Posts Tagged ‘drug’
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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, December 10th, 2011 at 08:02 | Comments Off
What is Plan B, Anyway? (And Can Guys Buy It?)Categories: Wall Street Journal
Plan B became the week’s big health story when, as the WSJ reported, the head of HHS overruled the FDA and blocked the emergency contraceptive pill from being made available to teens under 17 without a prescription.
President Obama joined the fray yesterday, when he said he didn’t influence HHS Secretary Kathleen Sebelius’s decision, but agreed with it. (We heard from plenty of you when we asked whether Sebelius was right.)
Here are answers to some basic questions about Plan B.
What is ..read more
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Saturday, November 26th, 2011 at 02:03 | Comments Off
Countdown to Generic Lipitor: What Are Your Questions?Categories: Wall Street Journal
When we wrote back in 2008 that Lipitor would face generic competition on Nov. 30, 2011, that date seemed a long way off. Now, it’s imminent.
Pfizer has been making plans to keep as many people as possible on the branded version of the anti-cholesterol blockbuster, even after the drug loses patent protection. For example, the pharma company is partnering with a specialty pharmacy to mail Lipitor to patients who order the drug directly from the pharmacy. And it is already ..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 00:37 | Comments Off
A.M. Vitals: Human Stem Cells Ease Parkinson’s Symptoms in RodentsCategories: Wall Street Journal
Human Cells, Rodent Brains: Research published in Nature describes how scientists treated Parkinson’s disease in mice and rats by converting human embryonic stem cells into nerve cells that released the neurotransmitter dopamine, then transplanting the cells into the rodents’ brains, the WSJ reports. Further animal studies are necessary before the technique could be tested in humans, the paper says.
MRSA and the Flu: Research published in Pediatrics finds infection by MRSA increased the chances that a previously healthy ..read more
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Wednesday, October 19th, 2011 at 09:50 | Comments Off
Does a Company Have a Soul?Categories: Wall Street Journal -
Monday, September 26th, 2011 at 22:26 | Comments Off
A.M. Vitals: Mela Sciences’ Melanoma Diagnostic On Track For ApprovalCategories: Wall Street Journal
A Path to Approval: Reversing an earlier decision, the FDA has cleared a path to approval for a medical device made by Mela Sciences that aims to help doctors more accurately diagnose melanoma, the WSJ reports. MelaFind is “approvable” pending some final negotiations, the FDA told the company last week; previously the agency had called on the company to conduct a large new study. The device is already approved for use in 27 European countries, the paper ..read more
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Tuesday, August 9th, 2011 at 06:37 | Comments Off
How Vulnerable Are Pharma Stocks to Fiscal Austerity?Categories: Wall Street Journal
At first blush, Washington’s tough talk about fiscal austerity doesn’t look good for drug makers. Government programs including Medicare and Medicaid spend $99 billion each year on prescription medicines, according to Washington consulting firm Avalere Health, making for a ripe cost-cutting target.
Not surprisingly, drug stocks have dropped with the rest of the market recently. As the WSJ reports, pharma companies have ramped up their lobbying, warning that cuts to the drug prices paid by Medicare’s drug benefit, for example, could ..read more
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Tuesday, August 9th, 2011 at 06:21 | Comments Off
Hospital Blood Tests Tied to Anemia in Heart-Attack PatientsCategories: Wall Street Journal
Ask anyone who’s spent time in the hospital — patients get a lot of blood taken over the course of their stay.
A blood test can provide crucial information that can’t be gotten any other way. But sometimes there may be a downside. A study of heart-attack patients just published online by the Archives of Internal Medicine finds that blood loss from diagnostic tests is associated with acquiring anemia in the hospital. And anemia — a decrease in the red blood ..read more

