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Sunovion launches ZETONNA Nasal Aerosol for allergic rhinitis

Sunovion Pharmaceuticals Inc. today announced the nationwide availability of ZETONNA (ciclesonide) Nasal Aerosol, 74 mcg once-daily, for the treatment of allergic rhinitis (AR), also known as hay fever or nasal allergies. ZETONNA is a corticosteroid indicated for the treatment of symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age and older.

30 Jul 2012

Positive results from XIAFLEX phase IIIb multicord trial for Dupuytren's contracture

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. The Company enrolled 60 patients at eight sites throughout the U.S. and Australia.

30 Jul 2012

Watson seeks FDA approval to market Epiduo Gel for severe acne

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Epiduo (adapalene and benzoyl peroxide) Gel, 0.1% / 2.5%.

30 Jul 2012

Antioxidants and pancreatic cancer risk: an interview with Dr Andrew Hart

The antioxidants that we mainly looked at were selenium, vitamin C and vitamin E. They are chemicals which inactivate pro-oxidants or free radicals. Smoking and normal metabolism can lead to the production of free radicals.

30 Jul 2012

Positive results from Vermillion OVA500 multi-center study for ovarian cancer

Vermillion, Inc., a leading molecular diagnostics company, today announced positive results from a new prospective, multi-center clinical study of its ovarian cancer diagnostic OVA1.

30 Jul 2012

FDA clears Proteus ingestible sensor

Proteus Digital Health, Inc. announced today that the U.S. Food and Drug Administration has cleared its ingestible sensor for marketing as a medical device. The ingestible sensor (formally referred to as the Ingestion Event Marker or IEM) is part of the Proteus digital health feedback system, an integrated, end-to-end personal health management system that is designed to help improve patients' health habits and connections to caregivers.

30 Jul 2012

FDA accepts Exelixis’ cabozantinib NDA for filing

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).

30 Jul 2012

Genentech's BREVACTA study of ACTEMRA on rheumatoid arthritis meets primary endpoint

Genentech, a member of the Roche Group, today announced that the BREVACTA study of ACTEMRA (tocilizumab) given as a subcutaneous (SC) injection to patients with rheumatoid arthritis (RA) met its primary endpoint.

28 Jul 2012

Takeda resubmits alogliptin and fixed-dose combination therapy NDAs with FDA

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Pharmaceutical Company Limited announced that its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc. has resubmitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone for the treatment of type 2 diabetes in adults.

28 Jul 2012

U of U researchers to develop new prosthetic device for veterans with limb amputations

Thousands of veterans and warfighters returning to the U.S. suffer with limb amputations, and for many, standard prosthetics are not an option. Skin issues or short remaining-limb length can cause amputees to forgo the typical socket-type attachment systems.

28 Jul 2012

Mylan receives FDA approval for generic Sporanox ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Itraconazole Capsules, 100 mg.

27 Jul 2012

Coca-Cola sold in California now contains little of cancer-causing chemical 4-methylimidizole

Carcinogenicity and regulation of caramel colorings by Michael Jacobson, (Executive Director, Center for Science in the Public Interest, USA), an article due to be published in the International Journal of Occupational and Environmental Health, states that Coca-Cola sold in California now contains little of the cancer-causing chemical 4-methylimidizole (4-MI).

27 Jul 2012

FDA DODAC recommends approval of ThromboGenics’ ocriplasmin for VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion.

27 Jul 2012

FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Horizon Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

26 Jul 2012

Takeda, Sucampo file AMITIZA sNDA with FDA for treatment of opioid-induced constipation

Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals U.S.A. Inc. today announced the filing of a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for a new indication for AMITIZA (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.

26 Jul 2012

Gilead Sciences second quarter total revenues increase 13% to $2.41 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2012.

26 Jul 2012

Brown fat fuels fight against obesity

Experts may have found a new method for assessing adipose tissue function that could be used in the fight against obesity.

26 Jul 2012

Researchers develop piglet model to study infant brain development

Events that take place early in life almost certainly have consequences for later cognitive development. Establishing the connections is difficult, however, because human infants cannot be used as laboratory subjects. Rodney Johnson and his collaborators have developed an alternative model for studying infant brain development. "Assistant professor Ryan Dilger and I became interested in establishing the neonatal piglet as a model of human brain and cognitive development 3 or 4 years ago," he said.

26 Jul 2012

Myotonia less important to patients with myotonic dystrophy than other symptoms

Complex, multi-system diseases like myotonic dystrophy - the most common adult form of muscular dystrophy - require physicians and patients to identify which symptoms impact quality of life and, consequently, what treatments should take priority. However, a new study out this month in the journal Neurology reveals that there is often a disconnect between the two groups over which symptoms are more important, a phenomenon that not only impacts care but also the direction of research into new therapies.

26 Jul 2012

Insomnia: an interview with Dr Darryle Schoepp

Insomnia is a very common disorder. In medical terms it can affect a third of people. It affects elderly as well as non-elderly people, and is more common in women.

26 Jul 2012