|Discovery Labs Reports FDA Approval of SURFAXIN's Specs; Santarus Announces Presentation of Phase III Data for Rifamycin SV MMX|
|By Staff and Wire Reports|
|Friday, 04 October 2013 18:46|
Discovery Laboratories, Inc. (NASDAQ: DSCO) announced the U.S. FDA has agreed to the Company's updated product specifications for SURFAXIN® (lucinactant) Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
The Company has initiated manufacturing of SURFAXIN for its planned commercial introduction in the fourth quarter of 2013. SURFAXIN is the first FDA-approved synthetic, peptide-containing surfactant available for the prevention of RDS in premature infants and the only approved alternative to animal-derived surfactants currently used today.
Santarus, Inc. (NASDAQ:SNTS) announced new data from its Phase III clinical study with the investigational drug rifamycin SV MMX® in patients with travelers’ diarrhea will be featured in a poster presentation at IDWeek™ in San Francisco at the Moscone Center (Poster Hall C) from 12:30 p.m. to 2:00 p.m. Pacific Time on Saturday, October 5, 2013.
The poster (#1306) is titled, Randomized, Double-Blind, Placebo-Controlled Study of Rifamycin SV MMX in the Treatment of Travelers’ Diarrhea. IDWeek is the combined annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS).
“The data from this clinical study indicate that rifamycin SV MMX significantly shortened the duration of travelers’ diarrhea and was well tolerated, with adverse events similar to that of placebo in the study. In addition, rifamycin SV MMX demonstrated broad activity, and of interest was the possible activity against invasive pathogens,” said Herbert L. DuPont, M.D., principal investigator and lead author of the poster. Dr. DuPont is Director of the Center for Infectious Diseases and Professor of Infectious Diseases at the University of Texas – Houston School of Public Health, Chief of Internal Medicine at St. Luke’s Hospital and Vice Chairman, Department of Medicine and Clinical Professor at the Baylor College of Medicine.
The company has previously announced that the Phase III study met the primary endpoint of reducing the time to last unformed stool (TLUS) in the intent-to-treat (ITT) population.
AbbVie (NYSE: ABBV) will announce its third-quarter 2013 financial results on Friday, Oct. 25, 2013, before the market opens.
Amgen (NASDAQ: AMGN) today announced that it will present data from several romosozumab and Prolia® (denosumab) studies at the American Society for Bone and Mineral Research (ASBMR) 2013 Annual Meeting in Baltimore from Oct. 4-7, 2013.
athenahealth, Inc.(Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management and care coordination, today announced that in light of the U.S. government shutdown, which has resulted in the furlough of almost 70 percent of the Centers for Disease Control and Prevention (CDC) workforce, it will monitor and share population health information from across its national health care 'big data' asset.
BioTime, Inc. (NYSE MKT: BTX), today announced that it has initiated the development of two new products based on its HyStem® hydrogel technology platform.
Cancer Genetics, Inc. (Nasdaq:CGIX), an emerging leader in DNA-based cancer diagnostics that personalizes the clinical management of difficult-to-diagnose cancers, today announced its president and CEO, Panna Sharma, will participate in a panel discussion at BioNJ's inaugural CEO Summit from 1:40 p.m. to 2:40 p.m. ET on October 4, 2013 in Bridgewater, New Jersey.
Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, today announced that Patrick J. McEnany, Chief Executive Officer, and Steven Miller, Ph.D., Chief Operating Officer and Chief Scientific Officer, will present at the 12th Annual BIO Investor Forum being held at The Palace Hotel in San Francisco, California, October 8-9.
CEL-SCI Corporation (NYSE MKT:CVM) announces that the NYSE MKT has granted the Company an extension until October 31, 2013 to regain compliance with the Exchange’s continued listing standards.
Cerner Corp. (Nasdaq:CERN) announced successful client deployments of CareAware Connect™, a new mobility and communications solution for clinicians at Fisher-Titus Medical Center in Norwalk, Ohio, and the NCH Healthcare System in Naples, Fla. CareAware Connect is a clinical mobility solution designed for a smart phone device, which brings together communications, alarm management and nursing workflow tools on a single device.
Cerner (Nasdaq:CERN) will host more than 10,000 people in Kansas City for the 28th annual Cerner Health Conference (CHC).
