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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
Pfizer has accelerated COVID-19 vaccine production and is on track to distribute 300 million doses in the U.S. before the end of July, said the company’s CEO Albert Bourla. 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In-person inspections of drug manufacturing plants by the FDA have been replaced by “remote interactive evaluations” only for the duration of the COVID-19 pandemic, the agency said in a new guidance released yesterday.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