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CombinatoRx announces Synavive Phase 2 extension trial results at the 2009 ACR meeting

CombinatoRx, Incorporated today announced the results of a 12 month knee osteoarthritis (OA) Phase 2 extension trial for Synavive™ (CRx-102) at the American College of Rheumatology (ACR) 2009 Annual Meeting in Philadelphia. The data demonstrated that Synavive-treated subjects maintained efficacy levels throughout the 12 month extension trial.

21 Oct 2009

FDA grants Fast Track designation for MacuSight's Perceiva

MacuSight, a developer of innovative therapeutics for the treatment of severe ocular diseases and conditions, today announced that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for Perceiva, the company's proprietary ocular sirolimus product, for the treatment of diabetic macular edema (DME).

21 Oct 2009

Study of aldosterone antagonist usage among patients hospitalised with heart failure published

A study published today in JAMA (October 21) by Nancy M. Albert and colleagues, exploring aldosterone antagonist usage among US patients hospitalised with heart failure, found that only one-third of patients meeting current US Clinical Practice Guidelines criteria were actually being treated.

21 Oct 2009

Genzyme commences patient enrollment in Genz-112638 phase 3 trials

Genzyme Corporation today announced that the company has begun enrollment in the first of two global, multi-center, phase 3 trials of Genz-112638, a potential new oral therapy for Gaucher disease type 1. The two multi-national, multi-center trials are being conducted to evaluate the safety and efficacy of the small molecule.

21 Oct 2009

Targacept presents data from Phase 2b clinical trial of TC-5214

Targacept, Inc., a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics-, today announced the presentation of data from its recently completed Phase 2b clinical trial of TC-5214 as an augmentation (add-on) treatment in subjects with major depressive disorder, or MDD, who did not respond adequately to first-line treatment with the representative SSRI citalopram hydrobromide.

20 Oct 2009

Merck Frosst Canada announces the use of ISENTRESS for treating HIV-1 infected adults

Merck Frosst Canada Ltd. is pleased to announce that (Pr)ISENTRESS(R) (raltegravir) is now indicated for use in treatment-naïve HIV-1 infected adults in combination with other antiretroviral agents.

20 Oct 2009

SIMPONI treatment results in greater inhibition of structural damage in arthritis patients

Phase 3 data reported for the first time show that once every four week subcutaneous injections of SIMPONI(TM) (golimumab) resulted in significantly greater inhibition of structural damage compared with placebo plus methotrexate in patients with active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA).

20 Oct 2009

Novavax, Avimex and GE Healthcare initiate clinical study of H1N1 VLP influenza vaccine

Novavax, Inc. (Nasdaq: NVAX) announced today that it has initiated a two-stage clinical study of its virus-like-particle (VLP) H1N1 influenza vaccine in Mexico in collaboration with Avimex Laboratories (Avimex) and GE Healthcare.

20 Oct 2009

Trial collaborators present results from Prime-Boost HIV Vaccine Clinical Trial

Detailed results from the Prime-Boost HIV Vaccine Clinical Trial involving more than 16,000 adult volunteers in Thailand show that an investigational HIV vaccine regimen was safe and modestly effective at reducing the rate of HIV infection compared to placebo.

20 Oct 2009

Cumberland Pharmaceuticals publishes data on its Phase III intravenous ibuprofen study

Cumberland Pharmaceuticals Inc. announced today that its Phase III study on intravenous ibuprofen as a post-operative analgesic was published in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, distributed in October. The study concludes that patients emerging from orthopedic and abdominal surgeries required less narcotic and experienced less pain with 800 mg of intravenous ibuprofen every six hours compared to morphine alone.

20 Oct 2009

NicOx presents data on its phase 3 naproxcinod study at the ACR meeting

NicOx S.A. announced the presentation of detailed 26-week efficacy, safety and tolerability data from the second pivotal phase 3 study for naproxcinod (the 302 study) yesterday, at the American College of Rheumatology (ACR) and Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting in Philadelphia, Pennsylvania.

20 Oct 2009

Rexahn Pharmaceuticals announces positive results from Phase IIa Serdaxin clinical study

Rexahn Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing multi-indication therapeutics in CNS and oncology, today announced top-line results from a Phase IIa clinical study of Serdaxin™, its major depressive disorder (MDD) drug candidate.

