Pharmaceutical Technology Editors

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.

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

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

The US Department of Health and Human Services awards contract to four companies for Fill–Finish manufacturing for pandemic influenza vaccines.

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.

Ireland?s life-sciences sector has grown significantly since the 1960s. To gain insights into the competitive edge that Ireland offers to the pharmaceutical industry, Pharmaceutical Technology Europe spoke with Barry Heavey from IDA Ireland, which is a government agency responsible for attracting pharmaceutical and biotech companies to Ireland.

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.

Cambridge Major Laboratories and AAIPharma Services plan to merge to form a global supplier of integrated CMC services.

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.

Cedarburg Hauser Pharmaceuticals has upgraded its API plant in Wisconsin.

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

Perrigo appoints Keith Webber as head of regulatory review.

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.

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

Sanofi?s plans strengthen its life-sciences presence at home in France and abroad in Africa.

Covance launches external laboratory-management services for clinical trials.

Almac introduces a web-based tool for clinical-trial drug-supply management and refrigerated reusable shippers for clinical supplies.

Molecular Profiles has secured a major pan-European formulation project, in which the company will be responsible for developing a topical and an oral formulation for Telormedix's psoriasis products, TMX-302.

A global collaboration between AbbVie and Galapagos is set to commercialize novel potentiator and combination therapies in cystic fibrosis.

Boehringer Ingelheim initiates a recall due to the potential for extrinsic foreign particles in the API used to manufacture Spiriva Handihaler (tiotropium bromide inhalation powder) capsules.

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

Capsugel?s Dosage Form Solutions business unit will expand facilities in France, the UK, and the US.

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