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Moderna and Pfizer/BioNTech are both pushing to get expanded Emergency Use Authorization (EUA) for a fourth dose/second booster of their COVID-19 vaccines, but a new study questions its effectiveness in the population at large. Read More
Merck’s mega blockbuster Keytruda (pembrolizumab) may soon have a new indication, this time in an earlier stage of disease than is typical for the anti-PD-L1 therapy. Read More
There’s a push by congressional Democrats to get President Biden to issue a host of executive orders as soon as possible on key priorities, including drug pricing, because they’re not convinced they can get legislation passed before the November midterms. Read More
Diversity is a critical area in clinical research that desperately needs to be improved, the pharma industry agrees, but policies that would require sponsors to enroll more diverse populations will backfire, contends industry trade group PhRMA. Read More
Drug compounding pharmacy Ideal Specialty Apothecary of Parsippany, N.J., has received a Form 483 detailing quality deficiencies observed during an FDA inspection from Sept. 13 through Nov. 18, 2021. Read More
Esai’s investigational anti-tau antibody E2841 grabbed some air time yesterday in Barcelona, Spain, with the first detailed look at a phase 2/3 study in people who are genetically predestined to develop Alzheimer’s disease. Read More
AstraZeneca (AZ) has agreed to pay Chugai Pharmaceutical $775 million to resolve allegations that AZ’s rare disease immunotherapy, Ultomiris (ravulizumab), infringed on the Tokyo-based company’s patents. Read More
Alnylam Pharmaceuticals is suing both Pfizer and Moderna in separate suits, alleging that both companies’ COVID-19 vaccines infringe on one of Alnylam patents for technology that allows RNA-based therapeutics or vaccines to be delivered safely into the body. Read More