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The FDA has approved Merck’s blockbuster cancer drug Keytruda (pembrolizumab) for certain patients with esophageal or gastroesophageal cancer taken in combination with platinum and fluoropyrimidine-based chemotherapy. Read More
In yet another setback for AstraZeneca, U.S. health officials raised concerns that the company included outdated information in its interim analysis of data from its U.S. phase 3 vaccine trial, prompting AZ to say it will release the results of its primary analysis by Thursday. Read More
Roche is stopping its phase 3 trial of tominersen, its investigational drug to treat Huntington’s disease, a rare neurodegenerative condition for which there is no known cure. Read More
Regeneron Pharmaceuticals’ and Roche’s antibody cocktail, REGEN-COV (casirivimab/imdevimab), reduced the risk of hospitalization or death by 70 percent in high-risk nonhospitalized COVID-19 patients in a late-stage trial, the companies have said. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to resume in-person inspections of drug facilities starting March 29 but it will adopt a hybrid approach that allows for both remote and on-site elements. Read More
Roche’s blockbuster oncology drug Tecentriq (atezolizumab) met its primary endpoint of disease-free survival in its phase 3 lung cancer study evaluating the drug as an adjuvant therapy, according to an interim analysis. Read More
The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasitic drug Stromectol (ivermectin) for the prevention and treatment of COVID-19. Read More
As the EU’s COVID-19 vaccine supply woes intensify, the 27-member bloc is signaling it could make good on its threat to halt exports of vaccine doses to the UK as soon as this week. Read More
The FDA has promised transparency as it implements data and technology modernization initiatives in its latest discussions with industry ahead of the next reauthorization of the Prescription Drug User Fee Act (PDUFA). Read More