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House Democrats Friday abruptly postponed a vote on the amended $1.85 trillion Build Back Better Act, with compromise, scaled-back provisions aimed at reducing the price of prescription drugs. Read More
The GAO’s assessment found that “14 of the 18 establishments that manufacture COVID-19 vaccines had been previously inspected at least once” within the past decade. Read More
Despite pleas for approval during a public comment period, the FDA’s Psychopharmacologic Drugs Advisory Committee failed yesterday to recommend Levo Therapeutics’ intrasanal carbetocin — an oxytocin analogue delivered via a spray pump — for treatment of hyperphagia and related anxiety in children with a rare genetic disorder, Prader-Willi Syndrome. Read More
House Democrats were expected to vote as soon as last night on the revised Build Back Better Act — including compromise provisions meant to lower the price of prescription drugs. Read More
The plaintiffs offered no evidence that false or misleading marketing caused an increase in medically inappropriate prescriptions, the judge said. Read More
EU regulators may delay a decision on the purchase and open a months-long investigation if they have serious concerns about the proposed deal. Read More
COVID-19 vaccine makers didn’t undergo pre-approval facility inspections before receiving Emergency Use Authorizations (EUAs) from the FDA for their jabs, the Government Accountability Office (GAO) says. Read More
In a 14-0 vote yesterday, a Centers for Disease Control and Prevention (CDC) expert panel recommended the Pfizer/BioNTech COVID-19 vaccine for children age five to 11 years. Read More
A federal judge in California has handed four drugmakers their first win in the ongoing opioid crisis liability wars, rejecting claims by three counties that the companies created a public nuisance by recklessly promoting their medications. Read More
Congressional Democrats have struck a compromise allowing drug pricing reform to be included in the $1.75 trillion Build Back Better Act — almost a week after the White House disappointed progressives and left out drug pricing provisions from the package’s framework. Read More
The FDA held a virtual public meeting yesterday to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA), the agency’s agreement with regulated industry on reauthorizing user fees for fiscal years 2023 through 2027, and the reception was positive. Read More