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Allergan receives FDA approval for Botox to treat specific form of urinary incontinence

The U.S. Food and Drug Administration today approved Botox injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.

25 Aug 2011

USPTO issues Notice of Allowance for Cortex AMPAKINE molecules to treat respiratory depression

Cortex Pharmaceuticals, Inc. announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent that protects the use of AMPAKINE molecules for the treatment or prevention of respiratory depression.

25 Aug 2011

FDA approves Allergan's BOTOX to treat specific form of urinary incontinence

Allergan, Inc. today announced the United States Food and Drug Administration (FDA) has approved BOTOX for injection for the treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to or are intolerant of an anticholinergic medication.

25 Aug 2011

Psoriasis drug and heart attack risk association unclear: Study

According to American researchers, although a review of published studies reveals that a new and highly effective class of psoriasis drugs does not appear to raise the risk of heart problems, the studies may not have been big enough to detect rare cases.

24 Aug 2011

KFDA approves IND for DP-b99 Phase III MACSI stroke study in Korea

D-Pharm Ltd., announced today that the Korean Food & Drug Administration (KFDA) approved the Investigational New Drug application for the Phase III MACSI study of DP-b99 in Korea. The IND has been submitted by D-Pharm's co-development partner in South Korea, Yungjin Pharmaceutical Company Ltd..

24 Aug 2011

United Therapeutics completes treprostinil diethanolamine Phase 3 trial in PAH

United Therapeutics Corporation announced today the completion of its FREEDOM-C(2) Phase 3 trial of treprostinil diethanolamine, an investigational sustained release oral formulation of treprostinil, a stable synthetic form of prostacyclin, in patients with pulmonary arterial hypertension.

24 Aug 2011

Health Canada accepts Sunovion Pharmaceuticals Canada's lurasidone NDS for review

Sunovion Pharmaceuticals Canada Inc., formerly Sepracor Pharmaceuticals, Inc., today announced that the New Drug Submission (NDS) for Lurasidone HCl, for the treatment of adult patients with schizophrenia has been accepted for review by Health Canada. The NDS was submitted to Health Canada in June 2011 and will receive a standard review.

24 Aug 2011

Trophos awarded US patent covering use of novel cardioprotective compound

Trophos SA a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, announced today that the United States Patent and Trademark Office (USPTO) has granted a patent for the use of their novel mitochondrial pore modulator, TRO40303, for cytoprotection. The patent provides coverage for the use of Trophos’ TRO40303 to reduce the cardiac reperfusion injury that contributes significantly to the morbidity and mortality seen after a heart attack (myocardial infarction - MI).

23 Aug 2011

Helsinn begins enrollment in anamorelin Phase III trial for NSCLC-associated anorexia/cachexia

Helsinn, a Swiss-based pharmaceutical company, announced today that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company's pivotal Phase III clinical program of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer.

23 Aug 2011

itm FlowMedical initiates Rhenium-PTA therapy clinical trial in PAOD

itm FlowMedical GmbH announced the start of OPEN-188 clinical trial. It will compare itm Rhenium-PTA, a therapy for the prevention of restenosis in peripheral vessels, to a regular PTA, the standard therapy for the treatment of PAOD.

23 Aug 2011

Combination of exercise and metformin less effective for people with diabetes

It's common enough for researchers to look at the impacts of prescribed drugs on the body. And if you're a diabetes researcher who believes that exercise has great benefits for those with type 2 diabetes, you're hoping your research will show that. But when Normand Boul- looked at the dual impacts of exercise and metformin - two of the most commonly-prescribed modalities for glucose control - on that very outcome, the hoped-for double whammy wasn't the result.

20 Aug 2011

Amgen to present data from several Prolia studies at ASBMR 2011 meeting

Amgen today announced that it will present data from several Prolia (denosumab) studies, including eight year efficacy and safety data from a Phase 2 extension study in women with postmenopausal osteoporosis with low bone mineral density (BMD), at the 2011 American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego, Calif. from Sept. 16-20, 2011.

19 Aug 2011

FDA grants Fast Track designation for DARA's KRN5500 neuropathic pain relief drug

DARA BioSciences, Inc. announced today that its investigational drug KRN5500 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer.

19 Aug 2011

NPS submits NDA CMC section to FDA for GATTEX

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has submitted the chemistry, manufacturing and controls (CMC) section of its new drug application (NDA) for GATTEX® (teduglutide) to the U.S. Food and Drug Administration (FDA).

18 Aug 2011

Endo terminates collaboration and axomadol development program with Grunenthal

Endo Pharmaceuticals announced today that it is terminating its research program and collaboration related to the development of axomadol.

18 Aug 2011

Syndax receives European patent allowance for entinostat to treat metastatic breast cancer

Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, today announced allowance by the European Patent Office for the patent application titled "N-(2-AMINOPHENYL)-4[N-(PYRIDINE-3-YL) - METHOXYCARBONYL - AMINOMETHYL]-BENZAMINE (MS-275) POLYMORPH B."

18 Aug 2011

New gout drug may help severely affected: Study

A new drug for gout could help very sick gout patients who don't get better with usual treatment, according to a new study. The research was designed and funded by the pharmaceutical company Savient, which markets the drug, called Krystexxa (pegloticase).

17 Aug 2011

Pegloticase can improve clinical outcomes of patients with chronic gout

Injections of pegloticase, a modified porcine enzyme, can produce significant and sustained clinical improvements in 2 out of 5 patients with chronic gout that is resistant to conventional therapies, researchers report in the August 17, 2011, issue of JAMA.

17 Aug 2011

Zinc lozenges might reduce duration of common cold episodes by 40%

Depending on the total dosage of zinc and the composition of lozenges, zinc lozenges may shorten the duration of common cold episodes by up to 40%, says Dr. Harri Hemila from the University of Helsinki.

16 Aug 2011

AVI BioPharma, MDA to initiate exon-51 Phase 2 trial in Duchenne muscular dystrophy

More than a decade of targeted Muscular Dystrophy Association-funded research, made possible as a result of generous public support of the MDA Labor Day Telethon and thousands of grass-roots special events, has today culminated in MDA providing financial assistance for the start of the first Phase 2 placebo-controlled, multiple dose efficacy, safety, tolerability and pharmacokinetics clinical trial of an exon-51 skipping drug, eteplirsen, as a potential therapy for Duchenne muscular dystrophy.

16 Aug 2011