicated cell and gene facility, could make Vertex the largest biotech by square footage in the city.

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    Maddie Meyer via Getty Images

    Moderna may seek to claw back payments to ex-CFO

    Jorge Gomez, who lasted one day on the job before being ousted over an investigation at his former company, is owed $700,000 — money Moderna says it can recoup if wrongdoing is proven.

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    Permission granted by Gilead Sciences

    Gilead, having resolved manufacturing issues, forges ahead with HIV drug

    The company can now resume testing in nearly a dozen studies that were paused due to FDA concerns about interactions between the drug, lenacapavir, and the glass vials in which it was contained.

    FDA
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    Image courtesy of Ultragenyx.

    Ultragenyx strikes deal with struggling Abeona for rare disease gene therapy

    The treatment, which is designed to treat Sanfilippo syndrome, could become Ultragenyx's first gene therapy to reach market in the U.S., according to the biotech's CEO.

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    Dimitrios Kambouris / Getty Images for Gabrielle's Angel Foundation via Getty Images

    Seagen CEO Siegall resigns amid domestic violence investigation

    The biotech company is searching for a permanent successor to Clay Siegall, who was arrested last month for alleged domestic violence. CMO Roger Dansey will continue as interim CEO.

    Updated May 16, 2022
  • Lilly wins FDA approval for new kind of diabetes drug

    Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline.

    Updated May 16, 2022
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    Jonathan Gardner / BioPharma Dive

    Agios to cut jobs as it moves away from exploratory research

    The biotech expects that, by keeping its focus on more advanced projects and clinical programs, it could save on average $40 million to $50 million annually for the next several years

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    Permission granted by Bristol-Myers Squibb

    Bristol Myers' Opdivo comes up short in bladder cancer trial

    The top-selling immunotherapy failed to improve survival in first-line urothelial carcinoma, a tumor type that's proved difficult to treat with drugs like Opdivo.