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Breaking News on Contract Research, Manufacturing & Clinical Trials

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.

Big Pharma's 'intellectual arrogance' stunts CMO partnerships, says GPCM Chair

22-Jul-2014 - Efficient relationships with contract manufacturers are being held back by Big Pharma’s ‘intellectual arrogance’ and ill-defined operational teams, according to an ex-Director at GlaxoSmithKline.

UPDATE

Baxter Q2: Drop in demand hits CMO biz, despite overall sales growth

21-Jul-2014 - Baxter BioPharma Solutions dropped four percent year-on-year for the second quarter 2014 due to a fall in demand for contract manufacturing services.

Catalent looks to cash in with $872m IPO

18-Jul-2014 - With its expected sale of 42.5m shares for $20.50 each, CDMO (contract development and manufacturing organization) Catalent is looking to become a public company.

Seizure treatment “special” recalled in UK after packaging problems

17-Jul-2014 - Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.

West is East - Indian plant opens to serve Asian-Pacific customers

17-Jul-2014 - West’s new pharmaceutical packaging facility in India will reduce supply lead times for its Asia-Pacific customers, the company says.

update

Hovione and Merrion team on solubility solutions

16-Jul-2014 - Hovione has teamed up with delivery tech developer Merrion Pharmaceuticals to provide developers of BCS class III and IV drugs with more solubility enhancement options.

Consultant: For CMO selection, its the (molecule) size that counts!

16-Jul-2014 - The complex nature of biopharmaceuticals dictates the choice of contract manufacturer when compared with selecting a partner for small molecule drugs, according to a life sciences consultant.