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Novavax is throwing two punches at Omicron, the new COVID-19 variant that’s sparking fresh waves of travel restrictions: evaluating how well its lead COVID-19 vaccine candidate NVX-CoV2373 targets the new variant and creating a new vaccine made specifically to target the highly mutated virus. Read More
Supreme Court justices heard oral arguments this week in a lawsuit — the American Hospital Association (AHA) vs. HHS Secretary Xavier Becerra — centering on a 2018 HHS decision to slash outpatient Medicare drug reimbursements to 340B hospitals by almost 30 percent. Read More
The single-armed study tested mirvetuximab in 106 patients with platinum-resistant high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer. Read More
Philip Dormitzer provided Pfizer scientific leadership for the development of the company’s mRNA-based COVID-19 vaccine co-developed with BioNTech. Read More
Several states and the Department of Justice have been seeking to stop pay out of the settlement, charging that the Sacklers weren’t held sufficiently accountable. Read More
Along an almost entirely Democratic party line vote, the House of Representatives voted 221 to 212 yesterday to pass a continuing resolution funding the government through Feb. 18 of next year. Hours later the Senate passed the bill in a 69-28 vote. Read More
The FDA has lifted the clinical hold it placed in 2019 on the research and development of Entolimod for acute radiation syndrome (ARS), allowing new owner Statera Biopharma to proceed with plans to look at the molecule in cancer patients. Read More
The FDA has sent a complete response letter (CRL) to BeyondSpring Pharmaceuticals denying approval of the company’s new drug application (NDA) for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN), an abnormally low white blood cell count. Read More
A federal appeals court has upheld Mylan’s challenge to a Biogen patent covering the latter’s blockbuster multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate). Read More