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CMS Will Hold A Meeting To Review Provenge
Wednesday, September 1st, 2010
Now that the Centers for Medicare & Medicaid Services has caused a ruckus by unexpectedly conducting a so-called National Coverage Analysis for the Provenge prostate cancer vaccine, the agency last night posted an announcement on its web site that a Nov. 17 meeting will be held to review on-label and off-label use of the Dendreon product.
Posted in: Regulatory | 0 Comments »
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Deborah Dunsire – Top 10 Women in Biotech
Monday, August 30th, 2010
Name: Deborah Dunsire Current Company: Millennium, the Takeda Oncology Company Title: President and CEO Profile:
Posted in: Pharma News | 0 Comments »
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Avandiagate: Glaxo And A Controversial Memo
Monday, August 23rd, 2010
Avandiagate, as some have called it, appears to be never ending. In the latest twist, a letter and accompanying memo that GlaxoSmithKline wrote and distributed at the behest of the FDA is now itself the subject of a flap because some experts say the contents are misleading
Posted in: Regulatory | 0 Comments »
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UT team tackles therapeutic Parkinson’s vaccine
Thursday, August 12th, 2010
Investigators engaged in preclinical studies have already seen how blocking a particular protein can reduce the level of nerve damage associated with Parkinson’s disease. Now researchers at the University of Texas Health Science Center at Houston want to see if that same approach can be
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UTHealth biotech center fills out with startups
Monday, July 26th, 2010
Just shy of a year after its formation, the Biotechnology Commercialization Center at The University of Texas Health Science Center at Houston, or UTHealth, is nearing capacity.
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OHSU Knight Cancer Institute gets $7.75 million in grants
Thursday, July 15th, 2010
The Knight Cancer Institute at Oregon Health & Science University has received $7.75 million in grants to fund breast cancer research and to explore treating leukemia, lymphoma and myeloma.
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And so the residual fallout from Avandia starts….
Thursday, July 15th, 2010
“ In making this plea to keep Avandia on the market, I believe I am pleading for my lif e.” For people like himself, he said, pulling Avandia would be a “death sentence.” Chuck Keyserling telling the advisory panel he had taken Avandia for the past 10 years. Then there is this line from today’s NY Times Editorial section: The clearest lesson to emerge from the hearings and other recent revelations is that GlaxoSmithKline, the maker of Avandia, can’t be trusted to report adverse clinical results fairly.
Posted in: DTC | 0 Comments »
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IOM – Ethical Issues in Studying Safety of Approved Drugs
Tuesday, July 13th, 2010
Just as an FDA Advisory Committee is mixing a batch of Avandia soup at a hearing held today to discuss and review the post-marketing safety of the drug, the Institute of Medicine (IOM) has issued a letter report on the ethical issues involved in the study of safety in drugs that are already approved and on the market.
Posted in: Regulatory | 0 Comments »
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An Avandia Study Author…Or So We Thought?
Tuesday, July 13th, 2010
Steve Haffner played a relatively modest role in the Avandia scandal, but until now, he was known primarily for leaking to GlaxoSmithkline the damaging meta-analysis of the diabetes pill that was published in The New England Journal of Medicine three years ago. Haffner later acknowledged breaching his responsibility as a peer reviewer, but blamed “bad judgment” because he wasn’t “feeling well.” In doing so, Glaxo was able to respond very quickly to the disclosure ( back story ). As it happens, Haffner felt just fine several years earlier when he allegedly had an Avandia study ghostwritten for him
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The Cholesterol Debate And Journal Disclosures
Wednesday, June 30th, 2010
Earlier this week, the Archives of Internal Medicine published a few articles and editorials about statins, although one, in particular, generated some heat – a review of the controversial Jupiter study from 2008. The study, which focused on AstraZeneca’s Crestor cholesterol pill, measured levels of a protein called CRP that can indicate arteries are inflamed and point toward heart disease. The results prompted debate over the extent to which CRP should be used as a guideline for treating cholsterol and the wisdom in prescribing Crestor and other statins to people with low cholesterol.
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