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The UK’s National Institute Health and Care Excellence (NICE) has released a new five-year plan to accelerate patient access to new treatments as it moves forward independently of the EU’s regulatory authority now that the UK has fully separated from the bloc. Read More
A California lawsuit against Johnson & Johnson (J&J), Teva Pharmaceuticals, AbbVie’s Allergan and Endo International, charging the companies with fueling the nation’s opioid epidemic, got under way yesterday, marking only the second such lawsuit to go to trial. Read More
Emergent BioSolutions has agreed to an FDA request to temporarily cease manufacturing at its Baltimore, Md.-based Bayview site, a pause that will last at least until the agency’s ongoing inspection concludes and remediation action is taken to clear the way for production of the Johnson & Johnson (J&J) vaccine. Read More
In an unusual move for a pharma company, New Jersey-based Pacira Biosciences has filed a libel lawsuit against the American Society of Anesthesiologists over several articles published in the society’s medical journal, charging the organization with unfairly disparaging its nonopioid painkiller Exparel. Read More
The Biden administration announced Friday that it is dedicating $1.7 billion in funding from the COVID-19 relief package to ramp up U.S. capabilities for genomic sequencing, an effort to improve the ability of the Centers for Disease Control and Prevention (CDC) and the nation’s health departments to detect potentially deadly mutations. Read More
A potential new treatment for a severe form of Type 1 diabetes received a boost Thursday when the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee voted 12-4, with one abstention, that the benefits of the therapy outweigh its risks. Read More
The House has sent a pair of bipartisan bills aimed at lowering drug costs to the Oval Office for signature, including one that looks to improve the competitiveness of generics by tightening FDA exclusivities granted for drugs. Read More
A Centers for Disease Control and Prevention (CDC) expert advisory panel failed to vote yesterday or make any recommendation on Johnson & Johnson (J&J)’s suspended COVID-19 vaccine, opting to punt the issue until the committee reconvenes in approximately a week. Read More
In-person inspections of drug manufacturing plants by the FDA have been replaced by “remote interactive evaluations” only for the duration of the COVID-19 pandemic, the agency said in a new guidance released yesterday. Read More
Rumors are circulating in Europe that the European Commission (EC) will decline to renew its COVID-19 vaccine contracts with AstraZeneca (AZ) and Johnson & Johnson (J&J) once they expire, and a commission spokesperson has given a less-than ringing endorsement of the vaccines. Read More
The U.S. Court of Appeals for the Fifth Circuit Tuesday rejected Impax Laboratories’ appeal of the Federal Trade Commission’s antitrust ruling against the company over a June 2010 agreement it had reached with competitor Endo Pharmaceuticals over Opana ER, Endo’s extended-release version of the opioid painkiller oxymorphone. Read More