Lilly pulls FDA application for Cymbalta for pain Reuters - Nov 28, 2008 The maker of schizophrenia drug Zyprexa, osteoporosis treatment Evista, and cancer drug Alimta, said it plans to resubmit the application to the FDA in the ...LLY
The 'treatment' of bipolar Glens Falls Post-Star, NY - Nov 29, 2008 ... an alternative to drug treatment options for schizophrenia. On Nov. 18, a federal panel, seated by the Food and Drug Administration to review the FDA's...
Vanda Pharmaceuticals takes second shot at FDA approval Bizjournals.com, NC - Nov 20, 2008 Vanda Pharmaceuticals Inc. will get a second try at winning federal approval for its most advanced drug candidate, a schizophrenia treatment that got ...VNDA
New Pfizer product given FDA approval PigProgress.net, Netherlands - The FDA recently approved new EXCENEL? RTU EZ (ceftiofur hydrochloride) Sterile Suspension to treat and control metritis, bovine and swine respiratory ...
Cook Medical Receives FDA Approval to Market Improved Zenith? AAA ... Business Wire (press release), CA - Aug 4, 2008 ?FDA approval of the Z-Trak Introduction System and Zenith AAA Flex Leg brings the flexibility and deliverability of our market-leading AAA platform to US ...
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FDA Issues Approvable Letter For Paliperidone ER For The Treatment Of Schizophrenia
Johnson & Johnson Pharmaceutical Research & Development (JJPRD), L.L.C. announced that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) regarding a New Drug Application (NDA) for paliperidone extended-release (ER) tablets for the treatment of schizophrenia.
Recognizing the importance of new treatment options in mental illness, JJPRD is evaluating the FDA letter and will work quickly to resolve the agency's questions in order to expedite approval of paliperidone ER.
JJPRD submitted a new drug application to the U.S. Food and Drug Administration in November 2005. Upon approval by U.S. regulatory authorities, paliperidone ER, a new chemical entity, will be marketed in the United States by Janssen, L.P.
Janssen, L.P., based in Titusville, N.J., is the only large pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia and bipolar mania. Concurrently, Janssen-Cilag, NV submitted a Marketing Authorization Application to European health authorities in May 2006 seeking approval to market the medication. The paliperidone ER submissions are based on an extensive global clinical development program that involved more than 1,600 patients in 23 countries.
Paliperidone ER uses the OROS extended-release technology developed by ALZA Corporation. This technology provides a consistent release of medication over a 24-hour period leading to smooth blood plasma levels. ALZA, Janssen and JJPRD are wholly owned subsidiaries of Johnson & Johnson. The trade name for the product has not yet been determined.
A global leader in pharmaceutical research and development, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. is a subsidiary of Johnson & Johnson and is committed to bringing to market high-value, cost-effective products that treat disease and significantly improve the health and lifestyles of people worldwide.
Worldwide, it is estimated that one person in every 100 develops schizophrenia, one of the most serious types of mental illness. Symptoms of schizophrenia are marked by hallucinations, delusions, depression, blunted emotions, social withdrawal and disorganized thinking.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov/ or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statements as a result of new information or future events or developments.)
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Another Manufacturer Warns of Defibrillator Problems
St. Jude Medical Inc. is warning doctors and patients that some of its older implantable defibrillators may suddenly lose power if exposed to significant levels of environmental radiation, the Associated Press reported Friday. Excessive environmental radiation occurs naturally, caused by decay in the earth's core.
Defibrillators are small devices that send electric jolts to the heart when the organ begins beating irregularly. St. Jude, headquartered in St. Paul, Minn., said the affected devices -- the Photon DR, Photon Micro VR/DR, and the Atlas VR/DR -- may soon be recalled by the U.S. Food and Drug Administration. An FDA spokesman was not available for comment, the wire service said.
Testing has indicated that about 60 of the 36,000 devices produced by St. Jude may be affected, the AP said. The problem lies with a faulty memory chip. The company has advised doctors to remove the device if they find it has been automatically reset because of a power drain.
