Posts Tagged ‘Fda’
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Wednesday, February 1st, 2012 at 07:41 | Comments Off
FDA Approves Vertex’s Kalydeco, But It Won’t Come CheapCategories: Wall Street Journal
A young patient holds Kalydeco, a cystic-fibrosis treatment from Vertex just approved by the FDA.
Certain cystic-fibrosis patients will now have an FDA-approved treatment that targets an underlying cause of their disease.
But that drug — Kalydeco, from Vertex Pharmaceuticals — won’t come cheap.
As Dow Jones Newswires reports, the annual cost will be $294,000. Vertex has set up a patient-assistance program to help patients pay for the treatment.
Kalydeco was approved to treat the estimated 4% of cystic-fibrosis patients who have a mutation ..read more
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Saturday, January 28th, 2012 at 09:19 | Comments Off
FDA (Finally) Gives Amylin’s Bydureon a Thumbs-UpCategories: Wall Street Journal
Bydureon, the once-weekly injection for treating patients with type 2 diabetes, has finally won the FDA’s okay.
As Dow Jones Newswires reports, it’s been a long, bumpy road to approval for the drug’s developer, Amylin Pharmaceuticals.
(Alkermes is behind the extended-release technology used to deliver the drug, a longer-acting version of Amylin’s twice-daily Byetta.)
Amylin started working on the drug in 1999 and first applied for FDA approval — with its then-partner Lilly — a decade later. But the agency in 2010 said ..read more
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Saturday, January 28th, 2012 at 08:35 | Comments Off
What Are the Obstacles to Digital Health Records?Categories: Wall Street Journal
What’s standing in the way of the wider spread of health IT?
Plenty of things, according to a new report from the Bipartisan Policy Center. The report says boosting use of electronic medical records and other health IT “enjoys bipartisan support.” It’s also being pushed by billions of dollars in government incentives.
The assumption is that health IT can help improve health outcomes, improve the experience of care and save money. But there are gaps and barriers to its effective use, the ..read more
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Friday, January 20th, 2012 at 00:39 | Comments Off
A.M. Vitals: FDA Wants More Data on Diabetes Drug from Bristol-Myers, AstraZenecaCategories: Wall Street Journal
Seeking More Data: The FDA wants more information about an experimental diabetes drug from Bristol-Myers Squibb and AstraZeneca before considering it for approval, Dow Jones Newswires reports. The companies said the agency wants more clinical data in order to better assess the risks and benefits of dapagliflozin, which is a new type of therapy for diabetes, and that they remain committed to the drug. An FDA advisory panel voted against approving the drug in July, raising safety ..read more
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Thursday, December 15th, 2011 at 15:59 | Comments Off
GAO Report Blames Drug Shortages On Manufacturing ProblemsCategories: Wall Street Journal
Central to the drug-shortage issue is a chicken-and-egg question that often leaves legislators scratching their heads at congressional hearings.
Chicken: Are the shortages of crucial drugs caused by factory flaws and shutdowns? Or egg: Are shortages somehow caused by economics, like the thin profit margins of generic drugs?
A federal report to be released Thursday comes down with both feet in the chicken camp.
“Manufacturing problems were the primary cause of most shortages,” says an analysis by the Government Accountability Office. And how ..read more
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Thursday, December 8th, 2011 at 10:12 | Comments Off
Reader Consult: Was Sebelius Right to Block Broader Plan B Availability?Categories: Wall Street Journal
The good news for Teva: the FDA agreed with the pharma company that Plan B One-Step, a pill intended to prevent potential implantation of a fertilized egg, should be sold over the counter and without a prescription to teens younger than 17.
The bad news for Teva, as the WSJ reports: HHS head Kathleen Sebelius didn’t agree, and overruled the agency’s recommendation. So Plan B will continue to be sold from behind pharmacy counters, and those under 17 will need a ..read more
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Thursday, December 8th, 2011 at 00:45 | Comments Off
A.M. Vitals: Breast Cancer Research Covers Radiation TreatmentCategories: Wall Street Journal
Breast-Cancer Developments: Research presented at the San Antonio Breast Cancer Symposium found that a genetic test called Oncotype DX can help pinpoint the patients with ductal carcinoma in situ, a very early form of breast cancer, who stand to benefit from post-surgical radiation treatment, the WSJ reports. Meantime, a separate study found that partial radiation therapy known as brachytherapy may be associated with an increased risk of a subsequent mastectomy compared to women who had standard radiation ..read more
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Saturday, November 19th, 2011 at 05:13 | Comments Off
What Does the FDA’s Avastin Decision Mean for Breast Cancer Patients?Categories: Wall Street Journal
The Food and Drug Administration’s decision to revoke approval of Roche’s Avastin for advanced breast cancer is likely to curtail use of the $6 billion-a-year drug for such patients. But it’s not likely to put an end to prescribing.
Today’s action doesn’t affect the drug’s other approved uses, which include certain types of colon, lung, kidney and brain cancers, the FDA said. And physicians are free to prescribe an approved drug for any use they see fit.
One question, ..read more
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Tuesday, November 8th, 2011 at 07:25 | Comments Off
New Cigarette Warnings On Hold After Judge’s RulingCategories: Wall Street Journal
Next September tobacco companies were due to start using graphic warnings on cigarette packs and in ads that highlighted the consequences of smoking and of secondhand smoke.
That may not happen now that a federal judge issued a preliminary injunction keeping the FDA from implementing the changes. As the WSJ reports, U.S. Judge Richard J. Leon sided with five tobacco companies — including Lorillard and Reynolds American — in their request that the new rules be put off until the court ..read more
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Monday, October 31st, 2011 at 23:32 | Comments Off
A.M. Vitals: Japan Finds Radiation Cleanup DifficultCategories: Wall Street Journal
Figuring Out a Cleanup: Efforts in Japan to figure out how to properly and quickly clean up the radiation from the Fukushima Daiichi nuclear accident have been hampered by a lack of leadership and diluted accountability, the WSJ reports. Making efforts even more difficult is uncertainty about the levels of contamination that pose a health hazard, the paper says.
Tackling Shortages: In order to deal with the increasing problem of drug shortages, President Obama will issue an executive ..read more
