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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
Skyhawk Therapeutics, a three-year-old biotech spawned by entrepreneur, inventor and documentary filmmaker Bill Haney, has inked a new deal with Sanofi that has the two companies working together on challenging oncology and immunology targets. 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
Faced with a barrage of pleas from both clinicians and patients, the FDA will hold a second expert panel hearing on Amylyx’s AMX0035, a drug intended to treat amyotrophic lateral sclerosis (ALS). Read More
AstraZeneca is buying TBio subsidiary TeneoTwo, which will shore up its hematology pipeline with TeneoTwo’s candidate for relapsed and refractory B-cell non-Hodgkin lymphoma. Read More