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Breaking News on Contract Research, Manufacturing & Clinical Trials

Opinion

Public or private: Where Catalent goes, will other CMOs follow?

18-Sep-2014 - Following the recent IPO from Catalent, has private equity called time on the CDMO industry? Outsourcing-pharma’s Dan Stanton thinks it has for now.

US FDA warns patients off all products from Texas compounding pharmacy

17-Sep-2014 - The US FDA has warned the public not to use any sterile medicines made by Downing-owned NuVision Pharmacy, Texas, which failed to comply with a recall order.

Dispatches from ChemOutsourcing

CMO consolidation: Do biopharma partners see any benefits?

17-Sep-2014 - As contract manufacturers continue to consolidate , some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies. 

Almac teams with Welsh academics to create P450 enzymes for industry

16-Sep-2014 - Almac has teamed up with Welsh Academics and industrial chemistry firm Hockley International to develop enzymes capable of making drug intermediates more quickly.

Relypsa selects Patheon for finished dose manufacturing of patiromer

15-Sep-2014 - Relypsa has entered into a multi-year commercial manufacturing and supply agreement with CMO Patheon for the finished product manufacture of patiromer, Relypsa's potential treatment of hyperkalemia.  

Industry groups take issue with FDA draft guidance on outsourcing facilities

11-Sep-2014 - Industry groups BIO (Biotechnology Industry Association) and GPhA (Generic Pharmaceutical Association) are calling for outsourcing facilities to be held to the same standards as other, larger manufacturers.

Molecular Profiles buys tech for liquid capsule manufacture

10-Sep-2014 - Molecular Profiles has expanded its capsule-filling services from solids to liquids with investment in equipment at its UK site.

Arrested: compounding pharmacist linked to 2012 meningitis deaths

09-Sep-2014 - US authorities have arrested Glenn Chin, a supervising pharmacist they say was involved in compounding the contaminated injections behind an outbreak of fungal meningitis that struck 751 patients and killed 64 in 2012....

Dispatches from the NYSE

Catalent sees growth strengthened by international softgel markets

09-Sep-2014 - CDMO (contract development and manufacturing organization) Catalent saw Q4 revenue rise 3% and income rise 66% thanks in part to an increase in its oral technologies segment.

Meda sells NJ facility to DPT; outsources intra-urethral ED drug

04-Sep-2014 - Meda has sold a New Jersey facility dedicated to its intra-urethral erectile dysfunction drug Muse as part of a strategic review of its manufacturing network.

Xellia says it planned to invest in Raleigh plant before new tax deal

04-Sep-2014 - Xellia has agreed to invest $100m in equipment, retain staff and create 40 full time jobs at the plant it bought in Raleigh, North Carolina in return for business incentives. 

BioLegend purchases Covance’s antibody products, manufacturing business

03-Sep-2014 - Antibody and reagent developer and manufacturer BioLegend on Tuesday acquired Covance’s antibody services unit for an undisclosed sum.

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.

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