20 Oct 2009

Human Genome Sciences and GlaxoSmithKline to present Phase 3 trial results of BENLYSTA

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced the full presentation of results from BLISS-52, the first of two pivotal Phase 3 trials of BENLYSTA™ (belimumab) in seropositive patients with systemic lupus erythematosus (SLE).

20 Oct 2009

Celgene Corporation updates on Phase II study evaluating apremilast in psoriatic arthritis patients

Celgene Corporation announced that updated results of a phase II, multi-center, randomized, double-blind, placebo-controlled, three-arm study of apremilast in adult patients with psoriatic arthritis (CC-10004-PSA-001) were presented today at the American College of Rheumatology (ACR) 2009 annual meeting in Philadelphia, PA.

20 Oct 2009

Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved TWYNSTA®, a new highly effective single pill combination therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]). TWYNSTA® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

20 Oct 2009

Positive results from Transave's Phase II ARIKACE clinical trials

Transave Inc., today reported additional positive clinical trial results on its lead investigational drug, ARIKACE(TM) (liposomal amikacin for inhalation), an antibiotic that aims to treat chronic lung infections.

20 Oct 2009

FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved a new indication for MICARDIS® (telmisartan) for the reduction of the risk of myocardial infarction (heart attack), stroke, or death from cardiovascular (CV) causes in patients 55 years of age or older at high risk of developing major CV events who are unable to take ACE inhibitors. MICARDIS® is the first treatment in its class to be approved for this indication.

19 Oct 2009

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

Amarin Corporation plc today announced that it has executed an agreement with Medpace, Inc. (‘Medpace’), a leading Contract Research Organization (CRO) with expertise in conducting clinical trials in cardiovascular and metabolic disease, to engage their services in the execution of its Phase 3 clinical trials with AMR101 in patients with very high triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia.

19 Oct 2009

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.(1) MICARDIS is the most studied ARB in this high-risk patient population and has been commercially available to treat hypertension (high blood pressure) since its approval in 1998.

19 Oct 2009

Ardea Biosciences reports results of RDEA594 Phase 2a study for hyperuricemia and gout

Ardea Biosciences, Inc. announced additional positive results from the completed first cohort of an ongoing Phase 2a, proof-of-concept study of RDEA594, its lead product candidate for the treatment of hyperuricemia and gout.

19 Oct 2009

Placebo News and Research

CombinatoRx announces Synavive Phase 2 extension trial results at the 2009 ACR meeting

FDA grants Fast Track designation for MacuSight's Perceiva

Study of aldosterone antagonist usage among patients hospitalised with heart failure published

Genzyme commences patient enrollment in Genz-112638 phase 3 trials

Targacept presents data from Phase 2b clinical trial of TC-5214

Merck Frosst Canada announces the use of ISENTRESS for treating HIV-1 infected adults

SIMPONI treatment results in greater inhibition of structural damage in arthritis patients

Novavax, Avimex and GE Healthcare initiate clinical study of H1N1 VLP influenza vaccine

Trial collaborators present results from Prime-Boost HIV Vaccine Clinical Trial

Cumberland Pharmaceuticals publishes data on its Phase III intravenous ibuprofen study

NicOx presents data on its phase 3 naproxcinod study at the ACR meeting

Rexahn Pharmaceuticals announces positive results from Phase IIa Serdaxin clinical study

Human Genome Sciences and GlaxoSmithKline to present Phase 3 trial results of BENLYSTA

Celgene Corporation updates on Phase II study evaluating apremilast in psoriatic arthritis patients

Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

Positive results from Transave's Phase II ARIKACE clinical trials

FDA approves Boehringer Ingelheim's MICARDIS for the reduction of risk of heart attack

Amarin selects Medpace as CRO for its Phase 3 AMR101 MARINE clinical study

Boehringer Ingelheim Pharmaceuticals receives NDA approval from FDA for its Micardis Tablets 80 mg

Ardea Biosciences reports results of RDEA594 Phase 2a study for hyperuricemia and gout

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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