EXCLUSIVE STUDY

Open source paradigm could swipe biz from CROs: Beroe

27-Sep-2012 - Open source drug developers could swipe business from CROs in the drug discovery field, according to Beroe.

FDA takes on oversight of ClinicalTrials.gov

27-Sep-2012 - The US FDA will make sure data in ClinicalTrials.gov is genuine from now on after the HHS delegated the job to the agency.

News in brief

Jubilant HollisterStier launches analytical services business

27-Sep-2012 - Jubilant HollisterStier has set up dedicated analytical services units in a bid to further expand its contracting offering.

Almac gets MHRA OK for clinical site and new ERP system

27-Sep-2012 - The MHRA has given Almac’s Northern Ireland clinical services facility and its new ERP system a thumbs-up after an inspection carried out this month.

BASF opens dermatology lab to solve formulation challenges

27-Sep-2012 - BASF has opened a contract dermatology lab in New York, US to work on topical formulation R&D.

Cedarburg Hauser boosts API production capacity

26-Sep-2012 - Cedarburg Hauser Pharmaceuticals (CHP) has increased its API plant in a bid to meet client demand.

update

SNBL adopts new temp and humidity control system

26-Sep-2012 - Preclinical CRO SNBL USA has automated control of temperature and humidity at its primate research laboratory.

Big Pharma clinical R&D group wants FDA and EMA involvement

26-Sep-2012 - Big Pharma group TransCelerate BioPharma plans to work with regulators and academics to address the bottlenecks that slow the clinical development of biologic drugs.

News in brief

US CRO contracted by FDA to answer generics safety questions

26-Sep-2012 - CRO Vince & Associated Clinical Research (VACR) has won a $5m grant to conduct bioequivalence studies for the US FDA.

News in brief

Big Pharmas team to tackle trial bottlenecks

25-Sep-2012 - The ten biggest drugmakers in the world want faster, more efficient R&D and claim a new non-profit organisation they formed last week is the solution to the industries development bottlenecks....

Clinipace doubles in size after purchase of Paragon

25-Sep-2012 - Clinipace has bought Californian CRO Paragon Biomedical in a bid to expand its therapeutic expertise.

SGS doubles capacity at testing lab citing pharma demand

25-Sep-2012 - SGS Life sciences has doubled testing capacity at its New Jersey, US laboratory citing pharma demand for both routine and complex analysis services.

Quintiles makes trial management system more interactive

24-Sep-2012 - Quintiles says it has improved its trial management services with a new navigation platform for its Infosario programme.

Generics firms could pay €20m a year for pharmacovigilance says EGA

24-Sep-2012 - Proposed EMA pharmacovigilance fees are too high and place a disproportionate burden on generics firms according to the European Generic Medicines Association (EGA).

News in brief

Carestream sells preclinical imaging biz to Bruker

24-Sep-2012 - Carestream Health has offloaded most of its preclinical molecular imaging systems in a deal with Bruker.

People on the move: jobs in pharma

24-Sep-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest new faces and changing places in the world of pharmaceuticals, including news from Quintiles, Cenduit and Althea Technologies.

Quintiles grants "prime site" status to Comprehensive

20-Sep-2012 - Quintiles has granted Comprehensive Clinical Development first refusal to work on its sponsored clinical trials.

Cyprotex and InSphero launch predictive tox testing service using 3D micro-liver

20-Sep-2012 - Cyprotex and InSphero have teamed up to offer predictive drug toxicity services using 3D micro-models of liver tissue.

Merck Millipore opens 'open source' process development and CMO plant in France

20-Sep-2012 - CMOs and Pharmas will own the manufacturing processes developed at a new facility as part of an ‘open source’ ethos Merck Millipore has introduced.

Clinical trials should involve the elderly more, say experts

19-Sep-2012 - Geriatric patients are left out of trials too often say experts who want researchers to 'open their minds' to the benefits of recruiting the elderly.

