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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

Merck discontinues MK-1903 niacin receptor agonist development program with Arena Pharmaceuticals

Arena Pharmaceuticals, Inc. announced today Merck and Co., Inc.'s decision (through an affiliate) to discontinue development of MK-1903, an investigational niacin receptor agonist to treat atherosclerosis being developed under its research collaboration with Arena. Merck also informed Arena that the company will not continue the collaboration.

24 Dec 2009

Synta Pharmaceuticals initiates STA-9090 Phase 2 clinical trial for GIST

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it is initiating a Phase 2 clinical study of STA-9090 in patients with advanced gastrointestinal stromal tumors (GIST). This is the sixth clinical study of STA-9090, a potent, synthetic, small molecule Hsp90 inhibitor with a novel chemical structure.

23 Dec 2009

Positive results from Alimera Sciences' Iluvien FAME trial for DME

Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported top-line results from the month 24 readout of the FAME Study.

23 Dec 2009

Rigel Pharmaceuticals announces milestone payment from Daiichi Sankyo

Rigel Pharmaceuticals, Inc. today announced that it has received a milestone payment from Daiichi Sankyo Co., Ltd. as part of their collaboration to research and develop cancer treatments aimed at selectively inhibiting ligases, which are intrinsic to cancer cell growth and proliferation. The compound, as yet unnamed, targets cell division.

23 Dec 2009

Compugen, Pfizer enter into multi-target collaboration

Compugen Ltd. announced today that it has signed a collaboration agreement with Pfizer for the predictive discovery by Compugen of therapeutic peptide product candidates for three drug targets of interest to Pfizer. The discovery process, which will be based on various Compugen discovery platforms and funded by Pfizer, is expected to take a few months, following which the predicted molecules will be synthesized and delivered to Pfizer.

23 Dec 2009

ARCA biopharma submits Gencaro trial protocol for review under the FDA’s SPA process

ARCA biopharma, Inc. today announced that it has submitted a study protocol for review under the U.S. Food and Drug Administration’s (FDA) Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of GencaroTM, in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond most favorably to Gencaro. Gencaro is the Company’s investigational, pharmacologically unique beta-blocker and mild vasodilator.

23 Dec 2009

US Phase 2 clinical trial of RVX-208 commenced by Resverlogix

Resverlogix Corp. ("Resverlogix" or the "Company") announced today that it has begun dosing patients in its US Phase 2 clinical trial lead by Cleveland Clinic. This trial will examine RVX-208, Resverlogix's oral small molecule therapy for the treatment of atherosclerosis, in patients with stable coronary artery disease (CAD).

23 Dec 2009

Eritoran well tolerated in Phase II trial for severe sepsis

The investigational compound, eritoran tetrasodium ("eritoran," also known as E5564) appeared to be well tolerated in patients with severe sepsis in a Phase II trial published in the January issue of Critical Care Medicine, the official journal of the Society of Critical Care Medicine, the largest multiprofessional organization dedicated to ensuring excellence and consistency in the practice of critical care.

22 Dec 2009

Effectiveness of Genfit’s GFT505 clinical drug candidate questioned

It has come to the attention of Genfit, a leading biotech company listed on Alternext, that an undisclosed group of so-called “well known scientific experts” have issued a press release, via a news wire, purporting to put into question the effectiveness of Genfit’s main clinical drug candidate GFT 505.

22 Dec 2009

Study results of CSL’s pandemic H1N1 2009 vaccine published in JAMA

CSL Limited, Australia’s leading biopharmaceutical company, announced the Journal of the American Medical Association (JAMA) has published data from a clinical trial conducted in Australia to study CSL’s pandemic H1N1 2009 ‘swine’ flu vaccine.

22 Dec 2009

DSM BioSolutions to manufacture Mayoly Spindler's 'MS1819' lipase biotherapeutic

DSM BioSolutions today announced that it has entered into an agreement with Laboratoires Mayoly Spindler, Chatou Cedex, France, for the manufacture of "MS1819" lipase.

22 Dec 2009