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Click World News (Free subscription) | 20/11/2009
It certainly won't come as much of a surprise to readers around here that lobbyists from Roche/Genentech were able to get 42 different members of Congress to include text they had written into the Congressional Record. For way too long, we've seen how much politicians seem to rely on lobbyists to write the legislation, create the talking points and (at times) even deferring questions to the lobbyists...
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The Street (Free subscription) | 20/11/2009
Costco flattens Coke; Genentech speaks Washington's language; GM's payback jive; the (Double) Cheeseburger Rebellion; and Kellogg waffles on Eggo.
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Medical News Today (Free subscription) | 20/11/2009
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. 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...
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Star Tribune (Free subscription) | 18/11/2009
Neither company disclosed the specific nature of the FDA's "complete response letter," which is typically a request for some type of information or input. The companies did say the FDA is not asking for new data on the drug and that it is still in discussion over the drug's labeling.
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Seattle Post-Intelligencer (Free subscription) | 18/11/2009
NEW YORK -- Genentech Inc. and partner Biogen Idec Inc. said Wednesday the Food and Drug Administration is withholding a decision to expand approval of Rituxan as a leukemia treatment, pending further discussion.
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San Fransisco Chronicle (Free subscription) | 18/11/2009
Genentech Inc. and partner Biogen Idec Inc. said Wednesday the Food and Drug Administration has asked for more information before considering approving Rituxan as a leukemia treatment. The drug is already approved as a treatment for rheumatoid arthritis and... BiogenIdec - Food and Drug Administration - Genentech - Rituximab - Health
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Business Wire (Free subscription) | 18/11/2009
SOUTH SAN FRANCISCO, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies’ applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment...
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Dispatches from the Culture Wars (Free subscription) | 18/11/2009
Marcy Wheeler does a brilliant job of mining the transcripts of the healthcare reform debate to show that Republican legislators were literally reading from a script written for them by lobbyists from Genentech. One after another they took to the podium to parrot the exact same phrases Genentech wanted them to parrot. From a post entitled What a Roomful of Republican Biotech-Paid Whores Looks Like...
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post-gazette.com (Free subscription) | 18/11/2009
Health-care reform was always going to be difficult to achieve, but it may yet turn out to be the best that money can buy -- except that it may be special-interest money buying what it wants, not promoting the public interest. If the public ever lacked for an example of this sad state of affairs, a New York Times story on Sunday provided one. It chronicled how statements submitted by lawmakers to...
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Firedoglake (Free subscription) | 17/11/2009
At least four of the Representatives who inserted Genentech's script into the Congressional Record have had parties thrown by Genentech lobbyists this year.
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Fiercebiotech (Free subscription) | 17/11/2009
In a move designed to demonstrate bipartisan support for provisions in a healthcare bill that includes 12 years of market exclusivity for biologics, Genentech was able to persuade some 22 Republicans and 20 Democrats in Congress to insert virtually identical language into the official record voicing their support. Covering the lobbying blitz , the New York Times found an e-mail message from one of...
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Contract Pharma Breaking News (Free subscription) | 17/11/2009
Genentech has submitted two sBLAs to the FDA for Avastin for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that evaluated Avastin in combination with docetaxel chemotherapy. The other is based on the Phase III study RIBBON 1 that investigated Avastin in combination...
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Medical News Today (Free subscription) | 17/11/2009
Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment)....