The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.
Roche announced that it will be closing its R&D site in Nutley, New Jersey, eliminating approximately 1000 positions.
FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research.
US court ruled in favor of Teva in its patent-infringement lawsuit against Momenta and Mylan's generic versions of Teva's Copaxone.
US District Court for NJ Rules Against Merck & Co. in Nasonex Patent Infringement Case; FDA Issues Complete Response Letter to Pfizer for Tafamidis Meglumine NDA; and More.
Merck Serono has revealed its final "final efficiency program" for operations in Switzerland, which includes confirmation of the closure of sites in Geneva and Coinsins and their associated job cuts.
My application uses a peristaltic pump with silicone tubing running through it and a different, heat-sealable tubing material before and after the pump section. Recently, an operator installed the wrong section of tubing in a pump, resulting in lost API, equipment replacement, and hours of extra work. How can we avoid this kind of mix-up in the future?
Legislation fails to establish national track-and-trace system, but tackles shortages.
The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.
Novartis, GlaxoSmithKline, and Lonza are among those participating in newly formed consortiums for developing and producing medical countermeasures.
Basilea, Stiefel Enter into Hand-Eczema Pact; Sandoz Recalls Generic Oral Contraceptive Drug; and More.
The European Federation of Pharmaceutical Industries and Associations has called for the German government to take "urgent action" regarding its pricing system, which is perceived as hindering the market entry of new, innovative medicines in the country.
Eli Lilly announced an increase in its manufacturing network in China through an expanded collaboration with Novast Laboratories, a generic and specialty pharmaceutical company based in Nantong, China.
The National Institutes of Health have gained the participation of Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, and Sanofi in their effort to advance new therapeutic research.
European and US associations call for continued vigilance against the threat of counterfeit medicines.
Updated European guideline provides more detail on quality issues surrounding biosimilar medicines.
Catalent Expands Fill–Finish Capabilities; Siegfried Acquires Alliance Medical Products; and More.
Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.
In July 2012, new pharmacovigilance legislation will come into effect across the EU as a result of changes adopted in 2010, specifically EU Regulation No. 1235 and Directive 84.
Takeda Pharmaceuticals announced that it has completed the acquisition of URL Pharma for an upfront payment of $800 million.
The pharmaceutical industry weighs in on WHO global health initiatives, including R&D for diseases of the developing world, a global vaccine action plan, neglected tropical diseases, and counterfeit medicines.
A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.
New guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.
The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity-Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."
BIO is calling for a more patient-centric approach to user-fee reauthorization.
US Pharmacopeia documents best supply-chain practices and seeks broad input on proposal.
New price-control policy has domestic and global firms waiting on the sidelines to launch products.
New coating technologies achieve high uniformity and reduce waste through mixing system advances and pan and airflow configuration.
Does global development have to entail multiple comparability studies?
Even the slightest of errors in exponential calculations can cause the biggest of headaches.