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PharmAthene suspends work on SparVax research and development contract with BARDA

PharmAthene, Inc., a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced today that pursuant to the Federal Acquisition Regulations and pending a ruling in a protest recently filed by a competitor the Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), has suspended work under the modification the Company announced on February 23, 2010 to its existing contract with BARDA for the research and development of SparVax™. June 11, 2010 is the deadline to rule on the protest.

22 Mar 2010

Formatech selects Tracon Pharmaceuticals’ TRC102 inhibitor as next Fillanthropy Program candidate

Today, Formatech, Inc. announces the selection of Tracon Pharmaceuticals’ TRC102 clinical product as the next Fillanthropy™ Program candidate. Under this program, Formatech donates the services required to aseptically fill and finish one lot of the drug candidate to support Tracon’s upcoming clinical trials.

22 Mar 2010

Phase II Topical Interferon Alpha-2b trial for AGW: Helix BioPharma achieves last-patient-out

Helix BioPharma Corp. announced today that it has achieved last-patient-out in its Phase II trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts.

22 Mar 2010

Major study shoots for personalized breast cancer drugs

Mutations in BCRA1 and BCRA2 genes are mainly associated with increased risk of breast cancer in women. Recently many other genetic variants have been found to be associated with breast cancer.

19 Mar 2010

CPEX Pharmaceuticals' Phase 2a Nasulin trial fails, Arcadia Capital Advisors issues statement

Richard S. Rofe, who serves as Managing Director for Arcadia Capital Advisors, LLC, and is part of a shareholder group that includes Arcadia with a 9.97 percent ownership interest in CPEX Pharmaceuticals, Inc.,, commented on CPEX's recent announcement of failed Phase 2a Nasulin study results.

19 Mar 2010

Synergy Pharmaceuticals commences dosing in Phase IIa clinical trial of SP-304 in CC patients

Synergy Pharmaceuticals, Inc., a developer of new drugs to treat gastrointestinal disorders and diseases, announced today the initiation of dosing in a Phase IIa clinical trial of SP-304 in patients with chronic constipation (CC). This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat, oral, dose-escalation study in patients with chronic constipation.

19 Mar 2010

A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter

A.P. Pharma, Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for APF530 in the prevention of both acute and delayed onset chemotherapy-induced nausea and vomiting.

19 Mar 2010

Abstract about Phase I/II trial of ThermoDox in RCW accepted for presentation at ASCO 2010

Celsion Corporation today announced that an abstract about the Phase I/II trial of ThermoDox® in Recurrent Chest Wall Cancer (RCW) has been accepted for presentation at the American Society of Clinical Oncology 2010 Annual Meeting.

19 Mar 2010

FDA drafts new rules for testing, approving drug cocktails; Public-private partnership for TB treatment development launched

The FDA is drafting new guidelines for testing and approving multidrug cocktails for life-threatening diseases, the Wall Street Journal reports. "Many diseases, such as AIDS, tuberculosis and cancer, require multidrug combinations. Such drug cocktails can prevent the development of drug resistance, because the microbe or cancer cell needs to undergo more mutations to escape several drugs than to escape just one. By attacking the disease in different ways, drug combinations also improve the chances of therapeutic benefit," the newspaper reports (Schoofs, 3/18).

19 Mar 2010

Phase 1B clinical study initiated to evaluate safety and efficacy of PMX-60056

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 1B clinical study to evaluate the safety and efficacy of PMX-60056 in reversing the anticoagulant activity of low molecule weight heparin (LMWH).

19 Mar 2010

ASCO Scientific Program 2010: Provectus Pharmaceuticals' Phase 2 data on PV-10 accepted for presentation

Provectus Pharmaceuticals, Inc., a development-stage oncology and dermatology biopharmaceutical company, announced today that data from its Phase 2 study of PV-10 for metastatic melanoma has been accepted for presentation at the 2010 American Society of Clinical Oncology (ASCO) Scientific Program to be held on June 4 – 8, 2010 in Chicago, Illinois.

19 Mar 2010

Novelos Therapeutics Phase 3 trial of NOV-002 in advanced NSCLC fails to meet primary and secondary endpoints

Novelos Therapeutics, Inc., a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that primary and secondary endpoints were not met in Novelos’ pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) with its lead product, NOV-002, in combination with first-line chemotherapy.

18 Mar 2010

Achillion Pharmaceuticals receives NIH SBIR grant for study of novel antibacterial compound series

Achillion Pharmaceuticals, Inc., a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that it has received a Phase 1 Small Business Innovation Research Grant (SBIR) from the National Institute of Allergy and Infectious Disease (NIAID) branch of the National Institutes of Health (NIH) for the further study and characterization of a back-up series of compounds related to its novel antibacterial, ACH-702.