In June, another defibrillator manufacturer, Guidant Corp. of Indianapoplis recalled 88,000 heart defibrillators, also because of electrical defects. The FDA is investigating whether Guidant deliberately withheld knowledge of the defects, HealthDay has reported.
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Legionnaire's Disease Most Likely Cause of Canadian Nursing Home Deaths
Legionnaire's disease is most likely behind a recent series of deaths at a Toronto nursing home, city health officials said Friday.
On Wednesday, six more elderly residents at the Seven Oaks Home for the Aged died from the respiratory illness, bringing the total to 16 fatalities. Dr. David McKeown, chief medical officer for Public Health Toronto, said there could be more deaths before the lethal bacteria that causes the disease was contained, the Associated Press reported.
In all, some 70 residents, 13 employees and five visitors to the home have been stricken, and at least 45 remain hospitalized, the AP said.
After preliminary tests, officials had initially ruled out Legionnaires, but changed their minds after autopsy cultures came back positive, the wire service said.
Legionnaire's is a type of pneumonia named after it was first diagnosed in 1976 at a meeting of the American Legion in Philadelphia. Thirty-four people who attended that convention died from the disease. The germ grows in warm water and tends to harbor in plumbing, heating and air conditioning systems.
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Politics Trumping Science in 'Plan B' Decision: Ex-FDA Consultant
Politics is overriding science in delaying approval of the "Plan B" contraceptive for over-the-counter sales in the United States, said Dr. Frank Davidoff, who cited the issue as his reason for resigning as consultant to the U.S. Food and Drug Administration's Nonprescription Drugs Advisory Committee.
Davidoff, editor emeritus of the journal Annals of Internal Medicine, resigned in September after the FDA said it was indefinitely delaying a decision on over-the-counter sales of Plan B, an emergency, morning-after contraception, the Associated Press reported.
The FDA announcement was made despite recommendations from scientists that Plan B is safe. Many U.S. religious conservatives oppose the drug.
"There wasn't any observable scientific or procedural reason for (the FDA) to first decline and then further delay the decision. I had to make the inference this was a decision that was made on the basis of political pressure, and it seemed to me that was unacceptable," Davidoff told the AP.
He's the second person to publicly resign over the Plan B issue. In late August, Susan Wood, the top FDA's top women's health official, also resigned in protest over the agency's handling of Plan B.
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Lab Tests Confirm E. Coli in Prepackaged Lettuce
Laboratory tests found E. coli bacteria in two bags of Dole prepackaged lettuce, says the U.S. Department of Agriculture. The two bags that were tested had the same "best if used by" date as bags of Dole prepackaged lettuce suspected as the cause of an E. coli outbreak in Minnesota.
"As far as we know, this is the first time a laboratory has been able to isolate E. coli from lettuce in an outbreak," Kevin Elfering, the USDA's dairy, food and meat inspection director, told the Associated Press.
"This is the proverbial 'smoking gun' that we try to identify in every outbreak we investigate," Elfering said.
The Minnesota outbreak has resulted in 17 confirmed cases of E. coli and eight people have had to be hospitalized. One person developed a severe complication that can lead to kidney failure, the AP reported.
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More Americans Are Becoming Active: CDC
Physical inactivity -- a risk factor for heart disease, osteoporosis, and diabetes -- has fallen an average of 0.6 percent per year during the past 11 years as more Americans find that it's wise to exercise, the U.S. Centers for Disease Control and Prevention said Thursday.
In 2004, the percentage of survey recipients who declared themselves "inactive" had fallen to decade-low rates of 21 percent of men and 26 percent of women, the CDC said in its Morbidity and Mortality Weekly Report.
While the trend is improving, too many people are still inactive, the agency said. Among people age 70 and older, 30 percent said they didn't exercise. In addition to being at high risk for the chronic diseases mentioned above, inactive older adults are also at greater risk of disability, loss of muscle mass, and falling, the CDC said.
