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EMA, Biopharma Industry Clash on Clinical Trial Data

July 31, 2013
By Cormac Sheridan
The European Medicines Agency (EMA) and the pharmaceutical industry look to be set on a collision course regarding the vexed issue of access to clinical trial data, following the joint publication of a set of principles on the topic by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
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Other News To Note

July 31, 2013
• Novamedica, of Moscow, said the government of Kaluga Region, the administrative board of the city of Kaluga and the biotech firm, which is a subsidiary of Rusnano and Domain Associates, inked a deal for an investment project to build a new pharmaceutical plant in the region.
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Adocia Shares Plunge as Lilly Terminates Diabetes Alliance

July 31, 2013
By Cormac Sheridan
Shares in Adocia SAS plunged by as much as 45 percent Tuesday on news that Eli Lilly and Co. has pulled out of an alliance to develop an ultra-fast-acting insulin analogue for diabetes based on Adocia's Biochaperone formulation technology.
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Three-D Receptor Structures 'Will Aid Drug Development'

July 31, 2013
By Sharon Kingman
LONDON – New oral drugs for diverse conditions such as diabetes, osteoporosis, depression and anxiety have edged closer to development as a result of new information about the structure of an important class of hormone receptor.
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Uniqure's Parkinson's Gene Therapy Moves into Clinic

July 31, 2013
By Nuala Moran
LONDON – The first patient has been treated in a Phase I trial of Uniqure BV's gene therapy for Parkinson's disease, with the company's CEO Jörn Aldag personally assisting in the surgery, in which the gene for glial cell line-derived neurotrophic factor (GDNF) was administered directly into the brain.
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Polytherics Lands $20.8M to Fund Antitope Acquisition

July 31, 2013
By Nuala Moran
LONDON – Polytherics Ltd. raised £13.5 million (US$20.8 million) in a private round to fund the acquisition of antibody engineering specialist Antitope Ltd. and provide working capital to build on the enlarged company's portfolio of antibody development technologies.
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GSK CEO: 'The China Situation Is a China Situation, Period'

July 31, 2013
By Shannon Ellis
SHANGHAI – Vowing to conduct an independent investigation and commit new resources to the case, Glaxosmithkline plc CEO Andrew Witty said the company's ongoing troubles in China are unlikely to spread to other countries.
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Perrigo Values Elan at $16.50 Per Share; Offers $8.6B Cash, Stock

July 30, 2013
By Cormac Sheridan
DUBLIN – With a $16.50-per-share cash and stock offer, Perrigo Co. is the latest contender bid for Elan Corp. plc.
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Cell Therapy Risk-Reduced? Reneuron Lands $50.7M

July 24, 2013
By Nuala Moran
LONDON – Stem cell therapy specialist Reneuron plc has raised £33 million (US$50.7 million), including a placing to bring in £23.35 million and a £7.8 million grant from the Welsh Government, in a financing package that will enable the company to build its own manufacturing facility and take three lead programs through to proof of efficacy in Phase II.
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Library of Mutant Mice Awaits Scientific Exploration

July 24, 2013
By Sharon Kingman
LONDON – A full range of about 5,000 mutant mice, each with a single known gene inactivated, will be openly available to researchers within the next few years for further study of abnormal features that will shed light on numerous human diseases.
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