Industry News

Merck & Co. has received a Complete Response Letter from FDA for the resubmission of its new drug application for sugammadex sodium injection.

West Pharmaceutical Services opens its second manufacturing plant in China to expand presence in Asian markets.

Coldstream Laboratories partners with the National Cancer Institute for developing parental dosage forms for cancer drugs.

Covance launches external laboratory-management services for clinical trials.

J&J's Janssen and PATH partner to improve drug formulation that could help prevent HIV infection.

ATMI has invested in sterile-connector and sterile-fill technology developed by Medical Instill Technologies.

Catalent Applied Drug Delivery Institute appoints Claus-Michael Lehr to advisory board.

GE Healthcare Life Sciences announced that it will build a KUBio modular biopharmaceutical factory in China for JHL Biotech.

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

Theorem Clinical Research?s alliance with Charles River Laboratories will provide nonclinical testing programs in the areas of bioanalysis, immunogenicity, and immunology.

EMD Millipore receives recertification of GMP compliance for Biodevelopment Centre in Martillac, France.

FDA updates guidance to reflect advances in technology.

VWR International has signed a global distribution agreement with Thermo Fisher Scientific.

Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.

CEO of Waters Corporation will retire within in the next two years.

BioReliance opens Clearance Services Laboratories in Maryland for downstream bioprocessing studies.

FDA approves BD Simplist product ondansetron injection, an injectable antiemetic.

Agilent Technologies opens multimillion dollar Spectroscopy Technology Innovation Center in Australia.

Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.

Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

Till, a PhRMA vice president, will lead AAPS starting in November; Executive Council and Section leadership positions were also announced.

FDA receives adverse event reports related to calcium gluconate infusions.

ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.

The companies sign a nonexclusive research license agreement, giving Sorrento's access to Lonza's GS Xceed Gene Expression System.

Gallus Biopharmaceuticals has signed a development and manufacturing supply agreement with Genzyme.

The guidance describes a risk-based approach to monitoring of clinical trials.