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PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.
Despite strong demand for weight-loss drugs, the lack of Medicare coverage is potentially interfering with prescription and dispensing rates of anti-obesity medications for elderly adults, according to a new study.
Bristol Myers Squibb’s $4.8 billion acquisition of Mirati pays off with strong data from the KRYSTAL-12 study of Krazati, showing that the KRAS inhibitor significantly improves progression-free survival.
Avalo Therapeutics rolled the dice on a big pivot Wednesday, acquiring AlmataBio and focusing on the biotech’s ex-Eli Lilly hidradenitis suppurativa candidate over its existing assets.
Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints.
Sanders says he wants Novo Nordisk to “do the right thing” and lower the costs of Ozempic and Wegovy. But only the Inflation Reduction Act can achieve that.
U.S. intelligence officials have informed senators that China-based biotech WuXi AppTec transferred an American client’s intellectual property to the Chinese government without consent, reports Reuters.
Citing the need for more time to review a major amendment, the FDA is pushing the target action date for the investigational aldose reductase inhibitor in the treatment of classic galactosemia to Nov. 28, 2024.
Gilead Sciences’ Vemlidy on Thursday secured a label expansion from the FDA, allowing the antiviral drug’s use to treat chronic hepatitis B in pediatric patients aged six years and older.
Data from a late-stage study showed that Bristol Myers Squibb’s Zeposia (ozanimod) was unable to significantly improve clinical remission in adult patients with moderate to severe active Crohn’s disease.