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Debiopharm receives AFSSAPS approval of CTA for Debio 0932 inhibitor, triggers milestone payment to Curis

Curis, Inc., announced today that its licensee Debiopharm S.A. has received approval from France's regulatory authority Agence Française de Securité Sanitaire des Produits de Santé (AFSSAPS) of a Clinical Trial Application (CTA) for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305. Under the terms of Curis’ and Debiopharm’s August 2009 license agreement, Curis will receive an $8 million milestone payment from Debiopharm for the achievement of this development objective.

12 Feb 2010

Better and standardized animal models needed for musculoskeletal regenerative medicine

Clinical testing and development of novel therapies based on advances in tissue engineering and regenerative medicine that will one day enable the repair and replacement of diseased or damaged human muscle, bone, tendons, and ligaments depends on the availability of good animal models.

12 Feb 2010

Second-quarter fiscal 2010 results announced by Pharmacyclics

Pharmacyclics, Inc. today reported financial results for its second fiscal quarter ended December 31, 2009.

12 Feb 2010

3SBio, Ascentage Pharma announce cancer therapeutics collaboration

3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, and Ascentage Pharma Group Corporation, Ltd. ("Ascentage Pharma") announced today that they have formed a strategic alliance to research, develop and commercialize best-in-class targeted cancer therapeutics focusing on programmed cell death, or apoptosis. The alliance will leverage Ascentage Pharma's expertise in structure-based small molecule design, lead optimization and preclinical development with 3SBio's proven drug development and commercialization capabilities in China.

12 Feb 2010

Amicus Therapeutics presents additional data from Amigal Phase 2 extension study for Fabry disease

Amicus Therapeutics announced today additional positive preliminary data from its ongoing Phase 2 extension study of its investigational drug Amigal™ (migalastat HCl) for Fabry disease at the Lysosomal Disease Network WORLD Symposium in Miami, Florida.

11 Feb 2010

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

PARI Pharma has enrolled the first patient in its Phase 2b clinical trial studying inhaled liposomal cyclosporine A (L-CsA) delivered via a customized Investigational eFlow Nebulizer System. The multinational study is investigating the safety and efficacy of PARI's L-CsA formulation. In previous clinical trials, reactions from physicians and lung transplant recipients to PARI's drug-device combination were encouraging.

11 Feb 2010

Excelimmune receives $1M investment as part of open Series-B financing round

Excelimmune, Inc. announced today they have received a $1 million investment as part of an open Series-B financing round. The investment comes from a mixture of existing and new investors.

11 Feb 2010

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a Phase I clinical trial for NuPIAO to the Chinese State Food and Drug Administration (SFDA).

11 Feb 2010

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

YM BioSciences Inc., is presenting posters on its JAK1/2 inhibiting small molecule (CYT387) and on its novel vascular disrupting agent (CYT997) at the Lorne Cancer Conference in Lorne, Victoria, Australia. CYT387 is an oral JAK1/2 inhibitor, originating from the seminal discovery of JAK1 and JAK2 kinases by Dr. Andrew Wilks, the founder of Cytopia Limited, now YM Australia. CYT997 is an orally-available agent with dual mechanisms of vascular disruption and cytotoxicity and has the potential to be broadly active against a range of tumor types.

11 Feb 2010

$NovaShunt initiates study to evaluate AFS for refractory ascites patients$

NovaShunt initiates study to evaluate AFS for refractory ascites patients

NovaShunt today announced the initiation of its pivotal multi- center clinical study named PIONEER, a Prospective, multi-center, open label, non-randomized study to Investigate the safety and perfOrmance of the Automated Fluid ShuNt in patiEnts with ascitEs and diuretic Resistance.

11 Feb 2010

PROMETA Treatment Program rapidly reduces cravings for methamphetamine subjects: Study

Hythiam, Inc. announced today that the results of a double-blind, placebo-controlled study on the impact of the medical component of the PROMETA® Treatment Program on methamphetamine dependent subjects were published in the Journal of Psychopharmacology, a peer-reviewed, international journal that publishes original research and review articles on preclinical and clinical aspects of psychopharmacology.

11 Feb 2010

4SC AG announces the first treatment in Phase I clinical study of 4SC-205

4SC AG a drug discovery and development company focused on autoimmune and cancer indications, today announced the first treatment in a Phase I study evaluating 4SC-205, an oral Eg5 kinesin spindle protein inhibitor, in patients with solid tumours or malignant lymphomas.

11 Feb 2010

ExonHit Therapeutics S.A. selected to participate in the European IMI consortium

ExonHit Therapeutics S.A. is pleased to announce that it has been chosen to participate in the European Innovative Medicines Initiative (IMI) consortium focused on identifying biomarkers for Alzheimer’s disease (PharmaCog).

