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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

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Alkermes, Inc. today announced the initiation of a multidose phase 1 clinical study of ALKS 37, an orally active, peripherally-restricted opioid antagonist with potential to block the effects of opioid agonists on gastrointestinal motility, commonly referred to as opioid-induced constipation (OIC). The randomized, double-blind, placebo-controlled, repeat-dose study will assess the safety, tolerability and pharmacokinetics of daily oral administration of two dose levels of ALKS 37 for a seven day period in approximately 24 healthy volunteers.

17 Mar 2010

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Zogenix, Inc., a privately held pharmaceutical company, announced that it has initiated a pivotal Phase 3 clinical trial with ZX002, a novel, oral, controlled-release formulation of hydrocodone without acetaminophen. ZX002 is being developed for the treatment of moderate to severe pain in individuals who require around-the-clock opioid therapy for the control of pain.

17 Mar 2010

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

According to results from a Phase III safety and immunogenicity study presented today, Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine, [13-valent, adsorbed]) was shown to be immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed). These data were presented today at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Tel Aviv, Israel.

17 Mar 2010

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, and Otsuka Pharmaceutical Co., Ltd., today announced that they have received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACU-4429, an investigational oral treatment for dry age-related macular degeneration (dry AMD).

17 Mar 2010

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Abraxis BioScience, Inc. today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE® (protein-bound paclitaxel) with Taxol® (paclitaxel) injection, both in combination with carboplatin, met the study’s primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), as assessed by independent radiologist review.

17 Mar 2010

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

Protalix BioTherapeutics, Inc. announced today that it has initiated a phase I clinical trial of PRX-105, the Company's plant cell expressed pegylated recombinant human acetylcholinesterase product candidate in development for biodefense indications. The trial is designed to study the safety of PRX-105 by administering a bolus intravenous injection of PRX-105 in healthy volunteers.

17 Mar 2010

Drug Trial News

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

Alkermes initiates multidose Phase 1 clinical study of ALKS 37 for OIC

Zogenix announces the initiation of pivotal Phase 3 clinical trial with ZX002

Prevenar 13: Immunogenic and well tolerated in young children previously vaccinated with Prevenar

Acucela, Otsuka Pharmaceutical granted FDA Fast Track designation for ACU-4429 in treatment of dry AMD

Abraxis BioScience's Phase 3 trial comparing ABRAXANE with Taxol injection meets primary endpoint

Protalix BioTherapeutics commences clinical trial of human acetylcholinesterase for biodefense indications

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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