The Latest
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Deep Dive
Biotech’s M&A outlook is uncertain. Track the deals that are happening here.
MannKind will pay about $300 million upfront to acquire scPharmaceuticals and its diuretic for chronic kidney disease and heart failure.
Updated Aug. 25, 2025 -
Lilly says breast cancer drug extended survival in study
Treatment with Verzenio helped people with a common type of early breast cancer liver longer than those given standard hormone therapy.
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News roundup
Amylyx drug comes up short; Sanofi names new CMO
AMX0035 missed the goals of a study in progressive supranuclear palsy. Elsewhere, Novartis and BioArctic struck a deal, and Genentech started building its first East Coast factory.
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Startup Wugen raises $115M for ‘off-the-shelf’ CAR-T
The St. Louis-based biotech hopes to submit an application for its leukemia and lymphoma therapy in 2027, if all goes well in an ongoing trial.
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RNA drug from Regeneron, Alnylam succeeds in rare autoimmune disease trial
Cemdisiran helped control symptoms of generalized myasthenia gravis, but combination treatment with a Regeneron antibody didn't appear as effective.
Updated Aug. 26, 2025 -
Deep Dive // Emerging biotech
Biotech IPOs are the industry’s lifeblood. Track how they’re performing.
Schizophrenia drug developer LB Pharmaceuticals on Friday filed plans for an initial public offering, after a six-month stretch with few substantive biotech offerings.
Updated Aug. 25, 2025 -
Obesity drugs
Lilly to submit obesity pill after hitting goal in third late-stage trial
In people with diabetes and obesity, orforglipron led to weight loss near what people without diabetes experienced in prior testing.
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AbbVie wagers more than $1B on Gilgamesh’s psychedelic drug
The asset deal thrusts AbbVie to the forefront of the psychedelic field, handing it a therapy that recently scored positive Phase 2 results in major depression.
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Vaccines
FDA suspends license for Valneva’s chikungunya shot
The agency said it had become aware of more reports of serious adverse events, leading center director Vinay Prasad to conclude the vaccine is no longer safe for its intended use.
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Royalty Pharma buys BeOne stake in Amgen lung cancer drug sales
An $885M deal with BeOne Medicine gives the pharma financier rights to a revenue stream from global sales of Imdelltra, which is sold by Amgen.
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Deep Dive // Emerging biotech
Biotech startups are built on venture capital. Track funding rounds here.
MapLight Therapeutics' $372.5 million Series D round is the third-largest venture financing this year involving VC firms tracked by BioPharma Dive.
Updated Aug. 7, 2025 -
FDA’s new accelerated pathway may open pharma up to risks, as well as benefits
Faster review times could leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty to the approval process.
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News roundup
FDA cancels adcomm on Biohaven drug; Catalent lays off staff
Analysts found the agency's decision to cancel the meeting encouraging. Elsewhere, the Novo Holdings-owned CDMO cut about 350 staff in Maryland.
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Emerging biotech
Gilead dives into ‘in vivo’ cell therapy with $350M buyout of Interius
The deal gives Gilead ownership of a technology that can genetically modify immune cells inside the body, an approach could that potentially widen access to CAR-T treatment.
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FDA approves Ionis’ hereditary angioedema drug
Dawnzera is the third medicine cleared by U.S. regulators this year for the rare genetic condition. Ionis set its list price at $57,462 per dose.
Updated Aug. 21, 2025 -
Deep Dive // Patent thickets
Drug patents protect pharma profits. Track when they’ll expire.
This database now covers the 50 best-selling pharmaceutical products and has been updated to reflect current patent expiry expectations.
Updated April 9, 2025 -
US, EU agree to terms of framework trade pact
The countries documented provisions of a deal that would set a 15% tariff on many EU imports, including cars, pharmaceuticals and semiconductors.
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Sarepta pushes off debt payments in bid to regain financial footing
A refinancing deal will delay the maturity of $700 million in debt until 2030, allowing the company to “fully fund” its pipeline and meet its near-term financial obligations, CEO Doug Ingram said.
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Biotech zombies
Xoma, a drug royalty specialist, buys another ‘zombie’ biotech
A deal to acquire Alkermes spinout Mural Oncology is Xoma’s fourth since June and the latest evidence of interest in buying and shutting down struggling drugmakers.
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Lilly searching for new neuro chief as White set to retire
Anne White, a 30-year company veteran who previously led the company’s oncology unit, will step down as head of Lilly Neuroscience at the end of December.
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Trump administration
The Trump administration is remaking HHS. Track the changes here.
Susan Monarez’s confirmation by the Senate as CDC director ends uncertainty about authority at the agency, which has not had a formal acting head since the spring.
Updated July 30, 2025 -
Rocket can resume gene therapy trial after FDA lifts hold
The company plans to continue with a lower dose and a change in the pre-treatment regimen after a trial participant died earlier this year.
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MAHA may take aim at pharma DTC ads
RFK Jr. has his sights set on increasing oversight and enforcement against drugmakers that run afoul of advertising laws.
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CSL to separate vaccine business, cut jobs
On an earnings call, CSL CEO Paul McKenzie described weakness in the U.S. market for seasonal flu vaccines as “disappointing” and “highly irrational.”
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PTC drug for Friedrich’s ataxia rejected; Lilly sells nearly $7B in bonds
The FDA said data for PTC's drug did not prove "substantial evidence of efficacy." Elsewhere, the FDA delayed its decision on a Regenxbio gene therapy and Skyhawk Therapeutics struck a deal.