|Edwards’s Sapien Trial Raises Question Among FDA Staff; J&J Agree to Drug Marketing Accord|
|By Staff and Wire Reports|
|Monday, 11 June 2012 19:44|
The way Edwards Lifesciences Corp. (NYSE:EW) selected and categorized patients in a trial for its Sapien heart valve may have been biased, making an evaluation of the device as an alternative to open-heart surgery difficult, U.S. Food and Drug Administration staff said.
The transcatheter heart valve, which can be implanted with minimal incisions, worked as well as an operation yet showed higher rates of strokes in the study, the staff said in a report posted online today. The staff said inconsistency in the trial “makes evaluation of these endpoint results difficult.”
“Therefore, the FDA believes that continued long-term follow-up is warranted in a post-approval study should this device be approved,” the staff wrote.
Advisers to the FDA meet June 13 to decide whether Sapien, currently used on heart patients who don’t qualify for surgery, should get expanded approval for people who are high-risk yet capable of handling an operation. The transcatheter valve market may total $2.5 billion in the U.S., said Jason Mills, a San Francisco-based analyst with Canaccord Adams Inc., said.
Edwards fell 0.3 percent to $88 at the close of trading.
The initial FDA approval of Sapien in November boosted Edwards’s transcatheter valve sales 67 percent in the first quarter to $122 million, Michael Mussallem, chairman and chief executive officer of the Irvine, California-based company, said in an April 24 earnings call.
Johnson & Johnson (NYSE:JNJ) agreed to pay as much as $2.2 billion to settle U.S. probes of the marketing of its Risperdal antipsychotic drug and other medications, two people familiar with the negotiations said.
The settlement, which might be announced this week, will include a misdemeanor plea and criminal penalty of as much as $600 million, said the people, who didn’t want to be identified because they weren’t authorized to speak publicly about the agreement. The accord also would resolve civil claims that J&J paid kickbacks to Omnicare Inc. (NYSE:OCR), a company that dispenses drugs at nursing homes, the people said.
Enlarge image J&J Said to Pay $2.2 Billion to End Risperdal Sales Probes
The agreement, which wouldn’t end claims by some states, would be the government’s second-biggest settlement with a pharmaceutical company, behind a $2.3 billion accord that Pfizer Inc. (NYSE:PFE) entered in 2009 to resolve U.S. investigations of improper marketing of its painkiller Bextra and other drugs.
“This is a gigantic settlement that reflects the seriousness of the criminal and civil allegations against J&J over Risperdal and the other drugs,” Carl Tobias, who teaches product-liability law at the University of Richmond law school, said in a phone interview.
The accord covers Risperdal claims by whistle-blowers and the U.S. and those by most of the states, and it resolves claims that J&J illegally marketed the heart-failure drug Natrecor and the antipsychotic medication Invega, the people said.
Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina™ clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada.
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), announced today that the Company plans to initiate two new LibiGel Phase III efficacy trials.
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced the Company’s five-year strategic aspirations – Building Blocks of Growth – at its Investor Day at the NASDAQ Market Site.
Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials today announced that Dr. Bill Petty, Chairman and CEO, will present to analysts and investors at the Wells Fargo 2012 Healthcare Conference in Boston on Wednesday, June 20 at 2:10 p.m. Eastern time.
Experts from Medidata Solutions (NASDAQ: MDSO) will be driving dialogue in nine conference sessions at the upcoming Drug Information Association’s (DIA) Annual Meeting, to be held June 24-28 in Philadelphia, Pa., and Medidata’s team will discuss current and future clinical research challenges and solutions in areas including protocol design, electronic health records integration and risk-based monitoring.
Forest Laboratories, Inc. (NYSE:FRX), an international pharmaceutical manufacturer, today announced revised FY 2013 earnings guidance.
InVivo Therapeutics Holdings Corp. (OTC/BB: NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that Frank Reynolds, InVivo’s Chief Executive Officer, is scheduled to make a presentation at the Sidoti Semi-Annual New York Micro-Cap Conference at 8:00-8:35 AM EDT on Thursday, June 14, 2012, in the Estate 4 Carnegie Hall room.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that a poster entitled “LGD-6972, a Potent, Orally-Bioavailable, Small Molecule Glucagon Receptor Antagonist for the Treatment of Type 2 Diabetes” was presented at the 72nd Scientific Sessions of the American Diabetes Association (ADA), June 8-12, 2012, in Philadelphia.
Navidea Biopharmaceuticals, Inc. (NYSE: NAVB), a specialty pharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that clinical data comparing its amyloid imaging candidate, AZD4694, to the benchmark amyloid imaging agent, 11C-PIB, was presented at the Society of Nuclear Medicine Annual Meeting in Miami, Florida.
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today that the independent Data Safety Monitoring Board (DSMB), providing safety oversight for the Company's Phase III SFP-iron replacement clinical program, met and informed the company that it has carefully reviewed the cumulative safety data from the Phase III CRUISE studies and identified no safety concerns.
Sigma-Aldrich Corporation (NASDAQ: SIAL) today announced that its custom manufacturing and services business unit, SAFC® (www.safcglobal.com), will consolidate its global chiral chromatography screening and small scale purification operations and locate them at its Pharmorphix® Solid State Research Laboratories in Cambridge, UK, to support its new integrated chiral chemistry offer.
Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF), an emerging Canadian specialty pharmaceutical company focused on the acquisition, licensing, development and management of pharmaceutical and healthcare products with its primary focus on the Canadian market announced today that its President and Chief Executive Officer, Rob Harris, will present at 2:30 p.m. ET at the Bloom Burton & Co. Healthcare Investor Conference to be held on Thursday, June 21, 2012 at the Toronto Board of Trade, 1 First Canadian Place, Toronto, Ontario M5X 1C1.
Transgenomic, Inc. (OTCBB:TBIO) announced that the US Patent and Trademark Office has issued patent number US 8,137,919 entitled “Method of Determining the Sensitivity of Cancer Cells to EGFR Inhibitors including Cetuximab, Panitumumab and Erlotinib”.
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, announced today that data presented at SLEEP, the 26th annual meeting of the Associated Professional Sleep Societies (APSS), show that seventy percent (70%) of totally blind people with sleep complaints suffer from Non-24-Hour Disorder (Non-24).
XTL Biopharmaceuticals Ltd. (TASE:XTL,OTC:XTLBY), a biopharmaceutical development company, announces it has been notified by the Tel Aviv Stock Exchange (TASE) that XTL's shares will be included in the following TASE Indexes; "TA MidCap-50" and "TA BlueTech-50", in addition to the "TA-Biomed" and "TA Composite" (also known as the "Yeter" index) indexes which already includes XTL shares since December 2010.