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FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

Knopp Neurosciences to accelerate the development of KNS-760704 in ALS, says CEO of Knopp

Knopp Neurosciences Inc. announced that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of KNS-760704 in amyotrophic lateral sclerosis (ALS).

2 Sep 2009

PROTECT clinical study aimed at the assessment of rolofylline effects

Despite the promising findings of the PROTECT Pilot study, the larger PROTECT trial found no difference with rolofylline versus placebo with respect of the primary and main secondary end-points of the study. Although more rolofylline patients than placebo patients experienced moderate or marked dyspnea improvement at 24 and 48 hours from randomization, this was counterbalanced by a lack of effect on persistent renal impairment. Lastly, the risk of important neurological events was increased in patients on rolofylline.

2 Sep 2009

Positive results from second pivotal phase III trial for Lodotra

Nitec Pharma AG ("Nitec" or "Nitec Pharma"), a Switzerland-based specialty pharma company focused on the development and commercialization of medicines to treat chronic inflammation and pain-related diseases, today announced positive results from the second pivotal phase III trial for its lead product, Lodotra(TM).

2 Sep 2009

PLATO study reveals that ticagrelor reduces the rate of cardiovascular events

The presentation of the PLATO (A Study of Platelet Inhibition and Patient Outcomes), showed that ticagrelor (Brilinta) reduced the rate of cardiovascular (CV) events (CV death, myocardial infarction or stroke) from 11.7% to 9.8% compared clopidogrel (Plavix®) XX% (p<0.001, RRR = 16%), without an increase in major bleeding.

2 Sep 2009

High-density lipoprotein cholesterol concentrations increased in patients treated with LIVALO

New data presented today showed that in patients treated with LIVALO (pitavastatin), high-density lipoprotein cholesterol (HDL-C) concentrations increased, and nearly three-fourths of patients attained low-density lipoprotein cholesterol (LDL-C) targets, with results sustained over 52 weeks.

2 Sep 2009

GS-101 effective in inhibiting and regressing corneal neovascularisation

Gene Signal, a company focused on developing innovative drugs to manage angiogenesis based conditions, today announced the publication of interim results from a phase II study suggesting that the antisense oligonucleotide GS-101 (eye drops) is safe and effective at inhibiting and regressing corneal neovascularisation (abnormal new blood vessel growth).

1 Sep 2009

Cimzia approved for treating adult patients with rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1 Sep 2009

TransPharma's Phase 2A trial of ViaDerm-hPTH(1-34) for treating severe osteoporosis is successful

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today the successful completion of the Phase 2A trial of ViaDerm-hPTH(1-34) which is being developed for the treatment of severe osteoporosis.

1 Sep 2009

Results of the first pivotal Phase III trial with pimavanserin in patients with PDP announced

ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the first pivotal Phase III trial with pimavanserin in patients with Parkinson’s disease psychosis, or PDP. The study did not meet its primary endpoint of antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS.

1 Sep 2009

Biovail announces Phase III trial results for pimavanserin

Biovail Corporation today announced top-line results from ACADIA Pharmaceutical Inc.’s first pivotal Phase III trial with pimavanserin in patients with Parkinson’s disease psychosis, or PDP.

1 Sep 2009

Phase II result reveals effectiveness of GS-101 eye drops at inhibiting corneal neovascularisation

1 Sep 2009

Traditional lipid risk factors to be strong predictors of cardiovascular events according to a study

For patients with established heart disease who were treated with a statin, 18 novel biomarkers including C-reactive protein (CRP) did not predict future cardiovascular events such as heart attack and stroke, according to results of an analysis presented today at the 2009 European Society of Cardiology Congress in Barcelona, Spain.

1 Sep 2009

Stanford University starts recruiting participants for swine flu vaccine clinical trial

The Stanford University School of Medicine is recruiting participants for a clinical trial to determine the safety of an experimental vaccine against the new H1N1 strain of influenza when the vaccine is combined with an immune-stimulating substance called an adjuvant. The trial will also examine whether use of the adjuvant improves the immune response to the vaccine.

