|Medtronic Says Stent Successfully Treats Long Lesions and Small Vessels; Celgene Reports Phase III Results|
|By Staff and Wire Reports|
|Tuesday, 23 October 2012 19:29|
The Resolute drug-eluting stent from Medtronic, Inc. (NYSE: MDT) delivered successful clinical results, according to new data presented at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium for the treatment of long lesions and small vessels -- two challenging characteristics of coronary artery disease commonly found in patients with diabetes.
"The Resolute stent continues to provide consistent and favorable clinical results," said Ronald Caputo, M.D., director of cardiac services and cardiology research at St. Joseph's Hospital in Syracuse, N.Y. "Patients with long lesions and small vessels are among the most difficult to treat, and for those who also have diabetes it can be even more challenging."
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) announced its phase III, multi-center, randomized, open-label study (MM-003) of pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma was reviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003 met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis. Additionally, at the OS interim analysis, the study crossed the superiority boundary for overall survival (OS), a key secondary endpoint that the study was also powered to evaluate. Improvements in PFS and OS were both highly statistically significant and clinically meaningful. As a result, the DSMB recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed-over to the pomalidomide plus low-dose dexamethasone arm.
Safety results observed in MM-003 were consistent with previous studies of pomalidomide in relapsed/refractory multiple myeloma patients. Full data from the study are being prepared for submission to a future medical meeting for presentation.
“The survival results in this study build on earlier observations of high response rates for pomalidomide and dexamethasone in multiple myeloma patients who had been exposed to multiple therapies, including immunomodulatory agents and proteasome inhibitors,” said Dr. Jesus San Miguel, Head of the Department of Hematology at the University of Salamanca, Director of the Biomedical Research Institute of Salamanca and principal investigator in the study. “The continued progress of new agents in this area of disease, particularly in later-stage patients is critical as we look to extend remissions and survival for these individuals.”
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it will host a conference call and live webcast to report its third quarter 2012 financial results on Tuesday, October 30 at 8:30 a.m. ET.
Amarantus BioSciences, Inc. (OTCQB: AMBS), a biotechnology company developing new treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centred on its proprietary anti-apoptosis therapeutic protein MANF, today announced that its Board of Directors has taken steps to improve its corporate governance by unanimously approving the adoption of certain corporate governance best practices.
Array BioPharma Inc. (Nasdaq: ARRY) will report financial results for the first quarter of fiscal 2013 on Monday, October 29, 2012, and will hold a conference call on Tuesday, October 30, 2012 at 9:00 a.m. eastern time to discuss these results.
AstraZeneca and Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today an agreement to co-develop and co-commercialize Ironwood’s linaclotide in China. Linaclotide is the first and only guanylate cyclase-C (GC-C) agonist approved by the US Food and Drug Administration, in August.
AVEO Oncology (NASDAQ: AVEO) today announced that financial results for the company’s third quarter ended September 30, 2012 will be released before the market opens on Tuesday, October 30, 2012.
Boston Scientific Corporation (NYSE: BSX) further demonstrated the strength of its structural heart program today at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation with four podium presentations showcasing the potential of the WATCHMAN® Left Atrial Appendage Closure (LAAC) Device and the Lotus™ Aortic Valve System to provide improved treatment options for millions of patients experiencing debilitating heart disorders.
Bovie Medical Corporation (the “Company”) (NYSE Amex: BVX), a manufacturer and marketer of electrosurgical products, today announced that Jeff Rencher, Vice President of Sales and Marketing of Surgical Products, will host a conference call at 11:00 am EDST on Thursday, November 1st to discuss Bovie’s J-Plasma technology.
Compugen Ltd. (NASDAQ: CGEN) today announced that the Company will host a conference call at 10:00 AM EDT on Tuesday, October 30, 2012 to review third quarter 2012 results.
Cytori Therapeutics (NASDAQ: CYTX) today announced that an investigator-sponsored and funded clinical study evaluating Cytori’s cell therapy as a potential treatment for limited and diffuse cutaneous systemic sclerosis (scleroderma) has been approved to begin in France by the National Agency for the Safety of Medicines and Health Products (ANSM, formerly AFSSAPS).
Elan Corporation, plc (“Elan”) (NYSE: ELN) announced today the expiration and final results of the cash tender offer and consent solicitation (the “Tender Offer and Consent Solicitation”), commenced on September 24, 2012, by its wholly-owned subsidiaries, Elan Finance public limited company (“Elan Finance”) and Elan Finance Corp. (“Elan Corp.” and together with Elan Finance, the “Co-Issuers”), to purchase any and all of their outstanding 8.75% Senior Notes due 2016 issued on October 2, 2009 (the “2009 Notes”) and 8.75% Senior Notes due 2016 issued on August 17, 2010 (the “2010 Notes” and, together with the 2009 Notes, the “Notes”).
GelStat Corporation (PINKSHEETS: GSAC), a consumer healthcare company primarily focused on the development and marketing of over-the-counter (OTC) products for the safe and effective treatment of pain, inflammation and sleep disorders, issues a letter by its CEO to shareholders discussing recent events.
Given Imaging Ltd (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced new studies underscoring the value of PillCam® SB in identifying and evaluating small bowel abnormalities.
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 the Company will be presenting a poster at the upcoming American Society of Nephrology’s Kidney Week 2012, taking place from October 30 to November 4 in San Diego.
mPhase Technologies, Inc. (OTCBB: XDSL) said today that on Thursday, October 25, 2012 at 9:00 am ET it will be releasing a multi-purpose video of the new product it has developed using advanced battery technology, targeted toward the automotive and marine industry.
NeoGenomics, Inc. (NASD OTC QB: NGNM) announced today that it plans to release its third quarter 2012 financial results on Wednesday, October 31, 2012.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, announced today financial results for the third quarter ended September 30, 2012.
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that it has expanded its antibody-drug conjugate (ADC) collaboration with Abbott (NYSE:ABT).
Sigma-Aldrich (NASDAQ: SIAL) Reports Q3 2012 Diluted EPS Of $0.92 And Diluted Adjusted EPS Of $0.94. Sales Increased 2% For Q3 2012. Reaffirms Full Year 2012 Adjusted Diluted EPS Of $3.80 to $3.90.
Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious diseases and unmet medical needs, announced today that Andrew Bristol, Ph.D., joined the team as its new Vice President of Research & Development.
Techne Corporation's (NASDAQ: TECH) financial results for the quarter ended September 30, 2012 .
United Therapeutics Corporation (NASDAQ: UTHR) announced today that it received a complete response letter from the United States Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for treprostinil diethanolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH).
Verastem, Inc., (NASDAQ: VSTM) a clinical-stage biopharmaceutical company focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, announced the appointment of Joanna Horobin, M.B., Ch.B., as Chief Medical Officer.