Europe

EMA recommends suspending medicines over flawed studies

Monday, January 26, 2015 12:43 PM

A number of medicines for which authorization in the European Union (E.U.) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended, according to the EMA. The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.

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Syncona, UCLB form Autolus cancer immunotherapy company

Friday, January 23, 2015 11:47 AM

Syncona, a London-based subsidiary of the Wellcome Trust, and UCL Business, the wholly-owned technology transfer company of University College London (UCL), have announced the creation of Autolus, a London-based biopharmaceutical company focused on the development and commercialization of next-generation engineered T-cell therapies for hematological and solid tumors. Autolus is founded upon the work of Dr. Martin Pule, an academic clinical hematologist and thought-leader in T-cell engineering. Syncona has committed $33.5 million to Autolus in a Series A financing. Dr. Christian Itin, former CEO of Micromet, has joined the company as chairman.

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Academy of Medical Royal Colleges not supporting Medical Innovation Bill

Friday, January 23, 2015 11:43 AM

The Academy of Medical Royal Colleges has released a statement on the proposed Medical Innovation Bill.

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PPD expands GMP laboratory in Ireland

Wednesday, January 21, 2015 12:59 PM

Pharmaceutical Product Development (PPD), a global CRO based in Wilmington, N.C., has expanded its good manufacturing practices (GMP) operations in Athlone, Ireland, by adding a new, state-of-the-art laboratory for cell-based assays to its existing portfolio of services at the facility. The new lab provides GMP bioassay testing with dedicated areas to support cell culture activities with multiple assay endpoint expertise.

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NHS increases budget for cancer drugs fund to an expected $400M

Wednesday, January 14, 2015 12:40 PM

The NHS Cancer Drugs Fund (CDF) has published a review of drugs included in the fund and increased the budget for cancer drugs. The budget for the CDF will grow from $235 million in 2013-2014, to $329 million in 2014-2015, and an estimated $400 million from April 2015. This represents a total increase of 70% since August 2014.

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EMA recommends record number of rare disease medicines for approval in 2014

Tuesday, January 13, 2015 10:00 AM

In 2014, the EMA recommended the highest number of orphan designated medicines for marketing authorization. Out of the 82 medicines for human use recommended in 2014, 17 are intended for the treatment of a rare disease, providing therapies for patients who often have only few or no treatment options.

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Survey: France Biotech recommends policies to develop innovative life sciences companies

Thursday, December 18, 2014 11:09 AM

France Biotech, an association of entrepreneurs in the life sciences industry, has published the twelfth edition of its annual survey, Panorama of the Life Sciences Industry, which outlines the industry's major trends for 2013 and 2014 in France and worldwide. This year, 214 French companies took part in the study. France Biotech included multiple recommendations to foster excellence in the life sciences industry.

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CluePoints wins European Venture Contest award

Thursday, December 11, 2014 10:57 AM

CluePoints, a Cambridge, Mass.-based provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has won a European Venture Contest award. The award program, which is part of the European Venture Summit, acknowledged CluePoints for its Central Statistical Monitoring (CSM) solution that employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data. The win represents the second industry award that CluePoints has secured this month after the company's risk-based monitoring solution also was recognized by the Scrip Awards.

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Report: Type 2 diabetes population to expand in China

Wednesday, December 10, 2014 01:01 PM

For the treatment of type 2 diabetes in China, patient access to premium-priced agents is impeded as not all patients can afford these drugs, Burlington, Mass.-based Decision Resources Group has found. The National Reimbursement Drug List was last updated in 2009, and several antidiabetic drug classes (e.g. DPP-IV inhibitors and GLP-1 receptor agonist) are not covered, as they were only approved for use in China after 2009.

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Recipharm acquires Flamel Technologies facility in France

Monday, December 1, 2014 12:57 PM

Recipharm, a contract development and manufacturing organization based in Sweden, will purchase Flamel Technologies’ development and manufacturing facility in Pessac, France. Recipharm also will provide development and manufacturing support to Flamel under a long-term services agreement.

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CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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