Efficacy News and Research

RSS

Cubist initiates CXA-201 Phase 3 trial in complicated urinary tract infections

Cubist Pharmaceuticals, Inc. today announced the initiation of a pivotal Phase 3 trial of CXA-201 in patients with complicated urinary tract infections.

1 Aug 2011

FDA should collect information needed to develop new framework for 510(k) clearance process

The U.S. Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new report from the Institute of Medicine.

30 Jul 2011

SACHDNC presents new recommendations for storing dried newborn blood specimens

The states should develop clear and open policies regarding retention and research uses of dried blood spot specimens left over from newborn screening, according to a new set of "recommendations for national guidance" published in Genetics in Medicine, the official peer-reviewed journal of The American College of Medical Genetics.

30 Jul 2011

ORENCIA SC formulation receives FDA approval for treatment of adults with RA

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved a subcutaneous formulation of ORENCIA (abatacept) for the treatment of adults with moderate to severe rheumatoid arthritis.

30 Jul 2011

Anthera reports increase in second quarter total operating expenses to $22.7 million

Anthera Pharmaceuticals, Inc., today announced financial results and business highlights for the quarter ended June 30, 2011.

29 Jul 2011

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

Efficacy News and Research

Cubist initiates CXA-201 Phase 3 trial in complicated urinary tract infections

FDA should collect information needed to develop new framework for 510(k) clearance process

SACHDNC presents new recommendations for storing dried newborn blood specimens

ORENCIA SC formulation receives FDA approval for treatment of adults with RA

Anthera reports increase in second quarter total operating expenses to $22.7 million

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

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Latest News