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FDA focuses on toxic side effects with Onyx drug

Posted: Published on June 19th, 2012

WASHINGTON (AP) -- The toxic side effects of an experimental cancer drug from Onyx Pharmaceuticals may outweigh its benefits for patients with a type of blood cancer, federal health regulators said Monday. The Food and Drug Administration warned that patients in a company study of the drug had a high rate of heart and lung side effects, some which were fatal. The FDA posted its review of carfilzomib online ahead of a meeting Wednesday, where its panel of cancer experts will recommend whether the drug should be approved. Despite the negative tone of the review, some analysts said they expect the FDA's panel of outside experts to take a more favorable view. FDA panels are mainly comprised of practicing physicians from leading universities and hospitals. BMO Capital Markets analyst Jim Birchenough said he expects "panel members to be more constructive toward the carfilzomib data package." Birchenough recommended buying the stock, in a note to investors. Shares of Onyx Pharmaceuticals Inc., based in San Francisco, fell $1.90 to close at $44.08 Monday after rising as high as $46.99 earlier in the session. They are near their 52-week high of $47.80 in late April. Onyx has asked the FDA to approve carfilzomib … Continue reading →

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An addict no more, says Cassopolis woman

Posted: Published on June 19th, 2012

CASSOPOLIS -- At one point, she was so strung out on meth, says Britia Anderson, that she had no hope for the future. "I got to the point where I thought an addict is all I'm ever going to be," the Cassopolis woman said. What a difference a Cass County Family Treatment Court program can make. At least, it can when participants such as Anderson apply themselves to get past their addictions. A function of Cass Probate Judge Sue Dobrich's 43rd Circuit Family Dependency Court, the program combines rigorous treatment and accountability to compel and support longtime drug users -- her drug use began in her teens, the 31-year-old Anderson said -- to change their lives. The program is effective, Dobrich said, but also limited as far as participants only because there's only so much federal grant money to go around. "We'd like to be able to do it for every parent because it works," she said. As for why it works, Dobrich said, parents in the program, like Anderson, often have lost custody of their children and know that their only chance of regaining them is to complete the program. "That's a pretty big hammer," Dobrich said. In Anderson's … Continue reading →

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DWI Drug Court program makes an impact

Posted: Published on June 19th, 2012

The Doa Ana County (DAC) Magistrate DWI Drug Court program is reaching out to repeat DWI offenders, and making a difference. In 1994, Judge Oscar C. Frietze co-founded the nation's first DWI Drug Court program. As an alternative to incarceration, defendants who have been found guilty of second or third DWI offenses in the community are routinely referred to participate in the program. The program is a court-centered treatment program, which realizes a team approach and works collaboratively with various agencies, to provide for a safer community, rehabilitate offenders and reduce recidivism. Through the use of various forms of cognitive behavioral therapy, participants are taught to cope with high-risk situations and make decisions from higher levels of moral judgment. "Drug courts work," said Priscilla Quiones, program coordinator and coalition partner with the Unified Prevention! (UP!) Coalition, an initiative of the Community Foundation of Southern New Mexico. "They are very effective in helping people and changing lives." The program offers intensive supervision, substance abuse counseling, random drug testing, DWI court review sessions, educational program referrals, family and parenting skills, case management services, employment and job development opportunities, community service opportunities, transitional care, gender and culturally sensitive programming, 12-step programming and assistance … Continue reading →

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Department of Health reaches deal on new drugs

Posted: Published on June 19th, 2012

The Irish Times - Tuesday, June 19, 2012 FIONA GARTLAND NEW DRUGS for the treatment of conditions including multiple sclerosis, bipolar disorder and hepatitis C are to be made available following an agreement between the Department of Health and the Irish Pharmaceutical Healthcare Association. The department announced last night it had reached a deal with the association to deliver savings worth 20 million a year. The savings will allow the Health Service Executive to approve the release of new, more expensive drugs. Drugs to be released will include Brilique, to prevent thrombosis in patients with acute coronary syndromes; Gilenya, for multiple sclerosis; Sycrest, for bipolar disorder; and Incivo and Victrelis, both for hepatitis C. Pradaxa, for the prevention of stroke, which had been released for a short period and then withdrawn, is also to be made available. An alternative to blood thinner Warfarin, the drug is believed to be safer and more effective for patients with atrial fibrillation, or an irregular heartbeat. The National Centre for Pharmacoeconomics had approved most of the drugs as cost-effective, and under a former agreement between the HSE and the pharmaceutical association the new medicines were to be made available within 40 days of an … Continue reading →

