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The European Commission’s (EC) proposals to reduce a component of intellectual property protection for breakthrough medicines will hasten a trend which has seen Europe’s position as a global innovator deteriorate further in comparison to the U.S., China and Japan, according to a new study. Read More
This month, FDAnews tackles Amgen’s promising phase 2 study on tarlatamab for SCLC, AbbVie’s Skyrizi and Lilly’s Mirikizumab take on Stelara and 10 year study results for Roche’s Ocrevus for multiple sclerosis. Read More
A new publicly searchable database contains detailed information on all 141 Alzheimer’s disease (AD)-targeting drugs involved in 187 active clinical trials in the U.S. and around the world. Read More
Oncologists were more likely to provide low-value cancer care drugs after receiving money from the pharmaceutical companies that make those drugs, raising questions about the harm caused to patients by the drug industry, according to a new study published in The BMJ. Read More
The FDA’s guidance on developing topical corticosteroids provides ANDA applicants with recommendations on pilot and pivotal studies to assess bioequivalence of the drugs. Read More
Increasing cultural and ethnic diversity in Alzheimer’s clinical trials is a must — but it’s going to take a complete rethinking of the way these studies are recruited, conducted, and analyzed, said a Fordham University psychology professor speaking at an Alzheimer’s conference. Read More
The FDA has issued a new final guidance intended to facilitate the development and assessment of regenerative medicine therapy (RMT) products CBER regulates through identifying and recognizing voluntary consensus standards (VCS). Read More
A study published in JAMA showed that glucagon-like peptide 1 (GLP-1) agonists medications used for weight loss — Ozempic and Wegovy (both semaglutide) and Mounjaro (liraglutide) — come with increased risks of gastrointestinal adverse events such as pancreatitis, bowel obstruction, and gastroparesis, the slowing or stopping of the movement of food from the stomach to the small intestine. Read More
Britain and the EU have mended their two-year post-Brexit science funding standoff, as the island nation rejoins Horizon, the EU’s largest source for research collaboration and funding. Read More