The European Medicines Agency’s (EMA) safety committee has recommended revised product safety information for Johnson & Johnson’s (J&J) and Moderna’s COVID-19 vaccines. Source: Drug Industry Daily
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. Source: Drug Industry Daily
Gilead Sciences has become the 15th major drugmaker to limit its involvement with the 30-year-old 340B Drug Discount Program that was designed to serve low-income patient populations in the U.S.…
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…
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…
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. Source:…
Senators lambasted the pharmaceutical industry yesterday in a hearing by the Senate Finance Committee on the high price of drugs in the U.S. Source: Drug Industry Daily
The FDA has sent a warning letter to Ivermectin24h.com, a website the agency said is marketing hydroxychloroquine as a COVID-19 treatment. Source: Drug Industry Daily
The FDA has approved the first generic version of AstraZeneca’s Symbicort, a blockbuster drug-device combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Source: Drug Industry…
The FDA is asking its vaccines advisory committee to meet next month to make a recommendation on Pfizer’s and BioNTech’s March 15 request to amend its Emergency Use Authorization (EUA)…