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Allergan, Bristol-Myers Squibb sign global exclusive license agreement for EHT/AGN 0001

ExonHit Therapeutics today reported the signing by Allergan, Inc. and Bristol-Myers Squibb Company of a global exclusive license agreement for the development and commercialization of EHT/AGN 0001 (AGN-209323), ExonHit’s lead compound from the most advanced program of its collaboration with Allergan.

4 Mar 2010

Endocyte's PRECEDENT study: DSMB recommends enrollment to continue

Endocyte, Inc., a biotech company developing guided therapeutics and diagnostics for personalized medicine, has announced that an independent data safety monitoring board (DSMB) recommended that enrollment into the PRECEDENT study continue.

4 Mar 2010

Androxal Type C meeting: Repros Therapeutics receives FDA’s version of minutes

Repros Therapeutics Inc. today announced that the Company has received the FDA’s version of the minutes of the Type C meeting held on January 25, 2010. The minutes confirmed the Company’s interpretation of the points the Agency made during the meeting. In correspondence from the FDA prior to the meeting the Agency noted that they could not currently agree with the Company’s stated indication for the use of Androxal® in the treatment of secondary hypogonadism in men wishing to preserve fertility.

4 Mar 2010

Negative results from latrepirdine Phase III clinical trial: Alzheimer's Association disappointed

"The Alzheimer's Association is disappointed to learn of the negative results from the Phase III clinical trial of latrepirdine (Dimebon)," said William Thies, Ph.D., Alzheimer's Association Chief Medical and Scientific Officer. "People with Alzheimer's, their families and caregivers desperately need more and better treatment options for this devastating, fatal brain disease."

4 Mar 2010

Zoraxel for treatment of ED: Rexahn Pharmaceuticals submits Phase IIb protocol to FDA

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the FDA for ZoraxelTM for the treatment of erectile dysfunction (ED).

4 Mar 2010

$Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer$

Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer

Sanofi-aventis announced today results from a Phase 3 trial which demonstrated cabazitaxel, an investigational compound, plus prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic (advanced) hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy.

3 Mar 2010

AGN-209323 small molecule for neuropathic pain: Bristol-Myers Squibb, Allergan announce global agreement

Bristol-Myers Squibb Company and Allergan, Inc. today announced a global agreement for the development and commercialization of AGN-209323, a Phase II-ready, orally administered small molecule in clinical development for neuropathic pain.

3 Mar 2010

Pfizer, Medivation announce results of two dimebon Phase 3 trials in AD patients

Pfizer Inc. and Medivation, Inc. today announced results from two Phase 3 trials of the investigational drug dimebon (latrepirdine) in patients with Alzheimer’s disease (AD). In the CONNECTION trial, dimebon did not meet its co-primary or secondary efficacy endpoints compared to placebo. Co-primary endpoints were measures of cognition and global function.

3 Mar 2010

FDA issues new draft guidance for Trius Therapeutics' proposed Phase 3 trial of torezolid phosphate

Trius Therapeutics, Inc. announced that on February 26th, 2010, the FDA issued new draft guidance on non-inferiority clinical trials that will apply to the design of the Company's proposed Phase 3 trials for its investigational antibacterial drug torezolid phosphate.

3 Mar 2010

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Data from two Phase III studies of Merck’s investigational fixed-dose combinations of mometasone furoate and formoterol fumarate (MF/F) were presented by researchers today in two poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

3 Mar 2010

Merck announces updated late-stage pipeline following its recent merger with Schering-Plough

Merck & Co., Inc. today announced its updated, newly integrated, late-stage pipeline following its recent merger with Schering-Plough. The new pipeline features a broad and diversified portfolio of investigational medicines and vaccines, including more than 20 candidates in Phase III or under regulatory review, and more than 20 candidates in Phase II of development.

3 Mar 2010

Phase III study results of Merck's allergy immunotherapy tablet

In new data from a Phase III study in 345 children and adolescents (ages 5-17 years), patients with grass pollen allergic rhinoconjunctivitis treated with Merck's investigational sublingual grass (Phleum Pratense) allergy immunotherapy tablet (AIT) showed a 26 percent greater improvement in the total combined score (daily symptom score and daily medication score), compared to patients receiving placebo

3 Mar 2010

Antares Pharma completes enrollment in Phase 3 clinical trial of Anturol for OAB

Antares Pharma, Inc. announced today that it has completed enrollment in the double-blind portion of the Company’s Phase 3 clinical trial of Anturol™, its transdermal oxybutynin ATD™ gel for the treatment of overactive bladder (OAB). Top line data from this pivotal trial, which is being conducted under a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA), is expected in the third quarter of this year.

