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The chief executive officer of troubled Emergent BioSolutions has promised to deliver “within days” the company’s response to a scathing Form 483 issued in April following a serious mix-up of vaccine materials that ruined millions of doses of Johnson & Johnson’s (J&J) COVID-19 vaccine. Read More
The uptick in opioid deaths emphasizes “the need to expand access to evidence-based treatments, including buprenorphine that can be prescribed in office-based settings,” said HHS. Read More
The FDA’s Oncologic Drugs Advisory Committee assembled yesterday for its third and final meeting this week to discuss accelerated approvals for cancer drugs that didn’t verify their benefit in confirmatory trials, advising the agency to withdraw indications for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) while defending another Keytruda indication. Read More
The latest round of GDUFA III reauthorization discussions between the FDA and industry focused on facility inspections, drug master files (DMFs) and annual reporting commitments. Read More
The European Medicines Agency (EMA) is reviewing Eli Lilly’s arthritis drug Olumiant (baricitinib) as a possible treatment for hospitalized COVID-19 patients age 10 years and older who require supplemental oxygen. Read More
“Unjust profitable dynamics in America’s healthcare system are blocking access to these alternatives, forcing patients to pay a far higher price for substantially similar medical care,” Rep. Tonko said. Read More
The Biden administration is implementing a Trump-era proposal that enables healthcare professionals to more easily administer the opioid addiction treatment buprenorphine. Read More
For the first time ever, the FDA has threatened enforcement and fines against a sponsor for failing to submit trial results to ClinicalTrials.gov by required deadlines. Read More
U.S. prices for nearly two dozen brand-name prescription drugs in 2020 were two to four times those seen by consumers in Australia, Canada and France, said the Government Accountability Office (GAO). Read More
On May 1, revisions will go into effect on the Pharmaceutical Inspection Co-operation Scheme (PICS) Good Manufacturing Principals (GMPs) Guide, addressing the manufacturing of advanced therapy medicinal products (ATMPs) in addition to biological medicinal substances and products. Read More
The FDA’s Oncologic Drugs Advisory Committee met Wednesday for its day two discussion of accelerated approvals for PD-1/L1 inhibitors that haven’t verified their benefit in confirmatory trials, recommending the agency hold off on withdrawing bladder cancer indications for Merck’s Keytruda (pembrolizumab) and Roche’s Tecentriq (atezolizumab). Read More
President Biden in his speech to Congress this week highlighted his support of lower drug prices by proposing to allow Medicare to directly negotiate with drugmakers, echoing language in H.R. 3, which has been reintroduced in the House. Read More