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Over the past week, the FDA issued final guidance on drug security at the package level and announced a meeting of the medical imaging drugs advisory committee. Read More
Senator Thom Tillis (R-N.C.) has warned the Biden Administration its invoking of a controversial policy framework that allows the government to access patents developed using federal funds will stop innovation in medicine and technology, not reduce prices. Read More
Building on the experience of other EU alliances that address major industrial challenges, the European Commission (EC) plans to bring together drugmakers, regulators, and civil representatives to address persistent drug shortages that have limited the supply of key medicines in the EU. Read More
In a decline from its 89 approvals in 2022, the European Medicines Agency (EMA) recommended marketing authorizations for 77 human drugs in 2023, including 39 new active substances, 17 orphan drugs, 14 generics, and eight biosimilars, according to the agency’s annual report. Read More
Brushing aside a pharmaceutical coalition’s First Amendment claims and upholding a 2023 advisory opinion, a federal judge has rejected a plan for a proposed cancer-drug price relief program, ruling that it runs afoul of the Anti Kick-Back Statute (AKS). Read More
Men taking valproate, a commonly prescribed antiepileptic, should be cautioned that the drug could increase the risk of neurodevelopmental disorders in their offspring by up to 50 percent compared to similar medications, according to the safety committee of the European Medicines Agency (EMA). Read More
A litany of failures spanning inadequate personnel, manufacturing, cleaning and other lapses have resulted in the FDA serving a Form 483 to Advanced Cosmetic Research Laboratories (ACRL) following the agency’s July 2023 inspection of the Chatsworth, Calif., facility. Read More
Looking back at FY 2023, CDER’s Office of Compliance’s recently issued annual report shows the office issued 170 human drug warning letters and classified 264 recalls affecting 1,178 drugs. Read More
Vertex announced FDA approval of Casgevy (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in patients 12 years and older. Read More
After an October 2022 advisory committee rejection of its initial genetic test for risk of opioid use disorder (OUD), SOLVD has won FDA approval for a revamped version of its DNA-based AvertD test. Read More
Recently introduced bicameral, bipartisan legislation could make it easier for competitors to enter the generic and biosimilar market by putting controls on patent thickets created by pharmaceutical companies. Read More
Delving into the development of AI in healthcare, Google researchers have penned an analysis of how AI has grown from a mere concept in the 1950s to be a dominant force in healthcare today, with leaders facing questions about its risks, problems and possibilities. Read More