|Discovery Labs Announces FDA Approval of SURFAXIN®; ViroPharma and Halozyme Announce Positive Data of Subcutaneous Cinryze®|
|By Staff and Wire Reports|
|Tuesday, 06 March 2012 19:50|
Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, announced the FDA has approved SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine. Discovery Labs anticipates that SURFAXIN will be commercially available in the United States in late 2012.
"The approval of SURFAXIN is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS," said W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs. "This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care."
RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require animal-derived surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in the United States are treated annually with currently available animal-derived surfactants.
ViroPharma Incorporated (NASDAQ: VPHM) and Halozyme Therapeutics (Nasdaq: HALO) announced the presentation of positive data from ViroPharma's Phase 2 subcutaneous trial of Cinryze® (C1 esterase inhibitor [human]) in combination with Halozyme's Enhanze™ technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), in patients with hereditary angioedema (HAE), a rare, debilitating and potentially fatal genetic disease. The presentation occurred as part of the late-breaker session at the 2012 annual meeting of the American Academy of Allergy Asthma & Immunology (AAAAI), held March 2 to 6, 2012 in Orlando, Fla. According to the presenters, these data demonstrate that subcutaneous co-administration of Cinryze with rHuPH20 was easy to administer, well tolerated and resulted in sustained physiologically relevant C1 INH functional concentrations. The presenters concluded that this innovative combination administered subcutaneously as a single injection will be further evaluated for the prevention of HAE attacks.
Cinryze is approved in the United States as intravenous (IV) administration for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE, and in Europe for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks in adolescent and adult patients with HAE.
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced its financial results for the fourth quarter and year ended December 31, 2011.
Akorn, Inc. (NASDAQ: AKRX), a niche generic pharmaceutical company, today reported financial results for the fourth quarter and year ended December 31, 2011.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Vikas Sinha, Chief Financial Officer of Alexion Pharmaceuticals, will present at the Barclays Capital Global Healthcare Conference in Miami at 3:15 p.m. Eastern time on Tuesday, March 13, 2012.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced it will report preliminary results from the first of two phase III clinical trials of Feraheme for the treatment of iron deficiency anemia regardless of the underlying cause after the U.S. financial markets close on Thursday, March 7, 2012.
AmerisourceBergen Corporation (NYSE: ABC) today announced that it has signed a definitive agreement to purchase World Courier Group, Inc., a privately held leading global specialty transportation and logistics provider for the biopharmaceutical industry, for $520 million in cash.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will webcast its presentation at the Barclays Capital Global Healthcare Conference in Miami. Harvey J. Berger, M.D., chairman and chief executive officer, will provide an overview of the Company’s business on Tuesday, March 13, 2012 at 10:45 a.m. (ET).
Foundation Medicine, Inc., a molecular information company that brings comprehensive cancer genomic analysis to routine clinical care, today announced a collaboration with Array BioPharma (NASDAQ: ARRY).
Astro-Med, Inc. (NASDAQ: ALOT), a manufacturer of high tech specialty printers, test and measurement systems, and electronic medical instrumentation, will announce its financial results for the Fourth Quarter and the Fiscal Year ended January 31, 2012 on Tuesday, March 20, 2012 at 4:00 pm Eastern Daylight Savings Time.
Biogen Idec Inc. (NASDAQ: BIIB) announced today that its presentation at the Barclays 2012 Global Healthcare Conference will be webcast live on Tuesday, March 13, 2012 at 1:30 p.m. ET.
Bristol-Myers Squibb Company (NYSE: BMY) will present at the Barclays Capital 2012 Global Health Care Conference Tuesday, March 13, 2012, in Miami. Charles Bancroft, executive vice president and chief financial officer, will make a formal presentation about the company at 11:15 a.m. EST.
CEL-SCI Corporation (NYSE Amex: CVM) announced today that it has fully paid off its outstanding convertible debenture. The Company had been making monthly payments of approximately $1 million per month to repay a $9 million convertible debenture which CEL-SCI had issued in connection with the settlement of litigation.
