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Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

Pfizer Inc. announced today top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), evaluating the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis.

23 Apr 2014

New study explores how fitness industry in many ways resembles that of fast food

Visit a typical gym and you will encounter a highly standardised notion of what the human body should look like and how much it should weigh. This strictly controlled body ideal is spread across the world by large actors in the fitness industry.

23 Apr 2014

FDA approves Cyramza to treat patients with advanced stomach cancer

Based on results of a clinical trial led by Dana-Farber Cancer Institute scientists, the U.S. Food and Drug Administration (FDA) approved a molecularly targeted drug as second-line treatment in advanced stomach cancer that has progressed after standard chemotherapy has failed.

22 Apr 2014

Cedars-Sinai researchers to receive $8M grant to fund Phase II clinical trial of experimental drug for stroke

Cedars-Sinai stroke intervention researchers have been informed that the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, will award an $8 million grant to fund a multicenter Phase II clinical trial of an experimental drug for stroke.

22 Apr 2014

FDA announces expanded approval of Arzerra in combination with chlorambucil for CLL treatment

The US Food and Drug Administration has announced the expanded approval of Arzerra (ofatumumab) in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukemia (CLL). Arzerra was previously approved by the FDA in October 2009 for the treatment of CLL resistant to other forms of chemotherapy. Diplomat has access to dispense Arzerra.

22 Apr 2014

First Edition: April 22, 2014

Today's early morning highlights from the major news organizations, including marketplace news about the Novartis purchase of GlaxoSmithKline's oncology unit for $14.5 billion.

22 Apr 2014

NBTY introduces Nature's Origin, a complete line of nutritional supplements

NBTY, Inc., a leading global manufacturer and distributor of high-quality vitamins and nutritional supplements, introduces Nature's Origin, its first complete line of vitamins, minerals and herbal supplements that are free from ingredients made with GMOs, preservatives, gluten and irradiation.

22 Apr 2014

MSU research pushes promising molecule toward clinical trials for treatment of neurological disorders

The most effective way to tackle debilitating diseases is to punch them at the start and keep them from growing.

22 Apr 2014

Manure from dairy cows contains newly identified antibiotic resistance genes

Manure from dairy cows, which is commonly used as a farm soil fertilizer, contains a surprising number of newly identified antibiotic resistance genes from the cows' gut bacteria. The findings, reported in mBio- the online open-access journal of the American Society for Microbiology, hints that cow manure is a potential source of new types of antibiotic resistance genes that transfer to bacteria in the soils where food is grown.

22 Apr 2014

FDA approves molecularly targeted drug as second-line treatment for advanced stomach cancer

Based on results of a clinical trial led by Dana-Farber Cancer Institute scientists, the U.S. Food and Drug Administration approved a molecularly targeted drug as second-line treatment in advanced stomach cancer that has progressed after standard chemotherapy has failed.

22 Apr 2014

Cubist submits ceftolozane/tazobactam NDA for treatment of cUTI and cIAI

Cubist Pharmaceuticals, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for approval of its investigational antibiotic ceftolozane/tazobactam for the treatment of Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI).

21 Apr 2014

FDA approves Cochlear's Aqua+ accessory for cochlear implant recipients

Cochlear Limited, the global leader in implantable hearing solutions, announced that the US Food and Drug Administration has approved the Aqua+ accessory, the only waterproof behind-the-ear solution for cochlear implant recipients on the market today.

21 Apr 2014

Synageva announces publication of LAL Deficiency review in Atherosclerosis

Synageva BioPharma Corp., a biopharmaceutical company developing therapeutic products for rare diseases, today announced the publication of an overview of lysosomal acid lipase deficiency (LAL Deficiency) in the online version and an upcoming print edition of Atherosclerosis, the official journal of the European Atherosclerosis Society.

21 Apr 2014

FDA grants Orphan Drug Designation to Emergent BioSolutions' BioThrax for PEP of anthrax disease

Emergent BioSolutions Inc. announced today that the U.S. Food and Drug Administration has granted Orphan Drug Designation to BioThrax (Anthrax Vaccine Adsorbed) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.

21 Apr 2014

Sarepta Therapeutics plans to submit eteplirsen NDA for treatment of Duchenne muscular dystrophy

Sarepta Therapeutics, Inc., a developer of innovative RNA-based therapeutics, today announced it plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration by the end of 2014 for the approval of eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

21 Apr 2014

FDA and EC grant Orphan Drug Designation to Boehringer’s volasertib for acute myeloid leukemia

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) and European Commission (EC) have granted Orphan Drug Designation to volasertib for acute myeloid leukemia (AML).

21 Apr 2014

Study: Maternal diet could have impact on food allergy in later life of children

About 20 million Europeans are subject to food allergies. Now scientists are looking at these allergies in new ways. It involves the food industry in its work and pays special attention to the link between early diets and allergy in later life. Clare Mills, professor of allergy in the university's Institute of Inflammation and Repair, at the University of Manchester, UK, is the coordinator of iFAAM.

21 Apr 2014

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

21 Apr 2014

Viewpoints: Obamacare still has more challenges; GOP needs to help make law work; census change is not Obama's decision

The first open enrollment period under the Affordable Care Act ended this week with roughly 7.5 million people obtaining policies through the new state insurance exchanges, including more than 1.3 million at Covered California.

18 Apr 2014

ARCA biopharma announces genetic screening of first patient in GENETIC-AF Phase 2B/3 clinical trial

ARCA biopharma, Inc., a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the first patient has been genetically screened in GENETIC-AF, its Phase 2B/3 adaptive design clinical trial.

From Medtronic 18 Apr 2014

Food News and Research

Pfizer reports positive results from two tofacitinib Phase 3 trials for moderate-to-severe plaque psoriasis

New study explores how fitness industry in many ways resembles that of fast food

FDA approves Cyramza to treat patients with advanced stomach cancer

Cedars-Sinai researchers to receive $8M grant to fund Phase II clinical trial of experimental drug for stroke

FDA announces expanded approval of Arzerra in combination with chlorambucil for CLL treatment

First Edition: April 22, 2014

NBTY introduces Nature's Origin, a complete line of nutritional supplements

MSU research pushes promising molecule toward clinical trials for treatment of neurological disorders

Manure from dairy cows contains newly identified antibiotic resistance genes

FDA approves molecularly targeted drug as second-line treatment for advanced stomach cancer

Cubist submits ceftolozane/tazobactam NDA for treatment of cUTI and cIAI

FDA approves Cochlear's Aqua+ accessory for cochlear implant recipients

Synageva announces publication of LAL Deficiency review in Atherosclerosis

FDA grants Orphan Drug Designation to Emergent BioSolutions' BioThrax for PEP of anthrax disease

Sarepta Therapeutics plans to submit eteplirsen NDA for treatment of Duchenne muscular dystrophy

FDA and EC grant Orphan Drug Designation to Boehringer’s volasertib for acute myeloid leukemia

Study: Maternal diet could have impact on food allergy in later life of children

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

Viewpoints: Obamacare still has more challenges; GOP needs to help make law work; census change is not Obama's decision

ARCA biopharma announces genetic screening of first patient in GENETIC-AF Phase 2B/3 clinical trial

Enhancing confidence in chemical ionization spectrometry data eBook

Managing vibration in IVF laboratories

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

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