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Last month, signs that magrolimab increases the risk of death prompted Gilead to shelve the drug for blood cancer, Vertex’s second-gen cystic fibrosis combo leaves the company’s first-gen efforts in the dust, a new drug combo looks promising for multiple myeloma, and Regenxbio hopes to snag an Accelerated Approval for a new rare disease gene therapy. Also, Astra Zeneca is touting “major advance” in treating one type of non-small cell lung cancer. Read More
AI models developed by GE HealthCare used readily available clinical data to forecast cancer immunotherapy outcomes and adverse reactions with 70-80 percent accuracy, according to an article published in the Journal of Clinical Oncology Clinical Cancer Informatics. Read More
The FDA has published new draft guidance on informed consent that lines up with revisions to the Common Rule made in 2017, offering up-to-date recommendations on starting the process with the sharing of essential clinical trial information in ways that patients can understand. Read More
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The FDA’s draft guidance on its Advanced Manufacturing Technologies (AMT) pathway would be restrictive to manufacturers in the cell and gene therapy spaces, the Alliance for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