Industry News

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

SGS Life Science Services opens a Center of Excellence for Biophysical Analysis in the UK.

Beckman Coulter Life Sciences combines its particle characterization business with the Hach Company particle counting business.

FDA has awarded 15 grants totaling more than $14 million to boost the development of products for patients with rare diseases.

FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.

Novozymes Biopharma will collaborate with Almac to provide a combined service for drug development applications.

The FDA grants Cornerstone Pharmaceuticals orphan drug designation for CPI-613 for the treatment of myelodysplastic syndrome.

The US Pharmacopeial Convention posted for public comments on its revisions to the USP Medicare Model Guidelines, which are posted for a 30-day public comment period, beginning Oct. 1, 2013.

PhRMA reports 452 new medicines are in development for rare diseases, including genetic disorders, neurological conditions, infectious diseases, and autoimmune disorders.

Sartorius and BD Diagnostics plan to collaborate on ready-to-use, prefilled media products for microbiological applications.

Vetter is investing $100 million to expand filling capacity in Germany and the United States.

Janssen Pharmaceuticals collaborates with CureVac and DCPrime in vaccines.

ABC Laboratories plans to move operations of its subsidiary, Morse Laboratories, based in California, to Missouri.

Pfenex modifies its contract with US government for Anthrax vaccine.

Carbogen Amcis has made several investments to increase capabilities in supplying antibody drug conjugates.

The Waters ACQUITY QDa Detector is a mass detector designed to bring high-quality, mass spectral data to chromatographic separations.

During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.

Malvern Instruments has acquired NanoSight, the UK-based nanoparticle characterization company.

he CMO Gallus BioPharmaceutical has acquired the biologics CMO Laureate Biopharmaceutical Services.

DSM Pharmaceutical Products appoints a new CEO and President.

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.

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