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Article evaluating StemEx therapy for leukemia and lymphoma to be published

Gamida Cell announced today the publication of an article evaluating carlecortemcel-l, the generic name of what is widely known as "StemEx", as a therapy for blood cancers such as leukemia and lymphoma.

19 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

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

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

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Endo Pharmaceuticals today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for FORTESTA(TM) (testosterone) 2% Gel for men diagnosed with low testosterone (Low T), also known as hypogonadism.

19 Oct 2009

Yashoda Cancer Institute in India to expand use of Varian Medical Systems' RapidArc radiotherapy

A hospital that is using RapidArc radiotherapy to treat cancers of the head & neck and cervix is announcing it will be expanding its use for treatment of other cancers. Yashoda Cancer Institute in Hyderabad has found it can deliver image-guided, intensity modulated radiotherapy (IMRT) faster and more precisely using the RapidArc technology from Varian Medical Systems.

19 Oct 2009

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Amgen Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia(TM) (denosumab) in the treatment and prevention of postmenopausal osteoporosis.

19 Oct 2009

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Schering-Plough announced that data on boceprevir, an investigational hepatitis C virus (HCV) protease inhibitor, will be reported in an oral presentation at the American Association for the Study of Liver Diseases (AASLD) Annual Meeting in Boston, Oct. 30-Nov. 3.

19 Oct 2009

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that it has initiated activities intended to complete the clinical development of the growth hormone secretagogue (GHS) / ghrelin agonist compound macimorelin (AEZS-130) which could be the first oral diagnostic test approved for growth hormone deficiency (GHD). Macimorelin is the International Non-proprietary Name (INN) designated for the compound by the World Health Organization (WHO).

19 Oct 2009

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

XenoPort, Inc. announced today that it has initiated a Phase 2b clinical trial of arbaclofen placarbil (AP), also known as XP19986, in patients with gastroesophageal reflux disease (GERD) who remain symptomatic despite treatment with a proton pump inhibitor (PPI). The trial is a multi-center, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of AP as adjunctive therapy to PPIs.

19 Oct 2009

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

The biopharmaceutical company Antisense Pharma GmbH has announced today that it has received the approval by Health Canada for its pivotal Phase III clinical trial SAPPHIRE in patients with recurrent or refractory anaplastic astrocytoma.

19 Oct 2009

Rich Plasma and Stem Cell therapies improve orthopedic conditions

Although stem cells sounds innovative and cutting edge, this therapy has been around for quite some time. In today's advanced medical climate stem cells are being used to treat many orthopedic conditions including osteoarthritis of the hip knee and shoulder, partial tears of tendons, muscles, and ligaments including rotator cuff tears, and various back conditions including disc herniations.

19 Oct 2009

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

AstraZeneca today announced the U.S. Food and Drug Administration (FDA) approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

19 Oct 2009

QLT receives exclusive U.S. sales and marketing rights for Visudyne therapy

QLT Inc. ("QLT" or the "Company") today announced that it has restructured its agreement with Novartis Pharma AG ("Novartis") to simplify the relationship, under which, effective January 1, 2010, it will, among other things, receive exclusive U.S. rights to the Visudyne(R) patents to sell and market Visudyne in the U.S. Visudyne, a photosensitizer co-developed with Novartis, is approved worldwide for the treatment of a form of wet age-related macular degeneration ("AMD"), the leading cause of legal blindness in people over the age of 55 in North America and Europe.

19 Oct 2009

Therapy News and Research

Article evaluating StemEx therapy for leukemia and lymphoma to be published

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

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

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

New data on Phase 3 SIMPONI clinical trials for rheumatoid arthritis

Update from Endo Pharmaceuticals regarding its New Drug Application for FORTESTA

Yashoda Cancer Institute in India to expand use of Varian Medical Systems' RapidArc radiotherapy

Amgen receives Complete Response Letter for the Biologic License Applications for Prolia from FDA

Schering-Plough to present data on boceprevir at the AASLD 2009 Annual Meeting

Phase 3 clinical trial of macimorelin (AEZS-130) to be completed by AEterna Zentaris

XenoPort commences Phase 2b arbaclofen placarbil clinical trial for treating gastroesophageal reflux disease

Antisense Pharma's SAPPHIRE Phase III trial evaluating trabedersen approved by Health Canada

Rich Plasma and Stem Cell therapies improve orthopedic conditions

AstraZeneca's CRESTOR approved for treating pediatric patients with HeFH

QLT receives exclusive U.S. sales and marketing rights for Visudyne therapy

Lubricin injections can reduce cartilage degeneration

Copper bracelets and magnetic wrist straps are ineffective in relieving arthritis pain, says study

IL-2 compound ineffective against HIV-AIDS

NCCN Clinical Practice Guidelines in Oncology updated to include pralatrexate drug

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Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

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