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Boston Scientific Corporation has received CE Mark approval for use of its PRECISION(TM) PLUS SPINAL CORD STIMULATOR (SCS) System in patients with the system and are in need for magnetic resonance imaging (MRI) head-only scans. The PRECISION PLUS SCS System is the world's first rechargeable SCS device. This approval provides physicians with an additional diagnostic option for patients with chronic intractable pain. 

ThromboGenics NV , a biopharmaceutical company focused on developing ophthalmic medicines, today announced 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 (VMA).

European Commission (EC) has issued Marketing Authorisation Approval for the use of Fycompa® (perampanel) as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in people with epilepsy aged 12 years and older.[1] With the EC's approval, the European Union is the first region in the world to approve Eisai's perampanel.

Almirall, S.A. (ALM.MC) and Forest Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Tudorza(TM) Pressair(TM) (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. 

COPD is a common, progressive, and debilitating lung disease characterized by persistent airflow limitation that makes it hard to breathe; it is currently the third leading cause of mortality in the US. Characteristic symptoms include breathlessness, excessive production of sputum, and a chronic cough.

Emotional Brain has announced that the United States Patent and Trademark Office (USPTO) has awarded a new patent (US Patent No. 8,227,453, issued today) for its combination of a PDE5-inhibitor and testosterone for the treatment of Female Sexual Dysfunction (FSD).  

There is no FDA-approved medicine available yet for this particular indication area, so American physicians annually prescribe off-label drugs for the treatment of FSD.  Dr Adriaan Tuiten, PhD, CEO of Emotional Brain, explains, 'It ensures protection of our medical applications and medical procedures aimed at the treatment of Female Sexual Dysfunction. The issuance of new patents in a country such as the United States is tremendously important and has a huge impact.' 

Janssen Biotech, Inc. and Janssen Biologics B.V. announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) requesting approval of SIMPONI® (golimumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy. Approximately 700,000 people in the United States[1] and 1.1 million people in the European Union (EU)[2] are affected by UC, a chronic inflammatory bowel disease marked by inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.