Efficacy News and Research

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Antioxidants may help treat infertility problems in both women and men

A growing body of evidence suggests that antioxidants may have significant value in addressing infertility issues in both women and men, including erectile dysfunction, and researchers say that large, specific clinical studies are merited to determine how much they could help.

29 Jul 2011

NIH selects Viamet's novel antifungal compound for inclusion in the TRND program

Viamet Pharmaceuticals, Inc. announced today that one of its novel antifungal compounds has been selected for inclusion in the National Institutes of Health's (NIH) Therapeutics for Rare and Neglected Diseases (TRND) program.

29 Jul 2011

FDA issues Refusal to File letter for Eisai's perampanel NDA to treat partial-onset seizures

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File letter in response to the company's New Drug Application (NDA) for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy which was submitted in May 2011.

29 Jul 2011

Scientist discovers novel way to convert human skin cells into neurons

A scientist at the Gladstone Institutes has discovered a novel way to convert human skin cells into brain cells, advancing medicine and human health by offering new hope for regenerative medicine and personalized drug discovery and development.

29 Jul 2011

RegeneRx to initiate enrollment in RGN-259 Phase 2 trial for dry eye syndrome

RegeneRx Biopharmaceuticals, Inc. has announced that it is set to begin a Phase 2 clinical trial in 72 patients with dry eye syndrome.

29 Jul 2011

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

28 Jul 2011

All Canadian provinces except Quebec announce funding agreement for PNH drug, Soliris

L'Association Québécoise de l'HPN regrets that Quebec remains one of the only jurisdictions in the developed world to decline including the only effective life-saving treatment against an ultra-rare blood disease - paroxysmal nocturnal hemoglobinuria (PNH) - on its public drug insurance plan drugs list.

28 Jul 2011

Smokers are misinformed about safety and efficacy of nicotine replacement therapy

Nearly half of all smokers in the United States attempt to quit at least once per year, yet the majority of these efforts fail. One factor contributing to the low annual rate of successful cessation is that the majority of quit attempts are made without evidence-based treatment such as nicotine replacement therapy.

28 Jul 2011

Inspiration presents OBI-1 pivotal study data on hemophilia at 23rd ISTH congress

Ipsen today announced that its partner Inspiration Biopharmaceuticals, Inc. presented data from its clinical development program for OBI-1, an intravenous (IV) recombinant porcine factor VIII product (rpFVIII), intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia.

28 Jul 2011

FDA accepts peginesatide NDA for anemia associated with CKD

Affymax, Inc. and Takeda Global Research & Development Center, Inc., U.S., today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for peginesatide (formerly known as Hematide™) for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis.

27 Jul 2011

Recruitment complete in Aeterna Zentaris' perifosine Phase 3 trial for advanced colorectal cancer

Aeterna Zentaris Inc. today announced the completion of patient recruitment for the ongoing Phase 3 trial with perifosine in refractory advanced colorectal cancer.

27 Jul 2011

Amphetamines can control ADHD symptoms in adults

Giving amphetamines to adults with Attention Deficit Hyperactivity Disorder (ADHD) can help them control their symptoms, but the side effects mean that some people do not manage to take them for very long.

27 Jul 2011

Cipher net revenue decreases to $0.7 million for Q2 2011

Cipher Pharmaceuticals Inc. today announced its financial and operational results for the three and six months ended June 30, 2011.

26 Jul 2011

THERAPY trial to evaluate benefits of catheter-based intervention for acute ischemic stroke

During the opening session of the SNIS Annual Meeting, J Mocco, MD, MS, Assistant Professor of Neurosurgery at The University of Florida in Gainesville, FL, announced the IDE approval and initiation of THERAPY, an industry-sponsored randomized controlled trial designed to prove the clinical benefit of interventional treatment of acute ischemic stroke.

