|Boston Scientific Announces FDA Approval of Stem Cell Drug; Osiris Receives Marketing Clearance for Prochymal|
|By Staff and Wire Reports|
|Thursday, 17 May 2012 18:59|
Boston Scientific Corporation (NYSE:BSX) announces U.S. FDA approval and market launch of the Epic" Vascular Self-Expanding Stent System. The Epic Stent is designed to open blocked arteries in patients with iliac artery stenosis, a form of peripheral vascular disease associated with severe leg pain caused by insufficient blood flow.
"The Epic Stent System demonstrates an excellent combination of flexibility, radial force and deployment accuracy - all important attributes when treating challenging atherosclerotic lesions in the iliac arteries," said Thomas Shimshak, M.D., medical director at Wheaton Franciscan Heart Care in Racine, WI. "The comprehensive stent size matrix should also help meet a variety of clinical requirements when treating iliac arterial disease with no compromise in deliverability or stent performance."
The Epic Stent is a self-expanding Nitinol stent designed to sustain vessel patency, while providing enhanced visibility and accuracy during placement. It employs an innovative Tandem Architecture", which is engineered to provide excellent stent flexibility while maintaining predictable radial force characteristics and fracture resistance. The Epic Stent employs distal and proximal radiopaque markers and all stent sizes are compatible with 6F sheaths. The stent delivery system is offered in two shaft lengths (75 cm and 120 cm) for all sizes and is compatible with 0.035" guidewires.
In January, Boston Scientific announced that the ORION trial met its primary clinical endpoint. The Epic Vascular Stent System demonstrated a low nine-month major adverse events (MAE) rate of 3.4 percent in the intent-to-treat population, which was significantly lower than the pre-specified performance goal of 17 percent (p<0.001) based on historical published outcomes for iliac stenting.
"The Epic Stent is another example of our commitment to innovation in treating peripheral vascular disease, a growing worldwide health concern," said Jeff Mirviss, president of the Boston Scientific Peripheral Interventions Division. "This next-generation stent expands our growing peripheral interventions portfolio, complementing the leading Express® LD balloon-expandable iliac stent, and offering physicians a versatile new option to treat patients with challenging lesions in the iliac arteries."
Iliac stenosis (narrowing) occurs when plaque accumulates within the arteries that supply blood to the legs, which can lead to poor blood flow, claudication (leg pain) and other complications. The disease can be treated with medication, surgery or angioplasty.
The Epic Vascular Self-Expanding Stent System received CE Mark approval and was launched in Europe and other international markets in 2009.
Osiris Therapeutics Inc. (NASDAQ: OSIR) announced it has received market authorization from Health Canada to market its stem cell therapy Prochymal® (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children.
The historic decision marks the world's first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD — a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.
ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, will host an investor call to update investorson MuGard commercialization activities, including progress with pharmacy benefit managers, payers and pharmacy formularies, and other new developments within the program.
Affymetrix, Inc. (NASDAQ: AFFX) and ScreenCell, a privately-held company, today announced the signing of a worldwide distribution agreement for ScreenCell’s isolation devices and dilution buffers,* designed for the collection of Circulating Tumor Cells (CTCs) in peripheral blood.
Alkermes plc (NASDAQ: ALKS) today reported financial results for its fourth quarter and fiscal year ended March 31, 2012, and provided financial expectations for its fiscal year 2013, which will be the first full fiscal year of the combined company, Alkermes plc (Alkermes), following the completion of the merger of Alkermes, Inc. with Elan Drug Technologies (EDT) on Sept. 16, 2011.
ArQule, Inc. (Nasdaq: ARQL) and Daiichi Sankyo, Co., Ltd. (TSE 4568) today announced that an oral presentation at the Annual Meeting of the American Society of Clinical Oncology (ASCO) will feature Phase 2 trial data with tivantinib as a single agent investigational second-line treatment in hepatocellular carcinoma (HCC).
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL) ("Auxilium") and FCB I LLC ("FCB") today announced that the United States Patent and Trademark Office ("USPTO") has issued U.S. Patent No. 8,178,518 covering, among other things, Testim® 1% testosterone gel, marketed by Auxilium under license from FCB.
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced that the New England Journal of Medicine published research from the companies’ global risk management program that updates the risk of TYSABRI® (natalizumab)-associated progressive multifocal leukoencephalopathy (PML), an infrequent but serious brain infection that usually leads to death or severe disability, in people with multiple sclerosis (MS).
China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP) ("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and Traditional Chinese Medicines ("TCM") in China, today announced that the Company recently attended and exhibited its anti-depressant products at the 67th PHARMCHINA fair ("the Fair") recently held in Hefei, China.
China Jo-Jo Drugstores, Inc. (NASDAQ:CJJD) (the “Company”), a retail pharmacy chain in Zhejiang and Shanghai, today announced two new store openings in Shanghai and Hangzhou, increasing the Company’s total store count to 61.
