Breaking News on Global Pharmaceutical Technology & Manufacturing

Top Headlines

Anti social? Big Pharma balks at US FDA social media guidance

Comments from Novartis, Eli Lilly and Pfizer revealed that industry is taking serious issue with some aspects of the draft guidance from the US FDA on social media and promotional materials online.

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News in brief

Swiss high potency active pharmaceutical ingredient (API) contractor Cerbios has broken ground on a building that will bring together its chemical and biological R&D departments.

Albemarle has agreed to sell its ibuprofen business to US chemical intermediates firm SI Group in a deal that will also see it divest the anaesthetic agent, propofol.

Thermo Fisher has launched a pump technology designed for applications across the bioprocessing production line and usable with "all" bioprocessing tech.

Roche has recalled nine batches of breast cancer drug Herceptin after tampered vials were discovered in the UK, Finland and Germany.

Global Industry News

AMRI: discovery services demand still strong despite closing NY plant from Outsourcing-Pharma.com

AMRI says its long-term outlook remains positive with continued demand for its contract research services despite plans to shutter a Discovery and Development Services facility.

People on the Move

Who's on the move in outsourcing? from Outsourcing-Pharma.com

Merck Millipore appoints a new CEO, senior changes at Quintiles' Novella, and more.

Certara buys CRO Synchrogenix as regulatory writing sees more outsourcing from Outsourcing-Pharma.com

Consultancy and drug developer Certara has acquired specialty contract research organization (CRO) Synchrogenix Information Strategies, which offers regulatory writing and related services to biopharma and medical device companies worldwide. 

Catalent to provide cell lines for at least three Hisun biosimilars in China from BioPharma-Reporter.com

Catalent will provide Hisun Pharmaceuticals with cell lines to help it develop infliximab, adalimumab and alemtuzumab biosimilars for the Chinese market.

NeoStem adds facility with $124M California Stem Cell acquisition from BioPharma-Reporter.com

Cell therapy developer NeoStem has agreed to acquire California Stem Cell in a deal worth up to $124M, and includes CSC’s manufacturing facility in Irvine, CA.

Private equity investments scare pharma clients, says CRO from Outsourcing-Pharma.com

Pharmaceutical clients view contract research organisations (CROs) with private equity investments as unstable and more focused on financial growth than their operations, according to Italian CRO Cromsource.

Spotlight

EMA to rejig variations procedures and industry contact staff in April

EMA to rejig variations procedures and industry contact staff in April

Pharmaceutical firms working in Europe may need to update their address books next month after more reorganisation...

Janssen Button? Will GSK's F1 team up prompt other collaborations?

Janssen Button? Will GSK's F1 team up prompt other collaborations?

GSK has ‘smashed’ production targets at a UK inhaler plant by revving up manufacturing operations with knowhow...

Indian API maker slammed with US FDA Warning over data issues

Indian API maker slammed with US FDA Warning over data issues

Failure in maintaining test and production data has landed an Indian API maker with a Warning Letter...

US FDA issues new bioavailability guidelines

US FDA issues new bioavailability guidelines

The US FDA has published guidance of how sponsors should best document the bioavailability of products for...

Bioavailability breakthrough key to new cancer drug OKed in Japan

Bioavailability breakthrough key to new cancer drug OKed in Japan

Japan has become the first country to approve a new cancer pill that treats disease by interfering...

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