26 Jul 2011

Swedish Orphan Biovitrum, Biogen Idec announce data of rFVIIIFc Phase 1/2a trial for hemophilia A

Biogen Idec and Swedish Orphan Biovitrum today announced Phase 1/2a trial data showing that the companies' long-lasting fully-recombinant factor VIII Fc fusion protein (rFVIIIFc) was well tolerated and demonstrated an approximately 1.7-fold increase in half-life compared with Advate, a commercially-available factor VIII product, in 16 previously-treated patients with severe hemophilia A.

26 Jul 2011

Advaxis submits protocol revision for ADXS-HPV CIN Phase II study

Advaxis, Inc., a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has submitted a protocol revision that has passed FDA review for the enrollment of the next 40 subject "mid strength" dose cohort in the dose-ranging Phase II study of ADXS-HPV, an immunotherapy for Cervical Intraepithelial Neoplasia.

26 Jul 2011

Promising drug for Duchenne muscular dystrophy

Duchenne muscular dystrophy is a severely debilitating and lethal condition that affects 1 in 3,000. Females and males are affected, though females are rarely affected and are more often carriers. It is caused due to a defective gene that normally codes for the protein dystrophin, which helps provide a protective membrane around muscle fibers. Without this skin, muscle fibers become damaged and eventually die.

25 Jul 2011

Enrollment commences in Lutonix LEVANT 2 drug-coated balloon IDE trial for PAD

Lutonix today announced the first patient enrolled in the LEVANT 2 clinical trial, a global, multicenter, randomized trial evaluating the safety and efficacy of the Moxy™ Drug Coated Balloon compared to a standard angioplasty balloon for the treatment of peripheral arterial disease (PAD). The first case was performed at St. John's Hospital in Springfield, IL by Dr. Jeff Goldstein.

25 Jul 2011

Nanoviricides lead anti-HIV candidate as good as HAART cocktail therapy

NanoViricides, Inc. reports that its lead anti-HIV candidate achieved anti-HIV efficacy equivalent to a HAART triple drug cocktail in its recently completed animal study.

25 Jul 2011

Threshold reports initiation of TH-302 and bevacizumab clinical trial for astrocytoma

Threshold Pharmaceuticals, Inc., today announced that the University of Texas at San Antonio initiated a clinical trial of TH-302 in combination with bevacizumab in patients with recurrent high grade astrocytoma including glioblastoma.

25 Jul 2011

Efficacy News and Research

Antioxidants may help treat infertility problems in both women and men

NIH selects Viamet's novel antifungal compound for inclusion in the TRND program

FDA issues Refusal to File letter for Eisai's perampanel NDA to treat partial-onset seizures

Scientist discovers novel way to convert human skin cells into neurons

RegeneRx to initiate enrollment in RGN-259 Phase 2 trial for dry eye syndrome

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

All Canadian provinces except Quebec announce funding agreement for PNH drug, Soliris

Smokers are misinformed about safety and efficacy of nicotine replacement therapy

Inspiration presents OBI-1 pivotal study data on hemophilia at 23rd ISTH congress

FDA accepts peginesatide NDA for anemia associated with CKD

Recruitment complete in Aeterna Zentaris' perifosine Phase 3 trial for advanced colorectal cancer

Amphetamines can control ADHD symptoms in adults

Cipher net revenue decreases to $0.7 million for Q2 2011

THERAPY trial to evaluate benefits of catheter-based intervention for acute ischemic stroke

Swedish Orphan Biovitrum, Biogen Idec announce data of rFVIIIFc Phase 1/2a trial for hemophilia A

Advaxis submits protocol revision for ADXS-HPV CIN Phase II study

Promising drug for Duchenne muscular dystrophy

Enrollment commences in Lutonix LEVANT 2 drug-coated balloon IDE trial for PAD

Nanoviricides lead anti-HIV candidate as good as HAART cocktail therapy

Threshold reports initiation of TH-302 and bevacizumab clinical trial for astrocytoma

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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