Sponsor oversight of CROs is lacking according to report; ACRO responds

29-Nov-2012 - Pharmaceutical sponsors are not doing enough to ensure the CROs they work with conduct trials safely and ethically, according to a new report.

SGS and blue inspection body to be excipact trained

29-Nov-2012 - The group behind the excipient certification scheme Excipact will train SGS and blue inspection body GmbH auditors under agreements signed this week.

Selecta to discover food allergy drugs for Sanofi

28-Nov-2012 - Selecta Biosciences will provide Sanofi with discovery services in a deal that could be worth up to $900m.

No job cuts planned at SAFC post Sigma-Aldrich realignment, says president

28-Nov-2012 - No job cuts or facility divestitures are planned at SAFC under reorganisation announced by parent company Sigma-Aldrich.

Merck Millipore wants to lead bioavailability solutions market

27-Nov-2012 - The bioavailability market lacks a leader that can offer comprehensive solutions according to Merck Millipore, which has set its sights on filling the gap with new lab.

Pfizer could re-launch virtual trial programme as soon as 2013

27-Nov-2012 - Pfizer is re-jigging its failed virtual trial model and could re-launch the programme as soon as 2013.

News from CPhI

India will stamp out "fly by night operators" in trial industry, says Gov

27-Nov-2012 - The Indian Government will stamp out “fly by night operators” in its clinical trials sector by plugging "loopholes" in the regulations.

Euticals suspends production after high levels of explosive chemical found at UK site

26-Nov-2012 - Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.

Risk-based monitoring could simplify trial data QC, according to Annex Clinical

26-Nov-2012 - Risk-based monitoring means certain aspects of clinical trials can be quality checked using a segment of the data, according to Annex Clinical.

People on the move: outsourcing jobs

26-Nov-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceutical outsourcing, including news from Onyx, Pacific Biomarker and Rx&D.

News from CPhI

Single-use lets some Pharmas make own potent drugs but outsourcing demand still strong: Alkermes

22-Nov-2012 - Single-use technology will see more HP production brought in-house but contract manufacturers will still win-out, according to Alkermes.

News in brief

SAFC to be renamed under Sigma-Aldrich business rejig

22-Nov-2012 - Sigma-Aldrich has announced a plan to realign its business operations along regional and customer-focused lines.  

News from PCT

CRA turnover in China too high: PCT discussion

21-Nov-2012 - High CRA turnover in China often hinders trials, according to an Oxford University expert.

Catalent's Swindon cuts are result of decline in Zydis demand

21-Nov-2012 - Catalent will cut 45 staff from its Swindon facility after customers reduce Zydis order volumes.

QPS opens expanded Phase I unit in the Netherlands

21-Nov-2012 - CRO QPS has added another 24 beds to its Phase I site in the Netherlands, citing increasing demand for complex, early-phase research.

Poll

What’s in a name? Confusion, apparently

20-Nov-2012 - Outsourcing-pharma.com witnessed a fascinating debate on the definition of ‘CRO’ yesterday with terms like 'collaboration' and 'release' being suggested as potential alternatives.

Contract sales market on the rise thanks to wider range of services from CSOs

20-Nov-2012 - The contract sales market is set to hit $3.9bn in 2013, according to visiongain.

NMR culture anlaysis complies with ICH Q2A and B, says Spinnovation

20-Nov-2012 - CRO Spinnovation Biologics says its cell culture optimization technique complies with analytical methods detailed in ICH Q2A and Q2B guidelines.

Medpace boost EU device offering through Meditech takeover

20-Nov-2012 - Medpace has acquired Meditech Strategic Consulting in a bid to expand its European clinical trial services.

Sponsors waste millions collecting 'non-core' data says study

19-Nov-2012 - More analysis suggests that collecting data for non-core endpoints costs individual sponsors millions per clinical trial and the industry billions each year.

News from PCT Europe

CROs will swipe the "lion's share" of clinical development work: predicts PCT panel

19-Nov-2012 - CROs must swipe the lion’s share of clinical development work from Big Pharma for innovation to happen, according to a PCT panel.

News in brief

Synerlab buys Lyofal and IDD-Tech Orleans

19-Nov-2012 - CMO Synerlab has added lyophilisation and solid dosage form development capabilities to its offering with the acquisition of LyoFal and IDD-Tech Orleans.

CQC oversight would be negative for preclinical CROs, says Human Tissue Authority

19-Nov-2012 - UK Government proposals to hand oversight of tissue handling to a non-specialist body would have a negative impact on the preclinical services sector says the Human Tissue Authority.

People on the move: outsourcing jobs

15-Nov-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceutical services. News from RPS, HCB Health and Cadient.

EFCG wants mandatory inspection of all API suppliers

15-Nov-2012 - A European industry group says EU efforts to ensure the quality of API made by manufactureres outside the region are inadequate and that mandatory inspections of overseas plants are a must....

News in brief

Catalent and Cevec team-up to offer protein CDMO services

15-Nov-2012 - Catalent and Cevec Pharmaceuticals have joined forces to offer cell line development and manufacturing services to biotechs.

