Breaking News on Contract Research, Manufacturing & Clinical Trials

Pfizer-Allergan deal: what next for contract manufacturers?

25-Nov-2015 - As CMOs wait to see the short-term fallout of the Pfizer-Allergan deal, an M&A expert says contract manufacturing will follow the CRO industry in embracing strategic alliances and consolidation....

Xellia buys ex-Ben Venue site and aims to restart production in 2017

25-Nov-2015 - Restarting production at the former Ben Venue facility in Ohio will be a “significant task” says Xellia Pharmaceuticals which plans to invest after buying the site from Hikma.

API sourcing leads US Gov to label Carlsbad's Acyclovir tablets as made in Asia

23-Nov-2015 - US Customs and Border Protection (CBP) says the country of origin of Carlsbad Technology’s acyclovir is where the API is sourced, not the US where the tablets are made.

'Drug-in-capsule' demand for trial material drives Juniper micro-dose investment

23-Nov-2015 - Juniper Pharmaceuticals has made a “significant capital investment” to expand its Xcelodose powder micro-dosing system to feed demand for Phase I study materials.

Stevenage bio-manufacturing site will hire 150

17-Nov-2015 - Cell Therapy Catapult, the UK fund for gene therapy, broke ground yesterday on a £55m bio-manufacturing centre in Stevenage, UK.

Catalent: Suspension at French plant likely due to human interference

17-Nov-2015 - Out-of-place softgel capsules have led to the suspension of manufacturing at a site in France, and Catalent says the problem is almost certainly due to malicious actions.

Roche: Small molecule exit will lead to outsourcing opportunities

16-Nov-2015 - Roche’s exit from four small molecule manufacturing plants will provide opportunities for third-party manufacturers, the firm says.

Women sue Endo for packaging mix-up ‘that left 113 pregnant’

12-Nov-2015 - More than one hundred women are suing a subsidiary of Irish manufacturer Endo International, claiming a packaging error caused their contraception to fail and result in unwanted pregnancies.

Recipharm signs $25m API contract extension with SK’s Daewoong

10-Nov-2015 - CDMO Recipharm has signed a €25m ($26.7m) contract to supply API for Korean multinational Daewoong to make and market the respiratory drug Erdosteine.

Almac to hire 180 at ex-AZ site in UK

09-Nov-2015 - CDMO Almac says it will hire 180 people following a £16m ($24m) expansion of formulation and analytical services.

Three Dr Reddy’s sites hit with Warning Letters in India

09-Nov-2015 - Dr Reddy’s shares have slumped 14% after the company received an FDA Warning Letter over manufacturing conditions at three Indian sites.

Acquisitions drive AMRI’s ambition to become a ‘billion dollar’ CDMO

09-Nov-2015 - AMRI attributed recent M&A activity to passing the $100m (€93m) quarterly sales milestone, reporting high double-digit growth across its API and small-scale manufacturing divisions.

Recipharm reports 55% sales growth; North America next step in M&A strategy

05-Nov-2015 - Gaining a foothold in North America would complete Recipharm’s growth strategy in becoming a global CDMO leader, the firm says.

Video Q&A

Niche tech and biologics the new drivers for CMO consolidation, says PBOA

05-Nov-2015 - CMO consolidation strategy has shifted from building scale and adding geographies towards niche technologies and biologics, according to the founder of trade association PBOA.

Lonza: industry should shift to QC automation

04-Nov-2015 - While pharma is increasing use of automation and data integration tools in process development and manufacturing, it lags behind in electronic documentation of quality control, according to Lonza Biologics QC...

Almac buys biocatalysis partner Arran, expanding capacity and services

04-Nov-2015 - Almac has acquired Arran Chemical Company to further grow its biocatalysis services and increase its large-scale intermediates capacity.

Lonza take note: Alexion looking to bring more manufacturing in-house

03-Nov-2015 - Alexion says it is looking to bring more manufacturing capabilities in-house, despite its CMO partner Lonza recently setting up a dedicated suite at a site in New Hampshire.

CPhI Worldwide 2015

Rush to acquire ex-pharma sites means survival of the biggest for CMOs

22-Oct-2015 - As pharma sells off manufacturing capacity and outsources to large and specialist CMOs, smart contract houses will have an opportunity to grab market share in a currently fragmented sector, say...

Compounder refuses to halt production despite FDA alert

20-Oct-2015 - The US FDA has issued an alert warning the public not to take drugs marked as sterile by compounding firm Qualgen.

Indian CMO latest acquisition in Recipharm's aggressive growth push

20-Oct-2015 - An agreement to buy Indian CMO Nitin boosts Recipharm’s presence in emerging markets and plays into its aggressive growth strategy, the firm says.

Hovione to refurbish ex-generics plant for oral and inhalable formulation site

20-Oct-2015 - Hovione will spend $10m refurbishing a plant acquired from a Portuguese generics company to create an oral and inhalation formulation site.

CPhI Worldwide Madrid

Aesica: 'Consolidate your CDMOs into one, easy to manage CDMO!'

19-Oct-2015 - Pharma is looking to condense the number of contract manufacturers it works with, says Aesica which has launched a service to help manage its customers’ supply chain.

Irish compounder Fannin recalls chemo drugs

19-Oct-2015 - An Irish compounding pharmacy has recalled several batches of chemotherapy medicines because of a sterility alert.

Althea building site for highly active bioproduction and ADCs

16-Oct-2015 - CDMO Ajinomoto Althea is opening a new facility to offer outsourced ADC (antibody drug conjugate) and HPAPI (highly potent active pharmaceutical ingredient) manufacturing, the Californian company has announced.

Dispatches from CPhI

EFCG: ‘API’ days for Europe as Big Pharma returns in search of quality

15-Oct-2015 - Big Pharma has returned to Europe for its API sourcing due to reasons of quality and reliability, according to the European Fine Chemicals Group (EFCG).

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