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Breaking News on Contract Research, Manufacturing & Clinical Trials

Safety board clears TxCell to restart Ovasave study that was halted last year

27-May-2016 - TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.

Xellia starts work on testing lab at Hungary API plant citing growing demand

26-May-2016 - Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.

Drugs tracked in Ongar: Selcia opens radiolabelled API plant

25-May-2016 - Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.

Colorcon to buy BASF's Kollicoat coating system product

25-May-2016 - Colorcon will buy BASF’s Kollicoat excipient coating product line in a deal announced today.

Recipharm will serialize customers' drugs for free until US and EU rules come into force

24-May-2016 - Recipharm has announced it will serialize customers’ products for free until legislation comes into force in key markets.

Albumedix tech key to Chinese efforts to develop once-a-week diabetes drug

23-May-2016 - Recombinant albumin supplier Albumedix will help Hebei Changshan Biochem Pharma develop a once-a-week diabetes treatment.

Ajinomoto Althea gets US patent for fast, industrial-scale antibody crystallization method

19-May-2016 - Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.

Aesica bolsters serialization tech offering

19-May-2016 - Aesica Pharmaceuticals has adopted a flexible serialization system capable of helping customer meet track and trace requirements in China, Korea and other key markets.

Biopharma CEOs shifting focus

19-May-2016 - According to the most recent Biopharma CEO Confidence Index, CEOs are shifting their focus back to their pipelines and have plans to increase outsourcing.

Finished dosage formulations demand driving changes for CMOs

18-May-2016 - As “one of the fastest growing areas in pharma,” the demand for finished dosage formulations is having an impact on several aspects of the CMO industries.

Saneca-owned generics firm Suir Pharma will sack 130 staff says liquidator

18-May-2016 - Suir Pharma is set to close or be sold with the loss of 130 jobs less than a year after it was acquired by Slovakian API manufacturer Saneca Pharmaceuticals.

Fermion invests $33m to add HPAPI capacity at Hanko plant

17-May-2016 - Fermion will invest €30m ($33m) to expand its API facility in Hanko, Finland to build its high potency drug ingredient manufacturing business.

Juniper invests in mixer tech for UK plant

17-May-2016 - Juniper Pharma Services has upped mixing capacity at its facility in Nottingham, UK to give it the ability to support Phase III studies of topical and semi-solid products.

Biogen eyes Regenxbio delivery tech for candidate occular gene therapies

17-May-2016 - Biogen has licensed rights use a gene therapy delivery technology from developer Regenxbio.

UK cell and gene therapy capacity hike signals long-term role says CGT

11-May-2016 - Recent capacity growth means the UK will be a cell and gene therapy hub for years to come according to the authors of a new manufacturing survey. 

Emergent ready to scale-up anthrax vax, wins follow-on US stockpile contract

11-May-2016 - The US Government is set to extend an anthrax vaccine supply contract, and Emergent Biosolutions believes its new commercial-scale facility coming online was a driving factor.

Almac launches pod for GDP, temperature-controlled shipping

10-May-2016 - The contract development and manufacturing organization (CDMO) launched its new Almac Pod™ service solution to safeguard customer’s products.

Biologics CDMO opens new facility in Research Triangle

10-May-2016 - The BioProcess Innovation Center is a new three-story, 62,000 square foot facility in Research Triangle Park, North Carolina.

Repligen to expand chromatography column production capacity in US and Europe

10-May-2016 - Repligen says it intends to build out a recently acquired German facility to support its European downstream technologies presence.

New spray-dryer to handle 20kg batches, as Juniper responds to solubility demand

10-May-2016 - Juniper Pharma Services will up its solubility enhancement capabilities through the addition of a new spray-dryer at its site in Nottingham, UK.

Europe delays Merck & Co.'s HCV drug on back of CMO quality issues

09-May-2016 - Inadequate record keeping at Merck & Co.’s contract manufacturer has delayed the European launch of its hepatitis C drug Zepatier (elbasvir and grazoprevir).

Catalent's oral biz hit by Beinheim suspension and low modified release demand

09-May-2016 - The manufacturing suspension at a French softgel plant and low demand for modified release tech stunted Catalent’s Q3 2016 results, the firm says.

AMRI acquires API business, expands into Europe

05-May-2016 - AMRI has acquired the Italy-based chemical company, Euticals, in a move that expands its API development and manufacturing business.

Merck says being a CMO that makes tech is good for clients

04-May-2016 - Germany's Merck has upped bioreactor capacity at its facility in Martillac, France in an investment it says broadens its biologics manufacturing offering.

Samsung on Samsung: Bioepis selects Biologics as a biosimilars CMO

03-May-2016 - Samsung Biologics has been contracted by its joint venture entity Samsung Bioepis to manufacturer biosimilars from its facility in Korea.

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