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The Minnesota Multistate Contracting Alliance for Pharmacy (MMCAP) Awards Medline With National Medical-Surgical …

Posted: Published on June 19th, 2012

MUNDELEIN, Ill., June 18, 2012 (GLOBE NEWSWIRE) -- Medline Industries, Inc. announced today that the Minnesota Multistate Contracting Alliance for Pharmacy (MMCAP), a group purchasing organization for government facilities, awarded Medline with a new national medical-surgical products distribution agreement. In the two year agreement, effective June 1, Medline will provide significant savings to MMCAP's membership of nearly 5,000 facilities, including state, county and municipal hospitals, long-term care and other health care facilities, as well as schools, correctional facilities, and non-profit organizations. The current MMCAP contract generates approximately $60 million in annual sales volume and has potential to increase substantially during the term of the new contract award. Medline will distribute both national branded products as well as its broad array of Medline brand medical and surgical products, to the health care facilities from its 34 distribution centers throughout the country. About MMCAP The Minnesota Multistate Contracting Alliance for Pharmacy (MMCAP) is a free, voluntary group purchasing organization for government facilities that provide healthcare services. MMCAP has been delivering pharmacy and healthcare value to members since 1985. MMCAP's membership extends across nearly every state in the nation, delivering volume buying power. Members receive access to a full range of pharmaceuticals and … Continue reading →

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SXC Health Solutions Receives URAC Specialty Pharmacy Accreditation

Posted: Published on June 19th, 2012

LISLE, IL, June 18, 2012 /CNW/ - SXC Health Solutions Corp. (SXCI) (SXC.TO), announced today that it has been awarded Specialty Pharmacy Accreditation from URAC, a Washington, DC-based health care accrediting organization that establishes quality standards for the health care industry. Specialty Pharmacy offers a high touch, comprehensive care system of pharmacological care wherein patients with chronic illnesses and complex disease states receive expert therapy management and support tailored to their individual needs. "SXC's robust specialty sector is a powerful contender in the PBM industry," said Mark Thierer, Chairman and CEO of SXC. "Our URAC accreditation is recognition of the quality and broad scope of our specialty pharmacy commitments. We look forward to continuing to provide unbeatable service and committed support to our clients." URAC made the decision to develop a Specialty Pharmacy accreditation program because it is one of the key distribution channels for pharmacy benefit management and extends URAC's consumer protection and empowerment efforts in managed care pharmacy. URAC offers the only third-party, voluntary accreditation program of this scope for pharmacy benefit management and prescription services industry. "By applying for and receiving Specialty Pharmacy Accreditation, SXC Health Solutions has demonstrated a commitment to quality health care," said Alan … Continue reading →

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Penumbra Inc. Launches the New MAX™ System Reperfusion Catheters for Acute Ischemic Stroke Patients

Posted: Published on June 18th, 2012

ALAMEDA, Calif.--(BUSINESS WIRE)-- The Penumbra System family of aspiration thrombectomy devices now includes the MAX System of Reperfusion Catheters for removal of clots in patients experiencing acute ischemic stroke. The MAX System neuro-interventional devices offer a fast, simplified cerebral thrombectomy procedure with single-operator, over-the-wire delivery without the need for a large proximal balloon guide. The MAX System includes two specialized aspiration catheters, 4MAX and 3MAX that incorporate a new polymer and a new nitinol reinforcement design at the distal tip, enabling a single operator to track the catheters through the tortuous vessels leading to a target lesion in the brain over a standard 0.014 guidewire. These new catheters also incorporate the tapering, larger proximal diameters pioneered by Penumbras industry leading Reperfusion Catheter 054, enabling the MAX System to achieve similar effectiveness and rapid reperfusion times. The MAX System represents a significant advancement in stroke treatment. The ability to quickly and easily deliver a 4MAX catheter over a standard guidewire to the arteries of the brain gives us more time to concentrate on treating the stroke. Likewise, the larger proximal lumen improves aspiration power giving us efficient removal of the clot; similar to the ability we had with the Reperfusion Catheter … Continue reading →

