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Almost 60 percent of the FDA’s staff will be retained to handle core agency activities if the federal government shuts down at midnight Friday, according to an existing contingency plan for fiscal 2019 — which HHS may update this week. Read More
Two different interests groups have asked a federal judge in Washington, D.C., for a chance to make their case against CVS’ proposed $69 billion acquisition of Aetna. Read More
Four democratic senators introduced legislation aimed at ending “predatory” pricing of insulin and other life-saving drugs. The bill would give HHS authority to block any price increases on drugs that it deems “unjustified.” Read More
The code bans nonmonetary gifts for the promotion of prescription-only drugs, but it allows for promotional aids “of minimal value and quantity” for over-the-counter drugs. Read More
CMS said the catalysts for slower retail drug spending include slower growth in the number of prescriptions dispensed and slower volume growth of expensive drugs. Read More
Drug sponsors should assess the safety of non-genotoxic impurities (NGIs) in chemically synthesized drugs on a case-by-case basis, the EMA’s Committee for Medicinal Products for Human Use suggests in a draft reflection paper released for stakeholder comment. Read More
Pfizer’s appeal for a second patent on Lyrica (pregabalin) has been denied by the UK’s highest court, ending the pharma giant’s long-running fight against drug companies marketing generic versions of its blockbuster pain treatment. Read More