18 Mar 2010

Combination of gemcitabine and cisplatin limits the progression of endometrial cancer: Study

Researchers from The University of Texas M. D. Anderson Cancer Center report that in a small study of women with advanced or recurrent endometrial cancer, gemcitabine and cisplatin, when used in combination, produced a response rate in fifty percent of patients.

18 Mar 2010

Positive preliminary results from MediciNova's Phase Ib clinical trial of MN-221 for COPD

MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market and the Hercules Market of the Osaka Securities Exchange, today reported positive preliminary results from a Phase Ib clinical trial to evaluate the safety and efficacy of MN-221 in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD). There were no clinically significant safety concerns noted. Preliminary results demonstrated clinically significant improvements in percent change in forced expiratory volume in one second (FEV(1)).

18 Mar 2010

Findings from Study 305 evaluating the effect of Northera reported

Chelsea Therapeutics International, Ltd. reported findings from Study 305, a study evaluating the effect of Northera™ (Droxidopa), an investigational agent being studied for the treatment of neurogenic orthostatic hypotension (NOH), on patients' 24-hour blood pressure (BP) profile.

18 Mar 2010

Agendia to participate in groundbreaking clinical trial for breast cancer

Agendia, a world leader in molecular cancer diagnostics, announced today it will participate in the highly anticipated I-SPY 2 TRIAL for breast cancer, set to launch at the first of nearly twenty research sites.

18 Mar 2010

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

CPEX Pharmaceuticals Inc. today reported preliminary results related to its Phase 2a proof-of-concept clinical trial of the Company’s nasal insulin product, Nasulin™. The study was designed to evaluate the efficacy and safety of Nasulin versus placebo over a 6-week treatment period in subjects with Type 2 diabetes who were being treated with basal insulin and oral anti-diabetes agents.

18 Mar 2010

Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

Nabi Biopharmaceuticals announced that it has initiated the second of two pivotal Phase III clinical trials for NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary vaccine to treat nicotine addiction and prevent smoking relapse. The FDA has agreed with Nabi on the study design, protocol and end points through a Special Protocol Assessment (SPA). The SPA forms a basic foundation to support approval of a New Drug Application. The Company also received scientific advice from the European Medicines Agency (EMEA) that confirms and supports the trial protocol.

17 Mar 2010

ONGLYZA-metformin combination: FDA accepts NDA for review

Bristol-Myers Squibb Company and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for an investigational fixed dose combination of ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor, and metformin HCl extended-release tablets as a once-daily treatment for type 2 diabetes mellitus in adults.

17 Mar 2010

Drug Trial News

PharmAthene suspends work on SparVax research and development contract with BARDA

Formatech selects Tracon Pharmaceuticals’ TRC102 inhibitor as next Fillanthropy Program candidate

Phase II Topical Interferon Alpha-2b trial for AGW: Helix BioPharma achieves last-patient-out

Major study shoots for personalized breast cancer drugs

CPEX Pharmaceuticals' Phase 2a Nasulin trial fails, Arcadia Capital Advisors issues statement

Synergy Pharmaceuticals commences dosing in Phase IIa clinical trial of SP-304 in CC patients

A.P. Pharma's NDA for APF530 in prevention of CINV: FDA issues Complete Response Letter

Abstract about Phase I/II trial of ThermoDox in RCW accepted for presentation at ASCO 2010

FDA drafts new rules for testing, approving drug cocktails; Public-private partnership for TB treatment development launched

Phase 1B clinical study initiated to evaluate safety and efficacy of PMX-60056

ASCO Scientific Program 2010: Provectus Pharmaceuticals' Phase 2 data on PV-10 accepted for presentation

Novelos Therapeutics Phase 3 trial of NOV-002 in advanced NSCLC fails to meet primary and secondary endpoints

Achillion Pharmaceuticals receives NIH SBIR grant for study of novel antibacterial compound series

Combination of gemcitabine and cisplatin limits the progression of endometrial cancer: Study

Positive preliminary results from MediciNova's Phase Ib clinical trial of MN-221 for COPD

Findings from Study 305 evaluating the effect of Northera reported

Agendia to participate in groundbreaking clinical trial for breast cancer

Phase 2a clinical trial results of CPEX Pharmaceuticals' Nasulin insulin

Nabi Biopharmaceuticals commences second Phase III study of NicVAX for treating nicotine addiction

ONGLYZA-metformin combination: FDA accepts NDA for review

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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