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Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Astellas Pharma Inc. today announced the submission of a New Drug Application and Market Authorisation Application for mirabegron to the U.S. Food and Drug Administration and the European Medicines Agency.

29 Aug 2011

Azithromycin can help reduce wheezing, other acute symptoms of COPD

A common antibiotic can help reduce the severe wheezing and other acute symptoms of chronic obstructive pulmonary disease, according to a large, multicenter clinical trial sponsored by the National Institutes of Health and conducted at the University of California, San Francisco (UCSF).

29 Aug 2011

Nasal spray with hot chili pepper ingredient may help people clear up sinus inflammation

Hot chili peppers are known to make people "tear up," but a new study led by University of Cincinnati allergy researcher Jonathan Bernstein, MD, found that a nasal spray containing an ingredient derived from hot chili peppers (Capsicum annum) may help people "clear up" certain types of sinus inflammation.

26 Aug 2011

Firazyr receives FDA approval for treatment of HAE acute attacks

The U.S. Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of a rare condition called hereditary angioedema (HAE) in people ages 18 years and older.

26 Aug 2011

Boehringer Ingelheim, Lilly receive EU approval for linagliptin to treat type 2 diabetes

Boehringer Ingelheim and Eli Lilly and Company today received Marketing Authorization from the European Commission for linagliptin 5 mg film-coated tablets for the treatment of adults with type 2 diabetes.

26 Aug 2011

Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

Shire plc, the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for FIRAZYR for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

26 Aug 2011

Allergan gets FDA nod for use of Botox in urinary incontinence

Allergan Inc. has received United States Food and Drug Administration (FDA) approval to market the wrinkle smoother Botox as a treatment for urinary incontinence. The FDA approved the drug for people with overactive bladders who have neurologic conditions such as multiple sclerosis and spinal cord injuries, the agency said today in a statement. The medicine is injected into the bladder to increase its capacity by relaxing muscles.

25 Aug 2011

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

Placebo News and Research

Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Azithromycin can help reduce wheezing, other acute symptoms of COPD

Nasal spray with hot chili pepper ingredient may help people clear up sinus inflammation

Firazyr receives FDA approval for treatment of HAE acute attacks

Boehringer Ingelheim, Lilly receive EU approval for linagliptin to treat type 2 diabetes

Shire receives FDA marketing approval for FIRAZYR to treat acute attacks of HAE

Allergan gets FDA nod for use of Botox in urinary incontinence

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

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

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

Psoriasis drug and heart attack risk association unclear: Study

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

United Therapeutics completes treprostinil diethanolamine Phase 3 trial in PAH

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

Trophos awarded US patent covering use of novel cardioprotective compound

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

itm FlowMedical initiates Rhenium-PTA therapy clinical trial in PAOD

Combination of exercise and metformin less effective for people with diabetes

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

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

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