Columbia Laboratories Inc. (Nasdaq: CBRX) received a notice on March 6, 2012, from the Nasdaq Stock Market indicating that it no longer meets the minimum bid price requirement for continued listing on the Nasdaq Global Market as set forth in Nasdaq Listing Rule 5450(a)(1) (the “Rule”).
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of the HALO60 Ablation Catheter, the latest addition to the HALO family of catheters for the endoscopic treatment of Barrett’s esophagus.
Dyax Corp. (NASDAQ: DYAX) today announced the presentation of data from KALBITOR® (ecallantide) clinical studies in hereditary angioedema (HAE) at the American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in Orlando, Florida.
Gilead Sciences, Inc. (Nasdaq:GILD) announced today that the Quad Study 102 results will be presented on a conference call on Wednesday, March 7, at 1:30 p.m. Pacific Time, 4:30 p.m. Eastern Time.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its corporate presentation will be webcast from the Barclays Capital 2012 Global Healthcare Conference in Miami.
Lannett Company, Inc. (NYSE AMEX: LCI) today announced that the company will present at the 24th Annual Roth OC Growth Stock Conference on Monday, March 12, 2012 at 3:30 p.m. PT (6:30 p.m. ET) at The Ritz-Carlton Hotel, Laguna Niguel, in Dana Point, California.
Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based antibody therapeutics, has entered into subscription agreements with various investors to raise approximately $9.3 million through the sale of 12,392,667 shares of Class A common stock.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG) (the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced financial results for the year ended December 31, 2011, and the filing with the U.S. Securities and Exchange Commission (“SEC”) of the Company’s Annual Report on Form 10-K.
Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS clinical technology solutions that enhance the efficiency of clinical development, today announced its financial results for the fourth quarter and full year 2011, and provided detailed financial guidance for the first quarter and full year 2012.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today re-confirmed its expectations for full-year 2012 non-GAAP EPS to be between $3.75 and $3.85, and the 2012 GAAP EPS range to be $2.04 to $2.30.
Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on bringing sustainable solutions to the plastics, chemicals and energy industries, today reported financial results for the three months and full year ended December 31, 2011.
Medifocus Inc. (Medifocusor the Company) (TSX VENTURE:MFS) (OTCQX:MDFZF) is pleased to announce that, after receiving approval from the TSX Venture Exchange (TSXV), it has completed a previously-announced shares for debt transaction.
mPhase Technologies, Inc. (OTCBB: XDSL) said today that it is exploring the printing of its Smart NanoBattery with Graphene and other advanced new materials.
Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today pointed out the potential for substantial partnership and licensing opportunities using the company’s cell encapsulation technology for applications in stem cell research and medicine.
Obagi Medical Products, Inc. (NASDAQ: OMPI), a leader in topical aesthetic and therapeutic skin health systems, today announced that Albert Hummel, the Company’s President and Chief Executive Officer, will present a corporate overview at the 24th Annual Roth OC Growth Stock Conference to be held at the Ritz Carlton Hotel in Dana Point, California.
Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced that Cooper Collins, President and Chief Executive Officer, will present at the 24th Annual ROTH Conference on Tuesday, March 13, 2012 at 10:30 a.m. PST.
PLX Technology, Inc. (NASDAQ: PLXT), a leading global supplier of high-speed connectivity solutions enabling emerging data center architectures, today reaffirmed its core portfolio PCI Express® (PCIe®) Gen3 and 10 Gigabit Ethernet products are perfectly aligned with the successful launch of the new Intel® Xeon® Processor E5-2600 product family (formerly codenamed Romley) that many server and storage manufacturers are preparing to deploy.
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today that it has elected Douglas Godshall to its Board of Directors.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced the promotion of Mr. John DiBella to the position of Vice President of Marketing and Sales.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it will host a webcast and teleconference with senior management to discuss its financial results and operating highlights for the fourth quarter and full year ended December 31, 2011 on Tuesday, March 13, 2012, at 5:00 pm Eastern.
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from an ongoing Phase 2 study designed to evaluate the safety and tolerability of INCIVEK® (telaprevir) tablets in combination with pegylated-interferon and ribavirin in people who are co-infected with genotype 1 hepatitis C virus and human immunodeficiency virus (HIV).