We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has accepted lecanemab — the potential heir to Aduhelm’s tarnished fortunes — into its Accelerated Approval pathway, giving the antiamyloid antibody a chance to put Biogen and Eisai back in the Alzheimer’s therapeutics race. Read More
A Democrat-sponsored bill could help solve some of the vexing problems that plague the FDA’s accelerated approval program, allowing it to still bring important new medicines to market quickly, but also increasing the agency’s ability to boot ineffective drugs off the shelves, according to a perspective published in The New England Journal of Medicine. Read More
Senate Democrats are advancing a long-awaited proposal for legislation that would allow Medicare to negotiate lower prescription drug prices. Read More
The FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the oral antiviral drug to COVID-19 patients. Read More
CureVac has filed a patent infringement lawsuit against BioNTech, claiming its messenger RNA (mRNA) technology was used without credit or compensation to create BioNTech’s and Pfizer’s Comirnaty, the world’s first approved COVID-19 vaccine and now the most widely used one. Read More
A Chicago jury has ruled that Endo Pharmaceuticals didn’t violate antitrust laws by paying Impax $112 million to delay the release of a generic that would compete against Opana ER, Endo’s extended-release version of the opioid painkiller oxymorphone. Read More
To help clear up confusion about the Drug Supply Chain Security Act (DSCSA) enhanced drug distribution security requirements that will go into effect on Nov. 27, 2023, the FDA has issued two draft guidances that detail matters related to trading partners and electronic reporting. Read More