|Medtronic Initiates Landmark U.S. Drug-Eluting Balloon Study; Mylan Launches First Generic Version of Lescol® Capsules|
|By Staff and Wire Reports|
|Friday, 13 April 2012 14:41|
Medtronic, Inc. (NYSE: MDT) announced the start of the Medtronic IN.PACT SFA II study, the company's first U.S. clinical trial for its line of IN.PACT drug-eluting balloons.
The first patients in this landmark study were treated this week by Dr. Ash Jain at Washington Hospital in Fremont, Calif., and Dr. Brian Bigelow at St. Vincent Hospital in Indianapolis; Dr. Monica Hunter at Christ Hospital in Cincinnati is planning to treat a patient in the study as early as next week. Drs. Jain, Bigelow and Hunter are the principal investigators at their respective trial site.
Peripheral artery disease is estimated to affect eight to 12 million people in the United States alone. A prevalent form of cardiovascular disease, lower-extremity peripheral artery disease is a prime cause of claudication (ischemic leg pain) and immobility, critical limb ischemia and amputations.
Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol® Capsules. This product is indicated for the treatment of both familial and nonfamilial hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of cardiovascular disease.
Pursuant to a settlement and license agreement with Novartis, Mylan was granted a license permitting launch prior to the expiration of the pediatric exclusivity associated with U.S. Patent No. 5,356,896, which expires on June 12, 2012.
Lescol Capsules had U.S. sales of approximately $27.9 million for the 12 months ending Dec. 31, 2011, according to IMS Health. Mylan has begun shipping its generic version of this product.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will present at the 19th Annual Future Leaders in the Biotech Industry Conference on Friday, April 20, 2012, at 11:00 a.m. Eastern Time at the Millennium Broadway Hotel in New York City.
Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it will webcast its Annual Shareholders’ Meeting to be held on Thursday, April 26th at the Hyatt Regency Suites, Palm Springs, 285 N. Palm Canyon Drive, Palm Springs, Calif.
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals U.S.A. (TPUSA) today announced that the Centers for Medicare and Medicaid Services (CMS) has granted a unique product reimbursement code, or Q-code, for OMONTYS® (peginesatide) Injection.
Allergan, Inc. (NYSE: AGN) announced today that April 15, 2012 will mark the 10-year anniversary of the U.S. Food and Drug Administration’s (FDA) approval of BOTOX® Cosmetic (onabotulinumtoxinA) to improve the look of moderate to severe frown lines between the eyebrows in patients age 18-65.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the BioCentury Future Leaders in the Biotech Industry Conference on Friday, April 20, 2012, at 11:00 a.m. ET in New York City.
Expanding its commitment to developing innovative treatments for cardiovascular disease and the evidence to support their adoption, Medtronic, Inc. (NYSE: MDT) announced today the start of the Medtronic IN.PACT SFA II study, the company’s first U.S. clinical trial for its line of IN.PACT drug-eluting balloons.
VisualMED Clinical Solutions Corp. (PINKSHEETS: VMCS) (FRANKFURT: VA6) announces it has entered into a partnership with the Maryland Center, Bowie State University, Intelaform and Verizon, as announced by the Maryland Center at Bowie State on Wednesday.