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The ranks of the top-earning contract research organizations (CROs) continued to shift this week as Thermo Fisher Scientific announced it will acquire PPD, one of the industry’s largest CROs, for $17.4 billion in cash plus the assumption of about $3.5 billion of net debt. Read More
Merck has decided to end research and development on MK-7110, an experimental oral drug for treatment of hospitalized coronavirus patients that had shown promise in a late-stage trial. Read More
People vaccinated with Pfizer/BioNTech’s double-dose COVID-19 vaccine will likely need to receive a booster shot within a year of full inoculation, as well as an annual shot, according to Pfizer CEO Albert Bourla. 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
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In-person inspections of drug manufacturing plants by the FDA have been replaced by “remote interactive evaluations” only for the duration of the COVID-19 pandemic, the agency said in a new guidance released yesterday.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