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Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

BioCryst Pharmaceuticals, Inc. announced favorable 52-week safety results and sustained efficacy from the extension phase of its randomized Phase 2b trial of ulodesine (BCX4208) added to allopurinol in patients with gout who had failed to reach the serum uric acid (sUA) therapeutic goal of <6 mg/dL on allopurinol alone, as well as positive Phase 2 safety results in patients with mild to moderate renal impairment.

25 Jul 2012

Novel combination drug regimen could be more effective than existing treatments for TB

A novel approach to discover the first new tuberculosis (TB) combination drug regimen cleared a major hurdle when Phase II clinical trial results found it could kill more than 99 percent of patients' TB bacteria within two weeks and could be more effective than existing treatments, according to a study published today in the Lancet.

24 Jul 2012

Topline results from first of four Phase 3 studies of Pfizer's bapineuzumab for Alzheimer's

Pfizer Inc. announced today that the co-primary clinical endpoints, change in cognitive and functional performance compared to placebo, were not met in the Janssen Alzheimer Immunotherapy R&D LLC (Janssen AI)-led Phase 3 trial of intravenous (IV) bapineuzumab in patients with mild-to-moderate Alzheimer's disease who carry the ApoE4 (apolipoprotein E epsilon 4) genotype.

24 Jul 2012

Pfizer’s Lyrica does not affect reproductive function in healthy males

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules CV Study A0081104 - Assessment of the Impact of Lyrica on Sperm Production in Healthy Volunteers - demonstrate that Lyrica does not affect the reproductive function in healthy males when compared to placebo.

24 Jul 2012

Debiopharm initiates Debio 8206 Phase III study on advanced prostate cancer

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced the treatment of its first patient in a multicentre, open, non-comparative Phase III study to investigate the efficacy, safety, and pharmacokinetics of two subcutaneous (SC) injections of Debio 8206 (triptorelin pamoate 22.5 mg 6-month formulation) in patients with advanced prostate cancer.

24 Jul 2012

TB combination drug trials progress

A novel approach to discover the first new tuberculosis (TB) combination drug regimen cleared a major hurdle when Phase II clinical trial results found it could kill more than 99 percent of patients’ TB bacteria within two weeks and could be more effective than existing treatments, according to a study published today in the Lancet. These results add to a growing body of evidence that the new regimen could reduce treatment by more than a year for some patients.

24 Jul 2012

Top-line result from Pfizer Bapineuzumab Phase 3 studies on Alzheimer's

Elan Corporation, plc announced today that Pfizer has issued a top-line result in the first of four Bapineuzumab Phase 3 studies carried out by Pfizer and Janssen AI.

24 Jul 2012

XenoPort initiates XP23829 Phase 1 study in healthy adults

XenoPort, Inc. announced today that the first subjects have been dosed in a Phase 1, randomized, double-blind, two-period crossover, food effect comparison study of XP23829 in healthy adults. The trial is designed to assess the pharmacokinetics, safety and tolerability of a single dose of XP23829 administered in both fasted and fed conditions.

24 Jul 2012

Ocular Therapeutix announces results from sustained release OTX-TP1 study on glaucoma

Ocular Therapeutix, Inc. announced today initial results of their sustained release travoprost-loaded punctum plug feasibility study for the treatment of glaucoma. This travoprost punctum plug (OTX-TP1) was evaluated for the reduction of elevated intraocular pressure in subjects with open-angle glaucoma or ocular hypertension over a 30 day period.

24 Jul 2012

Eating raisins may provide the same workout boost as sports chews

New research published in the Journal of the International Society of Sports Nutrition suggests that eating raisins may provide the same workout boost as sports chews.

24 Jul 2012

Once-daily Gralise significantly reduces pain intensity in PHN patients

Depomed, Inc. today announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN).

23 Jul 2012

New investment to fund Chiasma's Octreolin Phase 3 pivotal program for acromegaly

Chiasma, Inc., a privately held biopharma company, announced that it closed a $38.5 million equity financing co-led by new investor Abingworth and current investor MPM Capital that also included investments from existing shareholders 7 Med Health Ventures, ARCH Venture Partners, F3 Ventures and Fredric Price, Chiasma's Chairman & CEO.

23 Jul 2012

Berg Pharma initiates BPM 31543 clinical trial for chemotherapy-induced alopecia

Berg Pharma, a Boston-based pharmaceutical company focused on discovery and development of new treatments in cancer and metabolic diseases, announced the initiation of a clinical trial entitled "Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Topical Compound 31543 in Adult Patients Receiving Chemotherapy for the Treatment of Breast Cancer."

