Pharmaceutical Technology Editors

GT Biologics has been granted orphan drug designation by FDA Office of Orphan Product Development for Thetanix,

OncoMed Pharmaceuticals has been granted its first US patent on its MAbTrap antibody display technology.

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

Recipharm has invested EUR 32 million ($43 million) in its Wasserburg, Germany site to expand lyophilization capacity.

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

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

Sartorius announces offer to acquire TAP Biosystems Group, a UK-based company.

Aesica expands aseptic capabilities at its Nottingham, UK site with the acquisition of new pre-filled syringes manufacturing equipment.

Use of a continuous-flow reaction made it possible to scale up a highly exothermic reaction for the production of a key Suzuki−Miyaura coupling reagent.

The need to develop a final formulation process for a parenteral product sensitive to stainless-steel gave Patheon the opportunity to evaluate the potential of single-use technology in fill-finish operations.

Catalent has acquired Relthy Laboratorios in Brazil to expand its South American softgel technology business.

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.

AMRI has been awarded a seven-year contract for an active ingredient under clinical evaluation.

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

Hovione's plant in Portugal has successfully passed its twelfth FDA inspection in 18 months.

3M Drug Delivery will manufacture transdermal patch for ProStrakan.

United Drug's Packaging division rebrands as Sharp Packaging.

Marken announces a new depot in Russia and makes a senior appointment.

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.

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.