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Strativa receives FDA approval for Zuplenz oral soluble film

Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz® (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.

3 Jul 2010

Watson acquires U.S. rights to CRINONE, PROCHIEVE product line from Columbia Laboratories

Watson Pharmaceuticals, Inc. today completed the acquisition of the U.S. rights to Columbia Laboratories' CRINONE® and PROCHIEVE® progesterone gel product line and 11,200,000 shares of Columbia common stock.

3 Jul 2010

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Shire plc, the global specialty biopharmaceutical company, today announced positive data from its long-term extension to its open label Phase I/II study (TKT-025 EXT) for VPRIV® (velaglucerase alfa), the company's enzyme replacement therapy for patients with type 1 Gaucher disease. The data were presented at the 9th Annual European Working Group on Gaucher Disease (EWGGD) in Cologne, Germany, and add to the growing body of clinical evidence which supports the safety and sustained efficacy of VPRIV.

2 Jul 2010

Columbia Laboratories shareholders approve Watson's aquisition terms

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that shareholders of Columbia Laboratories, Inc. (Nasdaq: CBRX) have approved the terms and conditions of the previously announced acquisition by Watson of the U.S. rights to Columbia's CRINONE® and PROCHIEVE® progesterone gel product line and 11,200,000 shares of Columbia common stock.

2 Jul 2010

Clemizole can yield high-level synergy with protease inhibitor class: Research

Eiger BioPharmaceuticals, Inc., a biotechnology company developing antiviral therapies, announced today the publication of research from the lab of Stanford scientist and Eiger Founder, Dr. Jeffrey Glenn, M.D., Ph.D. and colleagues entitled, "The Hepatitis C Virus (HCV) NS4B RNA Binding Inhibitor Clemizole is Highly Synergistic with HCV Protease Inhibitors".

2 Jul 2010

Chelsea reports positive outcome from DMC review of droxidopa Phase II trial in fibromyalgia

Chelsea Therapeutics International, Ltd. announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.

2 Jul 2010

USPTO awards Furiex method patent for dapoxetine in treatment of premature ejaculation

Furiex Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office issued a patent on May 18, 2010, for the method for treatment of premature ejaculation using dapoxetine. Furiex developed dapoxetine in collaboration with Alza Corporation and its affiliates. U.S. Patent No. 7,718,705 includes claims directed to dosing dapoxetine on an as-needed basis, capturing the advantage dapoxetine has over other compounds in the same class, which require a pre-loading period for efficacy.

2 Jul 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Studies of a more-rapid-acting injectable human insulin formulation (VIAject®) in the treatment of type 1 and type 2 diabetes and of a novel insulin analog formulation (Vialog™) in an animal model of diabetes were reported this week in three poster presentations at the 70th Scientific Sessions of the American Diabetes Association in Orlando, Florida. The findings are based upon results from recent clinical and preclinical studies sponsored by Biodel Inc..

1 Jul 2010

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Preliminary results of a pre-specified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a statistically significant greater Least Squares mean reduction in blood pressure from baseline at week 12 (37.9/22.0 mm Hg versus 26.4-28.0/14.7-17.6 mm Hg, P less than or equal to 0.0013) as compared to corresponding dual combination therapy [olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg)].

1 Jul 2010

USPTO grants Semafore method patent for PI3K inhibitors

Semafore Pharmaceuticals today announced the United States Patent and Trademark Office (PTO) has issued United States Patent Number 7,745,485 entitled "Compositions and methods for identifying agents which modulate PTEN function and PI-3 kinase pathways." This patent covers methods of inhibiting the spread of cancer in patients using phosphoinositide-3-kinase (PI3K) inhibitors alone or in combination with chemotherapeutic agents.

1 Jul 2010

Researchers to study interventional endovascular therapy on symptoms and progression of MS

Buffalo medical researchers led by a team from the University at Buffalo Department of Neurosurgery, will embark on a landmark prospective randomized double-blinded study to test the safety and efficacy of interventional endovascular therapy -- dubbed "liberation treatment" -- on the symptoms and progression of Multiple Sclerosis.

1 Jul 2010

Celsis IVT files patent infringement lawsuit against Invitrogen, CellzDirect

Celsis In Vitro, Inc. announced today that it has filed a patent infringement lawsuit against Invitrogen Corporation and CellzDirect, Inc. in the United States District Court for the Northern District of Illinois in Chicago and has moved for a preliminary injunction. Invitrogen, the parent of CellzDirect, is itself a wholly-owned subsidiary of Life Technologies of Carlsbad, California.

