|CHMP Recommends Against Marketing Vivus' Qsiva; Biogen IDEC Says FDA Extends its Drug Review Date by 3 Months|
|By Staff and Wire Reports|
|Thursday, 18 October 2012 18:13|
VIVUS (NASDAQ: VVUS) announced it is has received the formal opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following their October 15-18 meeting. As expected, the CHMP recommended against approval of the Marketing Authorization Application (MAA) for Qsiva™ (phentermine/topiramate ER) for the treatment of obesity in the European Union. The reasons for their decision were due to concerns over the potential cardiovascular and central nervous system effects associated with long-term use, teratogenic potential and use by patients for whom Qsiva is not indicated. The company currently intends to appeal this opinion and request a re-examination of the decision by the CHMP.
"The lack of effective pharmacologic treatments for obesity remains a high medical need for many patients in Europe," stated Peter Tam, VIVUS' president. "We are committed to getting Qsiva approved in Europe and will work closely with the new rapporteur and co-rapporteur to make this happen."
Biogen Idec (NASDAQ: BIIB) announced the U.S. FDA has extended the initial PDUFA date for its review of the New Drug Application (NDA) for the marketing approval of BG-12 (dimethyl fumarate), the company's oral therapeutic candidate for the treatment of multiple sclerosis (MS). The 3 month extension is a standard extension period.
The FDA has indicated that the extension of the PDUFA date is needed to allow additional time for review of the application. The agency has not asked for additional studies.
AMRI (NASDAQ: AMRI) announced today that it has entered into a multi-year supply agreement for an undisclosed product with Shire US Manufacturing Inc., whose parent company, Shire plc (LSE: SHP, NASDAQ: SHPGY), is a global company that focuses its business on behavioral health, gastro intestinal diseases, rare diseases and regenerative medicine.
BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today reaffirmed its continued strong position and ongoing progress made in its defense of a process patent infringement lawsuit previously served against BDSI and its partners for ONSOLIS, by MonoSolRx, LLC (MonoSol).
Masimo (NASDAQ: MASI) announced today that eight significant new clinical studies evaluating Masimo noninvasive patient monitoring technologies were presented at the largest gathering of anesthesiologists in the world, the American Society of Anesthesiologists (ASA) Annual Meeting in Washington, D.C.
MediSwipe Inc. (OTCQB: MWIP), a merchant payment solutions and financial products company for the medical health care industry, today announced that 800 commerce (www.800commerce.com) has successfully filed its S-1 registration statement.
MYOS Corporation (OTCBB: MYOS), a company focused on the discovery, development and commercialization of therapeutic products that improve muscle health and performance, announced today the appointment of Andrew J. Einhorn as its Chief Financial Officer.
Omeros Corporation (NASDAQ: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system, today announced the appointments of two new vice presidents.
Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company") today announced that two research groups have reported on the ability of the Company's Pressure Cycling Technology ("PCT") Platform to improve the detection of DNA in challenging forensic samples.
PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that researchers will present data from the company's Phase II trial of its long-acting human growth hormone, hGH-CTP, in growth hormone deficient adults at the 6th International Congress of the Growth Hormone Research Society (GRS) and IGF Society.
Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced that the California Technology Assessment Forum completed an independent evaluation of the cell-free fetal DNA technology used in the Sequenom Center for Molecular Medicine's (Sequenom CMM) MaterniT21 PLUS™ laboratory-developed test (LDT).
TNI BioTech, Inc. (PINKSHEETS: TNIB) and Hubei Qianjiang Pharmaceutical Co., Ltd., a leading Chinese pharmaceutical company, today announced an agreement to co-develop new cancer drugs based on TNI BioTech's patents involving Methionine Enkephalin which when approved will be marketed in China under the brand name IRT-101 and IRT-102.
Trans-Lux Corporation (PINKSHEETS: TNLX), a world leader in Digital Displays and LED Lighting Technologies, is supporting its continued growth with the appointment of three key management executives. Joining the company are Craig Katt as Senior Vice President of Display Technologies for the TL Vision line of LED and flat panel displays; Brian Laroche as President of TL Energy responsible for LED lighting solutions; and Sami Sassoun as Chief Financial Officer.
ViroPharma Incorporated's (Nasdaq: VPHM) third quarter financial results for 2012 are expected to be released on Thursday, October 25, 2012 before the open of the U.S. financial markets.