|Abbott's ALK Test is Now Available in Europe; Pfizer's Xalkori Gets Conditional OK|
|By Staff and Wire Reports|
|Wednesday, 24 October 2012 19:44|
Abbott (NYSE: ABT) announced it will expand the current CE-IVD product labeling for its Vysis^® ALK Break Apart FISH Probe Kit, allowing the test to be marketed in the European Union as a companion diagnostic. The test is designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in advanced non-small cell lung cancer (NSCLC) patients who may be eligible for treatment with XALKORI (crizotinib), an oral first-in-class ALK inhibitor.
The Vysis ALK test kit uses Abbott's proprietary fluorescence in situ hybridization (FISH) technology and was the only diagnostic test used in multi-center global clinical trials in conjunction with Pfizer's XALKORI (crizotinib). Patients in these global clinical trials for XALKORI were screened with Abbott's ALK FISH test to detect possible gene rearrangements and allow physicians to make important treatment decisions.
The Abbott test has been used by oncologists in the United States since it was co-approved with XALKORI by the U.S. Food and Drug Administration in August 2011. The test offers clinicians a standardized, clinically validated method to identify patients more likely to benefit from the new therapy. In Europe, the CE-IVD test has been available to laboratories since September 2011 and has been used primarily in academic studies and to support evaluations of new therapies.
Pfizer Inc. (NYSE:PFE) announced the European Commission has given conditional marketing authorization for XALKORI® (crizotinib) in the European Union (EU) for the treatment of adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
“In the field of metastatic non-small cell lung cancer, XALKORI represents a major advancement. It brings to the patients with ALK-translocated tumors an oral compound that can achieve tumor shrinkage and delay disease progression,” said Dr. Jean-Charles Soria, professor of Medicine and Medical Oncology at South-Paris University and cancer specialist at Institut Gustave Roussy, France.
Akorn, Inc. (NASDAQ: AKRX), a niche specialty pharmaceutical company, today announced that its manufacturing and development partner, Sofgen Pharmaceuticals, LLC, has received approval of its abbreviated new drug application (ANDA) for Progesterone capsules, 100mg and 200mg.
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) (Alexion or the Company) today announced financial results for the three and nine months ended September 30, 2012. Alexion reported net product sales of Soliris® (eculizumab) of $294.1 million in the third quarter of 2012, compared to $204.0 million for the same period in 2011.
Anthera Pharmaceuticals, Inc. (NASDAQ: ANTH), today announced financial results and business highlights for the quarter ended September 30, 2012.
BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that it intends to conduct an interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia.
CIT Group Inc. (NYSE: CIT), a leading provider of financing to small businesses and middle market companies, today announced that it arranged and syndicated a $75 million senior secured credit facility to Dallas-based Homecare Homebase, a leading provider of home health and hospice agency software solutions.
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, announced today the closing of its previously announced underwritten public offering of 9,200,000 shares of common stock, including the exercise of the over-allotment option by the underwriters covering 1,200,000 shares, at a public offering price of $2.50 per share.
Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today reports a commercial update for SURFAXIN® and AFECTAIR®.
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM (NYSE, Euronext: DSM KON), announced today that it has signed a biologics contract manufacturing agreement with Paranta Biosciences Ltd of Melbourne, Australia.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced three-year results of a pivotal clinical study of inoperable patients with severe aortic stenosis treated with the Edwards SAPIEN transcatheter heart valve.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced financial results for the three and nine months ended September 30, 2012.
Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced results of two studies suggesting an increased role for capsule endoscopy in detecting Crohn's lesions in the small bowel.
Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced that its portfolio company Enlivex has completed a clinical trial and is reporting positive results that indicate efficacy and safety in its treatment for recipients of bone marrow transplants from foreign donors. Hadasit Bio-Holdings holds a 92% stake in Enlivex.
Ingen Technologies, Inc. (PINKSHEETS: IGNT), an emerging medical device manufacturer with proprietary medical products for the growing $4 billion respiratory markets, is pleased to announce the following statement from Gary B. Tilden, Chairman of the Board of Directors.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company focused on developing novel inhalation therapeutics for patients suffering from serious orphan lung diseases, will host a conference call on Wednesday, November 7th, 2012, at 8:30 AM ET, to discuss its financial results for the third quarter of 2012. Insmed intends to issue its quarterly financial results press release before the market opens on November 7th.
InspireMD, Inc. (OTC: NSPR) ("InspireMD" or the "Company"), announced its proprietary MGuard™ Embolic Protection Stent (EPS) was shown to be significantly superior when compared to standard bare metal and drug eluting stents in achieving complete ST resolution and restoring normal blood flow in a major study of 432 randomized patients undergoing emergency coronary intervention for potentially fatal heart attacks.
Mauna Kea Technologies (NYSE Euronext: MKEA) leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, today announced that more than nine presentations at the American College of Gastroenterology Annual Scientific Meeting (ACG) continue to validate the role of optical biopsy to speed and direct treatment decisions for digestive diseases including pancreatic, stomach, rectal cancers and Barrett's Esophagus. Physicians also reported that Cellvizio may play an important role in the diagnosis of irritable bowel syndrome (IBS).
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that the Company will report its third quarter 2012 financial results after the Nasdaq market closes on Wednesday, October 31, 2012.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today financial results for the quarter ended September 30, 2012.
Omeros Corporation (NASDAQ: OMER) today announced that it has identified compounds that functionally interact with each of four additional orphan G protein-coupled receptors (GPCRs).
Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY) today announced that it has completed patient enrollment in its U.S. Phase II clinical trial using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced or metastatic pancreatic cancer (REO 017).
Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced that it intends to offer shares of its common stock in an underwritten public offering. In connection with this offering, Orexigen expects to grant to the underwriters a 30-day option to purchase additional shares of common stock.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial and operating results for the third quarter of 2012 and provided an update on development programs.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will report third quarter 2012 financial results following the close of the U.S. financial markets on Wednesday, November 7, 2012.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) today reported third quarter 2012 financial results and accomplishments.
Santarus, Inc. (NASDAQ: SNTS) today announced that it will release third quarter 2012 financial results after market close on Wednesday, November 7, 2012.
Shire plc (LSE: SHP, NASDAQ: SHPG), today announced a long-term, broad based, multi-indication research collaboration in rare diseases with Fondazione Telethon, a major Italian biomedical charitable foundation, for research carried out at the Telethon Institute of Genetics and Medicine (TIGEM).
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that Fractional Flow Reserve (FFR)-guided treatment using PressureWire™ was cost effective for coronary interventions when compared to the best available medical therapy.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that it will release its third quarter 2012 financial results before the market opens on Tuesday, November 6, 2012.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the third quarter ended September 29, 2012.