|Boston Scientific Announces Launch of Dilatation Catheter; FDA Approves Use of Codexis Enzymes|
|By Staff and Wire Reports|
|Tuesday, 24 April 2012 19:22|
Boston Scientific Corporation (NYSE: BSX) announces CE Mark and European market launch of the Emerge™ PTCA Dilatation Catheter. The Emerge Catheter is a next-generation pre-dilatation balloon catheter designed specifically to offer exceptional deliverability to address challenging lesions. The company plans to launch the product immediately in CE Mark countries in both Monorail® and Over-The-Wire (OTW) options. Commercial availability is expected in the U.S. and additional international markets later this year.
The Emerge PTCA Dilatation Catheter includes a 1.2 mm diameter balloon option that features an ultra-low 0.017" tip profile and low crossing profiles designed to cross tight lesions. The Emerge 1.2 mm balloon also employs a durable balloon material that provides high rated burst pressure (18 ATM) for sizing flexibility. The Emerge Catheter platform offers a reduced, low-friction shaft profile which allows for simultaneous use of two Monorail balloon catheters in a 6F guide catheter and two OTW balloon catheters in an 8F guide catheter.
Codexis, Inc. (Nasdaq:CDXS), a developer of industrial enzymes to enable the cost advantaged production of biofuels, bio-based chemicals, and pharmaceutical intermediates, today announced that the FDA has approved a new process co-developed by Codexis for the manufacture of sitagliptin, the active pharmaceutical ingredient in Merck's Januvia®.
“FDA approval of this manufacturing process is a major milestone for Codexis,” said Peter Strumph, Interim Chief Executive Officer. “This is another example of how our directed evolution technology can deliver well controlled, cost advantaged commercial pharmaceutical, biofuel, or bio-based chemical production processes.”
The approved process, which won the Presidential Green Chemistry Award in 2010, is a more environmentally friendly and efficient production process than those used in the past. Specifically, it indicates the potential for improving the overall increase in yield of sitagliptin, while significantly decreasing waste byproducts.
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the Company’s three ongoing clinical trials, have recently authorized the Company to move forward with enrollment and treatment of additional patients with Stargardt’s disease (SMD). In the U.S. SMD trial, ACT will screen and enroll patients for the second cohort, who, in keeping with trial protocol, will be injected with 100,000 retinal pigment epithelial (RPE) cells - as compared with the 50,000 cell dose used in the patients of the first cohort.
Affymax, Inc. (NASDAQ:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that OMONTYS® (peginesatide) Injection is now available only for use in treating anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial results for the three months ended March 31, 2012. The Company reported net product sales of Soliris® (eculizumab) of $244.7 million, an increase of 47 percent from the same period in 2011.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced it will report unaudited consolidated financial results for the quarter ended March 31, 2012 after the U.S. financial markets close on Tuesday, May 1, 2012.
Baxter International Inc. (NYSE: BAX) announced today that it will present at Deutsche Bank Securities, Inc. 37th Annual Healthcare Conference on Wednesday, May 9, 2012, at 9:20 a.m. ET.
BioClinica®, Inc. (NASDAQ: BIOC) today announced Mark L. Weinstein, President and Chief Executive Officer will be presenting at the 11th Annual JMP Securities Research Conference in San Francisco on Monday, May 14, 2012 at 4:00 p.m. PDT.
Today Biogen Idec (NASDAQ: BIIB) announced that detailed positive data from CONFIRM, the second Phase 3 clinical trial of oral BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS), will be presented in three platform presentations at the 64th Annual Meeting of the American Academy of Neurology (AAN) in New Orleans.
Bruker Corporation (NASDAQ: BRKR) announced today that it plans to release its first quarter 2012 financial results on Tuesday, May 1st, 2012 before the market opens.
Cannabis Science, Inc. (OTCBB: CBIS) a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is providing an update and summary of our goals and product line advancements.
