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Anadys Pharmaceuticals reports positive 4-week results from its ANA598 Phase II study for HCV

Anadys Pharmaceuticals, Inc. today announced preliminary results from a planned interim analysis of data at four weeks for the first dose cohort, 200 mg bid, in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients.

17 Dec 2009

BDSI's BEMA Buprenorphine Phase 2 study meets primary efficacy endpoint

BioDelivery Sciences International, Inc. announced that the primary efficacy endpoint was achieved in the Company’s Phase 2 pain study assessing the efficacy and safety of BEMA Buprenorphine. The positive results follow BDSI’s March 2009 announcement of favorable Phase 1 study results.

17 Dec 2009

Investigational study of TRT to alleviate debilitating effects of tinnitus commenced

A University of Alabama researcher is embarking on a $5.6 million phase-three, randomized, controlled clinical trial to evaluate the effectiveness of an innovative treatment that uses a noise-generating device, along with counseling, to alleviate the debilitating effects of tinnitus - that ringing in the ears that drives some people to distraction.

17 Dec 2009

Roche discloses results of two of eight taspoglutide T-emerge phase III studies in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed headline results of the fourth and fifth of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence.

17 Dec 2009

FDA Advisory Committee votes against the approval of Tarceva

OSI Pharmaceuticals, Inc. and Genentech, Inc., a wholly owned member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one recommending against approval of the daily pill Tarceva® (erlotinib) for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed (grown or spread) following first-line treatment with platinum-based chemotherapy.

17 Dec 2009

Top-line efficacy and safety results from Phase 2b clinical trial of XIAFLEX announced

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced top-line efficacy and safety results from a Phase 2b clinical trial of XIAFLEX(TM) for the treatment of Peyronie's disease.

17 Dec 2009

Phase 3 registration clinical trial for perifosine initiated by Keryx Biopharmaceuticals

AEterna Zentaris Inc. (the "Company"), a global biopharmaceutical company focused on oncology and endocrine therapy, today announced the initiation, by its partner Keryx Biopharmaceuticals Inc. ("Keryx") ( KERX), of a Phase 3 registration clinical trial for perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in relapsed/refractory multiple myeloma patients.

16 Dec 2009

Advanced Life Sciences Holdings' Restanza promising against tularemia

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), today announced positive top-line results from a pivotal, non-human primate study of its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) against an inhaled lethal dose of tularemia. A 14-day course of Restanza achieved a 100% survival rate at the doses tested. All of the ten animals in the study that received 16 mg/kg once-a-day of Restanza (approximate to a human dose of 300 mg) within 24 hours after exposure to a lethal dose of inhaled tularemia survived while only one of the ten animals that received placebo survived.

16 Dec 2009

Keryx Biopharmaceuticals initiates Phase 3 registration clinical trial for perifosine

Æterna Zentaris Inc., a global biopharmaceutical company focused on oncology and endocrine therapy, today announced the initiation, by its partner Keryx Biopharmaceuticals Inc., of a Phase 3 registration clinical trial for perifosine (KRX-0401), the Company's PI3K/Akt pathway inhibitor, in relapsed/refractory multiple myeloma patients.

16 Dec 2009

Naurex commences dosing in its GLYX-13 Phase I clinical trial for treatment-resistant depression

Naurex Inc., a new clinical stage company developing innovative treatments for depression and other CNS disorders based on its novel GFPA NMDA receptor modulators, today announced that it has initiated a Phase I clinical trial of its lead compound GLYX-13 and has successfully dosed the first subjects in the study.

16 Dec 2009

Positive results from Auxilium Pharmaceuticals' XIAFLEX Peyronie's disease phase IIb trial

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced top-line efficacy and safety results for the phase IIb clinical trial for XIAFLEX™ (collagenase clostridium histolyticum) in the treatment of Peyronie's disease.

16 Dec 2009

ThromboGenics completes enrollment in second microplasmin Phase III trial

ThromboGenics NV, a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer, announces today that it has completed the enrolment of the second Phase III trial evaluating microplasmin for the non-surgical treatment of eye disease.

16 Dec 2009

Tarenflurbil drug does not appear to benefit Alzheimer’s patients

Although there were promising results in a phase 2 trial, patients with mild Alzheimer disease who received the drug tarenflurbil as part of a phase 3 trial did not have better outcomes on measures of cognitive decline or loss of activities of daily living compared to patients who received placebo, according to a study in the December 16 issue of JAMA.

