The Latest

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    Adeline Kon/BioPharma Dive
    Deep Dive

    Biotech M&A is picking back up. Here are the latest deals.

    AstraZeneca’s acquisition of Neogene is its third biotech buyout this year, expanding its capabilities in cell therapy, gene editing and bispecific antibodies.

    Updated Dec. 2, 2022
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    Yuri Arcurs/Alamy Stock Photo

    Sponsored by Allucent

    When it comes to small populations, biotechs need to think big

    Maria-Cruz Morillo, global therapeutic operations lead for rare diseases at Allucent, discusses the unique challenges of rare disease drug development and how the right expertise can help.

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    gorodenkoff via Getty Images

    Biotech layoffs claim more jobs at Sensei, Instil, TherapeuticsMD

    Cell therapy Instil Bio will cut 60% of its staff and Sensei Bio will reduce its headcount by 40%. TherapeuticsMD, meanwhile, is laying off all its employees days after announcing a deal to sell off its drug portfolio.

  • People pose with the Wall Street Bull in the financial district in Manhattan on June 14, 2022 in New York City.
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    Spencer Platt via Getty Images

    Pharvaris, pushing through trial pause, sees shares surge with new study results

    Though the FDA halted testing of the biotech’s pill for hereditary angioedema in August, enough patients were already enrolled to accrue results that sent shares soaring. 

  • Glass vials of Moderna COVID-19 vaccine.
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    Gabriel Kuchta via Getty Images

    FDA clears updated Omicron boosters for youngest children

    Pfizer's reformulated vaccine is now authorized for children 6 months to 4 years of age who have not completed its primary series, while Moderna's updated shot is cleared as a booster for those 6 months to 5 years old.

    FDA
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    Permission granted by Westlake Village BioPartners
    Emerging biotech

    Dantari emerges with a new way to make cancer drug conjugates

    As the success of drugs like Enhertu catalyzes new investment in antibody-drug conjugates, the California startup is launching with plans to develop more potent versions of the targeted cancer medicines. 

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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.

    Just 20 drugmakers have priced an initial public offering this year, less than one-fifth last year’s total of 104, according to BioPharma Dive data.

    Updated Dec. 5, 2022
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    Prapat Aowsakorn via Getty Images

    Relmada sinks further as depression drug fails second large trial

    The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result. 

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    Elizabeth Regan / Industry Dive

    Prometheus shares soar on new data for inflammation drug

    Having scored positive results in two key studies for ulcerative colitis and Crohn’s disease, Prometheus now intends to advance the drug, called PRA023, into pivotal testing.

  • An anatomical model of the heart sits on a desk in a doctor's office
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    Ivan-Balvan via Getty Images

    Esperion, without data, says cholesterol pill lowered heart risk in study

    The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.

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    Courtesy of Apogee Therapeutics
    Emerging biotech

    Immune drug developer Apogee emerges as first spinout of biotech Paragon

    The new biotech launches with $169 million in venture funding and plans to advance its first drug into clinical testing next year.

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    Permission granted by Steve Paul.

    Karuna switches CEOs ahead of FDA filing for schizophrenia drug

    Former Allergan commercial executive Bill Meury will take over for longtime CEO Steve Paul as the company prepares to seek U.S. approval of the treatment, known as KarXT, next year.

  • A photo of an Editas Medicine scientist in the lab.
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    Permission granted by Editas Medicine
    Gene editing

    Trailing rivals, Editas shares first study data for sickle cell treatment

    Editas said its gene editing therapy appeared safe and was well tolerated in two patients. The data comes five months after U.S. regulators lifted a partial hold on the trial.

  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images

    MEI, Kyowa stop lymphoma drug trials after FDA meeting

    The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

  • A low angle shot of the shining star Vega in the constellation Lyra.
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    Wirestock via Getty Images
    Emerging biotech

    Star Therapeutics launches Vega, growing its galaxy of drug startups

    The second startup to emerge from Star’s “hub-and-spoke” model aims to develop a Hemlibra-like antibody drug for the blood clotting disorder von Willebrand disease.

  • Entact Bio CEO Victoria Richon smiles at the camera with a laboratory setting in the background.
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    Permission granted by Entact Bio

    With $81M, Entact Bio takes a new approach to fixing helpful proteins

    Entact Bio aims to develop medicines that can enhance helpful proteins, rather than block harmful ones, a twist on the usual drugmaking playbook.

  • A photo of Sekar Kathiresan, CEO of Verve Therapeutics
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    Seth Babin/BioPharma Dive
    Gene therapy safety

    Verve shares slide after company reveals details on FDA trial hold

    In a letter to the biotech, the regulator asked for more information on its gene editing medicine for heart disease as well as on its potential risks.

    FDA
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    Novartis

    Novartis prostate cancer drug succeeds in study key to company’s sales hopes

    The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.

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    Elizabeth Regan / Industry Dive

    J&J drops out of hunt for Horizon, leaving Sanofi and Amgen to bid

    The two remaining suitors said they would make cash bids if they move forward with offers, for which they must declare “firm intent” by Jan. 10 under Irish takeover rules.

  • NK Cell (Natural Killer Cell) Attacking a Cancer Cell
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    luismmolina via Getty Images

    With new data, Nkarta builds case for ‘natural killer’ cell therapy

    The updated study results add to evidence that such therapies may help treat B-cell lymphomas. But it’s still unclear how long their effects could last. 

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    monsitj via Getty Images

    TherapeuticsMD to offload drugs to Australia’s Mayne after failed buyout

    After a private equity takeover unraveled this summer, the women’s health company is selling its drug portfolio to Mayne Pharma in a $153 million deal.

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    JuSun via Getty Images
    Gene editing

    FDA lifts pause on Beam plans to test base editing cancer therapy

    The FDA’s decision is a step forward for a type of drugmaking known as “multiplex editing,” which involves editing several genes simultaneously.

  • A photo of a sign showing the Food and Drug Administration logo
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    Sarah Silbiger via Getty Images

    Rigel wins US approval of rival drug to Servier leukemia treatment

    The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.

    FDA
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    Mario Tama via Getty Images

    J&J’s Duato to replace departing Gorsky as board chair

    The board reshuffling will consolidate Duato’s leadership of J&J as the company absorbs a big medtech acquisition and nears a planned spin out of its consumer health division.

  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
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    Sarah Silbiger via Getty Images

    FDA approves first microbiota-based treatment

    The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

    FDA
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    Courtesy of Roche

    Roche study failure gives Alzheimer’s researchers new clues in drug quest

    Detailed clinical trial data for Roche's gantenerumab showed treatment cleared far less toxic protein from patients' brains than expected, potentially explaining its divergent result from Eisai’s lecanemab.