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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
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
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
Familiarity with FDA regulations on the agency’s processes for approving drugs and devices is lacking among doctors, but differs by specialty, according to a national survey of physicians conducted by University of California San Francisco (UCSF) researchers. Read More