Big Pharma discovery deals for Chiromics, Aptuit and MorphoSys

15-Nov-2012 - Chiromics is one of a number of contractors to have landed deals with Big Pharmas this month, signing drug discovery agreements with BM-S and GSK.

News in brief

Particle Sciences joins MOTIF project on HIV prevention

14-Nov-2012 - Particle Sciences called in to provide formulation development by academics working on topical ARV delivery for HIV prevention.

Fujifilm to make Thrombogenics' newly US approved eye drug in UK

14-Nov-2012 - Fujifilm Diosynth Biotechnologies will manufacture the bulk API for ThromboGenics recently US approved eye treatment Jetrea at its facility in Billingham in the UK.

CRO round-up: collaboration, expansions and small providers teaming-up to take on the big players

14-Nov-2012 - A new personalised medicine-focused partnership for AstraZeneca, expansion in three continents for World Wide clinical and six small CROs team-up to create one super-team. Outsourcing-pharma.com presents a round-up of the...

SNBL USA gets FDA ‘close out’ letter for Everett animal testing lab

13-Nov-2012 - SNBL USA says some customers’ regulatory departments were put off by 2010 warning but that FDA ‘close out’ letter will open doors to new business.

News in brief

Icon boosts biorepository capabilities to meet personalised med demands

13-Nov-2012 - Icon has doubled its sample storage capacity through an expansion at its New York facility.

EXCLUSIVE

Symbiosis hunts US clients looking to run trials in EU

13-Nov-2012 - Symbiosis has opened a new US office in a bid to attract American clients looking to run trials in Europe.

Report from PCT Europe

SMEs are second best in partnerships with big CROs, says PCT panel

13-Nov-2012 - Small to mid-sized pharmas are often overlooked by CROs to focus more on larger clients, according to a PCT panel.

Demand for bioavailability drove spray drying investment says Agere

12-Nov-2012 - Agere Pharmaceuticals has added spray drying to its offering, citing developer demand for bioavailability boosting technologies.

News in brief

Boehringer set to make E.coli for clinical trials

12-Nov-2012 - Molecular Partners has contracted Boehringer Ingelheim to produce a range of highly potent molecules for its clinical pipeline.

Report from PCT Europe

Is risk-based clinical trial monitoring too flexible for the regulators?

12-Nov-2012 - Risk-based monitoring for clinical trials was a hot topic at this year’s PCT Europe thanks to recent draft guidances from the FDA and the EMA.

Restart of Singapore plant project unlikely to affect Lonza deal, says Novartis

12-Nov-2012 - Novartis says the decision to reactivate plans for a biotechnology plant in Singapore is unlikely to affect its deal with Lonza.

DISPATCHES FROM PCT EUROPE

Strategic deals fit with regulators' risk-based site monitoring

08-Nov-2012 - Risk-based site monitoring is easier under strategic partnerships than other relationship models according to Covance.

CRL buys back into China research models market

08-Nov-2012 - Charles River Laboratories (CRL) has acquired a stake in Beijing-based Vital River predicting an uptick in Chinese research models market.

People on the move: outsourcing jobs

08-Nov-2012 - Outsourcing-Pharma.com presents its weekly round-up of the latest movers and shakers in the world of pharmaceuticals, including news from Chiltern, Thermo Fisher and Penn Pharma.

Large scale manufacturing key for AMRI in Q3

08-Nov-2012 - AMRI has seen a lift in revenues thanks to its growing large scale manufacturing business.

UPDATE

PCT Europe 2012: Managing risk, emerging markets and industry criticism

08-Nov-2012 - Outsourcing-Pharma.com is in Hamburg,Germany this week to meet the CROs, sponsors and academics gathered at PCT Europe to discuss the future of partnerships in clinical trials.

News from CPhI

Aesica ramps up HPAPI capacity to meet industry demand

07-Nov-2012 - The technical challenge posed by potent APIs means drug industry demand for R&D-scale contract manufacturing is largely unmet, according to Aesica.

Icon rejigs FSP offering

06-Nov-2012 - Icon has followed up an impressive set of Q3 results and plans to delist in Ireland with the announcement of a new FSP focused strategy.

GE invests in second CRO in a year

06-Nov-2012 - GE has made its second move in the CRO space in a year by investing in Biocon’s IPO bound contract research unit.

Wacker adds half-life boosting tech to biologics offering

05-Nov-2012 - Wacker Biotech has added a low cost PEGytlation alternative to its biopharmaceutical manufacturing offering in a deal with developer XL-protein.

Wacker adds half-life boosting tech to biologics offering

05-Nov-2012 - Wacker Biotech has added a low cost PEGytlation alternative to its biopharmaceutical manufacturing offering in a deal with developer XL-protein.

Late phase services on rise thanks to need for "real world" data, says ISR

05-Nov-2012 - The late phase services industry is growing thanks to a new regulatory need for more “real world” data, says ISR Reports.

Is Eli Lilly distancing itself from outsourcing?

05-Nov-2012 - Eli Lilly is bringing more production in-house after investing $140m in the expansion of its US insulin site.

Contracts for Cytovance, Patheon and Angel Biotechnology

05-Nov-2012 - New contracts for Cytovance, Patheon and Angel Biotechnology in Outsourcing-pharma.com’s roundup of the latest manufacturing deals.