NDA for Regorafenib Submitted by Bayer; Mylan Announces Settlement Agreement in Patent Infringement Litigation Print E-mail
By Mary Davila   
Thursday, 24 May 2012 18:49
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 24, 2012.

Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX)
announced Bayer HealthCare has submitted a New Drug Application (NDA) to the U.S. FDA seeking approval for the oral multi-kinase inhibitor regorafenib for the treatment of patients with metastatic colorectal cancer (mCRC).  Regorafenib is a Bayer compound, and Onyx will receive a royalty on global net sales of regorafenib in oncology.

The submission is based on the results of the pivotal, global Phase 3 CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial. Results from the study were first presented at the Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI) in January 2012 and will be presented at the upcoming ASCO annual meeting in Chicago, IL (USA) in early June 2012.

Bayer has also submitted an application for European marketing authorization for regorafenib for the treatment of patients with mCRC.


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Mylan Inc. (Nasdaq: MYL)
announced Mylan Specialty L.P., f/k/a Dey Pharma, L.P., has entered into an agreement with Sunovion Pharmaceuticals Inc., f/k/a Sepracor Inc., to resolve the parties' patent litigation relating to Sunovion's Brovana® product.

The U.S. District Court for the Southern District of New York's Final Judgment and Order notes that the parties have entered into a settlement and license agreement and that Sunovion has acknowledged that two Mylan patents are valid, enforceable and infringed by Sunovion's Brovana® product. These patents expire on June 22, 2021. The terms of the parties' agreement are confidential.



Also Thursday:



AspenBio Pharma, Inc. (Nasdaq: APPY)
, today announced that Don Hurd has been appointed to the new position of Senior Vice President and Chief Commercial Officer, effective May 23, 2012.

Biostem U.S., Corporation, (OTCQB: HAIR) (PINKSHEETS: HAIR)
(Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announces a $5,000,000 financing agreement through private placement of stock.

Bristol-Myers Squibb Company (NYSE: BMY)
will take part in Sanford Bernstein’s 28th Annual Strategic Decisions Conference on Thursday, May 31, 2012, in New York.

Cepheid (NASDAQ: CPHD)
today announced that the U.S. Food & Drug Administration (FDA) has cleared its GeneXpert®Infinity-80 System, a high-throughput automated molecular system designed to deliver around-the-clock results for a wide variety of clinical testing applications.

China Integrated Energy, Inc. (OTC Pink: CBEH)
("China Integrated Energy" or the "Company"), a leading non-state-owned integrated energy company in the People's Republic of China, today announced the completion of the thorough Independent Investigation conducted by the Audit Committee into allegations raised in reports published in early 2011.

CONMED Corporation (NASDAQ: CNMD)
announced today that it will host an investor and analyst meeting on Friday, June 8, 2012, at CONMED Linvatec's surgical training facilities in Largo, Florida.

Dyax Corp. (NASDAQ: DYAX)
the manufacturer of KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older, has announced the launch of its HAE diagnostic testing refund program.

Dynasil Corporation of America (NASDAQ: DYSL)
today announced that it has entered into a technology collaboration agreement with Mayo Clinic, a not-for-profit worldwide leader in medical care, research and education for people from all walks of life.

GE Healthcare (NYSE: GE)
and Royal Philips Electronics (AEX: PHI, NYSE: PHG) applaud the Federal Communications Commission (FCC) today for its action allocating protected spectrum for wireless medical devices, called Medical Body Area Networks (MBANs), which could revolutionize the way patients are monitored and help eliminate the restrictive cables that tether patients to hospital beds.

Graymark Healthcare, Inc. (NASDAQ: GRMH)
, a provider of care management solutions to the sleep disorder market, announced today that it has engaged Genesis Select for investor relations services.

Hadasit Bio-Holdings (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 Thrombotech, a portfolio company which Hadasit holds a 24.8% stake in, signed a merger agreement with D-Pharm (TASE: DPRM), a clinical stage, technology-driven biopharmaceutical company developing proprietary products for treatment of CNS disorders.

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 Infarctions, today announced that is has completed enrollment in the MASTER  (MGuard™ for Acute ST Elevation Reperfusion) trial.

Integrated Management Information, Inc. (IMI Global) (OTCBB: INMG)
, a leading provider of verification and Internet solutions for the agricultural/livestock industry under the Where Food Comes From® brand, today announced it will team with the Heinen's grocery chain and two Heinen's Own Beef producers over Memorial Day weekend to showcase Heinen's Own Beef and the Where Food Comes From® program.

Manny Villafaña, Chairman and CEO of Kips Bay Medical Inc. (NASDAQ:KIPS) announced that Prof. Michele Genoni, MD, Chief of Cardiovascular Surgery of the Triemli Hospital, Zurich, Switzerland will be presenting his center’s early clinical experience with the eSVS® Mesh device at the 14th Annual meeting of the ISMICS in Los Angeles, CA.

NeuroMetrix, Inc. (Nasdaq: NURO)
, www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, reported today that it has engaged IRG, LLC (IRG), a prominent, full service corporate communications firm, to serve as its investor relations agency.

NeuroMetrix, Inc. (Nasdaq: NURO)
, www.neurometrix.com, a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today announced that it shipped its 500th NC-stat® DPNCheck™ device.

Patterson Companies, Inc. (Nasdaq: PDCO)
today reported that consolidated sales totaled $936,334,000 in the fourth quarter of fiscal 2012 ended April 28, an increase of 6% from $883,819,000 in the year-earlier period.

Pfizer Inc. (NYSE:PFE)
announced today that the United States Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee voted on Pfizer’s clinical data package for tafamidis meglumine.

Presentations at the recently concluded Digestive Disease Week Conference (DDW) in San Diego featured positive data on the ability of the SpectraScience (OTCQB: SCIE) (PINKSHEETS: SCIE) WavSTAT4 Optical Biopsy System to diagnose early stage colorectal and esophageal cancer.

Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR)
announced today that executive management will present at the Jefferies 2012 Global Healthcare Conference in New York on June 6, 2012 at 5:00 a.m. PT / 8:00 a.m. ET.

On its conference call today, Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) provided its current outlook for non-GAAP financial performance for the full year ending December 31, 2012.

Transgenomic, Inc. (OTCBB: TBIO)
today announced it has entered into an agreement with Gene Logic, Inc., an Ocimum Biosolutions Company, to acquire its biorepository assets for $250,000 in cash.

Unilens Vision Inc. (OTCBB: UVIC) (OTCQB: UVIC) (TSX VENTURE: UVI)
, which develops, licenses, manufactures, distributes and markets specialty contact lenses, today announced the refinancing of the Company's bank loan facilities.

Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX)
announced today that Valeant has agreed to acquire certain assets from Swiss Herbal Remedies Limited, a nutraceutical company that manufactures and markets a broad range of scientifically formulated vitamins, minerals and supplements, for less than one times sales.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
today announced that David Altshuler, M.D., Ph.D., joined its board of directors as an independent director.

XenoPort, Inc. (Nasdaq:XNPT)
announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to begin clinical studies of XP23829 as a potential treatment for relapsing-remitting multiple sclerosis (RRMS).



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