Merck hit its second roadblock in a week, following the failure of its Lynparza trial with negative results in KEYNOTE-412, a phase 3 trial of Keytruda (pembrolizumab) in patients with…

Labeling for proposed ready-to-use products that contain a range of drug strengths in a single container should contain instructions for determining the correct dose to be administered based on a…

Active pharmaceutical ingredient (API) manufacturer Bioiberica of Barcelona, Spain, was hit with a warning letter from the FDA for problems with contamination and lack of process controls. Source: Drug Industry…

Following their three-year partnership, Ultragenyx Pharmaceutical has acquired GeneTx for an upfront payment of $75 million plus undisclosed future milestone and royalty payments. Source: Drug Industry Daily

Merck is halting its phase 3 study of Lynparza (olaparib) in advanced colorectal cancer after a midstream futility analysis found no survival benefit associated with the drug. Source: Drug Industry…

Amarin’s fish oil-based heart drug Vascepa (icosapent ethyl) may not have been as effective as initially thought, according to a new analysis in the American Heart Association journal Circulation. Source:…

More than 180 House lawmakers have sent a letter to the Biden administration pressuring the Department of Health and Human Services (HHS) to penalize companies that limit 340B drug discounts…

Novo Nordisk is going after Biocon Pharma, claiming patent infringement over a generic version of Novo’s weight loss drug Saxenda (liraglutide injection), a glucagon-like peptide-1 (GLP-1) receptor agonist. Source: Drug…

A postsurgical chemotherapy regimen of Roche’s Perjeta (pertuzumab) plus Herceptin (trastuzumab) and chemotherapy cut the risk of death by 28 percent compared to Herceptin and chemo alone in patients with…

Eli Lilly has teamed up with China-based Triastek to use three-dimensional (3D) drug printing for targeted release in certain parts of the gastrointestinal (GI) tract. Source: Drug Industry Daily