Efficacy News and Research

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Only 15 U.S. pharmaceutical ads adhere to FDA Prescription Drug Advertising Guidelines

A study led by Mount Sinai School of Medicine researchers of 192 pharmaceutical advertisements in biomedical journals found that only 18 percent were compliant with Food and Drug Administration (FDA) guidelines, and over half failed to quantify serious risks including death.

19 Aug 2011

New Therapy Grants Program supports innovative approach to treat epilepsy

The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) announced today a New Therapy Grant to potentially help those with treatment resistant epilepsy.

19 Aug 2011

H1N1 vaccine safe, effective for hemodialysis and kidney transplant patients

When the influenza A (H1N1) virus swept around the world in spring 2009, infection was presumed to be more common in immunosuppressed patients, such as those who have had a kidney transplant. Later that year, the International Societies of Transplantation recommended that transplant recipients receive at least one dose of the H1N1 vaccine, although there was no information on the efficacy of the vaccine in that population.

19 Aug 2011

Amgen to present data from several Prolia studies at ASBMR 2011 meeting

Amgen today announced that it will present data from several Prolia (denosumab) studies, including eight year efficacy and safety data from a Phase 2 extension study in women with postmenopausal osteoporosis with low bone mineral density (BMD), at the 2011 American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego, Calif. from Sept. 16-20, 2011.

19 Aug 2011

Gene Security Network announces commercial launch of non-invasive prenatal test

Gene Security Network Inc. (GSN) today announced the commercial launch of its first non-invasive prenatal test powered by the company's proprietary bioinformatics technology, Parental Support™.

18 Aug 2011

NPS submits NDA CMC section to FDA for GATTEX

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has submitted the chemistry, manufacturing and controls (CMC) section of its new drug application (NDA) for GATTEX® (teduglutide) to the U.S. Food and Drug Administration (FDA).

18 Aug 2011

NCRM at Case Western Reserve to host stem cell conference in Cleveland

The National Center for Regenerative Medicine (NCRM) at Case Western Reserve University is proud to present "MSC 2011: Innovations in Cell-Based Regenerative Therapies," a three-day forum to highlight transformative breakthroughs in the area of adult stem cell medicine with a focus on how this research is being applied in patient care settings through innovative clinical trials.

18 Aug 2011

CEL-SCI receives Chinese patent for Multikine cancer drug

CEL-SCI Corporation today announced that the Chinese patent office has issued a key patent covering CEL-SCI's investigational cancer drug, Multikine.

18 Aug 2011

Emergent commences TRU-016 Phase 1b/2 combination trial in relapsed indolent NHL

Emergent BioSolutions Inc. today announced the initiation of a Phase 1b/2 study (16011) of TRU-016 in combination with rituximab and bendamustine for patients with relapsed indolent non-Hodgkin's B-cell lymphomas, including follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.

17 Aug 2011

Neovasc completes previously announced non-brokered private placement

Neovasc Inc. today announced that it has completed a previously announced non-brokered private placement of 4,720,500 equity units at the price of $1.00 per unit for aggregate gross proceeds of approximately $4,720,500.

17 Aug 2011

Patient recruitment complete in Kuros' KUR-023 dural sealant European clinical trial

Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has completed patient recruitment in a clinical trial investigating the safety and efficacy of KUR-023, its novel dural sealant product candidate.

17 Aug 2011

Study finds broadest immune response from LAIV nasal spray vaccines for children

Children younger than 3 years old receive the same protective antibody response from the recommended two doses of licensed seasonal influenza vaccines regardless of whether the two doses are injected by needle, inhaled through a nasal spray or provided through one dose of each in any order, according to researchers funded by the National Institutes of Health.

17 Aug 2011

LYSOGENE launches the first gene therapy clinical trials in Sanfilippo disease

LYSOGENE announces the authorization by AFSSAPS (the French Agency for the Safety of Health Products) and by the Ethical Review Board of SAF-301, its leading intra-cerebral gene therapy phase I/II clinical trial aiming at treating Sanfilippo Type A Syndrome.

16 Aug 2011

Study explores how some cognitive strategies and abilities boost self-efficacy

Sticking with an exercise routine means being able to overcome the obstacles that invariably arise. A key to success is having the confidence that you can do it, researchers report. A new study explores how some cognitive strategies and abilities increase this "situation-specific self-confidence," a quality the researchers call "self-efficacy."

16 Aug 2011

Combination immunotherapy more effective for patients with Sezary Syndrome

A three-pronged immunotherapy approach nearly doubles five-year survival among patients with rare leukemic form of cutaneous T-cell lymphoma, reports a new study by dermatologists from the Abramson Cancer Center and Perelman School of Medicine at the University of Pennsylvania.

16 Aug 2011

AVI BioPharma, MDA to initiate exon-51 Phase 2 trial in Duchenne muscular dystrophy

More than a decade of targeted Muscular Dystrophy Association-funded research, made possible as a result of generous public support of the MDA Labor Day Telethon and thousands of grass-roots special events, has today culminated in MDA providing financial assistance for the start of the first Phase 2 placebo-controlled, multiple dose efficacy, safety, tolerability and pharmacokinetics clinical trial of an exon-51 skipping drug, eteplirsen, as a potential therapy for Duchenne muscular dystrophy.

16 Aug 2011

Enrollment commences in Omthera's Epanova Phase III trial for hypertriglyceridemia

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that the first patient has been enrolled in its ESPRIT Phase III clinical trial of Epanova, in patients with hypertriglyceridemia (TG level greater than or equal to 200 and < 500 mg/dL) despite treatment with a statin.

16 Aug 2011

Enrollment commences in RegeneRx RGN-259 Phase 2 trial for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. has announced that the first patients have been enrolled and randomized to receive RGN-259 or placebo in its 72-patient, Phase 2 clinical trial in patients with dry eye syndrome.

16 Aug 2011

Starpharma starts bacterial vaginosis prevention study of VivaGel

Starpharma Holdings Limited today announced the commencement of its Phase 2 study of VivaGel for the prevention of bacterial vaginosis (BV), following receipt of ethics approval.

15 Aug 2011

Fibrate drugs may not prevent heart attacks in diabetes patients with elevated cholesterol

Type 2 diabetes patients, who face higher risk of cardiovascular disease, often take a combination of medications designed to lower their LDL or "bad" cholesterol and triglyceride levels while raising their HDL or "good" cholesterol because doctors long have thought that taken together, the drugs offer protection from heart attacks and improve survival.

12 Aug 2011