Medical
Testosterone Marketing Frenzy Draws Skepticism
September 10, 2012 9:54 am | by Matthew Perrone, AP Health Writer | News | CommentsAndrogel is one of a growing number of prescription gels, patches and injections aimed at boosting the male hormone that begins to decline after about age 40. Drugmakers and some doctors claim testosterone therapy can reverse some of the signs of aging — even though the safety and effectiveness of such treatments is unclear.
Miss. Company Pays $1.8M To Settle Ala. Fraud Claims
September 6, 2012 2:06 pm | News | CommentsFederal prosecutors say a medical supply company from Mississippi will pay almost $1.8 million to end fraud claims in Alabama. A settlement was filed Wednesday in Birmingham in a lawsuit involving Pinnacle Medical Solutions of Southhaven, Miss.
When Big Pharma Pays To Stall Generics, Is It Legal?
September 6, 2012 9:54 am | by Thomas Carey, Partner, Sunstein Kann Murphy & Timbers LLP | Blogs | CommentsThe Federal Trade Commission has long held that brand-name pharmaceutical companies may not pay generic-drug companies to stay out of the market. To its dismay, the FTC has had great difficulty convincing the courts that its dim view of such “reverse payments” is correct.
Routine Problems, Routine Explanations
September 4, 2012 10:06 am | by the QA Pharm | Blogs | CommentsOne clever approach to handling a particular recurring deviation was to have a pre-printed form. The investigation was already written with the exception of the slight nuances, which were accommodated by blanks. This "Mad Lib" approach was completed in a matter of minutes, and a quality assurance (QA) approval was handily secured.
Study: Is Organic Food Any Healthier?
September 4, 2012 9:59 am | by Lauran Neergaard, AP Medical Writer | News | CommentsPatient after patient asked: Is eating organic food, which costs more, really better for me? Unsure, Stanford University doctors dug through reams of research to find out — and concluded there's little evidence that going organic is much healthier, citing only a few differences involving pesticides and antibiotics.
Drugmaker Merck To Cut 1 Jobs In 10 In Germany
September 4, 2012 9:37 am | by The Associated Press | News | CommentsMerck has suffered development and marketing setbacks including the abandonment of its multiple sclerosis drug Cladibrine after it was rejected by EU regulators and questioned by the U.S. Food and Drug Administration. The company will try to find the cuts through either not filling the posts of people who leave or workers opting to take early retirement.
German Drug Firm Makes 1st Apology For Thalidomide
August 31, 2012 12:14 pm | by The Associated Press | News | CommentsThe German manufacturer of anti-morning sickness drug thalidomide has for the first time apologized to people who were born with congenital birth defects as a result of its use. Chief executive Harald Stock said Friday that the company had failed to reach out "from person to person" to the victims and their mothers over the past 50 years.
Bristol-Myers Recalls Vials Of Cancer Drug
August 30, 2012 1:49 pm | News | CommentsBristol-Myers Squibb Co. is recalling more than 31,000 units of a chemotherapy drug after discovering one vial was overfilled, putting patients at risk of an overdose. The company's action affects 10 lots of BiCNU, an injection of the drug carmustine, used to treat brain tumors, multiple myeloma, Hodgkin's disease and non-Hodgkin's lymphoma.
FDA Warns Of Possible Cataract Link With Kalydeco
August 29, 2012 1:54 pm | News | CommentsThe FDA says the warning is based on cases of cataract seen in juvenile rats studied by the drug's manufacturer, Vertex Pharmaceuticals. The study was designed to show that Kalydeco is safe for children younger than 2 years old. Cataract is a clouding of the eye's lens that can disrupt vision.
Hospira Gets Warning Letter After FDA Inspection
August 29, 2012 9:43 am | News | CommentsThe Lake Forest, Ill., company said it received the letter Thursday. The FDA said the facility was not complying with the agency's rules. The agency also said Hospira's initial response to the inspection was inadequate because the company has not made changes to correct problems, hasn't created proper procedures for accepting products coming in, and is not keeping adequate records of the devices it makes.
Bristol-Myers Taking $1.8B Hepatitis C Drug Charge
August 24, 2012 2:49 pm | News | CommentsThe company said Thursday that it was ending development of Inhibitex's most advanced drug candidate because of the death of one patient in a mid-stage clinical trial. Bristol-Myers stopped the trial on Aug. 1. It disclosed charge in a filing with the Securities and Exchange Commission Friday and said the write-down will be part of its third-quarter results.
FDA Warns Of Drugs In Reumofan Dietary Supplements
August 21, 2012 4:56 pm | by The Associated Press | News | CommentsThe Food and Drug Administration is warning consumers not to use Reumofan dietary supplements, after receiving reports of bleeding, stroke and death among people taking the pills. Reumofan Plus and Reumofan Plus Premium are marketed as natural remedies for arthritis and muscle pain, but the FDA says the products actually contain several prescription drugs.
New Coupons Aim To Keep People Off Generic Drugs
August 20, 2012 2:58 pm | by Linda A. Johnson, AP Business Writer | News | CommentsIf brand-name prescription medicines cost you as little as generic pills, which would you choose? A few drugmakers are betting Americans will stick with the name they know — and can pronounce. They've begun offering U.S. patients coupons to reduce copayments on brand-name medicines getting their first generic competition to about the same as for the new generic drug.
J&J Removing Harsh Chemicals From Products By 2015
August 15, 2012 6:39 am | by Linda A. Johnson, AP Business Writer | News | CommentsThe company will remove potentially cancer-causing and other dangerous chemicals from nearly all its adult products in the next 3 1/2 years.
FDA Approves Flu Vaccine For Coming Season
August 13, 2012 4:20 pm | by The Associated Press | News | CommentsEach year the FDA works with other federal agencies and global health experts to design a vaccine to protect against the three viral strains most likely to cause the flu.
Pfizer Files IPO Plan For Animal Health Business
August 13, 2012 1:28 pm | by The Associated Press | News | CommentsThe long-anticipated offering for Zoetis by the world's largest drugmaker will help pay off a sizable portion of Pfizer's debt.
J&J, Pfizer To Drop Intravenous Alzheimer's Drug
August 7, 2012 9:33 am | News | CommentsThe companies said bapineuzumab intravenous did not work better than placebo in two late-stage trials in patients who had mild to moderate Alzheimer's disease.
Teva Pharma Under SEC Bribery Investigation
August 6, 2012 2:30 pm | News | CommentsThe largest generic drug company in the world said it is the target of a federal bribery investigation into its business in Latin America.
Mass.-Based Hologic Plans To Close Wis. Plant
August 2, 2012 12:51 pm | News | CommentsThe medical device maker announced that it will cut130 jobs in the Madison area the same day it completed a $3.8B acquisition of Gen-Probe Inc.
The Defibrillator That Fails May Be The One You Need
August 1, 2012 12:58 pm | by Karl Stephan, Consulting Engineer, Texas State University, San Marcos | Blogs | CommentsAEDs are medical devices, aren’t they? And so they must go through the same rigorous Food and Drug Administration qualification and inspection tests as other medical devices, mustn’t they? Well, not quite, it turns out. AEDs are in a kind of legal gray area that allows manufacturers simply to say that their product is “substantially equivalent” to other AEDs.
Judge Lets Challenge To FDA Tobacco Panel Proceed
August 1, 2012 12:25 pm | by Michael Felberbaum, AP Tobacco Writer | News | CommentsIn the suit, the tobacco companies allege that the panel fails to meet the federal requirements that committee members should be fairly balanced.
Fake It Until We Make A Change
July 31, 2012 1:53 pm | by Jonnatha Mayberry, Associate Editor, Chem.Info | Blogs | CommentsNothing’s worse than being put on prescription after prescription while your physician attempts to find a cure all of your symptoms, right? Wrong. In reality, there is something that is worse than ineffective medicine: drugs that not only don’t work, but also cause serious harm. The current counterfeit drug crisis is nothing short of an epidemic. And, although this epidemic doesn’t seem to be growing, it doesn’t seem to be slowing either.
Perrigo Sells Plant To Medline
July 23, 2012 11:00 am | News | CommentsThe companies did not disclose terms. Medline will use the facility to make products including enema and douche products, as well as and oral saline laxatives.
The Little Things That Kill
July 22, 2012 2:58 am | by Jeff Reinke, Editorial Director | Blogs | CommentsLike all design engineers, Thom Haubert is a problem solver, but one of his latest projects offered the ultimate challenge in solving a puzzle with literally billions of pieces.
Report: J&J Will Pay $2.2B In Risperdal Settlement
July 20, 2012 1:30 am | News | CommentsThe settlement will include a $400 million criminal fine for paying out illegal kickbacks so that more nursing homes would prescribe the anti-psychotic drug.
