FDA Gives Positive Review of Colitis Drug in Kids
Posted on 19. Jul, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Infliximab (Remicade) appears to work just as well in children with ulcerative colitis as it does in adults and doesn’t seem to offer any new safety risks, FDA reviewers said.
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Washington Week: ACA Ruling, FDA Panel Move Top News
Posted on 02. Jul, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The first federal appeals court to rule on the healthcare reform law upheld the constitutionality of the individual mandate, and an FDA panel recommended that bevacizumab (Avastin) no longer be used to treat breast cancer.
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Medicare to Keep Paying for Avastin
Posted on 30. Jun, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — Medicare will continue to pay for bevacizumab (Avastin) when it’s used to treat metastatic breast cancer, even if the FDA decides to remove that indication from the drug, a spokesman for the Centers for Medicare and Medicaid Services (CMS) said.
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FDA Panel Votes to Yank Avastin’s Breast Cancer Indication
Posted on 29. Jun, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — An FDA advisory committee has voted unanimously, 6-0, that Genentech’s bevacizumab (Avastin) should no longer be approved to treat metastatic HER2-negative breast cancer.
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FDA Unswayed by Pleas to Retain Breast Ca Indication
Posted on 28. Jun, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — SILVER SPRING, Md. — FDA officials held firm in their view that bevacizumab (Avastin) should not be used to treat breast cancer during a heated first day of a two-day hearing, at which breast cancer patients pleaded with the agency to keep the drug available.
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FDA to Look Again at Drug’s Breast Ca Indication
Posted on 27. Jun, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The FDA’s Center for Drug Evaluation and Research is holding a two-day hearing this week at the request of bevacizumab (Avastin) maker Genentech to reconsider its decision to rescind the drug’s breast cancer indication.
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Washington Week: Busy Week for the Supreme Court
Posted on 25. Jun, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — The Supreme Court ruled this week that physician prescribing information is free speech under the First Amendment and also handed down a ruling in favor of generic drug companies. Meanwhile, the FDA said there is no new evidence that breast implants are harmful, and a congressional committee launched an investigation into the FDA approval of a spine device.
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FDA Panel Endorses Novel HAE Drug
Posted on 24. Jun, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — An FDA advisory committee has voted 12-1 to recommend approval for icatibant (Firazyr) to treat hereditary angioedema (HAE) attacks.
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FDA Sees No New Safety Signals for Silicone Breast Implants
Posted on 22. Jun, 2011 by Dr. Ellis in News and Updates
(MedPage Today) — The FDA’s preliminary review of postmarketing safety studies on silicone breast implants, released Wednesday, found no evidence that the products increase the risk of breast cancer, reproductive abnormalities, or other problems.
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Device Makers Grumble over FDA Processes
Posted on 13. Jun, 2011 by Dr. Ellis in News and Updates
WASHINGTON (MedPage Today) — When Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health addressed a conference of small device companies recently, he assured them, “We get it.”
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