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The FDA has released minutes from its meetings in early 2021 with industry on PDUFA reauthorization, discussions that focused on the agency’s Sentinel drug surveillance system and proposed Risk Evaluation and Mitigation Strategies (REMS) assessments. Read More
Eli Lilly’s and Incyte’s Janus kinase (JAK) inhibitor Olumiant (baricitinib) proved unable to significantly reduce progression to noninvasive ventilation for COVID-19 patients in a phase 3 trial, though the drug still managed to significantly reduce the risk of death. Read More
Novartis has entered into a licensing and development agreement with Cambridge, UK-based Artios Pharma to develop new precision oncology drugs. Read More
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has begun a phase 2 study to evaluate the risk of allergic reactions to the Moderna and Pfizer/BioNTech COVID-19 vaccines in patients who are severely allergic or have a mast-cell disorder. Read More
FibroGen admitted that it provided manipulated heart safety data to the FDA for its experimental oral anemia drug, roxadustat, throwing doubts over its potential approval as a treatment for anemia linked to chronic kidney disease (CKD). Read More
The European Medicines Agency (EMA) announced yesterday that AstraZeneca should include the risk of very rare blood clots on the list of possible side effects of its COVID-19 vaccine — and a UK vaccines advisory committee said it would be “preferable” not to give the vaccine to individuals under age 30. Read More
The FDA has moved to delay more reviews of oral Janus Kinase (JAK) inhibitors after recently pushing back its review timeframe for AbbVie’s Rinvoq (upadacitinib), postponing its decisions on separate submissions filed by Pfizer and Eli Lilly/Incyte by three months. Read More