News in brief

AMRI lands strategic deal with Knopp

19-Sep-2012 - AMRI said it has entered into a strategic agreement with drug discovery firm Knopp Biosciences.

Pfizer inks generics CMO JV with Hisun

19-Sep-2012 - Pfizer and manufacturing partner Zhejiang Hisun Pharmaceuticals will set up a dedicated research centre to develop drugs for the Chinese market.

Recipharm gets OK in France

19-Sep-2012 - Swedish CDMO Recipharm has been cleared by French regulators to fill biotech drug products at its site in Tours.

People on the move: outsourcing jobs

19-Sep-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest xcareer movers in the world of pharmaceuticals including news from Chiltern, AMRI and Cook Pharma.

update

Life science products sales and marketing pros get new industry association

18-Sep-2012 - A new organisation - ACP-LS – aims to help sales and marketing employees at CRO, CMOs, equipment makers and consultancies share knowledge, training and information.

update

Celerion OKed by patient rights group

18-Sep-2012 - US CRO Celerion has been awarded full accreditation by the Association for the Accreditation Human Research Protection Programs (AAHRPP), a group that assess patient safety and ethical concerns. ...

Quintiles signs 10-year Mexico deal with Sinclair

18-Sep-2012 - Quintiles will commercialise Sinclair IS Pharma’s products in Mexico under a 10-year licensing agreement.

Recruitment success in biosimilar trials relies on staff training: ISR

18-Sep-2012 - The key to improving patient recruitment in trials of biosimilar drugs is site staff training, according to ISR.

India to set up ‘competent authority’ to oversee APIs shipped to EU

17-Sep-2012 - The Indian Government will appoint a 'competent authority' to make sure API exporters comply with EU import regulations.

Catalent plans to bridge South Korean development gap with the West

17-Sep-2012 - Catalent has teamed up with CTC Bio to help South Korean pharmas work in the West.

News in brief

Almac launches histone manufacturing service

17-Sep-2012 - Almac has added epigenetics to its expanding drug discovery offering with a new bespoke histone production service.

New clinical packaging facility for Xcelience

13-Sep-2012 - Xcelience has opened a new clinical packaging facility in Tampa, US, in a bid to meet growing customer demands for its services.

News in brief

Patheon reports revenue growth in fiscal Q3

13-Sep-2012 - Patheon saw revenues increase in its fiscal third quarter thanks to ‘existing business” and ongoing transformation efforts.

INC opens clinical facility in "promising" Korea

13-Sep-2012 - INC Research has opened a new clinical operations facility in South Korea in a bid to grab a slice of what it says is a “promising” research market.

Wuxi comfortable with investment and risk profile of MedImmune JV

13-Sep-2012 - Wuxi AppTec expects to add capacity as needed to service the partnership it formed with MedImmune and is comfortable with the level of investment required.

Wuxi's JV with MedImmune will increase costs, says analyst

12-Sep-2012 - Wuxi Apptec's new risk-sharing JV with MedImmune is likely to have negative impact on short-term margins, says analyst.

News in brief

Jamaica issues $3bn worth of drug supply contracts

12-Sep-2012 - Lasco, Medimpax and GSK are among those to receive manufacturing and supply deals under the J$3.3bn ($37m) worth of contracts issued by the Jamaican Government.

API production will boost contract pharma manufacturing biz

12-Sep-2012 - Active pharmaceutical ingredient production will be the driving factor behind a predicted boom in the pharmaceutical contract manufacturing market, according to Visiongain.

EC GMP revisions have implications for CMOs

12-Sep-2012 - Changes to European GMP guidelines designed to align them with ICH Q10 have significant implications for CMO contracts.

Hermes partners to develop taste masking, particle coating tech

11-Sep-2012 - Hermes Pharma says it can solve the stability challenges that held back development of lipid-based particle coating techs.

Contract manufacturing facility additions: round-up

11-Sep-2012 - Outsourcing-Pharma.com brings you a round-up of the latest contract manufacturing facility additions, including news from Boehringer Ingelheim, Cambridge Major Laboratories, and B. Braun Group.

