Bayer Racks Kerendia Win in Subgroup Analysis
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…
Farxiga Trials Show Reduced Risk of Death and Worsening Heart Failure
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…
Califf Says Chronic Illness, Health Inequities Should Be Biomedical Priorities
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:…
Moderna Sues Pfizer and BioNTech for Patent Infringement on COVID-19 Vaccines
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:…
EU Releases Much-Anticipated GMP Annex on Sterile Products
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…
FDA Endorses Four Draft and Final ICH Quality Guidelines
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…
White House Orders Federal Agencies to Publicly Share Research Findings
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…
OPQ’s Annual Report Reveals Drop in Import Alerts, Other Quality Metrics
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…
Novartis to Spin Off Sandoz Generics and Biosimilars Division
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…
Paxlovid Offers No Benefit to the Middle-aged, Study Shows
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…