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The FDA gives advice for in vitro testing and labeling of oral drugs intended to be given by enteral tube in a draft guidance released yesterday, noting that in vitro testing prior to clinical studies will help identify any product-specific risks. Read More
Novartis said its top-selling drug Cosentyx (secukinumab) significantly delayed time to worsening of symptoms in pediatric patients with juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA) in a late-stage study. Read More
In a move to expand its cancer drug offerings, German biotech MorphoSys has entered into an agreement to acquire Cambridge, Mass.-based Constellation Pharmaceuticals for $1.7 billion. Read More
At the behest of Congress, the Federal Trade Commission (FTC) has issued a report on a drug industry tactic that involves leveraging rebates to block competing products, suggesting that the agency may be viewing the anticompetitive practice as a growing area of concern. Read More
Sanofi announced that it has halted its trial of drug candidate venglustat for the treatment of autosomal dominant polycystic kidney disease, or ADPKD, following disappointing results. Read More
Moderna has begun its bid for full U.S. approval for its COVID-19 vaccine in the hopes of advancing it beyond Emergency Use Authorization (EUA) status. If regulators grant the request, it will allow the company to market the vaccine directly to consumers and would mark Moderna’s first approved product for the coronavirus. Read More
World Trade Organization (WTO) negotiations resumed Monday over a revised version of a controversial proposal to temporarily waive patents for COVID-19 products, including vaccines and therapeutics. Read More
The Biden administration has asked a federal court to dismiss a PhRMA lawsuit that seeks to block authorization of a Canadian drug importation plan conducted at the state level. Read More