Breaking News on Global Pharmaceutical Technology & Manufacturing

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Discovery of tampered vials leads to Roche cancer drug recall

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

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News in brief

Comments from Novartis, Eli Lilly and Pfizer revealed that industry is taking serious issue with some aspects of the draft guidance from the US FDA on social media and promotional materials online.

The amines market will grow 5% over the next decade according to BASF, which cited drugmaker demand as a key driver for its investment in a new plant.

Acura has reacquired the rights to its opioid abuse-deterrent technology from Pfizer and is looking for pharma partners to relaunch its oxycodone HCL drug Oxecta.

Novartis subsidiary Alcon has opened the doors to its new $160m facility in Singapore for the manufacture of ophthalmic drugs.

Global Industry News

Thermo Fisher: new pumps compatible with all bioprocessing techs from BioPharma-Reporter.com

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

CROs moving away from strategic partnerships? Survey investigates from Outsourcing-Pharma.com

As larger partnerships between CROs and sponsors come to maturity, a new survey found that “a much greater proportion of CRO revenue growth” will come from small and medium-sized pharma and biotech sponsor deals.

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.

Race to develop anti-PCSK9 will boost Repligen's media sales, says analyst from BioPharma-Reporter.com

Development of new anti-choloesterol drugs containing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibiting monoclonal antibodies could double Repligen Bioprocessing’s earning power, according to a Jefferies analyst.

Stem cell developer ReNeuron relocates to take on more manufacture from BioPharma-Reporter.com

Stem cell company ReNeuron will move its operations and headquarters to Cardiff, UK after leasing an R&D and manufacturing facility from the Welsh government.

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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