Genentech & Biogen Idec get complete response lett...

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Sunday, March 14, 2010 8:48 AM

Published Nov 21 2009 by PharmaBiz

Genentech & Biogen Idec get complete response letter from US FDA for Rituxan to treat CLL

Genentech, Inc, a wholly-owned member of the Roche Group and Biogen Idec announced that the US Food and Drug Administration (FDA) issued a complete response on the companies' applications for Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukaemia (CLL). The US FDA has not requested...

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First Reported Mar 12 2010 - Updated 19 hours ago - 6 Documents

Plavix is given FDA's strongest warning

The Food and Drug Administration is adding its strongest warning to the label for Plavix, cautioning that some patients do not respond to the blood thinner.The FDA said Friday that certain patients with a genetic variation cannot metabolize the drug, ... [Published 19 hours ago by Baltimore Sun]

Entities: Plavix, Food and Drug Administration, Enzyme, Heart Attack

First Reported Mar 12 2010 - Updated 15 hours ago - 7 Documents

Medtronic Inc

FDA Advisory Panel Approves Medtronic Brain Stimulation Implant (MDT)

FDA Advisory Panel Approves Medtronic Brain Stimulation Implant (MDT) ... [Published 16 hours ago by FOXBusiness.com]

Entities: Medtronic Inc, Food and Drug Administration

First Reported Mar 12 2010 - Updated Mar 13 2010 - 6 Documents

FDA adds boxed warning to Plavix

ROCKVILLE, Md. (Mar. 12) A popular drug for preventing blood clots may be less effective when taken by a small percentage of patients, the Food and Drug Administration warned healthcare professionals and patients Friday.The Food and Drug Administration ... [Published Mar 12 2010 by Drug Store News]

Entities: Plavix, Food and Drug Administration, Enzyme, Center for Drug Evaluation and Research, Clopidogrel

First Reported Mar 12 2010 - Updated Mar 12 2010 - 5 Documents

Office of Criminal Investigations

FDA Warning: Fake Surgical Mesh

The U.S. Food and Drug Administration is warning surgical facilities that counterfeit polypropylene surgical mesh products have been distributed under the Bard Davol brand.The agency and the Murray Hill, N.J.-based manufacturer have at present identified ... [Published Mar 12 2010 by Outpatient Surgery]

Entities: Food and Drug Administration, Counterfeit, Murray Hill (United States), Office of Criminal Investigations

First Reported 20 hours ago - Updated 4 hours ago - 2 Documents

Food and Drug Administration

FDA Update on the Salmonella Outbreak Investigation

As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I. Â ... [Published 4 hours ago by Chem.info]

Entities: Salmonella, Food and Drug Administration, Montevideo (Uruguay)

First Reported Mar 12 2010 - Updated Mar 12 2010 - 3 Documents

Genentech Inc

Late-stage clinical trial of Avastin fails to meet expectations, Genentech says

SOUTH SAN FRANCISCO, Calif. (Mar. 12) A late-stage clinical trial of a Genentech drug for men with late-stage prostate cancer has failed, the biotech company announced Friday.Genentech, part of Swiss drug maker Roche, announced that a phase 3 trial of ... [Published Mar 12 2010 by Drug Store News]

Entities: Genentech Inc, prednisone, Chemotherapy, docetaxel

First Reported Mar 12 2010 - Updated Mar 12 2010 - 3 Documents

FDA Announces New Boxed Warning on Plavix / Alerts patients, health care professionals to potential for reduced effectiveness

SILVER SPRING, Md., March 12 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective ... [Published Mar 12 2010 by FinanzNachrichten.de]

Entities: Plavix, Food and Drug Administration, Health Care, Metabolism

Blogs

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NYT: Genentech Wrote Lawmaker Statements [Under The Influence - Nov 15 2009] The lobbyists working for Genentech must be feeling pretty good. The New York Times says that lobbyists working for Genentech put words into the mouths of lawmakers ...
FDA Social Media Guidelines Best Done in Baby S... [Pharma Marketing Blog - Nov 14 2009] In his closing remarks at yesterday's public hearing on FDA regulation of social media, Tom Abrams, Director of FDA's Division of Drug Marketing, Advertising, and ...
FDA Intern & the Next Steps Toward Pharma S... [Pharma Marketing Blog - Nov 22 2009] Now that the big FDA public hearing is over, many people are asking "What's the next steps?" If you are like me, you expect FDA to issue new guidance. My friend ...
Genentech's Revised and Extended Remarks [Daily Kos - Nov 16 2009] An already controversial component of the healthcare reform bill in the House has gotten more so, with the revelation over the weekend in the New York Times that ...
Debate on food safety - Our view: How many sick... [USATODAY.com - Opinion - Nov 24 2009] Our view on food safety: How many sick school kids kids does it take to get FDA regulators to act? Tortilla case illustrates what’s wrong with food inspection system. ...

Audio/Video

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Mainstreaming Psychedelics: From FDA to Harvard... [Google Tech Talks - YouTube - Nov 18 2009]
Rep. Melancon Reacts to FDA Decision to Hold Oy... [Rep. Charlie Melancon - YouTube Channel - Nov 17 2009]

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