Cerus Corporation (NASDAQ: CERS) and New York Blood Center (NYBC) announced today that they have entered into a research collaboration to explore the possibility of creating a red blood cell (RBC) biologic product with improved uniformity compared to a standard unit of red blood cells.
Clovis Oncology, Inc. (Nasdaq: CLVS) will announce its first quarter 2012 financial results on Tuesday, May 8, 2012, before the open of the U.S. financial markets.
Columbia Laboratories Inc. (Nasdaq: CBRX) will hold a conference call on May 4, 2012, to discuss financial results of the three-month period ended March 31, 2012.
Compugen Ltd. (NASDAQ: CGEN) today reported the initial validation of two additional therapeutic product candidates, CGEN-15031 and CGEN-15051, in animal models of autoimmune diseases.
CorMedix Inc. (NYSE Amex: CRMD), is a development stage pharmaceutical and medical device company that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiac and renal dysfunction, specifically in the dialysis and non-dialysis areas, today announced it received notice from the NYSE Amex LLC (“NYSE Amex”) indicating that the Company is not in compliance with certain of the NYSE Amex continued listing standards.
Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Olanzapine Tablets (2.5 mg, 5 mg, 7.5 mg, 10mg, 15 mg), a bioequivalent generic version of ZYPREXA® Tablets in the US market on April 23, 2012 following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy’s ANDA for Olanzapine Tablets.
Genzyme (EURONEXT: SAN and NYSE: SNY), reports today additional data from the Phase III CARE-MS II trial. Accumulation of disability was significantly slowed in patients with multiple sclerosis (MS) who were treated with alemtuzumab versus Rebif® (high dose subcutaneous interferon beta-1a), as measured by the Expanded Disability Status Scale (EDSS), a standard assessment of physical disability progression.
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced financial results for the quarter ended March 31, 2012, and provided recent highlights.
ICON (NASDAQ: ICLR) (ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the first quarter ended March 31, 2012.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced it will host its first quarter 2012 investor update conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, May 1, 2012.
Magellan Health Services, Inc. (NASDAQ: MGLN) announced today that Karen S. Rohan, President, and Jonathan N. Rubin, Chief Financial Officer, will present at the Deutsche Bank 37th Annual Health Care Conference on Tuesday, May 8, 2012, 10:40 a.m. EDT, at the InterContinental in Boston, MA.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today reported business and financial highlights for the quarter ended March 31, 2012.
PhotoMedex, Inc. (NasdaqGS: PHMD) today announced the pricing of concurrent registered offerings of 3,023,432 shares of its common stock at a price to the public of $13.23 per share.
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 Austrian Agency for Health and Food Safety (Österreichische Agentur für Gesundheit und Ernährungssicherheit, AGES) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
PURE Bioscience, Inc. (NASDAQ: PURE), creator of the patented silver dihydrogen citrate (SDC) antimicrobial, today announced that research conducted by scientists at the University of Arkansas demonstrates the superior efficacy of PURE Hard Surface over quaternary ammonia for cleaning and decontaminating food contact surfaces.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, updates its shareholders on the clinical progress and corporate developments the company achieved during 2011.
Seattle Genetics, Inc. (NASDAQ:SGEN) announced today that it will report its first quarter 2012 financial results on Tuesday, May 8, 2012, after the close of financial markets.
SGI (NASDAQ:SGI), the trusted leader in technical computing, today announced that researchers in the compute-intensive field of biotechnology research are continuing to make breakthrough progress with their selection of the SGI® UV™ high performance computing (HPC) system.
Targacept Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics (TM), today announced that it will report financial results for the first quarter of 2012 on Thursday, May 3, 2012, after the U.S. financial markets close.
In another industry first for pharmacy customers, Walgreens (NYSE: WAG) (NASDAQ: WAG) today launched a new online “Find Your Pharmacist” tool that allows customers to select a pharmacist by matching their health care needs with the areas of expertise, specialties, languages and clinical backgrounds of Walgreens pharmacists.