U.S. Supreme Court Rejects Amgen Challenge to Securities Suit | Fox Business
via foxbusiness.com The suit, brought by Connecticut pension funds on behalf of purchasers of Amgen stock, alleged the Thousand Oaks, Calif., company repeatedly reassured investors about the safety of anti-anemia drugs Aranesp and Epogen even as clinical trial data raised concerns that the drugs could harm cancer patients who were taking them. Amgen's statements led to inflated share prices, the suit alleged. Read more: http://www.foxbusiness.com/news/2013/02/27/us-supreme-court-rejects-amgen-cha... Posted via email from Jack's posterous (Source: PharmaGossip)
Source: PharmaGossip - February 27, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
A Mystery About Affymax & Its Anemia Drug Recall
Late yesterday, the FDA disclosed that Affymax and its marketing partner, Takeda Pharmaceuticals, issued a so-called voluntary recall of their Omontys medication, which is used to treat anemia in adult dialysis patients, after there were 19 reports of anaphylaxis, a serious and life-threatening allergic, at dialysis centers in the US. Three of the cases ended in death and several other patients required hospitalization (here is the FDA statement).
Not surprisingly, the recall is killing Affymax (AFFY) stock, since the drugmaker was hoping to penetrate a huge market dominated by billion-dollar-sellers such as Epogen and Ara...
Source: Pharmalot - February 25, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Affymax Amgen Anemia Aranesp Biosimilars Epogen FDA JJ Johnson & Johnson Omontys Procrit Takeda Pharmaceuticals Source Type: blogs
Amgen Settlement and Corporate Integrity Agreement
Adding to the long list of pharmaceutical settlements involving off-label promotion, Amgen Inc., the world’s largest biotechnology company, recently entered into a settlement agreement with the U.S. Department of Justice to resolve criminal liability and false claim act allegations involving its improper promotion of certain drugs. Amgen, a biotechnology company, agreed to pay $762 million—the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history, according to the announcement.
Amgen entered a guilty plea before U.S. District Judge Sterling Johnson of the...
Source: Policy and Medicine - February 19, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
#175: Apixaban approved: Now, which anticoagulant to use?; darbepoetin alfa disappoints in RED-HF; suspect thrombus with signs of early valve degeneration after TAVI; half of cardiology practices now integrated with hospitals
Apixaban approved: Now, which anticoagulant to use?; darbepoetin alfa disappoints in RED-HF; suspect thrombus with signs of early valve degeneration after TAVI; half of cardiology practices now integrated with hospitals (Source: Blogs@theHeart.org)
Source: Blogs@theHeart.org - January 25, 2013 Category: Cardiology Authors: theheart.org Tags: This week in cardiology from heartwire Source Type: blogs
How the "Revolving Door" and Other Aspects of Corporatism Benefited Amgen Just After its Settlement and Guilty Plea
At least here in these United States, our health care corporatism is bipartisan. Here we present a sorry story of how a company that should have been shamed by dishonest behavior that likely harmed patients instead apparently was awarded special treatment through its cozy relationships with top government leaders Accusations of Kickbacks and Deceptive Marketing of Aranesp Last month, biotechnology giant pleaded guilty to a charge of misbranding and settled civil charges with the US government for $762 million (look here). Soon after, New York Times article described the unethical practices the comp...
Source: Health Care Renewal - January 23, 2013 Category: Health Medicine and Bioethics Commentators Tags: Amgen deception kickbacks stealth health policy advocacy crime revolving doors corporatism adverse effects Source Type: blogs
Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients
The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-stimulating agent. The drug is intended to stimulate red cell blood production in patients with anemia. Amgen today announced the top line results of a large phase 3 heart failure trial of the drug and said the trial had failed to meet its primary endpoint. The RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial, which started in 2006, had randomized 2,278 patients with heart failure and anemia to receive either Aranesp or placebo. Click here to read the full story on Forbes. ...
Source: CardioBrief - January 16, 2013 Category: Cardiology Authors: Larry Husten Tags: Heart Failure Policy & Ethics Amgen anemia Aranesp Clinical trial Darbepoetin alfa Erythropoietin health Source Type: blogs
Some "Off-Label" Speech is No Longer Politically Correct
The Supreme Court has ruled that corporations are people protected by the U.S. Constitution and Bill of Rights just like us ordinary folk. That means, for one thing, the government cannot limit the freed of speech of corporations. This issue has been much discussed since last month's U.S. Court of Appeals 2-to-1 split decision to throw out the conviction of a sales representative for promoting off-label use of a prescription drug (see here).This decision is already having an impact on speech, but not the speech of drug companies. It could be making the word "off-label" politically incorrect for use by the U.S. Department o...
Source: Pharma Marketing Blog - January 5, 2013 Category: Pharma Commentators Tags: off-label promotion DOJ Source Type: blogs
Amgen Whistleblower: ‘Wearing A Wire Was Stressful’
From November 1990 to December 2005, Jill Osciecki was a sales representative for Amgen , mostly in the Midwestern US, where she promoted the Aranesp medicine that is used to treat anemia caused by chemotherapy and chronic kidney disease. However, she was one of a handful of Amgen reps who eventually chafed at allegedly illegal marketing tactics that have now become a familiar refrain in the lore of pharmaceutical marketing over the past two decades. Last month, the biotech paid $762 million to settle civil and criminal charges of off-label marketing and paying kickbacks (back story). The US Department of Justice found the...
Source: Pharmalot - January 3, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Amgen Anemia Aranesp Epogen JJ Johnson & Johnnson Procrit Whistleblower Source Type: blogs
Pharmalot… Pharmalittle… Good Morning
Top of the morning to you. And a fine one it is, if a bit cold. But it is wintertime, so we are not surprised. Another thing that is unsurprising is the amount of goings-on now that the new year has sprung. So to celebrate – and to cope – we are brewing a delicious cup of stimulation and invite you to join us. After all, this may help tackle that to-do list. Meanwhile, here are some tidbits. Have a grand day and stay in touch…
Merck CEO Sees More Consolidation (Wall Street Journal)
Novartis Wins UK NICE OK For Lucentis After Price Cut (Bloomberg News)
Merck Resubmits Combo Cholesterol Pill To FDA (Associa...
Source: Pharmalot - January 3, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Abbvie ALS Amgen Aranesp Bayer Biogen Cholseterol Drug Shortages Lucentis Merck Novartis Salix Pharmacuetical Synergy Pharmaceutical Whistleblower Source Type: blogs