1 Jul 2010

Sepracor announces preliminary results from OMNARIS HFA Phase III study for seasonal allergic rhinitis

Sepracor Inc. announced today the preliminary results of a large-scale, 671-patient Phase III study of OMNARIS® (ciclesonide) HFA, an aerosol nasal formulation of ciclesonide, for the treatment of seasonal allergic rhinitis (SAR) in adult and adolescent patients. In this study, OMNARIS HFA met its primary efficacy endpoint by demonstrating a statistically significant reduction versus placebo in the reflective total nasal symptom score averaged over a two-week treatment period.

1 Jul 2010

Evotec commences EVT 101 proof-of-concept Phase II study in treatment-resistant depression

Evotec AG today announced the start of the proof-of-concept Phase II study in treatment-resistant depression with its NR2B subtype selective NMDA receptor antagonist EVT 101. This clinical development is part of an alliance between Evotec and Roche.

1 Jul 2010

BIDMC physician-scientist receives Young Investigator Award to research on prostate cancer

Akash Patnaik, MD, PhD, a physician-scientist in the Hematology/Oncology Divison at Beth Israel Deaconess Medical Center and Instructor of Medicine at Harvard Medical School has received a Young Investigator Award from The Prostate Cancer Foundation. The three-year $225,000 award, one of 21 made to young scientists from across the U.S. and Canada, is designed to encourage the most innovative minds in cancer research to focus their careers on prostate cancer.

1 Jul 2010

Threshold Pharmaceuticals initiates Phase 2 clinical trial of TH-302 in patients with first line pancreatic cancer

Threshold Pharmaceuticals, Inc. today announced that it has initiated a multi-center, randomized, controlled, crossover Phase 2 clinical trial of TH-302 in combination with gemcitabine in patients with first line pancreatic cancer. TH-302 is a proprietary tumor selective Hypoxia-Activated Prodrug that specifically targets tumor hypoxia.

1 Jul 2010

ResponseDX: Lung genetic test panel launched to detect EML4-ALK gene variants in lung cancer patients

Response Genetics Inc., a company focused on the development and sale of molecular diagnostic tests for cancer, today announced that it has expanded its ResponseDX: Lung genetic test panel to detect the presence of EML4-ALK gene variants in lung cancer patients. EML4-ALK fusion genes are present in about four percent of tumors from patients with non-small cell lung cancer.

1 Jul 2010

pSivida's licensee submits NDA to FDA for Iluvien

pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has submitted a New Drug Application to the U.S. Food and Drug Administration for Iluvien for Diabetic Macular Edema.

1 Jul 2010

Cubist commences enrollment in Phase 2 study of CXA-201 for complicated intra-abdominal infections

Cubist Pharmaceuticals, Inc., a leading acute care therapeutics company, today announced the enrollment of the first patient in a Phase 2 study with CXA-201. This multicenter, double-blind, randomized, study will compare the safety and efficacy of intravenous CXA-201 with an active comparator in patients with complicated intra-abdominal Infections (cIAI). This international study is expected to enroll 120 patients.

1 Jul 2010

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

Transition Therapeutics Inc. announced today that the first patient has been dosed with drug candidate TT-301 in a Phase 1 clinical study. TT-301 is a small molecule compound that has demonstrated efficacy in preclinical models of rheumatoid arthritis, intracerebral haemorrhage and traumatic brain injury.

30 Jun 2010

Efficacy News and Research

Strativa receives FDA approval for Zuplenz oral soluble film

Watson acquires U.S. rights to CRINONE, PROCHIEVE product line from Columbia Laboratories

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Columbia Laboratories shareholders approve Watson's aquisition terms

Clemizole can yield high-level synergy with protease inhibitor class: Research

Chelsea reports positive outcome from DMC review of droxidopa Phase II trial in fibromyalgia

USPTO awards Furiex method patent for dapoxetine in treatment of premature ejaculation

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

USPTO grants Semafore method patent for PI3K inhibitors

Researchers to study interventional endovascular therapy on symptoms and progression of MS

Celsis IVT files patent infringement lawsuit against Invitrogen, CellzDirect

Sepracor announces preliminary results from OMNARIS HFA Phase III study for seasonal allergic rhinitis

Evotec commences EVT 101 proof-of-concept Phase II study in treatment-resistant depression

BIDMC physician-scientist receives Young Investigator Award to research on prostate cancer

Threshold Pharmaceuticals initiates Phase 2 clinical trial of TH-302 in patients with first line pancreatic cancer

ResponseDX: Lung genetic test panel launched to detect EML4-ALK gene variants in lung cancer patients

pSivida's licensee submits NDA to FDA for Iluvien

Cubist commences enrollment in Phase 2 study of CXA-201 for complicated intra-abdominal infections

Transition commences dosing in TT-301 Phase 1 clinical study for rheumatoid arthritis, ICH, TBI

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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