News in brief

Eckert & Ziegler boosts early phase offering with Vitalea Science takeover

11-Sep-2012 - Isotope technology firm Eckert & Ziegler has acquired bioanalytical CRO Vitalea Science.

Merck Serono signs master agreement with its new spin-off

10-Sep-2012 - Merck Serono has inked a master services agreement with its recently spun-out biomarker analysis services firm Quartz Bio.

People on the move: pharma consultants special

10-Sep-2012 - Outsourcing-Pharma.com presents a low-down of the latest chops and changes in the world of pharma and biopharma consultancy, including news from PM Group, MedCap and BioBridges.

News in brief

Icon expands UK and US labs

10-Sep-2012 - Icon has added bioanalytical testing capacity at sites in the US and UK citing demand for biomarkers as the key driver for the investment.

More biomedical expansion for Charles River with new US facility

10-Sep-2012 - Charles River has opened a new US biomedical diagnostic facility in a bid to boost its drug discovery and pharmacology business.

update

FDA criticizes DPT's efforts to fix sterility problems

06-Sep-2012 - US CDMO DPT Labs has not done enough to investigate sterility failures observed during a March inspection according to the Food and Drug Administration (FDA) which wants a ‘comprehensive evaluation’...

Improving Biopharma R&D efficiency a mixed blessing for CROs

06-Sep-2012 - Improving efficiency in biopharma research is a “mixed blessing” for contract research organisations (CROs), according to Wells Fargo.

Wuxi enters Ab sector in partnership with transgenic rat developer OMT

06-Sep-2012 - WuXi PharmaTech has formed an antibody discovery partnership with US transgenic animals firm Open Monoclonal Technology (OMT).

People on the move: outsourcing jobs

06-Sep-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest career changes in the pharmaceutical industry, including news from RSP, CMC Biologics and the NIH.

Pii named as manufacturer of drug withdrawn by Sun Pharma

05-Sep-2012 - US CMO Pharmaceutics International (Pii) has been named as the manufacturer of the cranial bleeding treatment voluntarily withdrawn by India’s Sun Pharmaceutical Industries earlier this week.

updated

Patheon sells clinical packaging biz to Bellwyck

05-Sep-2012 - Patheon has sold its clinical packaging business to Bellwyck Packaging Solutions.

Contract manufacturing news round-up

05-Sep-2012 - Outsourcing-Pharma.com presents a round-up of the latest from the world of contract manufacturing, including extensive jobs cuts for Merck, a monoclonal antibody agreement for Cobra and Algeta and Aesica’s latest...

Regulation, theft and payors dominate pharma supply chain concerns, says UPS

05-Sep-2012 - Worries about increasing regulatory scrutiny and penalties top the list of API and drugmaker concerns about supply chains according to a survey by contract distributor UPS.

IFPMA code of conduct discusses research motivations and data disclosure

04-Sep-2012 - The IFPMA pharma wants members that sponsor clinical trials to do so only if the research develops knowledge and benefits patients.

Online drug accountability systems will replace paper, says Cenduit

04-Sep-2012 - Automated drug accountability systems are becoming “the norm” in clinical trials because they can improve compliance and cut working time drastically, according to Cenduit.

Chinese drugmaker accused of using cooking oil in antibiotic production

03-Sep-2012 - Chinese manufacturer Joincare Pharmaceutical Group has been accused of using reprocessed cooking oil in the manufacture of an antibiotic intermediate.

Former Aptuit unit boosts Catalent in Q4, offsetting falling European injectables demand

03-Sep-2012 - Higher demand for clinical services drove growth at Catalent in fiscal Q4, offsetting falling European demand for injectables and flat oral delivery technology sales.

Marken adds depots in Germany and the US and eyes Russia and Brazil

03-Sep-2012 - Marken has set up new clinical trial supply depots in Germany and the US and is eying further expansion in China, Brazil and Russia.