China Cord Blood Corporation (NYSE: CO), China's leading provider of cord blood collection, laboratory testing, hematopoietic stem cell processing, and stem cell storage services, today announced that the Company will hold its 2013 annual general meeting of shareholders at its Hong Kong office at 48/F, Bank of China Tower, 1 Garden Road, Central, Hong Kong, at 9:00 p.m. Hong Kong Time on December 16, 2013 (8:00 a.m. U.S. Eastern Time on December 16, 2013).
The Clorox Company (NYSE: CLX) launched its fiscal year 2013 integrated annual report, titled "Powerful. Purposeful. Proven." which, for the third year, combines its financial, environmental, social and governance performance.
Coastal.com (NASDAQ:COA) (TSX:COA), the leading online provider of eyewear, announced today its choice contestant for 'The Voice', the vocal competition series on NBC.
Curis, Inc. (Nasdaq:CRIS), an oncology-focused company developing novel drug candidates for the treatment of human cancers, today announced that Roche initiated a Phase 1b/2 study of Erivedge® (vismodegib) in patients with relapsed/ refractory acute myelogenous leukemia (AML) and relapsed/refractory high-risk myelodysplastic syndrome (MDS).
DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care pharmaceutical company dedicated to providing health care professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment, is sponsoring a breast cancer patient education segment on The Balancing Act® airing on Lifetime Television.
Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the U.S. Food and Drug Administration (FDA) has agreed to the Company's updated product specifications for SURFAXIN®(lucinactant) Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today announced the closing of its previously announced initial public offering of 7,666,667 shares of its common stock at a public offering price of $6.00 per share, including 1,000,000 shares of common stock issued upon the exercise in full by the underwriters of their option to purchase additional shares.
Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Mark W. Schwartz, Ph.D., Executive Vice President and Chief Operating Officer will present a corporate update at the 12th Annual BIO Investor Forum.
Humana Inc. (NYSE: HUM), one of the nation’s leading health and well-being companies, and CVS/pharmacy, America’s leading retail pharmacy, today announced a strategic retail partnership designed to educate individuals and their families about their health care coverage options under the Affordable Care Act (ACA).
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced the appointment of Daniel P. Regan to the Company's Board of Directors.
Lannett Company, Inc. (NYSE MKT: LCI) today announced the pricing of an underwritten public offering of 5,869,566 shares of the Company’s common stock at a price of $18.00 per share.
Masimo (NASDAQ: MASI) announced today that its EMMA™ Capnograph with waveform display earned a prestigious EMS World Top Innovation Award, another accolade for a powerful, portable device, that offers immediate waveform capnography, end-tidal carbon dioxide and respiration rate at your fingertips.
MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its results for the third quarter ended September 30, 2013, will be released before the opening of the market on Wednesday, October 30, 2013.
Palatin Technologies, Inc. (NYSE MKT: PTN) announced that it will be presenting at the 12th Annual BIO Investor Forum on Tuesday, October 8, 2013 at 3:30 p.m. Pacific Time.
Puma Biotechnology, Inc. (NYSE:PBYI), a development stage biopharmaceutical company, announced that it initiated a Phase II clinical trial of its lead drug candidate PB272 (neratinib) as a single agent in patients with solid tumors who have an activating HER2 mutation (basket trial).
Santarus, Inc. (NASDAQ:SNTS) today announced that new data from its Phase III clinical study with the investigational drug rifamycin SV MMX® in patients with travelers’ diarrhea will be featured in a poster presentation at IDWeek™ in San Francisco at the Moscone Center (Poster Hall C) from 12:30 p.m. to 2:00 p.m. Pacific Time on Saturday, October 5, 2013.
SpectraScience, Inc. (OTCQB:SCIE), a San Diego-based medical device company, today announced that its board of directors has appointed Lowell Giffhorn as the Company's new Chief Financial Officer.
Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced that it presented additional TKM-PLK1 data at the 6th Annual NET Conference hosted by the North American Neuroendocrine Tumor Society (NA-NETS) to be held in Charleston, South Carolina from October 4-5, 2013.
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active Biotech (NASDAQ OMX NORDIC:ACTI) announced today the presentation of additional analyses of the Phase III ALLEGRO and BRAVO studies supporting the hypothesis that once-daily, oral laquinimod may have an effect on both inflammation and the broader underlying mechanisms associated with disease progression in relapsing-remitting multiple sclerosis.
TherapeuticsMD, Inc. (NYSE MKT: TXMD) announced today that the Company will present at the 12th Annual BIO Investor Forum.