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Janssen's Manufacturing Problems May Lead to Criminal Charges in Korea

Though Janssen Korea says it is confident it will resolve its manufacturing issues, product recall and suspensions could be followed by lawsuits and imprisonment.

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Russia Working to Align Biologics Regs with International Stanadards

Regulators and the drug industry met in Moscow last week to develop a framework for firms developing biologics and biosimilars in the Russian Federation.

EMD Millipore says its new chromatography tech can help manufacturers avoid compromising their processes when switching from multi-use to single use

In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Bayer, Valeant and Eisai.

Lower sales of off-patent former blockbuster Lipitor have prompted Pfizer to try and sell off its third Irish API plant in as many years. 

Global Industry News

PRA Prepares to Go Public with Confidential SEC Filing from Outsourcing-Pharma.com

US CRO PRA is proposing to go public again, more than six years since it was taken private, according to a confidential draft registration statement submitted to the US SEC.

Covance Pushes Further into Biologics Development, Lead Optimization from Outsourcing-Pharma.com

Although preclinical work for CROs has fallen flat in recent quarters, Covance is looking to take advantage of the industry’s shift to early biologic developments and lead optimization.

Cobra Confident of Commercial Vaccibody Contract

Cobra Confident of Commercial Vaccibody Contract from Outsourcing-Pharma.com

Cobra Biologics is confident it can win the commercial contract for Vaccibody AS’ candidate DNA vaccine, citing its production platform and recent capacity expansion as key.

Former RPS CIO's Lawsuit Claims Wrongful Termination from Outsourcing-Pharma.com

Research Pharmaceutical Services' (RPS) former chief information officer (CIO) claims he was unfairly dismissed after discovering the CRO was unlawfully storing potential employees' personal data.

‘Animal research’ labelling may have unintended impact says Cyprotex

UK ‘animal research’ labelling plan may have unintended consequences says Cyprotex from Outsourcing-Pharma.com

Proposed UK “animal research” labelling laws may backfire if improvements in culture-based toxicology testing continue, according to in vitro CRO Cyprotex. 

Spotlight

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients
Dispatches from Excipient Fest in Baltimore - UPDATE

Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients

As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and...

China Looks to Tighten Excipient Regulations with Limited Resources
Dispatches from Excipient Fest in Baltimore

China Looks to Tighten Excipient Regulations with Limited Resources

China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have...

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex Gets China Approval; Glide to Make Solid-Dose Anthrax for Pfenex

Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax...

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

GMP Plants and BioPharma Clusters Drive Russia's Pharma 2020

International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020...