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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

Elan and Biogen Idec to present TYSABRI study data at ACG meeting

Elan Corporation, plc and Biogen Idec today announced multiple presentations at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 23-28 in San Diego.

20 Oct 2009

Study explores the efficacy of antidepressant drugs for patients with severe depression and medical disorder

This study demonstrates that over 6 weeks of treatment, patients with melancholic depression and medical comorbidity (MC) (specifically cardiovascular or endocrinological MC) had poorer treatment response and a worse functional outcome as opposed to their counterparts without MC. Interestingly, these effects were not related to various antidepressant treatment regimens.

20 Oct 2009

CMS requested for coverage of two FDG PET scans during the initial treatment

Seven medical imaging groups wrote a joint letter to the Centers for Medicare and Medicaid Services (CMS) to formally request coverage of two fluorodeoxyglucose (FDG) positron emission tomography (PET) scans for a patient during the initial treatment evaluation. Currently, CMS covers only one FDG-PET study during initial treatment-a limitation that the groups believe is contrary to good clinical practice under certain circumstances.

20 Oct 2009

Stemedica completes pre-IND meeting with the FDA concerning allogeneic mesenchymal bone marrow cells

Stemedica Cell Technologies, Inc., a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigative New Drug) to evaluate the safety and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke.

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

New technique to treat metabolic disorders in babies while still in the womb

Researchers say a new development in cord blood transplants for inherited metabolic disorders may be curative for some babies who are treated while still in the womb.

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

URL Pharma's Colcrys approved by FDA for prevention of gout flares

URL Pharma, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare.

19 Oct 2009

Alnara Pharmaceuticals’ announces results of its international Phase 3 study of liprotamase

Alnara Pharmaceuticals, a pharmaceutical company developing novel, non-systemic orally delivered protein therapeutics for the treatment of metabolic diseases, today announced results from an international, Phase 3 open-label, long-term safety study demonstrating the safety and nutritional benefits of liprotamase, a novel pancreatic enzyme replacement therapy (PERT) for patients with cystic fibrosis (CF).

19 Oct 2009

Philippines and Malaysian regulatory agencies approve Celsion’s Phase III Thermodox trial

Celsion Corporation announced today that it has received approval from the regulatory agencis in the Philippines and Malaysia for its Pivotal Phase III primary liver cancer Clinical Trial Application.

19 Oct 2009

Durham VA Medical Center receives Daxor's BVA-100 Blood Volume Analyzer

Daxor Corporation, a medical instrumentation and biotechnology company, today announced the receipt of a signed trial agreement from the Institute for Medical Research at the Durham Veterans Affairs (VA) Medical Center of Durham, North Carolina.

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

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

New long-term data from two pivotal, Phase 3 clinical trials showed that patients with active rheumatoid arthritis (RA) receiving SIMPONI(TM) (golimumab) every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year. These new data were presented today at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting.

19 Oct 2009

Positive results from Trubion Pharmaceuticals' Phase 2B study of TRU-015 for rheumatoid arthritis

Trubion Pharmaceuticals, Inc. today announced favorable safety and efficacy data following administration of a second course (R2) of re-treatment with 800 mg of TRU-015 for rheumatoid arthritis (RA). These data are the latest results from the ongoing open-label re-treatment portion of the Phase 2b (15002) RA study of TRU-015. Pfizer Inc. and Trubion are collaborating on the development of TRU-015 for the treatment of autoimmune and inflammatory diseases, including RA.

19 Oct 2009

Efficacy News and Research

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

Elan and Biogen Idec to present TYSABRI study data at ACG meeting

Study explores the efficacy of antidepressant drugs for patients with severe depression and medical disorder

CMS requested for coverage of two FDG PET scans during the initial treatment

Stemedica completes pre-IND meeting with the FDA concerning allogeneic mesenchymal bone marrow cells

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

New technique to treat metabolic disorders in babies while still in the womb

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

URL Pharma's Colcrys approved by FDA for prevention of gout flares

Alnara Pharmaceuticals’ announces results of its international Phase 3 study of liprotamase

Philippines and Malaysian regulatory agencies approve Celsion’s Phase III Thermodox trial

Durham VA Medical Center receives Daxor's BVA-100 Blood Volume Analyzer

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

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

Positive results from Trubion Pharmaceuticals' Phase 2B study of TRU-015 for rheumatoid arthritis

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