|FDA Has Granted Priority Review Status to Sucampo's Amitiza; Vertex's AL-2158 Development Discontinued on Lack of Efficacy|
|By Staff and Wire Reports|
|Tuesday, 25 September 2012 19:16|
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Takeda Pharmaceuticals U.S.A., Inc. (TPUSA) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of their supplemental new drug application (sNDA) filing.
The sNDA was filed in late July seeking approval for an additional indication for AMITIZA^® (lubiprostone) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX [FREE Stock Trend Analysis]) and its collaborator Alios BioPharma, Inc. today announced results from a viral kinetic study of the adenosine nucleotide analogue pro-drug ALS-2158 for the treatment of hepatitis C.Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and its collaborator Alios BioPharma, Inc. announced results from a viral kinetic study of the adenosine nucleotide analogue pro-drug ALS-2158 for the treatment of hepatitis C. Data showed that seven days of dosing with up to 900 mg of ALS-2158 was well-tolerated in people with genotype 1 chronic hepatitis C, but that there was insufficient antiviral activity to warrant proceeding with further clinical development.
The companies also announced new data from an additional cohort of an ongoing viral kinetic study of the uridine nucleotide analogue pro-drug ALS-2200 in combination with ribavirin. There was a median 4.18 log10 reduction from baseline in HCV RNA after seven days of dosing with a once-daily 200 mg dose of ALS-2200 in combination with ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment (n=8).
Amarantus BioSciences, Inc. (OTCBB: AMBS), a California-based biotechnology company developing new treatments and diagnostics for Parkinson's disease (PD) and Traumatic Brain Injury (TBI) centered around its patented therapeutic protein MANF, today announced that Co-Founders Dr. John and Gerald Commissiong were selected among BlackMoney.com's 13th annual "50 Most Important African-Americans in Technology" for 2012.
AtheroNova Inc. (OTCBB: AHRO) ("AtheroNova"), a biotech company focused on the research and development of compounds to regress atherosclerotic plaque and to safely improve lipid profiles in humans, today announced that Chairman and CEO, Thomas W. Gardner, will present a corporate overview at the 2012 Aegis Capital Healthcare Conference.
BioRestorative Therapies, Inc. (OTCQB: BRTX), a life sciences company focused on stem cell based cellular therapies for various personal medical applications, announced today that Wayne A. Marasco, M.D., Ph.D. has been appointed as Chairman of the Company's Scientific Advisory Board.
GenVec, Inc. (Nasdaq: GNVC) announced today that it is lowering its operating costs to conserve capital including eliminating 23 positions, or approximately 30% of its workforce.
Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced it will be hosting a meeting for analysts and investors on October 2, 2012 in New York.
InspireMD, Inc. (OTCBB: NSPR) (the "Company" or "InspireMD"), announced today that it filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed $40 million underwritten public offering of shares of its common stock, subject to market and other conditions. InspireMD also intends to grant to the underwriters a 30-day option to purchase up to an aggregate of 15 percent additional shares of common stock to cover over-allotments, if any.
InspireMD, Inc. (OTCBB: NSPR) (the "Company" or "InspireMD"), announced today that Ofir Paz, co-founder, board member and Chief Executive Officer of InspireMD since its founding in 2005, intends to step down as CEO as part of a planned transition to prepare the Company for formal commercialization of its proprietary MGuard™ Embolic Protection Stent (EPS) platform technology for patients with Acute Myocardial Infraction.
Neogen Corporation (Nasdaq: NEOG) announced today that its net income for the first quarter of FY 2013, which ended Aug. 31, increased 11.8% from the prior year to $6,714,000, or $0.28 per share.
PAREXEL International Corporation (NASDAQ: PRXL) will release financial results for the First Quarter of Fiscal Year 2013 on Tuesday, October 30, 2012 after the close of the stock market.
Senomyx, Inc. (NASDAQ: SNMX), a company using proprietary taste science technologies to discover and develop novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that Kent Snyder, the Company's Chief Executive Officer, and Tony Rogers, Senior Vice President & Chief Financial Officer, will present an overview of the Company's technology and programs on Wednesday, October 3 at 12:05 p.m. Eastern Time (9:05 a.m. Pacific Time) during the Telsey Advisory Group (TAG) 3rd Annual Fall Consumer Conference.
Star Nutrition, Inc. (PINKSHEETS: STAU), a California-based diversified health and wellness industry firm, has announced the addition of Peak Performance Products, Inc. as its newest Canadian distributor.
TelVue® Corporation (OTCQB: TEVE), the innovation leader in Television and Internet Broadcasting for communities, cable operators, and media companies has appointed Emmett Hume as its Chief Financial Officer.
At a ceremony officiated by University of North Texas (UNT) Provost Warren Burggren, Waters Corporation (NYSE: WAT) welcomed UNT's Metabolomics and Metabolic Signaling Pathway Research Laboratory into the Waters Centers of Innovation Program.