Both the agency and the American College of Sports Medicine recommend 30 minutes of moderate-intensity exercise, such as brisk walking, on most, and preferably all, days of the week. Regular exercise, even if begun in a person's later years, can offer significant health benefits, the CDC said.
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Illinois Gov. Proposes Universal Child Health Insurance
Illinois Gov. Rod Blagojevich is proposing to make Illinois the first state to offer universal health coverage for children, the Associated Press reported Thursday.
The Democratic governor's "All Kids" program would cover 250,000 of the state's children who currently lack health insurance, the wire service said. The plan would target families that don't earn enough for private coverage but earn too much for state-subsidized insurance.
The cost, estimated at $45 million in the first year, would be offset by using managed care programs to cut $56 million from the state's health programs, the AP reported, citing a statement from Blagojevich.
Parents of uninsured children would be able to buy insurance from the state with premiums and deductibles that are much lower than those offered by the private sector, the statement said.
Take Time to Pick the Right Health Plan
At open enrollment and every time you switch jobs, your employer offers you a choice of health plans, with varying premium requirements, co-payment levels and benefits. How do you choose the best option for you and your family?
Is cost what counts in the decision-making process or should workers scrutinize benefits?
"They should look at both," said Ed Kaplan, national health practice leader with Segal Co., a health benefits consulting firm based in New York City.
As medical costs continue to outpace annual growth in general inflation, many businesses are scaling back their financial commitments to workers. As a result, employees are facing steeper out-of-pocket costs and sometimes reductions in benefits. To know what they're really getting, workers must closely examine the available health insurance options.
"There's much more at stake today," Kaplan said. "You could end up picking a plan that costs you $1,000 more each year out of your pocket," compared with a plan that you might think was more costly, he said.
On the cost side, Kaplan advises people to compare the amount that the company will deduct from their paycheck every month under each health plan option. But don't stop there. Workers also need to look for co-payments and benefit limitations or exclusions, which could end up costing them a lot more, he said.
For example, say you've narrowed your choice to two plans, one requiring a $60 monthly premium contribution and another that will cost you $100 a month. You might be leaning toward the $60 plan based on the lower payroll deduction. But if that plan requires a lot of co-payments and excludes a service or prescription drug option you know you may need, opting for the plan with the lower premium contribution could be a shortsighted decision.
Workers typically share the cost of physician office visits, prescription drugs and even hospital admissions with their employer through a fixed-dollar co-payment. In 2004, more than a quarter of covered workers were in a health plan with a co-payment of $20 to see a doctor, according to a survey by the Kaiser Family Foundation and the Health Research and Educational Trust (HRET).
Some employer health plans have switched to "coinsurance," in which employees share a percentage of their medical care expenses after meeting the deductible. For example, if the health plan picks up 80 percent of the cost of services, the worker must pay the remaining 20 percent.
As for benefits, consultants urge employees to learn about any exclusions or limits ahead of time.
In 2004, for example, just over a quarter of all employers and roughly half of large employers covered gastric bypass surgery, a popular treatment for severe obesity, a survey by Mercer Human Resource Consulting found. But large employers that cover the surgery increasingly are limiting eligibility to individuals who have met certain prerequisites, such as participating in a behavior modification program, the survey showed.
Employees also should assess whether a health plan's network of doctors will accommodate their needs, Kaplan added. If the plan has a limited number of health-care providers, find out what it's going to cost you to see an out-of-network physician.
Traditionally, he explained, employers offered a 70 percent to 80 percent out-of-network benefit and capped the employee's total out-of-pocket expense at some dollar amount; at that point, the plan would resume 100 percent coverage. Now, it's more common to see a 50 percent out-of-network benefit with no cap on how much employees can spend, he said.
"If there's a network that's got deep discounts and lower prices, but it's such a limited choice of providers that you end up using out-of-network providers, what good is it?" Kaplan asked rhetorically.
Whatever you decide, consultants say it pays to do your homework. Many large employers now offer consulting services or online tools to help their workers make more informed health decisions.