31 Aug 2009

Clinical trial results of Dabigatran proves its effectiveness for treating atrial fibrillation

Researchers today published promising results for a drug that could lead to a replacement for the very effective but difficult-to-use blood thinner Coumadin (sold generically as Warfarin), currently taken by millions of Americans to reduce their risk of stroke.

31 Aug 2009

Celladon announces completion of patient enrollment for Phase 2 CUPID clinical trial

Celladon Corporation and Momentum Research, Inc. today announced completion of enrollment of the phase 2 double-blind portion of the Calcium Up-regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) trial. Momentum Research is Celladon’s consulting and management organization with clinical expertise in the development of cardiovascular products and trials.

31 Aug 2009

Sonomax Hearing Healthcare completes Phase II trials of a delivery mechanism that inflates a V3 earplug successfully

Sonomax Hearing Healthcare Inc. (SHH:TSX Venture Exchange) is proud to announce that it has successfully passed its Phase II milestone, proof-of-performance of a delivery mechanism that inflates a V3 earplug as per fit function criteria.

31 Aug 2009

BrainStorm Cell Therapeutics partners with Protein Production to start production of clinical-grade stem cell therapeutic product

BrainStorm Cell Therapeutics Inc. (OTCBB:BCLI), a leading developer of adult stem cell technologies and therapeutics, announced today that it has entered into an agreement with Protein Production Services Ltd. (PPS), a leading manufacturing contractor, in order to start Good Manufacturing Practice (cGMP) production of its stem cell therapeutic product.

31 Aug 2009

Cancer researcher to serve as Peregrine Pharmaceuticals' clinical advisor for bavituximab cancer program

Peregrine Pharmaceuticals, Inc., today announced that noted cancer researcher Bruce Chabner, M.D., will serve as a clinical advisor to the company on the design of clinical trials for the bavituximab cancer program.

31 Aug 2009

Results of the Phase II SEPIA-ACS1/ TIMI-42 study presented at the plenary session of the Annual European Society of Cardiology

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the investigational anti-Xa intravenous anticoagulant otamixaban reduced by 27 to 42 percent the odds of the composite primary endpoint of death, myocardial infarction, urgent revascularization or rescue GPIIb/IIIa use in 4 out of the 5 otamixaban tested doses, versus standard UFH/eptifibatide combination in [non-ST] ACS patients suitable for invasive strategy.

31 Aug 2009

Drug Trial News

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Knopp Neurosciences to accelerate the development of KNS-760704 in ALS, says CEO of Knopp

PROTECT clinical study aimed at the assessment of rolofylline effects

Positive results from second pivotal phase III trial for Lodotra

PLATO study reveals that ticagrelor reduces the rate of cardiovascular events

High-density lipoprotein cholesterol concentrations increased in patients treated with LIVALO

GS-101 effective in inhibiting and regressing corneal neovascularisation

Cimzia approved for treating adult patients with rheumatoid arthritis

TransPharma's Phase 2A trial of ViaDerm-hPTH(1-34) for treating severe osteoporosis is successful

Results of the first pivotal Phase III trial with pimavanserin in patients with PDP announced

Biovail announces Phase III trial results for pimavanserin

Phase II result reveals effectiveness of GS-101 eye drops at inhibiting corneal neovascularisation

Traditional lipid risk factors to be strong predictors of cardiovascular events according to a study

Stanford University starts recruiting participants for swine flu vaccine clinical trial

Clinical trial results of Dabigatran proves its effectiveness for treating atrial fibrillation

Celladon announces completion of patient enrollment for Phase 2 CUPID clinical trial

Sonomax Hearing Healthcare completes Phase II trials of a delivery mechanism that inflates a V3 earplug successfully

BrainStorm Cell Therapeutics partners with Protein Production to start production of clinical-grade stem cell therapeutic product

Cancer researcher to serve as Peregrine Pharmaceuticals' clinical advisor for bavituximab cancer program

Results of the Phase II SEPIA-ACS1/ TIMI-42 study presented at the plenary session of the Annual European Society of Cardiology

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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