Policy
The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.
FEATURED STORIES
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
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Moderna announced it is filing lawsuits against Pfizer and BioNTech, alleging that the companies’ COVID-19 vaccine infringes patents covering its mRNA technology.
The United States and China are reportedly close to an agreement that would allow the PCAOB to audit companies listed on the U.S. stock exchange, per the Wall Street Journal.
AstraZeneca announced a series of wins in Japan with regulatory approvals for Tagrisso, Ultomiris and Lynparza, to treat non-small cell lung cancer, myasthenia gravis and breast cancer, respectively.
BioMarin’s Roctavian was granted conditional authorization in the European Union, making it the first gene therapy approved for severe hemophilia A. Now, the company is shooting for U.S. approval.
NIH researchers found that symptomatic herpes viruses were associated with neurological symptoms, but there was no evidence that herpes viruses are linked to Alzheimer’s disease.
Of the 1,400 jobs Novartis plans to eliminate in Switzerland, about half will include leadership and management positions, the company reported Monday.
A day after Pfizer and partner BioNTech submitted an EUA request to the FDA for their booster shot targeting Omicron variants BA.4 and BA.5, the regulator appears close to approving it.
Shares of Foghorn are tumbling after the FDA placed a full clinical hold on a Phase I dose escalation study that had already been subject to a partial hold following a patient death.
Drug development can be done better, faster and less expensively. The industry is facing up to that reality, moving a variety of disruptive innovations forward with the blessing of regulators.
Cases of monkeypox infections reported in the latest viral outbreak have surpassed 14,000 in the U.S., according to the CDC. Some scientists believe the outbreak was predictable.