WASHINGTON, Oct. 16, 2015 /PRNewswire-USNewswire/ — U.S. News & World Report, publisher of Best Hospitals for more than 25 years, today announced the 2015-16 Most Connected Hospitals. Most Connected Hospitals examines the importance of information exchange in the healthcare industry as hospitals move from paper to electronic medical records to make patient care better and more efficient. read more
Heater-Cooler Devices: FDA Safety Communication Use of Devices Associated With Nontuberculous Mycobacteria Infections
ISSUE: Through analysis of adverse event reports, the medical literature, and information from national and international public health agencies, FDA is aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedures. NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems. read more
Valeant Pharmaceuticals International, Inc. Completes Acquisition Of Synergetics USA, Inc.
LAVAL, Quebec, Oct. 15, 2015 /PRNewswire/ — Valeant Pharmaceuticals International, Inc. (NYSE:VRX) (TSX:VRX) today announced that it has completed the previously announced acquisition of Synergetics USA, Inc. (“Synergetics”). Synergetics is a leading supplier of precision surgical devices. Synergetics’ primary focus is on the surgical disciplines of ophthalmology and neurosurgery.
Allergan Announces New Long-Term OnabotulinumtoxinA Treatment Study Results at the American Urogynecologic Society Meeting
DUBLIN, Oct. 15, 2015 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company today announced that results from an extension study of two phase 3 trials showed that long-term onabotulinumtoxinA treatment consistently decreased urinary incontinence in female patients with overactive bladder (OAB) symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication. Final results were presented in a podium session at the American Urogynecologic Society read more
Simplify™ Cervical Artificial Disc Receives Two-Level IDE Approval
SUNNYVALE, Calif., Oct. 15, 2015 /PRNewswire/ — Simplify Medical, Inc. is pioneering disc arthroplasty with the non-metal, MRI compatible Simplify™ Disc, a cervical artificial disc. The Company announced today that it received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate its two-level clinical trial comparing Simplify Disc with anterior cervical discectomy and fusion (ACDF) as a control. This approval allows the expansion of Simplify Medical’s clinical operations. read more
AGREEMENT CONCERNING THE INTEGRATION OF THE GASTROINTESTINAL DISEASE BUSINESS OF EISAI CO., LTD. AND AJINOMOTO PHARMACEUTICALS CO., LTD. BY ABSORPTION-TYPE SPLIT
Eisai Co., Ltd. (Eisai) and Ajinomoto Co., Inc. (Ajinomoto Co.) announced that respective meetings of Eisai’s Executive Committee and Ajinomoto Co.’s Board of Directors today resolved to enter an integration agreement concerning the splitting off of a portion of Eisai’s gastrointestinal disease treatment business and its subsequent succession by Ajinomoto Co.’s wholly-owned subsidiary AJINOMOTO PHARMACEUTICALS CO., LTD. (AJINOMOTO PHARMACEUTICALS) via an absorption-type split, and on the same day, a corresponding integration agreement was signed between Eisai and Ajinomoto Co. read more
22nd Century Announces New Cannabis Research Collaboration with Anandia Laboratories
CLARENCE, N.Y.–(EON: Enhanced Online News)–22nd Century Group, Inc. (NYSE MKT: XXII), a leader in tobacco harm reduction, announced today an important new initiative in plant biotechnology: 22nd Century has entered into a new cannabis research collaboration with strategic partner Anandia Laboratories, Inc. (Anandia), based in Vancouver, Canada. As a part of this research collaboration, Anandia will develop and grow cannabis strains that express highly desirable characteristics and will lead to exciting commercialization opportunities. Dr. Paul Rushton, 22nd Century’s new Vice President of Plant Biotechnology, will have responsibility for this partnership with Anandia. read more
Pfizer Receives Complete Response Letter from FDA for Oral XELJANZ® (tofacitinib citrate) Supplemental New Drug Application for Moderate to Severe Chronic Plaque Psoriasis
Pfizer Inc. (NYSE: PFE) announced today it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of XELJANZ for the proposed indication read more