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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In-person inspections of drug manufacturing plants by the FDA have been replaced by “remote interactive evaluations” only for the duration of the COVID-19 pandemic, the agency said in a new guidance released yesterday.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
FDA Acting Commissioner Janet Woodcock has denied that the FDA’s moves to delay several drug reviews are a sign that the agency is becoming less flexible in its evaluations, advising people not to read too much into the recent delays. Read More
Watchdog group Public Citizen has asked FDA to add recently banned weight loss drugs and antibiotics to the official list of drug products that were withdrawn or removed from the market for reasons of safety or effectiveness. Read More
A federal agency has drafted recommendations calling on Congress to require drugmakers to pay higher Medicaid rebates for high-cost specialty drugs until they complete confirmatory trials following accelerated approvals by the FDA. Read More
As Democratic lawmakers push ahead for legislation this congressional session aimed at lowering U.S. drug prices, PhRMA has come out with a seven-figure national ad campaign and a new policy agenda that puts forward ideas of its own for lowering the costs of drugs. Read More