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Breaking News on Contract Research, Manufacturing & Clinical Trials

CMO Kentucky Bioprocessing grows Ebola mAb from tobacco

02-Sep-2014 - ZMapp, the experimental Ebola therapy given to a handful of infected patients in West Africa, is being produced in tobacco plants for Mapp Biopharmaceutical by CMO Kentucky Bioprocessing in collaboration...

Patheon: Expediting supply of Ph I trial drugs can cut pharma costs

01-Sep-2014 - Patheon has sliced four weeks off its Quick-to-Clinic service saying speedier supply of materials for first in human trials increases pharma’s return on investment.

Patheon propels itself into US biologics market in Gallus acquisition

27-Aug-2014 - Patheon has acquired Gallus BioPharmaceuticals adding two US biologics plants and says with an industry shift towards medium sized bioreactors it now holds the market advantage.

Recipharm: 'Client investment gives us competitive edge in CDMO space'

26-Aug-2014 - Parallel deals to invest in Isofol Medical and manufacture the alternative chemotherapy agent Modufolin on its behalf are evidence of Recipharm’s ambitious growth strategy, the CDMO says.

DEA approves manufacture of GHB at Patheon Cincinnati plant

26-Aug-2014 - Patheon has received approval from the DEA to bulk manufacture the schedule I product Gamma Hydroxybutyric Acid (GHB) from its facility in Cincinnati, Ohio.

Catalent contract secure as Roche buys InterMune for $8.3bn

25-Aug-2014 - Roche has bought InterMune for $8.3bn (€6.3bn) and says it will continue contracts with Catalent and two API suppliers for the manufacture of its lead product Esbriet (pirfenidone).

PSC to enter US injectables space with new CMO at former PurTox site

25-Aug-2014 - PSC Biotech plans to enter the US sterile injectables contracting space after buying a plant originally set up by J&J unit Mentor Biologics to make a Botox rival.

Lonza not asked for back taxes following decision to close Hopkinton site

19-Aug-2014 - Lonza has not been asked to pay back taxes after abandoning plans to expand its biologics plant in Hopkinton, Massachusetts last year.

Elite opts to keep anti-abuse opioid manufacturing in-house

19-Aug-2014 - Elite Pharma has decided to manufacture its developmental anti-abuse pain drug in-house despite offers from several CMOs interested in the contract.

Recipharm to buy Corvette to drive Italian growth and boost freeze drying clout

19-Aug-2014 - Recipharm will buy Corvette Pharmaceutical Services Group from private equity owners LBO Italia Investimenti to add much needed lyophilisation capacity and increase access to the Italian market.

Recipharm cites sales and earnings hike in acquisition plan

14-Aug-2014 - Recipharm AB will continue its spending spree of the past few years according to CEO Thomas Eldered, who reiterated the CMO’s plan to grow through takeovers in a results presentation...

UPDATE

Shire takes over SCM Pharma, after manufacturing license is revoked

14-Aug-2014 - Shire has entered SCM Pharma into administration and acquired its assets after the CDMO lost its cGMP license at a UK sterile plant.

Roche's oral octreotide pull-out no risk for Capsugel, says Chiasma

12-Aug-2014 - Chiasma says a scale-up manufacturing agreement with Capsugel will be unaffected despite Roche pulling out of a commercialisation contract for its oral peptide drug octreotide acetate.

CMO issues persist as Cubist announces third recall for potential glass in antibiotic

11-Aug-2014 - For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by...

Carbogen Amcis takes over Swiss plant to boost ADC offering

08-Aug-2014 - Carbogen Amcis has expanded its operations in light of unrelenting demand for antibody-drug conjugate (ADC) services by signing a long-term lease for a facility in Switzerland.

Injectables outsourcing growing despite pharma M&A, says AMRI

06-Aug-2014 - Big Pharma is still reliant on CMOs despite talk of returning in-house, says AMRI, which has launched into the top ten manufacturers in the US injectables sector following its recent...

Chinese firm imported misbranded API into US, says FDA warning letter

30-Jul-2014 - Zhejiang Jiuzhou Pharmaceutical has received an FDA warning letter after shipping a misbranded active pharmaceutical ingredient to the US.

Ben Venue assets will bolster sterile injectables network, says Hikma

28-Jul-2014 - Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term, despite the transfer of equipment across its sterile injectables network.

Strategic partnerships driving consolidation of CDMO industry, says report

24-Jul-2014 - Growth of Pharma strategic partnerships with contract development and manufacturing organisations (CDMOs) is driving consolidation, according to an industry report.

Profits and capacity utilisation up at Lonza in H1 thanks to pharma

24-Jul-2014 - Lonza saw profits and capacity utilisation improve in the first half of 2014 with new pharma and biopharma supply contracts and ongoing restructuring being the key drivers.

Onyx contracted for API R&D and manufacturing by UK cancer charity

23-Jul-2014 - Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.

USFDA approves Novasep facilities for kinase inhibitor contract

23-Jul-2014 - Novasep has received the regulatory nod to manufacture a kinase inhibitor new molecular entity (NME) following pre-approval inspections at two facilities in France.

ADHD API sales up, specialty opiates down at Johnson Matthey in Q1

23-Jul-2014 - Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.

UPDATE

Sterile injectables M&A could indicate return to in-house production

22-Jul-2014 - Drugmakers are bringing sterile injectables capacity back in-house according to a Frost & Sullivan analyst, who says industry risk aversion is the key driver.

Pamplona CMO bullish about biopharma prospects after fundraising

22-Jul-2014 - 3P Biopharmaceuticals has raised funds and announced plans to invest in its manufacturing capabilities to meet the needs of international clients.