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• FDA Offers Pfizer's HIV Drug Selzentry New Life -- For All the Good It Will Do

  BNET - 2009-11-30

  The FDA approved Pfizer's anti-HIV drug Selzentry for expanded use in combination with other antiretroviral agents for treatment-naïve patients who are infected with only CCR5-tropic HIV-1. Contrary to company expectations, perceived limitations of this entry inhibitor could stall efforts to facilitate usage beyond salvage therapy. by David Phillips

  Tags: FDA, Pfizer Inc., HIV Virus, Federal Government, Government, David Phillips

• Pfizer Used Docs Accused of Misconduct to Prep Geodon Submission to FDA

  BNET - 2009-09-22

  Pfizer used three physicians who have since been accused of misconduct to prepare submissions to the FDA for the approval of the antipsychotic Geodon, according to a whistleblower lawsuit brought by a Harrisburg, Pa., doctor. by Jim Edwards

  Tags: FDA, Pfizer Inc., Federal Government, Government, Jim Edwards

• Pfizer - Bextra: DOJ press conference

  BNET - 2009-09-02

  Justice Department Announces Largest Health Care Fraud Settlement in Its History Pfizer to Pay $2.3 Billion for Fraudulent Marketing WASHINGTON – American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay...

  Tags: Settlement, Health Care, Pfizer Inc.

• Pfizer Exec Says FDA's Lack of Social Media Guidance Is "a Problem"

  BNET - 2009-08-31

  Pfizer PR chief Ray Kerins blasted the FDA's lack of guidance on social media as "a problem" at a recent conference: "There actually are no guidelines for corporations like Pfizer in what we can and cannot do in social media, and that's a problem." by Jim Edwards

  Tags: FDA, Pfizer Inc., Social Media, Federal Government, Government, Jim Edwards

• FDA Gives Pfizer's Penis-Straightening Drug Priority Review

  BNET - 2009-04-30

  The FDA granted priority review status to a drug Pfizer is developing that will cure curvature of the penis. BNET readers first learned about Xiaflex -- and the rather less well publicized fact that it must be administered by injection into the organ itself -- back in December. by Jim...

  Tags: FDA, Pfizer Inc., Federal Government, Government, Jim Edwards

• Document Shows Rogue Bextra Operation Inside Pfizer

  BNET - 2009-04-06

  The "information" document filed by federal prosecutors against Mary Holloway describes what appears to be a rogue sales unit inside Pfizer dedicated to selling the painkiller Bextra off-label and at unapproved doses. Holloway is believed to be a former Pfizer employee (see Peter Rost's join-the-dots conclusion) although documents in the...

  Tags: FDA, Pfizer Inc., Bextra, Holloway, Sales Strategy, Federal Government, Sales Force Management, Sales, Government, Jim Edwards

• Wyeth v. Levine: A Conflicted Roberts Didn't Recuse Himself; Ruling Encourages Unilateral Label Changes

  BNET - 2009-03-04

  There are three interesting things about the U.S. Supreme Court's ruling against Wyeth's preemption claim. (The case was about whether the FDA preempts state courts from ruling on drug safety.) First, Chief Justice John Roberts took part in the decision even though he owns Pfizer stock (Pfizer...

  Tags: Wyeth, FDA, Pfizer Inc., Federal Government, Government, Jim Edwards

• Federal Prosecutor Warns Drug Companies on Off-Label Promotion: "This Must Stop''

  BNET - 2009-01-27

  Laurie Magid, the acting U.S. attorney for Pennsylvania's Eastern District, has written a strongly worded warning to drug companies that they must stop promoting off-label uses for drugs or face the consequences. The warning comes after both Pfizer and Eli Lilly paid record fines for off-label promotion...

  Tags: FDA, Patient, Pfizer Inc., Cephalon Inc., Federal Government, Sales Strategy, Government, Sales, Jim Edwards

• FDA Caves to Pfizer, Industry on Antibiotics Ruling

  BNET - 2008-12-12

  The Food and Drug Administration has quietly withdrawn its order banning extralabel use of the antibiotic cephalosporin, so that it can "fully consider the comments" it has received on the issue. When the agency announced the order on July 3, drug companies and agriculture groups were outraged....

  Tags: Drug Company, FDA, Federal Government, Government, Katherine Glover, Pfizer Inc.

• Q&A: Peter Rost on His Quixotic Bid to Become Obama's FDA Chief

  BNET - 2008-12-04

  Pfizer whistleblower and compulsive blogger Peter Rost has tossed his Panama hat into the ring for the post of FDA commissioner in the new Obama administration. He's got the "backing" -- or at least the paperwork -- of Sen. Sherrod Brown and Rep. Jo Ann Emerson. Rost...

  Tags: FDA, Pfizer Inc., Peter Rost, Federal Government, Government, Jim Edwards