11 Feb 2010

Ricerca Biosciences to acquire Discovery and Preclinical business of MDS Pharma Services

Ricerca Biosciences, LLC, announced today its execution of a purchase agreement to acquire the Discovery and Preclinical business of MDS Pharma Services with facilities in Bothell, Washington; Lyon, France; and Taipei, Taiwan. Company headquarters will remain in Concord, Ohio.

11 Feb 2010

Bioactive lipid LPA mediates fibrogenesis in bleomycin mouse model of scleroderma

Amira Pharmaceuticals, Inc. announced today that their collaborators, Andrew Tager, M.D. and Flavia V. Castelino, M.D. of Massachusetts General Hospital, Harvard Medical School, will present a preclinical proof-of-concept study which demonstrates that the bioactive lipid lysophosphatidic acid (LPA), through its high affinity LPA1 receptor, is an important mediator of fibrogenesis in the bleomycin mouse model of scleroderma. Data will be presented as part of a poster session for the 1st Systemic Sclerosis World Congress to be held in Florence, Italy, February 11 to 13, 2010.

11 Feb 2010

MDS to divest remaining MDS Pharma Services Early Stage business for $45M

MDS Inc., a leading provider of products and services to the global life sciences markets, today announced that it has signed agreements to divest its remaining MDS Pharma Services Early Stage business, which provides Discovery through Phase IIa clinical trial services to biotechnology and pharmaceutical companies, for $45 million and certain minority equity interests.

10 Feb 2010

Positive results from Naurex's Phase I clinical trial of GLYX-13 reported

Naurex Inc., a clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel glycine site functional partial agonist (GFPA) NMDA receptor modulators, today reported positive top-line results from its Phase I clinical trial of lead compound GLYX-13.

10 Feb 2010

SafeStitch Medical's AMID Stapler receives European CE Mark

SafeStitch Medical, Inc. announced today that it has received CE Mark authorization to commercialize its AMID StaplerTM in the European Economic Community. The new stapler is to be used for fixation of mesh in the repair of hernia defects and also for the approximation of tissues, including skin. The AMID Stapler™ is the first surgical stapler designed specifically for use in inguinal hernia repairs using the Lichtenstein method, in which mesh is implanted for reinforcement. SafeStitch announced in November 2009 that it had received 510(k) clearance from the Food and Drug Administration for sale of the AMID StaplerTM in the U.S. market.

10 Feb 2010

Cerus enters into collaborative agreement with EFS for development of INTERCEPT Blood System

Cerus Corporation announced today that it has entered into a collaborative agreement with France's national transfusion service, the Etablissement Français du Sang (EFS), for the development of the company's INTERCEPT Blood System for red blood cells.

10 Feb 2010

Johns Hopkins Hospital initiates Phase I trial with Neogenix's NPC-1C

Neogenix Oncology, Inc. (Neogenix) announced today that the Johns Hopkins Hospital has initiated a Phase I trial with the company’s first therapeutic antibody, NPC-1C, in patients with late stage pancreatic or colorectal cancer.

10 Feb 2010

Preclinical News and Research

Debiopharm receives AFSSAPS approval of CTA for Debio 0932 inhibitor, triggers milestone payment to Curis

Better and standardized animal models needed for musculoskeletal regenerative medicine

Second-quarter fiscal 2010 results announced by Pharmacyclics

3SBio, Ascentage Pharma announce cancer therapeutics collaboration

Amicus Therapeutics presents additional data from Amigal Phase 2 extension study for Fabry disease

PARI Pharma commences enrollment in L-CsA Phase 2b efficacy study

Excelimmune receives $1M investment as part of open Series-B financing round

3SBio submits application for Phase I clinical trial of NuPIAO to the Chinese SFDA

YM Biosciences to present JAK1/2 inhibiting small molecule and vascular disrupting agent data at Cancer Conference

NovaShunt initiates study to evaluate AFS for refractory ascites patients

PROMETA Treatment Program rapidly reduces cravings for methamphetamine subjects: Study

4SC AG announces the first treatment in Phase I clinical study of 4SC-205

ExonHit Therapeutics S.A. selected to participate in the European IMI consortium

Ricerca Biosciences to acquire Discovery and Preclinical business of MDS Pharma Services

Bioactive lipid LPA mediates fibrogenesis in bleomycin mouse model of scleroderma

MDS to divest remaining MDS Pharma Services Early Stage business for $45M

Positive results from Naurex's Phase I clinical trial of GLYX-13 reported

SafeStitch Medical's AMID Stapler receives European CE Mark

Cerus enters into collaborative agreement with EFS for development of INTERCEPT Blood System

Johns Hopkins Hospital initiates Phase I trial with Neogenix's NPC-1C

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Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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