Following a year in which vaccine manufacturing plant Emergent BioSolutions spent many months in the headlines for botching 75 million Johnson & Johnson (J&J) COVID-19 vaccines, the federal government and…
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…
A drugmaker in Jiangsu, China failed to properly back-up data, among other IT-related lapses observed during an FDA inspection. Source: Drug Industry Daily
A federal appeals court has struck down Moderna’s coronavirus vaccine-related challenge to patents held by Arbutus Biopharma. Source: Drug Industry Daily
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…
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…
Negotiations hit an impasse in the House yesterday on a stopgap measure to fund federal agencies beyond an upcoming deadline on Friday night. Source: Drug Industry Daily
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). Source: Drug Industry Daily
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)…
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…