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InVivo Therapeutics to Present at the Inaugural Marcum MicroCap Conference on June 20th in NYC

Posted: Published on June 18th, 2012

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- InVivo Therapeutics Holdings Corp. (NVIV), a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that Frank Reynolds, InVivo Therapeutics Chief Executive Officer, will present at the Marcum MicroCap Conference on June 20th in New York City at the Roosevelt Hotel. The event is held by Marcum LLP, one of the top ten auditors of U.S. public companies. Presentation Details Presenting on behalf of InVivo Therapeutics will be Frank Reynolds, CEO. A live audio webcast of this presentation will be available at http://execvid.com/marcum-microcap-conference-2012. The Marcum MicroCap conference is designed for investors interested in the micro-cap arena, and is expected to gather over 500 participants, including institutional investors, mutual funds, hedge funds, wealth managers, and family offices. The conference will also feature panels on subjects highly relevant to small-cap corporate finance. The event is free to attend for qualified investors and the company will make a formal presentation and be available for one-on-ones. For full event details and registration information, please click here. About Marcum LLP Marcum LLP is one of the largest independent public accounting and advisory services firms in the nation. Ranked among the top firms in the nation, Marcum offers … Continue reading →

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Abbott Presents Results of Clinical Studies Evaluating Its Investigational Treatment for Advanced Parkinson's Disease

Posted: Published on June 18th, 2012

DUBLIN, June 18, 2012 /PRNewswire/ -- Today Abbott (ABT)announced results from five abstracts evaluating levodopa-carbidopa intestinal gel (LCIG), its investigational compound for advanced Parkinson's disease. The abstracts include the results from the second interim analysis of a long-term safety and tolerability trial, as well as secondary endpoint analyses from the Phase 3 pivotal trial. All of the abstracts were presented at The 16th International Congress of Parkinson's Disease and Movement Disorders, June 17-21 in Dublin, Ireland. LCIG is currently approved in 40 countries. In the U.S., LCIG is an investigational therapy that is currently being evaluated in patients with advanced Parkinson's disease in additional Phase 3 clinical trials. In these trials, levodopa-carbidopa is administered in gel form, directly into the small intestine via a procedurally-implanted tube connected to a portable pump that delivers continuous supply of LCIG during awake hours. Long-Term Safety and Tolerability In a 54 week open-label safety and tolerability study of 354 patients with advanced Parkinson's disease, the primary endpoint of safety showed adverse events (AEs) were mostly mild to moderate, were generally associated with the Percutaneous Endoscopic Gastrostomy (PEG) tube placement procedure and its complications, were transient, and resolved over time. In the secondary endpoint analysis … Continue reading →

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Boy, 6, with cerebral palsy takes first steps after family raise £50,000 for life-changing surgery in America

Posted: Published on June 18th, 2012

Operation involves cutting the nerves in the spine to release the spasticity (tension) in AJs muscles By Daily Mail Reporter PUBLISHED: 04:08 EST, 18 June 2012 | UPDATED: 04:10 EST, 18 June 2012 A little boy born with cerebral palsy has taken his first steps just days after a life-changing operation in America. AJ Tighe, from Newton Heath, Manchester, was unable to walk unaided because of his condition but less than three weeks after a pioneering operation in Missouri he has defied the odds by bravely taking his first strides. Members of the public helped six-year-old AJs family raise the 50,000 needed for the four-hour operation following a 10-month fundraising campaign. His mother Leeanne, who is terrified of heights, even managed a 300ft bungee jump as part of their mission. Standing tall: AJ Tighe's mother Leeanne said his progress has been remarkable. He recently managed 15 unaided steps Doctors have said AJs progress since the operation has been remarkable and proud mother Leeanne said watching her son take his first unaided steps had made all the hard work worthwhile. She said: 'It was an unbelievable moment, it was everything we have dreamed of for so long and something we thought … Continue reading →

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