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EnVivo initiates EVP-0962 GSM Phase 1 clinical trial for Alzheimer’s disease

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced today that it recently initiated a Phase 1 clinical trial of EVP-0962, its potent and selective gamma secretase modulator (GSM), in healthy volunteers.

27 Jun 2011

FDA responds to EpiCept Ceplene SPA

EpiCept Corporation today announced that it has received initial written responses from the U.S. Food and Drug Administration regarding the Company's application for a Special Protocol Assessment (SPA) of the Ceplene (histamine dihydrochloride) Phase III protocol.

27 Jun 2011

Endo recalls two lots of Endocet Tablets

Endo Pharmaceuticals today issued a voluntary nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV.

27 Jun 2011

First Edition: June 27, 2011

Today's headlines include reports about the status of ongoing deficit negotiations and details about a "stealth" survey on access to doctors.

27 Jun 2011

FDA accepts for filing Columbia's PROCHIEVE progesterone gel NDA

Columbia Laboratories, Inc. and Watson Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application (NDA) for PROCHIEVE (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy.

27 Jun 2011

FDA issues Complete Response Letter for Pfizer's REMOXY NDA

DURECT Corporation today reported that Pfizer Inc. has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY, a controlled-release form of oxycodone designed to discourage common methods of tampering.

27 Jun 2011

FDA recommends conservative dosing guidelines for ESAs to treat anemia in patients with CKD

The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.

27 Jun 2011

Mortality, morbidity rates linked with AF remain 'unacceptably high' despite new treatments

Despite recent advances in the treatment of heart rhythm disturbances, mortality and morbidity rates associated with atrial fibrillation (AF) remain "unacceptably high", according to a new report.

27 Jun 2011

IFT honors Elsevier's Academic Press authors for research in food engineering

Elsevier's Academic Press congratulates its authors in the food sciences for their recent awards. The Institute of Food Technologists, which for 70 years has served as a leading advocate for food science and a catalyst for change around the world, has honored two Academic Press authors for their contributions.

27 Jun 2011

Policy leaders to identify targeted strategies for creating national breastfeeding agenda

One hundred invited health and policy leaders will meet again in Washington, D.C. on June 29-30 to identify targeted strategies for establishing a national breastfeeding agenda as part of our nation's Health Reform, building on the essential recommendations and positive outcomes of the Second Annual Summit held last June.

27 Jun 2011

New data from Zafgen's ZGN-433 Phase 1b study on obesity presented at ADA 2011

Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced new data from a Phase 1b study of ZGN-433, a selective methionine aminopeptidase 2 inhibitor (MetAP2), which showed a significant improvement in cardiovascular risk markers in severely obese subjects.

27 Jun 2011

Isotechnika's partner Lux to appeal EMA CHMP decision against Luveniq

Isotechnika Pharma Inc. today announced that its partner, Lux Biosciences, Inc. will appeal the European Medicines Agency's (EMA) decision not to approve Luveniq™ (voclosporin) as a treatment for noninfectious uveitis involving the intermediate or posterior segments of the eye.

24 Jun 2011

UNAIDS board approves accountability framework

UNAIDS' Programme Coordinating Board, the agency's governing body, this week unanimously endorsed the Unified Budget, Results and Accountability Framework 2012-2015, which "will ensure accountability in both programmatic results and in delivering value for money," according to a UNAIDS press release.

24 Jun 2011

Financial Times examines race for FAO Director-General

The Financial Times examines the race to lead the U.N. Food and Agriculture Organization (FAO), saying that "since the 2007-08 food crisis and the price shock of 2010-11, the formerly low-profile FAO has been catapulted to the centre of global policymaking," with six countries putting forth candidates for director-general.

24 Jun 2011

FDA approves Laureate's Electronic Submission Gateway application

Laureate Biopharmaceutical Services, Inc. announced today that the U.S. Food and Drug Administration ("FDA") approved its application for an Electronic Submissions Gateway (ESG) to the Agency.

24 Jun 2011

EMA CHMP recommends approval of linagliptin for type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today received a positive opinion from the European Medicines Agency's (EMA) medicinal committee recommending approval of linagliptin, 5 mg, film-coated tablets (to be marketed under the trade name Trajenta® in Europe) for the treatment of adults with type 2 diabetes.

24 Jun 2011

Woods Institute at Stanford University awards seven new Environmental Venture Project grants

The Woods Institute for the Environment at Stanford University has awarded seven new Environmental Venture Projects (EVP) grants for interdisciplinary research aimed at finding practical solutions promoting global sustainability.

24 Jun 2011

Scientific evidence is key driver for gaining reimbursement for MR-guided focused ultrasound

Medical researchers have a critical role to play in gaining optimal health insurance reimbursement for MR-guided focused ultrasound. As Susan Klees, Director of Patient Access for the Focused Ultrasound Surgery Foundation, reports, "Scientific evidence is the key driver for reimbursement, and it all begins with the way studies are designed. Today, research priorities must be grounded in sound science as well as the realities of the marketplace."

24 Jun 2011

Recommendations to curb high rates of obesity among young children

Limiting television and other media use, encouraging infants and young children in preschool and child care to spend more time in physically active play, and requiring child care providers to promote healthy sleeping practices are some of the actions needed to curb high rates of obesity among America's youngest children, says a new report from the Institute of Medicine.

24 Jun 2011

FDA approves second anti-HIV drug from Rutgers-Janssen collaboration

Two decades after Rutgers scientists began working with Paul Janssen, a legendary drug developer and founder of Johnson & Johnson subsidiary Janssen Pharmaceutica, to create new and potent drugs to fight AIDS, the FDA has approved the second anti-HIV drug that came from this collaboration.

24 Jun 2011