Medtronic to settle suits over defibrillator leads. U.S. FDA seeks advice on anemia drugs. Print E-mail
By Mary Davila   
Thursday, 14 October 2010 19:23

Below is a look at some of the headlines for companies that made news in the healthcare sector on October 14, 2010.

Medtronic to settle suits over defibrillator leads. Medtronic Inc (NYSE:MDT) has settled a U.S. lawsuits over the Sprint Fidelis defibrillator faulty leads used with its implantable heart defibrillators and has agreed to pay $268 million. The company plans to take a special charge in its second fiscal quarter ending Oct. 29.

The medical device maker said it will settle U.S. lawsuits pending as of Oct. 15.

Under the terms of the settlement, the parties will file joint requests to terminate the Multi-District Litigation (MDL) and Minnesota state court proceedings relating to the product and dismiss the plaintiffs' appeals pending before the U.S. Court of Appeals for the Eighth Circuit and the Minnesota Court of Appeals. They also agreed to request dismissal of other Fidelis-related cases throughout the country.


U.S. FDA seeks advice on Amgen, J&J anemia drugs. U.S. health regulators want advisers' input on how to adjust dosing and possible label changes and the risks of blockbuster anemia drugs sold by Amgen Inc (NASDAQ:AMGN) and Johnson & Johnson (NYSE:JNJ) in certain chronic kidney disease patients.

The FDA, in a document released on Thursday, said they agreed with Amgen that its recent TREAT trial failed to show anticipated benefits of its drug, Aranesp, in patients not yet on dialysis and showed a higher risk of stroke and death in those who had a history of cancer.

While such drugs, known as erythropoiesis-stimulating agents, still rake in billions, their sales have fallen off in recent years after concerns emerged that doctors may be overusing the drugs in certain patients.

FDA released its review ahead of a public meeting set for Monday to discuss the safety issues in the wake of the trial's findings. Roger Perlmutter, Amgen's executive vice president of research and development, said the drugmaker has already proposed label changes aimed at reducing Aranesp's use.


Here are other companies that made news on Thursday:

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) will present at the Cancer Immunotherapy: A Long Awaited Reality conference taking place on October 21, 2010, at the New York Academy of Medicine in New York.

BioSpecifics Technologies Corp. (Nasdaq:BSTC), a biopharmaceutical company developing first in class collagenase-based products, today announced that BioSpecifics' President, Tom Wegman, will present at the upcoming BioCentury Newsmakers in the Biotech Industry Conference on Friday, October 22, 2010 at 3:00 pm ET at the Millennium Broadway hotel in New York, New York.

Caliper Life Sciences, Inc. (Nasdaq:CALP) will conduct a conference call discussing the company's third quarter 2010 financial results at 9:00 a.m. ET on Thursday, October 28.  Kevin Hrusovsky, President and Chief Executive Officer and Peter McAree, Chief Financial Officer, will host the call.

Cephalon, Inc. (Nasdaq:CEPH) today announced that a Risk Evaluation and Mitigation Strategy (REMS) for its antiepileptic medication GABITRIL(R) (tiagabine hydrochloride) has been approved by the U.S. Food and Drug Administration (FDA).  

Clinical Data, Inc. (NASDAQ: CLDA), today announced that Drew Fromkin, President and Chief Executive Officer, will be presenting a Company overview at the BioCentury Newsmakers in the Biotech Industry Conference, October 22, 2010 at the Millennium Broadway Hotel, New York, NY.

CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that 2010 third quarter financial results will be released on Thursday, November 4, 2010.  

CYTOGENIX, INC (Pink Sheets:CYGX) announced today that it has appointed Mr. Kevin Cassidy to its Board of Directors.

Delcath Systems, Inc. (Nasdaq:DCTH) announced today that it has executed a multi-year supply agreement with Synerx Pharma, LLC and Bioniche Teoranta, an affiliate of Mylan, Inc., for the supply of Delcath's branded melphalan hydrochloride for injection ("melphalan").

Generex Biotechnology Corporation (Nasdaq:GNBT) (www.generex.com) advises its stockholders that votes cast in respect of the reverse stock split proposal put forward at the Annual Meeting of the Company's stockholders held on July 28, 2010 DO NOT COUNT as votes cast in respect of the reverse stock split proposal being put forward at the Special Meeting of stockholders scheduled for 10 a.m. EDT on Friday, October 15, 2010.

International Stem Cell Corporation (OTCBB:ISCO), www.internationalstemcell.com, and a new firm to be formed by John Mauldin announced today the formation of a new joint marketing venture to launch a line of skin care products developed by ISCO’s wholly owned subsidiary, Lifeline Skin Care, Inc. (“LSC”).

Medtronic, Inc. (NYSE:MDT) today announced that it has entered into an agreement to settle existing U.S. lawsuits relating to its Sprint Fidelis® family of defibrillation leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949) that were the subject of a field action announced on October 15, 2007.

NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), reports that it has filed its financial year end annual report (Form 10K) with the Securities and Exchange Commission (SEC) yesterday in a timely manner.

Omeros Corporation (Nasdaq:OMER) today announced that the National Institute on Drug Abuse (NIDA) has provided an additional grant to fund clinical studies for the Company's Addiction program.

PharmAthene, Inc. (NYSE Amex:PIP), a biodefense company developing medical countermeasures against biological and chemical threats, announced today that based on information provided by PharmAthene in its compliance plan, and discussions with Exchange staff, the NYSE Amex LLC (NYSE Amex) has determined that the Company made a reasonable demonstration of its ability to regain compliance with the  NYSE Amex listing requirements and granted PharmAthene an extension until January 26, 2012 to demonstrate its compliance.  

POZEN Inc. (NASDAQ:POZN), announced today that it plans to release third quarter 2010 results on October 28, 2010, before the market opens.

Questcor Pharmaceuticals, Inc. (Nasdaq:QCOR) announced that it is partnering with the Child Neurology Foundation (CNF) to fund a $30,000 grant to support research into infantile spasms (IS). Catherine Chu-Shore, MD, of Massachusetts General Hospital was selected by CNF as the recipient of this first-ever "Logan Infantile Spasms Research Award."

Sequenom, Inc. (Nasdaq:SQNM) today announced the formation of a new clinical advisory board focusing on retinal diseases and conditions.

Talecris Biotherapeutics (Nasdaq:TLCR) announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex®-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).




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