The Latest

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    Adeline Kon/BioPharma Dive
    Deep Dive

    Biotech M&A, while far from recent heights, is picking back up. Here are the latest deals.

    UCB's buyout of Zogenix, the first major biotech acquisition of 2022, carries a premium and total value that would rank among the top 10 deals of last year, during which M&A trailed off sharply.

    Updated Jan. 19, 2022
  • Cancer biotech Zymeworks to lay off more than 100 staff in restructuring

    The biotech's newly minted CEO said the 25% workforce reduction should help make Zymeworks more financially stable as it focuses on developing experimental cancer drugs and forging new deals.

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    Courtesy of Merck & Co.

    Generic manufacturers sign pact to supply Merck COVID pill to lower-income countries

    The licenses will help make molnupiravir available to people in more than 100 countries, giving public health authorities a needed tool despite the drug's limited effectiveness.

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    Courtesy of EQRx

    EQRx builds case for cancer drug it hopes can disrupt market

    Study results show EQRx's drug, which it means to position as a lower-cost alternative to widely used cancer immunotherapies, extended the lives of lung cancer patients. But it's unclear whether that will be enough to sway the FDA.

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    Sarah Silbiger via Getty Images

    Bluebird faces longer wait for FDA verdict on experimental gene therapies

    The FDA has extended by three months its review of Bluebird's treatments for beta thalassemia and a rare brain disorder, the latest delay in the company's lengthy road to market in the U.S.

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    Adeline Kon/BioPharma Dive
    Deep Dive

    Record numbers of biotechs are going public. Here's how they're performing.

    Bausch & Lomb, the 169-year-old eye drug developer and subsidiary of the former Valeant Pharmaceuticals, filed for what could be one of the sector’s largest IPOs.

    Updated Jan. 17, 2022
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    Courtesy of Roche

    Roche revives a closely watched Huntington's disease drug

    Ten months after Roche stopped giving the drug to patients in a Phase 3 trial, the pharma is planning a new study on the belief the medicine may help younger adult patients with less advanced disease.

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    AbbVie

    FDA approves AbbVie, Pfizer drugs for eczema, creating competition for Sanofi

    AbbVie's Rinvoq and Pfizer's Cibinqo are both JAK-inhibiting drugs that are taken orally, a convenience which could help them compete against injectable treatments like Sanofi and Regeneron's Dupixent.

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    Permission granted by Biogen

    Medicare faces blowback over plan to limit coverage of Biogen's Alzheimer's drug

    Biogen, along with allies in industry, plans to pressure Medicare to water down its policy, which limits coverage of Aduhelm and drugs like it to clinical trials.

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    Danielle Ternes/BioPharma Dive

    5 questions facing gene therapy in 2022

    As record levels of money pour into gene therapy research, biotechs are under increased pressure to address issues related to safety, delivery and overlapping pipelines. 

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    Brian Tucker / BioPharma Dive

    5 questions facing biotech M&A in 2022

    Analysts expect that deal engines are ready to start firing again following the recent quiet period. Still, uncertainty remains about how biopharma acquisitions could play out in the coming months.

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    Danielle Ternes / BioPharma Dive

    JPM22: Aftershocks for Lilly, CRISPR versus CRISPR and Bluebird's crucial year

    A restrictive Medicare decision on Alzheimer's drugs sent Lilly shares tumbling, while the CEO of Editas brushed off competitive threats to his company's gene editing technology. 

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    Danielle Ternes / BioPharma Dive

    JPM22: M&A anxiety, Roche's comeback plan and Vir's omicron moment

    Pharma executives fielded many questions about their dealmaking intentions on the conference's second day, while Roche outlined its plan to compete against Merck and Bristol Myers in cancer immunotherapy.

  • 5 questions facing the FDA in 2022

    If Robert Califf wins Senate confirmation as expected, he will face a lengthy agenda as well as questions on Aduhelm controversy, accelerated approval and agency funding.

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    Permission granted by Biogen

    Medicare proposes to limit coverage of Biogen Alzheimer's drug

    The program will only cover Aduhelm, which the FDA controversially approved last June, for patients enrolled in rigorous clinical trials, likely forestalling broader adoption of the treatment.

    Updated Jan. 11, 2022
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    libre de droit via Getty Images

    Amgen partners with Arrakis to develop drugs aimed at RNA

    Arrakis, a specialist in designing oral drugs that target RNA, will receive $75 million under the deal, which could be worth "several billion dollars" more. 

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    Danielle Ternes / BioPharma Dive

    JPM22: Pfizer's big bet on mRNA, Biogen 'proven wrong' on Aduhelm price and the next cell therapies

    The healthcare conference's first day brought a trio of mRNA deals from Pfizer, a rare admission from Biogen's CEO and new focus on what's next in cell therapy.

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    Courtesy of Sarepta

    Sarepta, with new Duchenne results, to broach 'possibility' of speedy gene therapy approval

    The biotech will take new Phase 2 data to U.S. regulators, CEO Doug Ingram said Monday, though it still expects to need data from an ongoing late-stage trial to win approval. 

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    cgtoolbox via Getty Images

    Allogene cleared by FDA to resume 'off the shelf' cancer cell therapy trials

    A "chromosomal abnormality" that led regulators to halt Allogene's trials was judged to be unrelated to its technology, a finding with important implications for the field of donor-derived cell therapies.

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    Dan Kitwood via Getty Images

    Pfizer expands into gene editing with Beam research deal

    Pfizer's work with mRNA vaccines led it to explore other applications of the technology, resulting in a multiyear partnership with the high-profile biotech Beam Therapeutics on gene editing treatments for rare diseases.

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    ismagilov via Getty Images

    BioMarin plans return to FDA with updated data on hemophilia gene therapy

    Two-year results from a Phase 3 study of Roctavian show treatment prevented bleeding, potentially giving BioMarin the data it needs to resubmit an application for approval. 

    Updated Jan. 10, 2022
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    Kena Betancur via Getty Images

    As three biotechs head to Wall Street, a battered sector braces for a pullback

    Amylyx, CinCor and Vigil raised about $480 million combined, a sign of continued investor interest in biotech IPOs. But industry analysts expect fewer and smaller offerings in 2022 due to investor fatigue from high valuations.

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    Permission granted by The ALS Association
    Deep Dive // ALS drug development

    On the hunt for new ALS drugs, researchers see progress, and a long road ahead

    The fatal nerve disease has few treatments. But despite continued setbacks, drug developers are hopeful that genetic technologies and a better understanding of biology will bring new options in the not-too-distant future

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    Lisa Maree Williams via Getty Images

    AstraZeneca adds to rare disease drug pipeline with Neurimmune deal

    Neurimmune, which will license to AstraZeneca an early-stage treatment for a rare form of cardiomyopathy, is probably best known for its invention of the antibody that became Biogen's Alzheimer's drug Aduhelm. 

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    Alnylam Pharmaceuticals

    Novartis turns to Alnylam in research deal aimed at liver failure

    The Swiss pharma is familiar with Alnylam's RNA-based technology, which underpins Novartis' newly approved cholesterol drug Leqvio.

    Updated Jan. 6, 2022