23 Jul 2012

Top-line results in Pfizer's Lyrica long term safety study for Generalized Anxiety Disorder

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules Study A0081147 - Long Term Safety and Efficacy of Pregabalin in Subjects with Generalized Anxiety Disorder (GAD) - demonstrate that drug discontinuation symptoms were low after tapering Lyrica treatment following three months and six months in GAD patients.

23 Jul 2012

Positive results from BrainStorm's interim NurOwn stem cell therapy clinical trial for ALS

BrainStorm Cell Therapeutics announced today that it has completed the planned interim safety review of its Phase I/II ALS (Amyotrophic Lateral Sclerosis) clinical trial, indicating that autologous transplantation of the Company's cell therapy was well-tolerated, appears to be safe for use, and did not present any undue risks to the study participants.

23 Jul 2012

Cerulean commences dosing in CRLX101 Phase 2 study for ovarian cancer

Cerulean Pharma Inc., a leader in developing dynamically tumor-targeted nanopharmaceuticals, today announced that the first patient has been dosed in a Phase 2 study of its lead candidate, CRLX101, in platinum-resistant ovarian cancer patients.

23 Jul 2012

FDA meeting confirms Orexo regulatory submission of OX219 NDA on track

A meeting with the US regulatory agency FDA held on July 17 has confirmed that the Swedish pharmaceutical company Orexo is on track with its preparation for a regulatory submission of a new drug approval (NDA) for its medicine for treatment of opioid dependency, OX219.

23 Jul 2012

Linagliptin safe and effective for long-term management of type 2 diabetes

An extended trial of a drug for people with type 2 diabetes has confirmed that the oral DPP-4 inhibitor linagliptin is a safe and effective means of lowering glucose levels for up to 102 weeks, either on its own or in combination with other selected oral anti-diabetic medication.

23 Jul 2012

Foundation Fighting Blindness grants US$125,000 to Oxford BioMedica for UshStat Phase I/IIa trial

Oxford BioMedica plc, the leading gene-based biopharmaceutical company, today announces that the US non-profit organisation, the Foundation Fighting Blindness (FFB), has granted an award of US$125,000 to the Company via its translational research arm, the Foundation Fighting Blindness Clinical Research Institute (FFBCRI) formerly known as the National Neurovision Research Institute (NNRI).

23 Jul 2012

Bayer, Onyx and Astellas announce results from Tarceva plus Nexavar Phase 3 trial on HCC

Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, Inc., and Astellas Pharma Inc. today announced that a Phase 3 trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib) tablets to Nexavar (sorafenib) tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. Nexavar alone.

23 Jul 2012

Drug Trial News

Favorable results from BioCryst’s ulodesine plus allopurinol Phase 2b trial on gout

Novel combination drug regimen could be more effective than existing treatments for TB

Topline results from first of four Phase 3 studies of Pfizer's bapineuzumab for Alzheimer's

Pfizer’s Lyrica does not affect reproductive function in healthy males

Debiopharm initiates Debio 8206 Phase III study on advanced prostate cancer

TB combination drug trials progress

Top-line result from Pfizer Bapineuzumab Phase 3 studies on Alzheimer's

XenoPort initiates XP23829 Phase 1 study in healthy adults

Ocular Therapeutix announces results from sustained release OTX-TP1 study on glaucoma

Eating raisins may provide the same workout boost as sports chews

Once-daily Gralise significantly reduces pain intensity in PHN patients

New investment to fund Chiasma's Octreolin Phase 3 pivotal program for acromegaly

Berg Pharma initiates BPM 31543 clinical trial for chemotherapy-induced alopecia

Top-line results in Pfizer's Lyrica long term safety study for Generalized Anxiety Disorder

Positive results from BrainStorm's interim NurOwn stem cell therapy clinical trial for ALS

Cerulean commences dosing in CRLX101 Phase 2 study for ovarian cancer

FDA meeting confirms Orexo regulatory submission of OX219 NDA on track

Linagliptin safe and effective for long-term management of type 2 diabetes

Foundation Fighting Blindness grants US$125,000 to Oxford BioMedica for UshStat Phase I/IIa trial

Bayer, Onyx and Astellas announce results from Tarceva plus Nexavar Phase 3 trial on HCC

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