The Latest
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Deep Dive
Biotech IPOs are the industry’s lifeblood. Track how they’re performing.
Should Contineum go public, nine of the last 14 IPOs will have come from biotechs with drugs in Phase 2 testing or later, a significant shift from a few years ago.
Updated 19 hours ago -
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Bristol Myers cell therapy wins first-of-its-kind approval
Sold as Breyanzi, the therapy is now cleared for use in certain adults with hard-to-treat forms of relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Madrigal wins FDA approval of first drug for MASH
Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.
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BIO changes stance, backs bill to limit China’s role in US biotech
Pressed by lawmakers, the lobbying group is also “taking steps” to end its relationship with WuXi-AppTec, a major contract manufacturer to the biopharmaceutical industry.
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J&J, Novo support Asgard’s push to make ‘in vivo’ cell therapies
The Swedish biotech will use the investment to advance a personalized cancer therapy that reprograms tumor cells inside the body.
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German biotech Tubulis cashes in on ADC ‘momentum’ with €128M financing
The funding for the startup, which partnered with Bristol Myers Squibb last year, adds to a surge of recent investments in developers of antibody-drug conjugates.
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FDA to focus on ‘early deaths’ in meeting on broader CAR-T use in myeloma
Briefing documents posted ahead of Friday’s advisory panel zeroed in on increased rates of early death in tests of cell therapies from Bristol Myers Squibb and Johnson & Johnson.
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Deep Dive
Biotech M&A is on the upswing. Track the latest deals here.
Novartis and AstraZeneca have each snapped up a private biotech to boost their respective immunology and rare disease pipelines.
Updated March 14, 2024 -
Emerging biotech
IFM, an unorthodox biotech startup, scores third buyout with Novartis deal
With a decision by the Swiss pharma to acquire another one of its subsidiaries, IFM Therapeutics has now sold three spin-offs for a total of $700 million upfront and the potential for billions more in future payments.
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Roche, following setbacks, turns to its next Alzheimer’s drug
Roche said its experimental Alzheimer’s disease drug trontinemab showed it might be able to clear brain plaques faster than other medicines.
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Merck reveals plans to develop newer HPV shots
The pharma intends to test a single-dose regimen as well as a shot that may provide broader protection than the current versions of Gardasil that regularly generate billions in annual sales.
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Allogene taps Arbor in pursuit of ‘off-the-shelf’ CAR-T therapies for autoimmune disease
The partnership is designed to help the company stand out in what’s quickly become one of the industry’s hottest areas of drug research.
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Acadia drug fails schizophrenia trial, setting back company’s expansion plans
The setback shuts out Acadia’s top medicine from a large sales opportunity and heightens the biotech’s dependence on a pipeline filled with risky drug prospects.
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Q&A
Amylyx CEOs look for a path forward following major setback
Justin Klee and Joshua Cohen spoke to BioPharma Dive about the next steps for their company, which is considering pulling its only product from market after the drug failed a confirmatory study in ALS.
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FDA delays decision on Lilly’s closely watched Alzheimer’s drug
The agency expects to convene a group of outside experts to more closely scrutinize the safety and efficacy of the medicine, donanemab, pushing back the timing of its potential approval.
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Emerging biotech
Biotech IPOs heated up to start 2024. Will the surge last?
Following the sector’s best IPO start in three years, BioPharma Dive spoke with industry insiders about what they expect to see in the months ahead.
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Boehringer, Sosei Heptares team up in schizophrenia drug deal
Sosei Heptares could receive more than 700 million euros in a deal to develop medicines aimed at the protein GPR52, an emerging drug target in multiple neurological diseases.
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J&J’s growing rare disease focus brings a potential multi-use treatment to the table
The head of J&J’s autoantibody programs believes nipocalimab is unique among potential rare disease drugs because it can harness a common thread among them.
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Amylyx ALS drug fails crucial study, putting company’s future in doubt
The results have led Amylyx to pause promotion of Relyvrio and potentially pull it from the market in the coming weeks, a major blow to the company and ALS patients.
Updated March 8, 2024 -
FDA clears use of Novo’s obesity drug to protect heart health
The approval makes Novo’s Wegovy the first weight-loss drug with such a claim on its prescribing information, which could have important implications for use and insurance coverage.
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Deep Dive
Why Cigna is capping cost increases for pricey obesity drugs
The first-of-its-kind move comes as pharmacy benefit managers continue to try to prove their value to clients, and shows how major players are working to meet demand for the fast-selling medicines.
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Novo’s latest obesity pill spurs major weight loss in small trial
Early results from a Phase 1 study suggest the drug, amycretin, could be as potent as injectable medicines already sold by Novo and rival Eli Lilly.
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NodThera says inflammation drug has positive effect in Parkinson’s
The results from the privately held biotech add to early evidence supporting the potential of an increasingly popular drug target known as NLRP3 inflammasomes.
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Biden proposes strengthening Medicare’s drug pricing power
The administration seeks to significantly increase the number of drugs each year that would be subjected to price negotiations under provisions of the Inflation Reduction Act.
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Boundless Bio, a Bayer-backed cancer biotech, seeks an IPO
The startup, which has raised nearly $254 million privately, is in early testing with drugs designed to target particularly tough-to-treat tumors.