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EnVivo Pharmaceuticals announces initiation and dosing of patients in Phase 2b study of EVP-6124

EnVivo Pharmaceuticals today announced the initiation and dosing of patients in a Phase 2b study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with schizophrenia. EnVivo is conducting the multi-center, dose ranging, placebo controlled, three-month study in the U.S. and Europe.

6 Jan 2010

IBI initiates Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090

Icon Bioscience, Inc., (IBI), a privately held biopharmaceutical company that specializes in the development and commercialization of novel ophthalmic pharmaceuticals announced today that it has initiated its Phase 2/3 pivotal clinical trial to assess the safety and efficacy of IBI-10090 in patients undergoing cataract surgery.

6 Jan 2010

Cancer Research UK and CRT to undertake phase I clinical trial of DI-B4

CANCER RESEARCH UK and Cancer Research Technology (CRT), the charity's development and commercialisation arm, are to undertake a phase I clinical trial of an investigational monoclonal antibody1 drug from Merck KGaA, Darmstadt, Germany, called DI-B4 - it is announced today (Monday).

6 Jan 2010

Enrollment for sham-controlled study of radiation therapy for treatment of wet AMD announced

Oraya Therapeutics, Inc., announced today that enrollment is now underway for the first ever masked and sham-controlled study to demonstrate the efficacy and safety of radiation therapy for the treatment of wet age-related macular degeneration (AMD).

6 Jan 2010

DSMB recommends Quark Pharmaceuticals to continue clinical study of QPI-1002

Quark Pharmaceuticals, Inc., the world leader in clinical development of RNAi-based therapeutics, announced today that the independent Data Safety Monitoring Board ("DSMB") recommended that QPI-1002 (I5NP) continue on to the next phase of clinical testing.

5 Jan 2010

Phase 2 study evaluating VBL Therapeutics' lead compound VB-201 initiated

VBL Therapeutics today announced the initiation of a Phase 2 efficacy and safety study evaluating lead compound VB-201 for the treatment of patients with psoriasis. VB-201 is poised to be a first-in-class, orally-administered immune response modifier expected to reduce inflammation in a broad range of conditions such as psoriasis.

5 Jan 2010

Talampanel slows progression of amyotrophic lateral sclerosis

A drug already used to treat symptoms of epilepsy has potential to slow the muscle weakening that comes with amyotrophic lateral sclerosis (ALS), scientists report after completing a Phase II clinical trial-an early, small-scale test to show if the drug works and continues to be safe.

5 Jan 2010

Headline results from first phase III study of Balaglitazone announced

Dr. Reddy’s Laboratories Ltd. and Rheoscience, a subsidiary of Nordic Bioscience A/S, today announced the headline results from the first phase III study for their investigational agent, Balaglitazone.

4 Jan 2010

DSPA submits lurasidone NDA to the FDA

Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lurasidone, an investigational atypical antipsychotic agent for the treatment of schizophrenia. The application, submitted on December 30, 2009, includes data from more than 40 clinical studies involving more than 2,500 lurasidone-treated patients.

4 Jan 2010

BioInvent International begins BI-505 drug study on patients with advanced multiple myeloma

BioInvent International AB announced today that the first patient has been treated in an open, dose-escalation phase I study of the company’s antibody BI-505 for patients with advanced multiple myeloma.

4 Jan 2010

Novelos continues NOV-002 Phase 3 combination trial for lung cancer

BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, is reporting Pfizer Inc. has announced that it has decided to discontinue the late-stage study of its lung cancer candidate figitumumab (CP-751,871) while Novelos' pivotal Phase 3 trial, with a primary efficacy endpoint of improvement in median overall survival, continues across approximately 12 countries and 100 clinical sites.

4 Jan 2010

D-Pharm commences enrollment in MACSI Phase III clinical study for acute ischemic stroke

D-Pharm Ltd announced enrollment of patients with acute ischemic stroke into its Phase III clinical study of DP-b99 (MACSI). The first patient has been enrolled at the Wolfson Medical Center, Israel. The MACSI trial involves numerous medical centers in the US, Canada, Europe, Israel, South Africa, South Korea and Brazil. DP-b99 is D-Pharm's most advanced product developed for protection of brain cells suffering from restricted blood and oxygen supply (ischemia).

3 Jan 2010

FDA evaluates Phase III randomized trial in acute myeloid leukemia

VION PHARMACEUTICALS, INC., announced today that the U.S. Food and Drug Administration ("FDA") had responded to its Special Protocol Assessment ("SPA") request to evaluate the Phase III randomized trial HOVON AML 92 sponsored by the Dutch-Belgian Cooperative Group for Hematology Oncology ("HOVON") of its lead product Onrigin(TM).

31 Dec 2009

Santarus submits rifamycin SV MMX IND to the FDA

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) requesting approval to begin a Phase III clinical program evaluating rifamycin SV MMX® in patients with travelers’ diarrhea.

30 Dec 2009

Phase 3 trial of figitumumab discontinued by Pfizer

Pfizer Inc. announced today the discontinuation of A4021016 (also known as ADVIGO 1016), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) as first-line treatment in patients with advanced non-adenocarcinoma non-small cell lung cancer (NSCLC) due to the study meeting predefined boundaries for early termination.

30 Dec 2009

Advaxis reports 3-year survival data from its ADXS11-001 Phase I trial for cervical cancer

The Phase I trial of ADXS11-001, the lead vaccine candidate of Advaxis, Inc., the company that pioneered the live, attenuated Listeria monocytogenes (Lm) vaccine, has shown thirty-six (36) month survival in two (2) of the thirteen (13) evaluable patients treated with Advaxis’ therapeutic cancer vaccine, indicating the possibility of persistent immune protection, from only a two (2) dose initial regimen.

29 Dec 2009

Promising results from Soligenix' RiVax vaccine against ricin toxin

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today the publication of an article in the January 2010 edition of Infection and Immunity, detailing the characteristics of several immunodominant regions of ricin A chain, the antigenic component of RiVax((TM)). RiVax((TM)) is Soligenix's vaccine to protect against exposure to ricin toxin and is currently being evaluated in Phase 1 human safety and immunogenicity trials, as well as nonhuman primate trials for efficacy.

29 Dec 2009

SVA submits the first clinical trial application for HFMD vaccine in China

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has filed the application with China's State Food and Drug Administration (SFDA) to commence a human clinical trial for its vaccine against human enterovirus 71 (EV 71), which causes hand, foot, and mouth disease (HFMD). This is the first clinical trial application for HFMD vaccine submitted in China.

28 Dec 2009

SemBioSys Genetics' Apo AI(Milano) program progress update

SemBioSys Genetics Inc. provided an update today on its progress on plant-produced Apo AI(Milano) in light of the Apo AI(Milano) license agreement between Pfizer Inc. and The Medicines Company, of Parsippany, New Jersey.

24 Dec 2009

Forest Laboratories acquires additional rights to NXL 104 beta-lactamase inhibitor

Forest Laboratories announced today its agreement to acquire additional rights to NXL 104, which amends the terms of its prior agreement with Novexel covering the combination of NXL 104 with ceftaroline and adds additional rights to the combination of ceftazidime and NXL 104, through a transaction with AstraZeneca executed immediately following AstraZeneca’s announced acquisition of Novexel, S.A.

24 Dec 2009