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U.S. sales of arformoterol tartrate inhalation solution reached an estimated $104 million for the 12-month period ending June 2022, according to healthcare analytics firm IQVIA. Read More
The FDA endorsed a number of International Council for Harmonization (ICH) guidelines last week, issuing three draft guidances and one final guidance in support of the council’s recommendations on drug interaction studies, analytical procedure development/validation and clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential. Read More
Moderna announced Friday it is filing patent infringement lawsuits against Pfizer and BioNTech for allegedly infringing on the messenger RNA (mRNA) technology it developed for its COVID-19 vaccine, Spikevax. Read More
The White House’s Office of Science and Technology Policy has issued a memo directing federal agencies with R&D spending to publicly share the findings and data from government-funded research as soon as they’re published, a move that should expand the amount of data available to researchers outside of the government. Read More
Seeking to clarify how manufacturers can “take advantage of new possibilities using innovative tools,” the European Commission has released the updated Annex 1 to its good manufacturing principles regulation, addressing manufacture of sterile products. Read More
The FDA levied import alerts on 49 manufacturing sites in fiscal year 2021 for refusing inspections or records requests, noncompliant laboratory testing and noncompliant findings from inspections and records requests — a marked decrease over a high of 128 import alerts issued in fiscal year 2020. Read More
FDA Commissioner Robert Califf highlighted the role the biomedical “ecosystem” should play in reversing the decline in life expectancy in the U.S. in a Science magazine editorial last week. Read More
Novartis announced that it intends to spin off Sandoz as a fully independent company in a move that could be completed in the second half of next year. Read More
Paxlovid, Pfizer’s oral antiviral drug to treat COVID-19, offers little or no benefit for adults between age 40 and 65, according to a large study in Israel. Read More
Combined with talk therapy, two strong doses of psilocybin – the active chemical of “magic mushrooms” – reduced heavy drinking by 83 percent, significantly more than when subjects just had therapy alone, according to researchers at NYU Langone University. Read More
The number of drug manufacturing facilities registered with the FDA has grown by an average of 3 percent worldwide since 2018, according to the FDA Office of Pharmaceutical Quality’s 2021 report, with the U.S. surging ahead with a 5 percent increase in facilities. Read More