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Westwood Laboratories’ Azusa, Calif., contract manufacturing facility lacks adequate sterility procedures, according to a Form 483 issued following a March 24 to April 5 inspection. Read More
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. Read More
FDA’s draft guidance on mitigating drug shortages is inconsistent with the law, would place an unnecessary weight on drug manufacturers and could make drug shortages worse, according to industry stakeholders’ comments. Read More
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. Read More
Silbersher can still argue that he is the original source of the public information and that his case against AbbVie should be allowed to proceed. Read More
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