Industry News
EMA Revises Biosimilars Guideline
EMA?s revised guideline on biosimilars containing biotechnology-derived proteins is published for public consultation.
FDA Issues Warning Letter to Baxter Healthcare
FDA cites cGMP violations of finished pharmaceuticals at the company's facilities in Marion North Carolina and Jayuya, Puerto Rico.
FDA Discovers Microbial Contamination in Compound Pharmacy Products
Novartis Receives FDA Warning Letter for cGMP Violations at Austrian Plant
The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.
Celerion Adds Containment Room
Modular containment room at Belfast facility allows studies of biologics and vaccines.
BT and Accelrys Unlock Value in Big Data
Cloud-computing solutions and software enable researchers to garner insight from large, public-health datasets.
FDA Issues Warning Letter to Boehringer Ingelheim for cGMP Violations
Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products from its facility in Ingelheim am Rhein, Germany.
SCHOTT Introduces Cartridge Design for High-Speed Filling
New design meets new process requirements.
Moscow Hosts IFPMA's Biosimilars Conference
Representatives of national health regulatory authorities from around the world convened in Moscow to discuss ways to harmonize regulatory standards for biotherapeutic medicines.
ATMI Offers Helium Integrity Testing System
Evaluation system for single-use bags and assemblies is now available for onsite testing.
Uhlmann Group Spins Off visiotec GmbH
New company will focus on inspection, monitoring, and control systems for automated pharmaceutical manufacturing processes.
PerkinElmer Announces Collaboration with China's National Center for Drug Screening
A personalized drug research and development platform will validate biomarkers for individualized disease treatment for Chinese patients.
Vetter's New Commercial Line Validated for cGMP Filling
Prefilled-syringe line features automation and novel disinfection techniques.
Institute of Medicine Releases Report on Studying the Safety of Approved Drugs
At the request of FDA, the IOM prepared a report containing recommendations for how FDA might better monitor the safety of drugs after they have been approved.
