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…
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)…