The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Eli Lilly and Company plans to invest $72 million in an insulin-manufacturing project at one of its facilities in Indianapolis, Indiana, The project is part of the company's $850-million investment in US capital projects, which Lilly announced in...
The Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade group of innovator-research-based pharmaceutical companies, and nine of its member companies and the US National Institutes of Health (NIH) have partnered to create...
The US Senate Health, Education, Labor and Pensions (HELP) Committee held a second hearing in a series of hearings to address prescription-drug costs.
Among the organizations testifying were the Pharmaceutical Research and Manufacturers of America...
Novartis plans to close an oral solid-dosage manufacturing facility in Broomfield, Colorado that is owned by its generics arm, Sandoz. Approximately 450 jobs will be affected as a result of the closure.
The move results from Sandoz’s plan to stop...
Pfizer has issued a voluntary Class I recall in Australia of 10 batches of its antibiotic, gentamicin Injection BP 80 mg in 2-mL Steriluer ampoules in packs of 10 and 50, to the consumer level.
The Australian Therapeutic Goods Administration...
Eli Lilly and Company and CureVac, a Tübingen, Germany-headquartered clinical-stage biopharmaceutical company focused on mRNA (messenger ribonucleic acid)-based drug development, have partnered to develop cancer vaccine products in a deal worth up...
The US Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor T cell (CAR-T) therapy, from Kite Pharma, a Santa Monica, California-headquartered cell therapy company and a subsidiary of...
A federal district court has ruled against Allergan in patent litigation for one of its top-selling drugs, Restasis (cyclosporine ophthalmic emulsion), a drug to treat dry eyes, and separately, Allergan has reached a settlement with InnoPharma, a...
Amneal Pharmaceuticals, a Paterson, New Jersey-based generic-drug manufacturer, and Impax Laboratories, a Hayward, California-based specialty pharmaceutical company focused on controlled-release and specialty generics, have agreed to merge, to...
Sanofi is investing EUR 170 million ($201 million) to expand a vaccine manufacturing site in Val de Reuil, France.
The new facility will allow Sanofi Pasteur, the vaccines global business unit of Sanofi, to expand supply of its quadrivalent...
Merck KGaA has opened a new life-science center in Burlington, Massachusetts. The new center is positioned to serve as a regional hub for scientific advancement and customer collaboration.
The new 280,000-square-foot life-science center houses...
The European Medicines Agency (EMA) plans to launch a new version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic...
Rutgers University and the New Jersey Innovation Institute, a corporation of the New Jersey Institute of Technology, plan to form the New Jersey Continuous Manufacturing Institute (NJCMI) to advance manufacturing technologies in the pharmaceutical...
The European Directorate for the Quality of Medicines & HealthCare (EDQM), a body responsible for the European Pharmacopoeia, and Agência Nacional de Vigilância Sanitária (Anvisa), the national health surveillance agency of Brazil, have signed...
The Swiss Agency for Therapeutic Products (Swissmedic), the national pharmaceutical regulatory authority in Switzerland, reports on new measures, taking effect January 1, 2018, regarding cross-border inspections, including inspections carried out...
