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Wednesday, August 31, 2011

MedinCell Invites Data Review for Long-Acting, Controlled-Release Schizophrenia Treatments

MedinCell
MONTPELLIER, FRANCE and SAN DIEGO, CA - Aug 9, 2011 – MedinCell, developer of the MedinGel™ biodegradable drug release platform, is pleased to invite potential pharmaceutical development partners to review data from their RisperMed pilot program. “Schizophrenia is a tragic and severe condition with challenging dose and compliance issues. We’ve designed the RisperMed program to address clinical needs that are unmet by today’s oral and injectable Risperidone products,” said Dr. Stephane Lucchini, MedinCell’s Business Development Manager. “RisperMed, if approved, will be the first once-quarterly, subcutaneous antipsychotic product available for the long-acting injectable antipsychotic market. Additionally, by using subcutaneous delivery to minimize administration discomfort, we believe RisperMed will improve treatment adherence — which has been estimated to cost the US over $1.4 billion per year,” Lucchini concluded. Potential partners may request access to the RisperMed Data Room through MedinCell’s web portal, and will have until September 23, 2011 (4:00 pm EDT) to gauge the effectiveness of the MedinGel formulations and propose licensing terms. The repository includes an analysis of the schizophrenia treatment market space, in vitro and in vivo pharmacokinetic data from candidate Risperidone formulations, and histopathology comments regarding injection safety in animal models. MedinCell will also show release profile and cost of goods comparisons with the only existing long-acting injectable risperidone product, Risperdal® Consta®*, which achieved global sales of $1.5 billion in 2010... [...] ...About MedinCell Using proprietary polymer technology, MedinCell designs controlled-release formulations that form a biodegradable, biocompatible matrix after administration. This patent-pending MedinGel™ technology limits the initial release of drug molecules to reduce off-target effects and extend release duration. This also allows Medincell’s formulations to use substantially reduced API amounts in sustained release formulations... MedinCell's Press Release -

Tuesday, August 23, 2011

Bertin Pharma opens its Pharmaceutical Establishment

Bertin Pharma01-07-2011: Bertin Pharma opens its Pharmaceutical Establishment -

...This new platform of 2 000 m2, renovated and labelled Good Manufacturing Process, offers you a large range of expertise and equipments giving you access to all the formulations including highly potent drugs.

Bertin Pharma is a one of the major European actors as Contract Research Organisation for pharmaceutical industry... Bertin Pharma's news -

About Bertin Pharma

Bertin Pharma is a global R&D solution provider offering R&D outsourcing services along with bioreagent tools, in the fields of pharmacy, biotechnologies, cosmetics and nutrition for both industries and academic research.

Ellipse Pharmaceuticals
Bertin Pharma, subsidiary of Bertin Technologies , results from the merging of 4 complementary French companies (SPI-Bio, Biotec Centre, Ellipse Pharmaceuticals & IDPS) to bring... About Bertin Pharma -

Wednesday, August 10, 2011

SPAULDING CLINICAL AND EUROFINS OPTIMED CLINICAL RESEARCH : NEW JOINT PARTNERSHIP FOR GLOBAL CLINICAL STUDIES

Eurofins Optimed Clinical ResearchAugust 8, 2011 – Eurofins Optimed Clinical Research, an experienced European clinical research service provider and Spaulding Clinical Research, LLC., US-based, leading-edge Clinical Pharmacology, Cardiac Core Lab, and Medical Device Manufacturer, announce a joint partnership agreement. This partnership leverages the strengths of both companies and facilitates collaboration on integrated clinical services to engage pharmaceutical clients who demand a global footprint.

Both companies disclosed that a primary driver of this relationship was finding a high-quality partner that would meet their standards for study conduct and participant safety, with metrics to back up their claims. “The culture of excellence and research facilities designed to execute high-quality studies was very impressive to our team. We felt immediately comfortable with the Optimed clinical team and witnessed their efficient execution of studies”, states Daniel Selness, General Manager and Senior Vice President of Operations. “We were very impressed that Spaulding achieved ISO certification, which is not common among US clinical research facilities. Their innovative systems approach with Electronic Data Capture is something that we have been looking to implement, so the partnership will allow us to consider how to collaborate more closely as these systems are put in place”, states Yves Donazzolo, MD, CEO and President of Optimed...

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...Eurofins Optimed (www.optimed.fr), founded in 1990, is located in France and provides services in clinical research, from phase I to phase II-IV clinical trials and surveys. Eurofins Optimed operates 100 beds in two clinical pharmacology units, in Grenoble and Lyon. Studies in healthy volunteers or ambulatory patients are conducted in the units while patient trials are set up and performed in various European centers. As a member of the Eurofins Group, the company offers a complete and customized range of services in drug development, in an international environment... Spaulding Clinical Research's Press Release -

Wednesday, August 3, 2011

MEDICREA'S GRANVIA®-C: Launch of a Pre-Ide Pilot Trial With a View to Initiating the Approval Process in the United States

MEDICREAJune 30, 2011 - LYON, France -
  • Worldwide (outside of USA): Marketing schedule reaffirmed and launch in 6 new countries over the second half of the year
The MEDICREA Group (FR0004178572-ALMED) (Paris:ALMED), listed on Alternext by NYSE Euronext Paris, a medical device company specialized in the development of innovative surgical technologies for the treatment of spinal pathologies, reaffirmed its ambitious marketing schedule for GRANVIA®-C, its next-generation cervical disc prosthesis, and also announced the launch of a pre-IDE pilot trial with a view to initiating the approval process in the United States.

  • GRANVIA®-C: a patented technological feat.
A flagship product of MEDICREA’s Research & Development laboratories, GRANVIA®-C is the first cervical disc prosthesis that allows “natural” physiological movement and extreme longevity, thus providing patients with very similar functionalities to those of healthy cervical discs.
In terms of biomechanics, cervical mobility is offered by 6 degrees of freedom, through differentiated centers of rotation and a patented mobile core with an integrated shock absorber system. In terms of material, the prosthesis’ high-tech ceramic design allows both a reduction in friction and optimal wear and fatigue resistance, giving the prosthesis a very long lifespan. Furthermore, using ceramic also ensures that it is perfectly MRI1 compatible, unlike the cervical prostheses currently on the market, whose metallic components result in MRI artifacts incompatible with visualizing the spinal cord, discs and soft tissue around the zone concerned.

Matching MEDICREA’s development philosophy of “innovating for next-generation vertebral implantology”, the GRANVIA®-C prosthesis is supplied with a disposable sterilized inserter. This has a number of advantages: it is easy to insert so saves significant time, and therefore enhances patient wellbeing and lowers hospital costs. Furthermore, this also minimizes the risk of infection and optimizes traceability, resulting in an unparalleled improvement in safety conditions...

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...About MEDICREA :

MEDICREA specializes in the design, development, manufacture and distribution of orthopedic implants dedicated to spinal surgery.
In a $9 billion market, MEDICREA is a very dynamic small to medium-sized business of 100 employees with unique innovation capabilities. The Company enjoys an excellent and ever-improving reputation and develops unique relationships with the most visionary and creative spine surgeons in France, the UK, and the USA. Products developed and patented by MEDICREA provide neurosurgeons and orthopedic surgeons specialized in the spine with new and less-invasive surgical solutions that are faster and easier to implement than traditional techniques. The Group’s headquarters are based in Lyon, France, and it also has a manufacturing facility located in La Rochelle as well as three distribution subsidiaries in the USA, the UK and France... MEDICREA's Press Releases - Communiqués de presse de MEDICREA -