The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
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...
The US Food and Drug Administration (FDA) has issued draft guidance, Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA, to help applicants understand how to best respond to Complete Response Letters (CRLs) from the...
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Pfizer and J&J.
Editor's Note: This article was updated on a continuous basis for news announced from Wednesday, October 11, 2017 to...
A roundup of the latest drug pipeline news, including from the pharmaceutical majors, featuring news from Merck & Co., J&J, Lilly, Astellas, and Pfizer.
Editor's Note: This article was updated on a continuous basis for news announced from...
Brammer Bio, a Lexington, Massachusetts-headquartered cell and gene therapy contract development and manufacturing organization, has partnered with Abeona Therapeutics, a Dallas, Texas-headquartered clinical-stage biopharmaceutical company, to...
Bavarian Nordic, a Kvistgaard, Denmark-based biotechnology company, has partnered with SGS, a contract analytical laboratory, to develop a new respiratory syncytial virus (RSV) challenge strain.
SGS says the partnership will assist with advancing...
Merck & Co. and Aeglea BioTherapeutics, an Austin, Texas-headquartered biotechnology company, have entered into a clinical collaboration to evaluate the combination of Merck & Co.’s anti-PD-1 therapy, Keytruda (pembrolizumab), with Aeglea’s...
Roche and Warp Drive Bio, a Cambridge, Massachusetts-headquartered pharmaceutical company, have partnered to develop antibiotics for drug-resistant bacterial infections in a deal worth up to $300 million.
Under the collaboration, Warp Drive will...
Lupin, a Mumbai, India-headquartered pharmaceutical company, has completed its $150-million acquisition of Symbiomix Therapeutics, a Newark, New Jersey-headquartered biotechnology company. Lupin agreed to acquire the company earlier in 2017.
The...
