|FDA Advisory Panel's Recommendation on Investigational Medtronic Phased RF Ablation System; Biogen Raises Low End Of Prior FY 2011 Revenue|
|By Staff and Wire Reports|
|Friday, 28 October 2011 19:14|
Medtronic, Inc. (NYSE:MDT) announced the FDA Circulatory Systems Devices advisory panel voted against the Medtronic Phased RF Ablation System, the first atrial fibrillation ablation therapy under investigation for the treatment of persistent and long-standing persistent atrial fibrillation. While the panel unanimously agreed the technology is effective, the majority did not believe there is reasonable assurance of the safety of the Medtronic (MDT) Phased RF Ablation System, and that the clinical benefits of the technology do not outweigh the potential risks based on the TTOP-AF clinical trial data.
The committee recommendation, although not binding, will be considered by the FDA as it reviews the pre-market approval application for the Medtronic Phased RF Ablation System. Medtronic submitted a modular pre-market approval (PMA) application with the last submission completed in June 2011 based on data from its pivotal TTOP-AF (Tailored Treatment of Persistent Atrial Fibrillation) clinical trial, the first randomized study comparing ablation therapy to traditional medical management (antiarrhythmic drugs and direct current cardioversion) in patients with persistent or long-standing persistent atrial fibrillation.
While we are disappointed with todays outcome, Medtronic looks forward to continuing discussions with the FDA to determine the best path forward, said Reggie Groves, vice president and general manager of Medtronics AF Solutions business. We believe this technology would represent an important option for the persistent or long-standing persistent atrial fibrillation population, for whom treatment is limited.
Currently, the only FDA approved atrial fibrillation ablation medical devices are indicated for the treatment of paroxysmal atrial fibrillation, a type of disease in which irregular heartbeats in the upper chambers start and stop suddenly on their own, usually for minutes or days at a time. As the disease progresses into persistent (recurrent episodes that last more than 7 days) or long-standing persistent (continuous episodes that last more than one year) atrial fibrillation, it becomes more complex to treat. Persistent atrial fibrillation patients often have increased hospitalizations and healthcare costs, and the condition is more debilitating in terms of quality of life.
Biogen Idec Inc (NASDAQ:BIIB) announced for fiscal 2011, the revenue growth is expected to be in the mid-single digits versus fiscal 2010. GAAP diluted earnings per share (EPS) is expected to be above $4.91 and Non-GAAP diluted EPS is expected to be above $5.70.
The Company reported revenue of $4.7 billion in fiscal 2010. According to I/B/E/S Estimates, analysts are expecting the Company to report revenue of $4.957 billion and EPS of $5.88 for fiscal 2011.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has entered into a definitive Convertible Notes Purchase Agreement (Agreement) for the purchase of the aggregate principal value of approximately $2.3 million of Convertible Promissory Notes (Notes) for an aggregate purchase price of approximately $2.0 million.
Amarantus BioSciences, Inc. (OTCBB:AMBS), a biotechnology company developing MANF, a first-in-class disease–modifying therapeutic protein that mitigates an underlying cause of cell death known as apoptosis and is currently in development for the treatment of Parkinson’s disease, today announced that Mr. Gerald Commissiong has been appointed to President & Chief Executive Officer and will remain a member of the Board of Directors where he has served since 2008.
Bacterin International Holdings, Inc. (NYSE Amex: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, is sponsoring the 2012 Donate Life Rose Parade® Float entitled "...One More Day."
Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing and commercialization of innovative therapies, today announced its third quarter 2011 results.
China Biologic Products, Inc. (Nasdaq: CBPO), one of the leading plasma-based biopharmaceutical companies in the People's Republic of China, today announced that it has been selected as a nominee for the 7th Annual Scrip Awards in the category of "Best Company in an Emerging Market."
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in flexible catheter robotics and the developer of robotic technology for accurate 3D control of catheter movement, today announced that it will release its financial and operating results for the third quarter and nine months ended September 30, 2011 after market close on Wednesday, November 2, 2011.
MannKind Corporation (Nasdaq: MNKD) will release its 2011 third quarter financial results on Thursday, November 3, 2011 and its management will host a conference call to discuss the third quarter financial results and other Company developments at 5:00 PM (Eastern Time) on November 3, 2011.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2011.
Nutra Pharma Corporation (OTCBB: NPHC), a biotechnology company that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV/AIDS), Adrenomyeloneuropathy (AMN) and Pain, announced today that its Chief Executive Officer, Rik J. Deitsch, was interviewed by The Wall Street Reporter Senior Analyst Juan Costello.
Osiris Therapeutics, Inc. (NASDAQ: OSIR) today announced that it will report its financial results for the third quarter ended September 30, 2011, on Friday, November 4, 2011.
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces results for the three months to September 30, 2011.
Spherix Incorporated (NASDAQ: SPEX) – an innovator in biotechnology for therapy in diabetes, metabolic syndrome and atherosclerosis, and providers of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies – today announced the closing of previously announced agreements to sell $1.25 million of shares of its common stock together with warrants to purchase additional shares of its common stock in a private placement transaction.
XYTOS, Inc. (the "Company") (OTC: XYTS); In an effort to keep the shareholders informed XYTOS offers the following update: After months of Due Diligence on the company by the German Regulators, XYTOS was cleared to start trading in Germany on September 12, 2011.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company employing small molecule and synthetic biology approaches to cancer therapy, today announced the presentation of promising preclinical data with palifosfamide (Zymafos™ or ZIO-201) in a pediatric sarcoma model.