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11/2 Amgen: Whistleblower Suit Claims Convoluted Kickback Scheme
Amgen Is Accused of Illegal Kickbacks ...tiny extra amounts of the drug in each vial. The medical practices could then make a profit by billing insurers, including state Medicaid programs, for the extra drug …[NY Times]
Amgen sued by California and 14 other states over anemia drug … overfill allowed doctors, hospitals and other medical providers to bill their patients' insurers for medicine that the provider had essentially gotten free …[LA Times]
See Also: Similar Report From Bloomberg
11/2 As If That Weren't Bad Enough…
A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease … fatal or nonfatal stroke was more likely to occur in the patients assigned to darbepoetin alfa (101 patients [5.0%] vs. 53 patients [2.6%]; hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001)…[NEJM.ORG 10.1056/NEJMoa0907845]
Anemia Drug May Raise Stroke Risk in Kidney Patients … 101 patients taking Aranesp had a fatal or non-fatal stroke compared with 53 of the placebo patients … benefits we assumed we would have by treating anemia were less striking … [Atlanta Journal-Constitution]
Study finds stroke risk from anemia drug Aranesp …[AP]
11/2 2X/ Day Telaprevir Practically Good 3X/ Day Regimen
Vertex hep C drug works well in twice daily dosing … nearly equally effective in a twice daily regimen as three times a day, knocking out the virus in more than 80 percent of patients…[Reuters]
11/2 Complete Response Letter: Peg Intron For Skin Cancer
FDA concerns remain over new use for Schering drug …FDA staff reviewers also questioned whether the drug actually helped people live longer or just increased the time before cancer recurred…[Reuters]
11/2 Glaxo Biggest Money Maker In H1N1 Vaccine (But Not In USA)
Glaxo takes biggest slice of swine flu market … ($1.66 billion) of H1N1 vaccine sales in the fourth quarter … orders totalling more than 440 million doses. The developed world price is about 5 pounds a dose…[Reuters]
Q: Why does Glaxo sell very little vaccine in the USA"
A: Click HERE
11/2 Actos Running Out Of Steam?
Takeda holds forecast, drugs outlook still tough … Actos, will lose its U.S. patent protection towards the end of the next business year to March 2011 … tough sales conditions in Japan and the United States, its two main markets …[Reuters]
11/2 Why Pfizer CEO Likes Obamacare
Pfizer backs US health reform … rejected suggestions from critics that there would be "an enormous offsetting windfall from new customers"… stressed the importance in the final healthcare legislation of avoiding price controls …[FT]
11/2 AZN To Pay $520 Mln Fine In Seroquel Whistle Blower Case
AstraZeneca Pays Millions to Settle Seroquel Cases … e-mail message showed a company official saying "a great 'smoke and mirrors' job' " had been done on a "buried" study in 1997, the year the F.D.A. approved Seroquel …[NY Times]
Yet Another Qui Tam Grand Slam … one of the investigations related to "selected physicians who participated in clinical trials involving Seroquel ...the other case related to off-label promotion of the drug …[Wall Street Journal; FREE]
11/2 Sanofi Boss: Blockbuster Schmockbuster
Living Without Blockbusters … Sanofi-Aventis' Christopher Viehbacher is slashing R&D and moving into emerging countries … Sanofi, like most drugmakers, has been unable to invent new medicines that will make up sales lost to generic versions of old ones …[Forbes]
11/2 Shire Subpoenaed Over ADD Stable
Shire Subpoenaed In U.S. Drug Marketing Probe … sking it for documents related to the sales and marketing of Adderall XR, Daytrana and Vyvanse, three drugs for attention deficit hyperactivity disorder, or ADHD …[NASDAQ]
11/2 Skinny On 3 Hopeful Slimming Pills
Obesity drugs lumber toward marketplace … one or more new weight-loss drugs may become available next year … three leading candidates for approval: … Lorcaserin… Qnexa… Contrave…[ LA Times]
Editor's Note: Overview of the 3 obesity drugs closest to approval, who makes them and their relative efficacy.
11/2 Internet Drug News Miscellaneous Short Takes:
Abbott sues Impax Labs over generic TriCor
AP
Biogen, Elan's Drug Linked to 24 PML Cases, 4 Deaths
Bloomberg
Shire Gains on Gaucher Drug's Prospects Amid Genzyme Shortage
Bloomberg
Byetta Gets 1st Line Indication
Amylin Press Release
Epidemic of Sexually Transmitted Hepatitis C Infection in HIV-infected Men
American Association for the Study of Liver Diseases Press Release
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