ChromaDex® Corporation (OTCBB: CDXC), an innovative natural products company that provides proprietary, science-based solutions and ingredients to the dietary supplement, food & beverage, cosmetic and pharmaceutical industries, announced today that customer demand and unit sales of its recently launched BluScience™ line of dietary supplements have exceeded the Company's initial forecast and expectations during the first quarter ended March 31, 2012.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax® (Anthrax Vaccine Adsorbed) to a three-dose primary series of intramuscular injections at 0, 1, and 6 months.
Exact Sciences Corp. (Nasdaq: EXAS) today announced that it has expanded its collaboration and license agreement with Mayo Clinic.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that its Board of Directors, after careful review and consideration with the assistance of the Company’s management and financial and legal advisors, has unanimously determined that the unsolicited tender offer from GlaxoSmithKline (“GSK”) to acquire all outstanding common shares of HGS for $13.00 per share in cash (the “Offer”) is inadequate, undervalues the Company and is not in the best interests of HGS and its stockholders.
Human Genome Sciences, Inc. (NASDAQ: HGSI) (“HGS” or the “Company”) announced today that its Board of Directors has adopted a Stockholder Rights Plan (the “Rights Plan”) and declared a dividend of one share purchase right (a “Right”) for each share of HGS’s common stock (the “Common Stock”) held of record at the close of business on May 29, 2012.
InspireMD, Inc. (OTC BB: NSPR) (the "Company" or "InspireMD"), a medical device company focusing on the development and commercialization of its proprietary stent platform technology for use in patients with Acute Myocardial Infarction, announced positive three-year results from the EF (extended follow up) MAGICAL trial yesterday at a Company-sponsored symposium at the EuroPCR conference in Paris.
Magellan Health Services, Inc. (NASDAQ: MGLN) announced today that Karen S. Rohan, President of the Company, and Jonathan Rubin, Chief Financial Officer, will present a general overview of the Company and discuss its business strategy via live webcast at the Goldman Sachs 33rd Annual Global Healthcare Conference on Tuesday, June 5, 2012 at 1:40 p.m. Eastern in Rancho Palos Verdes, CA.
Medgenics, Inc. (NYSE MKT: MDGN) (AIM: MEDU) (AIM: MEDG) (the “Company”), developer of the novel Biopump™ technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the U.S. Food and Drug Administration (“FDA” or the “Agency”) to proceed with a Phase IIb clinical trial of EPODURE™ for the treatment of anemia in patients undergoing renal dialysis.
Magellan Health Services Inc. (NASDAQ: MGLN) was named as a finalist for the Best Practices in Health Care Consumer Empowerment and Protection Awards by URAC, a leading health care accreditation organization.
MedPro Safety Products, Inc. (OTCBB:MPSP), a leading developer of transformational technologies that enable safer medication delivery and blood collection, will participate in two leading industry conferences during the week of May 21, 2012.
Medtronic, Inc. (NYSE: MDT) today announced new results from the Medtronic CoreValve ADVANCE Study, which found that women and men benefitted similarly from the Medtronic CoreValve® System.
Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clopidogrel Tablets USP, 75 mg and 300 mg.
NeuroMetrix, Inc. (Nasdaq: NURO), www.neurometrix.com, is a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes.
Osiris Therapeutics Inc. (NASDAQ: OSIR) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal® (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children.
PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, today announced that it will provide a live webcast of its Investor Day on Thursday, May 31, 2012, from 8:30 a.m. to 12:30 p.m. (EDT).
Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that clinical abstracts on Bruton's Tyrosine Kinase inhibitor, ibrutinib (formerly, PCI-32765) have been selected for oral presentations at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 1-5, 2012 in Chicago, IL.
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the expiration on May 15, 2012 of warrants to purchase 2,735,337 shares of pSivida common stock.
Puma Biotechnology, Inc. (OTCBB: PBYI), a development stage biopharmaceutical company, announced that clinical data for its lead drug candidate PB272 (neratinib) in patients with metastatic breast cancer will be presented in the HER2/ER Breast Cancer poster session at the American Society of Clinical Oncology (ASCO) 2012 Annual Meeting.
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, will present an overview of the company’s technology and programs on Thursday, May 24 at 8:15 a.m. Eastern Time (5:15 a.m. Pacific Time) during the Citi 2012 Global Consumer Conference.
ShangPharma Corporation (NYSE: SHP) ("ShangPharma" or the "Company"), a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced its unaudited financial results for the first quarter ended March 31, 2012.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the initiation of a Phase 2 study evaluating ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use + rituximab in combination with motexafin gadolinium (MGd) in patients with rituximab-refractory low-grade or follicular B-cell non-Hodgkin’s lymphoma (NHL).
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced scheduled presentations at the 2012 American Society for Clinical Oncology (ASCO) Annual Meeting June 1-5 at the McCormick Place in Chicago.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that its Board of Directors has unanimously voted to re-elect Dr. Phillip Frost as Chairman of the Board for a term of three years.
Ambit Biosciences and Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) ("Teva") today announced the clearance of an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) for CEP-32496, a novel BRAF (V600E) kinase inhibitor.