15 Dec 2009

Can-Fite BioPharma to commence Glaucoma Phase II clinical study in Israel

Can-Fite BioPharma, a biotechnology company traded on the Tel Aviv Stock Exchange, announced on December 13 the initiation of the regulatory process for a Glaucoma Phase II clinical study in Israel. Leading Medical Centers in Israel will enroll 44 patients with Ocular Hypertension or Glaucoma for the first segment of the trial, who will be treated for 16 weeks with CF101 or placebo.

15 Dec 2009

Spinal Restoration receives FDA SPA concurrence letter for its Phase 3 Biostat System study

Spinal Restoration, Inc. announced today it has received a Special Protocol Assessment concurrence letter from the U.S. Food and Drug Administration (FDA) for the design of its Phase 3 study of the Biostat System for the treatment of chronic discogenic low back pain.

15 Dec 2009

Celgene announces positive data from its apremilast Phase IIb study for plaque-type psoriasis

Celgene Corporation announced clinical data from an investigational Phase IIb, double-blind, placebo-controlled study of apremilast (CC-10004) in patients with moderate-to-severe plaque-type psoriasis (PSOR-005). This was a 352-patient, multi-center study in which patients received either 10mg, 20mg or 30mg of apremilast twice per day (BID), or placebo.

15 Dec 2009

Modifications to Phase II study AD201 and open label extension study AD251 for ELND005 notified

Elan Corporation, plc and Transition Therapeutics, Inc. today notified clinical investigators of modifications to the Phase II study AD201 and open label extension study AD251 for ELND005, a compound being developed for the potential treatment of Alzheimer’s disease.

15 Dec 2009

Phase III clinical trial evaluating darusentan misses its co-primary efficacy endpoints

Gilead Sciences, Inc. today announced that DAR-312 (DORADO-AC), a Phase III clinical trial evaluating darusentan, the company’s endothelin receptor antagonist (ERA) for the treatment of resistant hypertension, did not achieve its co-primary efficacy endpoints of change from baseline to week 14 in trough sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) compared to placebo.

15 Dec 2009

Microbicide does not reduce women's risk of HIV infection, study shows

Pro 2000, a vaginal microbicide gel designed to reduce women's risk of HIV infection, showed "no evidence that it reduces the risk of HIV infection," according to the results of a series of clinical trials in Africa, Britain's Medical Research Council (MRC) said on Monday, Reuters reports.

15 Dec 2009

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Alexza Pharmaceuticals, Inc. today announced that it has submitted its New Drug Application (NDA) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration (FDA).

15 Dec 2009

Placebo News and Research

Anadys Pharmaceuticals reports positive 4-week results from its ANA598 Phase II study for HCV

BDSI's BEMA Buprenorphine Phase 2 study meets primary efficacy endpoint

Investigational study of TRT to alleviate debilitating effects of tinnitus commenced

Roche discloses results of two of eight taspoglutide T-emerge phase III studies in diabetes patients

FDA Advisory Committee votes against the approval of Tarceva

Top-line efficacy and safety results from Phase 2b clinical trial of XIAFLEX announced

Phase 3 registration clinical trial for perifosine initiated by Keryx Biopharmaceuticals

Advanced Life Sciences Holdings' Restanza promising against tularemia

Keryx Biopharmaceuticals initiates Phase 3 registration clinical trial for perifosine

Naurex commences dosing in its GLYX-13 Phase I clinical trial for treatment-resistant depression

Positive results from Auxilium Pharmaceuticals' XIAFLEX Peyronie's disease phase IIb trial

ThromboGenics completes enrollment in second microplasmin Phase III trial

Tarenflurbil drug does not appear to benefit Alzheimer’s patients

Can-Fite BioPharma to commence Glaucoma Phase II clinical study in Israel

Spinal Restoration receives FDA SPA concurrence letter for its Phase 3 Biostat System study

Celgene announces positive data from its apremilast Phase IIb study for plaque-type psoriasis

Modifications to Phase II study AD201 and open label extension study AD251 for ELND005 notified

Phase III clinical trial evaluating darusentan misses its co-primary efficacy endpoints

Microbicide does not reduce women's risk of HIV infection, study shows

Alexza Pharmaceuticals submits its NDA for Staccato loxapine to FDA

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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