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A student group that filed a citizen petition aimed at improving what it alleges are “hugely deficient” trial reporting enforcement efforts by the FDA has gained some ground in the ongoing effort to increase trial transparency, with the agency granting one of its requests and pledging to consider another. Read More
Enhanced access to real world data (RWD) sources critical to regulators, pharma companies and researchers is the objective for the two electronic catalogues launched last week by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). Read More
The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) pathway would be restrictive to manufacturers in the cell and gene therapy spaces, the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy said in filed comments. Read More
The FDA is offering drugmakers the opportunity to become involved in an agency effort to find ways to evaluate quality management maturity (QMM) by using a prototype assessment protocol. Read More
There’s been a rising concern with clinical trial fraud and misconduct, particularly over the number of “zombie” trials that have been discovered in recent years — that is, trials in which a portion of the data is either invented out of whole cloth or is manipulated to the point of dishonesty. Read More
The Orphan Drug Act yielded 491 approvals from 1990-2022 — and 73 of these drugs are among the top 200 most profitable in the world, with global sales exceeding $1 billion, a new analysis has determined. Read More
Suzhou Ribo Life Science and Ribocure Pharmaceuticals (Ribo) announced a $2 billion collaboration with Boehringer Ingelheim to develop novel treatments for nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH). Read More
While the FDA has signaled concerns that drugs like Ozempic and Wegovy (semaglutide) come with an increased risk of suicidal ideation, a new study in the journal Nature says they don’t. Read More
Research updates in this edition include drug successes for multiple myeloma, COPD, breast cancer and weight loss as well as disappointments in drugs for colorectal and endometrial cancer as well as hyperkalemia.Read More
A recent study raises questions about the safety of Sage Therapeutics’ Zurzuvae (zuranolone) for postpartum depression, charging that the drug exerts risks similar to those seen with benzodiazepines and that the clinical trials supporting its approval were inappropriately conducted. Read More