News

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.

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.

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.

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.