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The University of Michigan and University of South Florida are suing Novartis for patent infringement, claiming that the pharma giant used a complex method of crystal engineering developed by their researchers to design the heart failure drug Entresto, a combination of sacubitril and valsartan. Read More
A new study of cancer drugs awarded FDA accelerated approval debunks the theory that drugmakers benefit financially from postmarket confirmatory trials that support the approval. 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FDA’s draft guidance on mitigating drug shortages is inconsistent with the law, would place an unnecessary weight on drug manufacturers and could make drug shortages worse,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
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
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
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
Pfizer will ask the FDA to approve its respiratory syncytial virus vaccine, RSVpreF, based on phase 3 data showing that it prevented about 86 percent of severe disease. Read More