2 Mar 2010

Synta Pharmaceuticals receives FDA approval for resuming elesclomol clinical development

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today reported that the U.S. Food and Drug Administration (FDA) has approved resuming clinical development of elesclomol, the Company's first-in-class oxidative stress inducer.

2 Mar 2010

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today that its affiliate VGX International Inc. has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza.

2 Mar 2010

Archimedes Pharma raises GBP65 million in new funding

Archimedes Pharma, the leading specialty pharma company, today announced that it has raised GBP65 million (approx US$100 million) in new funding. The round was led by new investor Novo Growth Equity, the growth equity fund of Novo A/S, and included participation by major current investor, Warburg Pincus, a global private equity firm. Archimedes also announced the appointment of a new President and Chief Executive Officer, Jeffrey H. Buchalter, formerly President and Chief Executive Officer of US-based Enzon.

2 Mar 2010

IgPro20 protects PI patients against infection

Data presented today suggest that 20 percent liquid formulation, Immune Globulin Subcutaneous (Human) (SCIg), or IgPro20 effectively protects patients with primary immunodeficiencies (PI) against infection. The 20 percent formulation, the highest Ig concentration currently available, was also shown to sustain serum IgG levels without causing unexpected rates of adverse events. The data were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in New Orleans, US.

2 Mar 2010

PTSD drug: Cannabis Science to file first application for FDA clinical trials

Cannabis Science Inc., a pharmaceutical cannabis company in the US, is pleased to announce that it now has the results of its survey of more than 1,300 individuals with PTSD, including a large cohort of veterans. The survey was conducted by Cannabis Science Advisory Board member Dr. Mitch Earleywine PhD. of the State University of New York (Albany).

2 Mar 2010

Celsion to commence Phase II Study of ThermoDox and RFA for CRLM

Celsion Corporation today announced that it will initiate a Randomized Phase II Study of Lyso-Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Radiofrequency Ablation (RFA) for Colorectal Liver Metastases (CRLM). Dr. Steven K. Libutti, Professor and Vice Chairman, Department of Surgery and Director of the Montefiore-Einstein Center for Cancer Care and Albert Einstein College of Medicine in New York City, will serve as Principal Investigator for the study.

2 Mar 2010

Quark Pharmaceuticals commences dosing in clinical study of QPI-1007 for NAION

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, announced today the dosing of the first patient in a Phase I study of the investigational neuroprotective agent, QPI-1007.

2 Mar 2010

Drug Trial News

Allergan, Bristol-Myers Squibb sign global exclusive license agreement for EHT/AGN 0001

Endocyte's PRECEDENT study: DSMB recommends enrollment to continue

Androxal Type C meeting: Repros Therapeutics receives FDA’s version of minutes

Negative results from latrepirdine Phase III clinical trial: Alzheimer's Association disappointed

Zoraxel for treatment of ED: Rexahn Pharmaceuticals submits Phase IIb protocol to FDA

Phase 3 trial: Cabazitaxel improves survival in patients with metastatic hormone-refractory prostate cancer

AGN-209323 small molecule for neuropathic pain: Bristol-Myers Squibb, Allergan announce global agreement

Pfizer, Medivation announce results of two dimebon Phase 3 trials in AD patients

FDA issues new draft guidance for Trius Therapeutics' proposed Phase 3 trial of torezolid phosphate

Merck’s MF/F Phase III study data presented at AAAAI annual meeting

Merck announces updated late-stage pipeline following its recent merger with Schering-Plough

Phase III study results of Merck's allergy immunotherapy tablet

Antares Pharma completes enrollment in Phase 3 clinical trial of Anturol for OAB

Synta Pharmaceuticals receives FDA approval for resuming elesclomol clinical development

Inovio Biomedical's SynCon preventive DNA vaccine receives approval in Korea for Phase I clinical trial

Archimedes Pharma raises GBP65 million in new funding

IgPro20 protects PI patients against infection

PTSD drug: Cannabis Science to file first application for FDA clinical trials

Celsion to commence Phase II Study of ThermoDox and RFA for CRLM

Quark Pharmaceuticals commences dosing in clinical study of QPI-1007 for NAION

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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