Europe

Alzheimer's Research U.K. launches three Drug Discovery Institutes

Wednesday, February 18, 2015 11:57 AM

Alzheimer's Research U.K., a dedicated dementia research charity, has announced a $46.3 million Drug Discovery Alliance, launching three flagship Drug Discovery Institutes at the Universities of CambridgeOxford and University College London (UCL). The Drug Discovery Institutes will see 90 new research scientists employed in state-of-the-art facilities to fast-track the development of new treatments for Alzheimer's disease and other dementias.

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Quest Diagnostics

eClinicalHealth gains approval for Europe’s first fully remote diabetes trial

Wednesday, February 11, 2015 12:44 PM

eClinicalHealth, a Stirling, Scotland-based technology and consulting company providing innovative clinical trial solutions, has announced the Ethical Committee approval of Verkko in Finland—Europe's first remote clinical study to include full electronic informed consent.

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Genticel to continue per protocol its phase II study with ProCervix after review by DSMB

Thursday, January 29, 2015 10:54 AM

Genticel, a French biotechnology company and developer of therapeutic vaccines, has announced that the Data and Safety Monitoring Board (DSMB), an independent committee of experts which monitors safety data every six months during a study, met as scheduled on Jan. 22. It recommended the RHEIA-VAC study proceed without any modifications. The DSMB already had made the same recommendation during the first review on July 1, 2014.

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genae buys e-novex

Wednesday, January 28, 2015 11:56 AM

genae, a global CRO and services provider, has acquired e-novex, a provider of electronic data tools for medical research. Both companies are based in Antwerp, Belgium.

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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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CWWeekly

April 13

Quintiles-Quest Diagnostics joint venture latest in CRO-central lab deals, more could be on horizon

Biotech companies raise record amount of capital in Q1

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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