News

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.

Budget issues and changing global markets are prompting FDA to revise its growing network of overseas offices.

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.

USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems.

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

The rapid uptake of single-use vessels for use in bioprocessing applications has made assuring integrity that much more crucial; helium integrity testing can be used to test integrity and prevent failures.

Through its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.

Contract service providers position in China as biopharmaceutical and pharmaceutical companies align their strategies in emerging markets for growth.

A look at the happenings at this year's installment of CPhI Worldwide.

Contract manufacturers of both APIs and finished products expand manufacturing capacity and services for high-potency manufacturing.

A roundup of expansion activity of manufacturing capacity and service offerings from fine-chemical producers and contract API manufacturers.

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.

Researchers from the University of Bradford, UK, have developed a solvent-free, continuous method to manufacture the more soluble and bioavailable form of artemisinin. The metastable form produced using high-temperature extrusion has been shown to have greater stability and longer shelf-life.

FDA publishes guidance on ANDA submissions.

EMA revises HIV treatment guideline.

The collaboration with Pfizer aims to develop next-generation, continuous manufacturing for solid-dosage pharmaceuticals.

Ablynx and AbbVie sign license agreement for Anti-IL-6R Nanobody, ALX-0061 to treat inflammatory diseases.

Cedarburg Hauser Pharmaceuticals has upgraded its API plant in Wisconsin.

Catalent Applied Drug Delivery Institute appoints Claus-Michael Lehr to advisory board.