All 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.

Cell Medica, a T cell therapeutics company, has opened a European manufacturing facility in Berlin-Buch, Germany to develop, manufacture, and market treatments of infections and cancers related to oncogenic viruses.

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

AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.

CHMP recommended 11 new medicines for approval, the most approval recommendations at a CHMP meeting thus far in 2013.

The CMDh agrees to suspend the marketing authorization of Numeta G13%E because of a risk of hypermagnesaemia.

The Biomanufacturing Research Program (BioMAN) at Massachusetts Institute of Technology (MIT) has received $10.4 Million from the Defense Advanced Research Projects Agency (DARPA) to develop new technologies and manufacturing platforms that will provide an emergency supply of medicines for front-line military medics.

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

Unilife grants Sanofi long-term exclusivity for the use of Unilife?s prefilled syringe with Sanofi?s Lovenox.

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

EMA releases details of restructuring.

The alliance with Teva will focus on mechanisms and molecular targets related to the emergence of treatment-resistant cancer cells.

FDA Issues Draft Guidance on Patient Counseling Info for Labeling

FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial.

Roche nominates Christoph Franz, currently CEO of the Lufthansa Group, to succeed current Roche chairman Franz B. Hummer.

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

FDA updates guidance to reflect advances in technology.

The association representing the research-based pharmaceutical industry in Europe is concerned that an EMA policy will put transparency ahead of public-health interests.

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

Myriad Genetics and AstraZeneca expand their companion diagnostic pact for AztraZeneca?s investigational drug candidate olaparib.

Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.

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

CordenPharma will acquire Peptisyntha SA, based in Belgium.

Zealand will join efforts with Eli Lilly to design and develop therapeutic peptides for Type 2 diabetes and obesity.