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The current state of political affairs in the U.S. does not bode well for the direction of that turn. The country is at real risk of losing its long-held lead in biotech innovation.
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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.
The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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A federal appeals court Monday backed Teva and Viatris’ challenge to a lower court ruling, finding that the companies can again make their case against Johnson & Johnson’s patent covering its schizophrenia drug Invega Sustenna.
Alongside the abrupt departure of Chinese biotech WuXi from BIO, Congress is rattling sabers over perceived national security implications of the U.S.’s R&D relationship with the country.
While some companies look to AI models to stop revenue leakage in business operations, experts say more fundamental issues must first be addressed.
Fresh from its IPO, Fractyl Health got an Investigational Device Exemption from the FDA, clearing a pivotal study of its Revita system to help maintain weight loss following the discontinuation of GLP-1 drugs.
AstraZeneca has secured the FDA’s green light for Voydeya, a first-in-class, oral, Factor D inhibitor developed as an add-on to its standard-of-care Ultomiris or Soliris for certain patients with paroxysmal nocturnal haemoglobinuria.
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.