FDA APPROVES THE RESHAPE™ INTEGRATED DUAL BALLOON SYSTEM, A FIRST-OF-ITS-KIND NON-SURGICAL WEIGHT LOSS PROCEDURE FOR PEOPLE WITH MILD TO MODERATE OBESITY

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/ PR Newswire / — ReShape Medical® today announced that the U.S. Food and Drug Administration (FDA) has approved the ReShape Integrated Dual Balloon System, a first-of-its-kind non-surgical weight loss procedure for people with mild to moderate obesity. The ReShape Procedure provides a new option for adults with a BMI of 30-40 and a related health condition who haven’t succeeded at diet and exercise alone, and do not want or do not qualify for bariatric surgery. read more

Novartis partners with Phase 4 Partners and institutional investors to help create Mereo BioPharma Group Ltd

Basel, July 29, 2015Novartis announced today a swap of clinical assets for equity with Mereo BioPharma Group Ltd. The deal involves compounds in areas of unmet medical need including BPS-804, to improve bone density in brittle bone syndrome, an orphan disease; BCT-197 for acute exacerbations in COPD, and BGS-649 for obese men with hypogonadotrophic hypogonadism to normalize testosterone levels.Under the terms of the agreement, Novartis will have an equity stake in Mereo and will share in the success of the development of these compounds, including a share on milestones and royalties on future commercial sales.“We are pleased that through this deal with Mereo we have found a way to work together to bring these valued innovations to patients,” said David Epstein, Head of Novartis Pharmaceuticals.Mereo is a recently formed specialty biopharmaceutical company based in the UK who focuses on the acquisition and development of innovative medicines, particularly in rare and specialist disease areas, through the acquisition of validated, mid stage development programs.

Mereo BioPharma Announces Formal Launch of Company; Raises $119m (c.£76.5m) and Acquires Innovative Mid-Stage Clinical Product Portfolio From Leading Pharmaceutical Company  

Mereo BioPharma Group Ltd (“Mereo”), a recently-formed speciality biopharmaceutical company, announces that it has successfully raised $119m (c. £76.5m), gross, from blue chip institutional investors and simultaneously acquired a portfolio of three innovative clinical-stage development programmes from Novartis Pharmaceuticals. Novartis, through the shares issued in consideration for the acquisition of products, will also hold an equity stake in Mereo.  read more

CMC Biologics and River Vision Development Corporation Announce Manufacturing Agreement for RV001, a Monoclonal Antibody to Treat Grave’s Orbitopathy

SEATTLE, Wash., NEW YORK and COPENHAGEN, Denmark, July 29, 2015 /PRNewswire/ — CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, announced today that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is in development for treatment of Grave’s Orbitopathy and other indications.  read more

FDA Accepts for Review CSL Behring’s Biologics License Application for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A

KING OF PRUSSIA, Pa., July 28, 2015 /PRNewswire/ — CSL Behring announced today that the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A. In the pivotal clinical trial, rVIII-SingleChain met all primary endpoints. read more

inSleep® Health’s Cloud9® Anti-Snoring System Receives FDA Clearance

WESTON, Fla., July 28, 2015 /PRNewswire/ — inSleep® Health announced today that it has received 510(K) clearance for the company’s Cloud9® Anti-Snoring System.  The indication for use is to reduce or eliminate simple snoring in adults.  Cloud9 is a prescription device for home use. This is the first clinically proven device, using continuous low positive airway pressure, specifically labeled to treat simple snoring. read more

 

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