News

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.

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

Governor Jerry Brown cites physician notification requirements for dispensing biosimilars as premature in the absence of FDA specifications for interchangeability.

Genzyme will build a facility in Massachusetts to expand purification capacity for Fabrazyme (agalsidase beta).

MedImmune expands its antibody-drug conjugate capability through acquisition and collaboration.

Roche plans multimillion biologic manufacturing expansions in California, Switzerland, and Germany.

The generic-drug manufacturer Teva Pharmaceutical Industries plans to cut 10% of its workforce.

Janssen Pharmaceuticals collaborates with CureVac and DCPrime in vaccines.

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.

PhRMA report reflects robust R&D in vaccine development.

The sterile injectable manufacturer Ben Venue decides to end production despite efforts to remediate cGMP violations.

Advanced Biosciences Laboratories will support the development and production of a novel Shigella vaccine candidate for PATH.

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

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

Soligenix has been awarded a multimillion BARDA contract for the advanced preclinical and manufacturing development of OrbeShield, a treatment for gastrointestinal acute radiation syndrome.

The first part of CPhI's Annual Expert Industry Report examines ADCs, single-use technology, and regulatory failure.

GlaxoSmithKline?s sale of its thrombosis brands is part of a focus on its late-stage pipeline.

Fujifilm Diosynth Biotechnologies? new mammalian cell-culture facility uses primarily single-use technologies.

Merck announced plans to reduce its workforce by 8,500 and move its headquarters in order to sharpen its commercial and R&D focus.

DSM Pharmaceutical Products appoints a new CEO and President.

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

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.