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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

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

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

PLC Systems' RenalGuard to be utilized in a live case transmission at the GISE 2009 conference

PLC Systems Inc., a company focused on innovative cardiac and vascular medical device-based technologies, today announced that its RenalGuard System(TM) will be utilized as part of a live case transmission from the Clinica Mediterranea, Naples, Italy, to the 30th Congresso Nazionale della Societa' Italiana di Cardiologia Invasiva (GISE) during the conference.

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

Oral salmon calcitonin using absorption-enhancing Eligen Technology holds promise for osteoarthritis

Emisphere Technologies, Inc. announced study results in which twice-daily oral salmon calcitonin using Emisphere’s proprietary Eligen® Drug Delivery Technology significantly suppressed markers of cartilage and bone degradation versus placebo in men and women with osteoarthritis, the most common form of arthritis.

19 Oct 2009

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

Angiochem, Inc. a clinical-stage biotechnology company developing drugs that are uniquely capable of crossing the blood-brain barrier to treat brain diseases, announced today that its lead drug candidate, ANG1005, has demonstrated a favorable safety and efficacy profile in more than 100 patients with brain cancer from two separate Phase 1 /2 clinical studies in patients with progressive gliomas, including recurrent glioblastoma, and in patients with progressive brain metastases.

19 Oct 2009

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

19 Oct 2009

Rituxan's sBLA receives a Complete Response from the FDA

Genentech, Inc. a wholly-owned member of the Roche Group, and Biogen Idec announced today that the companies received a Complete Response from the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application (sBLA) for Rituxan (rituximab) plus methotrexate (MTX) in patients with moderately-to-severely active rheumatoid arthritis (RA) who no longer respond to treatment with a disease modifying antirheumatic drug (DMARD), including MTX.

19 Oct 2009

Study to examine the impact of LASIK procedure on patients’ quality of life

The U.S. Food and Drug Administration today announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from Laser-Assisted In Situ Keratomileusis (LASIK), a surgical procedure that uses an eximer laser to permanently change the shape of the cornea.

19 Oct 2009

Novel HIV drug to be studied in cell cultures and patients

A $6 million, five-year federal grant to The Children's Hospital of Philadelphia Research Institute will enable researchers to investigate a novel approach in treating HIV infection---a unique class of drugs focused on developing therapies for psychological and neurological effects in AIDS.

19 Oct 2009

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Biogen Idec and Biovitrum AB (STO: BVT) today announced that they plan to advance the companies’ long-acting, fully-recombinant Factor IX Fc fusion protein (rFIXFc) into a registrational clinical trial in hemophilia B patients.

19 Oct 2009

Phase I clinical study of PENNVAX-B preventive DNA vaccine using electroporation technology

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced today the initiation of a phase I clinical study of Inovio’s PENNVAX-B preventive DNA vaccine delivered using its proprietary electroporation technology.

19 Oct 2009

Recently approved Gleevec drug for cancer treatment

Investigators have identified a drug that is currently approved to treat certain types of cancer, Gleevec, that could provide the first treatment for scleroderma, a chronic connective tissue disease for which a treatment has remained elusive. The news will be presented at the annual meeting of the American College of Rheumatology on October 18 in Philadelphia.

19 Oct 2009

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

19 Oct 2009

China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Celsion Corporation announced today that it has received official approval from China’s State Food and Drug Administration (“SFDA”) for its Clinical Trial Application for ThermoDox that permits Celsion to include Chinese clinical trial sites in its Phase III ThermoDox HEAT trial for the treatment of primary liver cancer, also known as hepatocellular carcinoma (HCC).

15 Oct 2009

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Soligenix, Inc., formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has initiated enrollment in its confirmatory Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating orBec(®) for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD).

15 Oct 2009

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

Inspire Pharmaceuticals, Inc. announced today Inspire scientists and collaborators will present data from the denufosol tetrasodium cystic fibrosis (CF) program in a poster presentation at the 23rd Annual North American Cystic Fibrosis Conference (NACFC) October 15 - 17, 2009 in Minneapolis, MN.

15 Oct 2009

Clinical Trial News and Research

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

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

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

PLC Systems' RenalGuard to be utilized in a live case transmission at the GISE 2009 conference

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

Oral salmon calcitonin using absorption-enhancing Eligen Technology holds promise for osteoarthritis

Angiochem reports Phase 1/2 efficacy study results of ANG1005 for treating brain cancer

Angiochem announces results of Phase 1 /2 clinical trials of ANG1005

Rituxan's sBLA receives a Complete Response from the FDA

Study to examine the impact of LASIK procedure on patients’ quality of life

Novel HIV drug to be studied in cell cultures and patients

Biogen Idec and Biovitrum to conduct rFIXFc clinical trial in hemophilia B patients

Phase I clinical study of PENNVAX-B preventive DNA vaccine using electroporation technology

Recently approved Gleevec drug for cancer treatment

GlaxoSmithKline receives FDA approval for cervical cancer vaccine

China's SFDA approves Celsion’s global Phase III ThermoDox HEAT trial for treating liver cancer

Soligenix commences enrollment in its Phase 3 Orbec clinical trial for acute GI GVHD

Inspire to present its denufosol tetrasodium cystic fibrosis program data at the 23rd NACFC

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