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Emergent BioSolutions said, “These are mutually agreed-upon terminations for convenience and neither party is alleging breach of default by the other.” Read More
Following a year in which vaccine manufacturing plant Emergent BioSolutions spent many months in the headlines for botching 75 million Johnson & Johnson (J&J) COVID-19 vaccines, the federal government and the troubled company have parted ways. Read More
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