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Captisol-enabled Melphalan meets primary end points in phase 2 pivotal trial

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, today announced that its pivotal trial of Captisol-enabled (propylene glycol-free) Melphalan met its primary end points.

23 Apr 2014

NovaBay introduces new eye care product to help patients with eyelids irritation

NovaBay Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today announced that it is introducing a new eye care product, i-Lid Cleanser.

23 Apr 2014

Nuvo Research collaborates with Ferndale to develop 2 topical dermatology products

Nuvo Research Inc., a specialty pharmaceutical company with a diverse portfolio of topical and immunology products, today announced a collaboration involving Ferndale Laboratories, Inc. and a leading Contract Research Organization with significant dermatology experience to develop two topical dermatology products based on Nuvo's patented Multiplexed Molecular Penetration Enhancer technology.

23 Apr 2014

Symposium focused on Surefire Medical's COSY clinical trial to be held at ECIO meeting

Surefire Medical, Inc. announced that a symposium focused on the Coiling vs. Surefire Infusion System in Y90 (COSY) clinical trial will be held during the European Conference on Interventional Oncology (ECIO) meeting taking place in Berlin, Germany April 23-26. T

23 Apr 2014

New FDA-approved device reduces seizures in patients with medication-resistant epilepsy

A recently FDA-approved device has been shown to reduce seizures in patients with medication-resistant epilepsy by as much as 50 percent. When coupled with an innovative electrode placement planning system developed by physicians at Rush, the device facilitated the complete elimination of seizures in nearly half of the implanted Rush patients enrolled in the decade-long clinical trials.

23 Apr 2014

Bayer's Ciprofloxacin DPI receives FDA orphan drug designation for NCFB treatment

Bayer HealthCare today announced that the U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation for its investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) for the treatment of non-cystic fibrosis bronchiectasis (NCFB).

23 Apr 2014

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

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

Aperion Biologics receives CE Mark approval for Z-Lig ACLR device

Aperion Biologics, Inc. was granted the CE Mark approval for its lead product, the Z-Lig ACLR device, to be used by surgeons in the European Union and other territories that accept the CE Mark.

22 Apr 2014

Vietnam's pharmaceutical market records growth rate of nearly 17% in 2013

Decision Resources Group finds that Vietnam is currently one of the fastest growing pharmaceutical markets in Southeast Asia, recording a growth rate of nearly 17 percent and exceeding $3 billion in size in 2013. Increasing affluence, a rapidly aging population and the steady extension of public health insurance are among factors that are driving demand for prescription medicines.

22 Apr 2014

CT angiography provides accurate assessment of arterial plaque in diabetic patients

Imaging of the coronary arteries with computed tomography (CT) angiography provides an accurate assessment of arterial plaque and could have a dramatic impact on the management of diabetic patients who face a high risk of heart attacks and other cardiovascular events, according to a new multicenter study published online in the journal Radiology.

22 Apr 2014

Shiseido Cell-Processing and Expansion Center to be opened in Kobe, Japan

Shiseido Co., Ltd. announces plans to open the Shiseido Cell-Processing and Expansion Center (SPEC) on May 1, 2014. The center, located in the in the Kobe Biomedical Innovation Cluster in Kobe, Japan, will centralize research and development on hair regenerative medicine with an aim toward commercialization.

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

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

Can-Fite BioPharma signs agreement with Smart Assays to develop A3AR predictive biomarker kit

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today it has signed an agreement with Smart Assays to develop a commercial biomarker blood test kit for the A3 adenosine receptor (A3AR).

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

Blog explains why NeutroPhase can play important role in treating 'flesh-eating' infections

NovaBay Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, today announced that WoundSource™ has highlighted NovaBay's NeutroPhase wound cleanser in a recent blog posting. The blog explains why NeutroPhase can play an important role in treating life-threatening necrotizing fasciitis, or 'flesh-eating' infections.

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

Clinical Trial News and Research

Captisol-enabled Melphalan meets primary end points in phase 2 pivotal trial

NovaBay introduces new eye care product to help patients with eyelids irritation

Nuvo Research collaborates with Ferndale to develop 2 topical dermatology products

Symposium focused on Surefire Medical's COSY clinical trial to be held at ECIO meeting

New FDA-approved device reduces seizures in patients with medication-resistant epilepsy

Bayer's Ciprofloxacin DPI receives FDA orphan drug designation for NCFB treatment

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

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

Aperion Biologics receives CE Mark approval for Z-Lig ACLR device

Vietnam's pharmaceutical market records growth rate of nearly 17% in 2013

CT angiography provides accurate assessment of arterial plaque in diabetic patients

Shiseido Cell-Processing and Expansion Center to be opened in Kobe, Japan

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

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

Synageva announces publication of LAL Deficiency review in Atherosclerosis

Can-Fite BioPharma signs agreement with Smart Assays to develop A3AR predictive biomarker kit

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

Blog explains why NeutroPhase can play important role in treating 'flesh-eating' infections

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

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