Archive for August 2022

A narrowly missed primary endpoint didn’t prevent Bayer from touting a phase 3 win for Kerendia (finerenone) as a cardioprotective agent for people with late-stage chronic kidney disease and type 2 diabetes. Source: Drug Industry Daily

AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin) cut the risk of cardiovascular death and worsening heart failure by 16.4 percent relative to placebo, researchers announced at the European Society of Cardiology Congress in Barcelona. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily