Androgel 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.
Federal 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.
The 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.
One 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.
Patient 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.
Merck 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.
The 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 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.
The 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.
The 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.
The 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.
The 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.
If 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.
The company will remove potentially cancer-causing and other dangerous chemicals from nearly all its adult products in the next 3 1/2 years.
Each 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.
The long-anticipated offering for Zoetis by the world's largest drugmaker will help pay off a sizable portion of Pfizer's debt.
The 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.
The largest generic drug company in the world said it is the target of a federal bribery investigation into its business in Latin America.
The 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.
AEDs 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.
In the suit, the tobacco companies allege that the panel fails to meet the federal requirements that committee members should be fairly balanced.
Nothing’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.
The 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.
Like 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.
The settlement will include a $400 million criminal fine for paying out illegal kickbacks so that more nursing homes would prescribe the anti-psychotic drug.