The Latest

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    Deep Dive

    Biotech M&A is on the upswing. Track the latest deals here.

    Gilead’s proposed deal for CymaBay is its largest since acquiring Immunomedics and bolsters a historical area of strength for the large biotech.

    Updated Feb. 12, 2024
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    J&J secures EMA backing for earlier CAR-T use in multiple myeloma

    European drug regulators recommended clearing J&J and Legend Biotech's Carvykti for use as early as after first relapse, potentially giving the therapy an advantage over Bristol Myers’ Abecma.

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    Outgoing AbbVie CEO leaves a divisive Humira legacy and lasting impact on pharma

    Richard Gonzalez led AbbVie to become one of the largest pharmaceutical firms, but the company's pricing and patent tactics brought criticism, too.

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    Biden administration pledges $100M toward women’s health research

    The commitment is part of an initiative led by First Lady Jill Biden to change how research into diseases that mostly affect women gets funded in the U.S.

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    ORI Capital, the venture firm behind CG’s big IPO, raises new biotech fund

    The $260 million fund will be used to back startups working on new drugmaking approaches like protein degraders and RNA therapies.

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    Adeline Kon/BioPharma Dive
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    Deep Dive

    Biotech IPOs are the industry’s lifeblood. Track how they’re performing.

    After more than a year in the queue, pain drug developer Chromocell Therapeutics finally priced an offering on Thursday, though its $7 million IPO is one of the smallest in recent years.

    Updated Feb. 16, 2024
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    Novavax agrees to pay Gavi in settlement over COVID vaccine contract

    Under the deal’s terms, Novavax will pay the vaccine alliance up to $475 million over five years.

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    Sarah Silbiger via Getty Images
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    United Therapeutics, in unusual step, sues FDA over rival’s drug application

    The biotech alleges the agency is letting rival Liquidia sidestep the rules by accepting an amendment to an application that’s involved in a patent dispute.

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    Bavarian Nordic terminates cancer vaccine work

    The Danish company scrapped a vaccine in Phase 1 testing and will exit oncology altogether, focusing instead on infectious disease research.

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    Vir, in midst of restructuring, loses its chief medical officer

    The departure of Phil Pang, who played a key role in developing Vir’s COVID-19 antibody, comes amid a broader company restructuring.

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    Permission granted by Iovance Biotherapeutics
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    Behind the new kind of cell therapy that just won FDA approval

    One expert views Amtagvi’s approval as a catalyst for further investment in TIL therapies, akin to how Kymriah’s 2017 clearance buoyed CAR-T treatment.

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    Rick Gonzalez, longtime AbbVie CEO, to step down in July

    The veteran executive, who guided AbbVie through its separation from Abbott Laboratories, will be succeeded by Chief Operating Officer Robert Michael. 

  • Packaging for Iovance Biotherapeutics' cellular medicine Amtagvi is held by a technician wearing gloves.
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    Courtesy of Iovance Biotherapeutics
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    Iovance, with approval of ‘TIL’ cell therapy, readies for complex launch

    The biotech set a price of roughly $515,000 per patient for its therapy Amtagvi, the first to be approved based on a decades-old technique of using tumor-infiltrating lymphocytes. 

    FDA
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    FDA puts hold on Rapt trials of drug for eczema, asthma

    Rapt reported one case of liver failure in a study participant who received the biotech’s drug, which is seen by analysts as a possible competitor to Dupixent.

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    AstraZeneca gets new Tagrisso OK as drug succeeds in another trial

    The FDA approved the targeted therapy together with chemo for first-line metastatic lung cancer, while fresh trial results supported earlier use.

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    ALS drug development

    ALS drug from Denali, Sanofi falls short in mid-stage study

    The disclosure the experimental therapy missed its trial goal comes after Sanofi had earmarked the drug for advancement into Phase 3.

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    Gilead reviewing drug acquired in $5B buyout after latest setback

    The FDA paused enrollment in the only remaining tests of the drug, as Gilead reviews the program it acquired through a buyout of biotech Forty Seven.

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    Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies

    Kelonia will receive $40 million upfront through the partnership, and could receive $35 million more if Astellas opts into another program.

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    FDA to review expanded use of Sarepta Duchenne gene therapy

    The agency will decide by June 21 whether to broaden eligibility for Elevidys, and won’t convene a group of outside experts beforehand.

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    Alnylam changes to heart drug trial spark doubts, sinking shares

    Analysts pressed Alnylam executives on the reasons for changes to HELIOS-B, a Phase 3 study in ATTR amyloidosis with cardiomyopathy that is important to the company’s future. 

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    Aurinia to cut research after sale process fails to find a buyer

    The lupus drug developer said it engaged more than 60 parties during its eight-month business review, but only one expressed interest before walking away.

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    Intellia, ReCode partner on genetic medicines for cystic fibrosis

    The partnership will use Intellia's "DNA writing” technology, and focus on people with the lung disease who have limited or no available treatments

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    Emerging biotech

    Versant-backed Firefly Bio wants to make the next generation of ADCs

    Armed with $94 million in funding, the biotech is marrying antibody-drug conjugates with protein degraders to create a new kind of cancer medicine.

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    Emerging biotech

    Hunting a non-opioid painkiller, a biotech reveals plans to chase Vertex

    Latigo Biotherapeutics has raised $135 million to develop drugs that block NaV1.8, the target of a Vertex therapy that just succeeded in Phase 3 trials.

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    Sage offers details on launch of new postpartum depression pill

    The company and partner Biogen say signs from payers and doctors suggest the launch of Zurzuvae, the first oral therapy for PPD, is off to a good start.