A U.S. Food and Drug Administration advisory panel has voted against approving Johnson & Johnson’s blood thinner Xarelto for prevention of blood clots in people with acute coronary syndrome.
According to U.S. News and World Report, the 6-to-4 decision came as a surprise because an FDA briefing document filed Monday in advance of the ruling gave the drug a favorable assessment.
But panel members reportedly said company studies did not provide enough ...
continue reading...
A study published in The New England Journal of Medicine found more U.S. women had unplanned pregnancies while using short-acting birth control methods such as pills, patches and vaginal rings, compared to long-term reversible contraception methods including intrauterine devices (IUDs), hormone shots and skin implants.
According to a Reuters report, the study involved 7,500 women and teens in the St. Louis area.
Among about 1,500 women who chose to use a contraceptive ...
continue reading...
In a Motley Fool article for MSNBC, Sara Wright recommends against investing in manufacturers of dangerous medical devices that made it onto the market through a regulatory loophole.
“I cannot see clear to investing my money in companies that do not take the safety and efficacy of their products more seriously,” she writes.
Among the companies she spotlights are Johnson & Johnson, owner of a subsidiary that made read more.... --> continue reading...
A U.S. Food and Drug Administration medical reviewer recommended the agency not approve tafamidis, a drug developed by a Pfizer Inc. subsidiary to treat a rare genetic disorder that affects the nervous system. The reviewer said there was “inadequate” evidence the drug works, according to the Wall Street Journal.
This is the second recent setback for Pfizer. Last week, the New England Journal of Medicine published a study that found the pharmaceutical giant’s popular antibiotic azithromycin, sold under the brand name continue reading...
Consumers Union, the policy and advocacy arm of Consumer Reports, has placed a full-page print ad in Washington, D.C.-based publication Politico, calling on Congress to close a loophole that allows dangerous devices to make it on the market without clinical testing.
The ad is running as the U.S. Senate prepares to vote on a bill this week to reauthorize the statute governing medical device oversight.
It specifically makes reference to two medical ...
continue reading...
Lawyers representing Pennsylvania and Johnson & Johnson both argued their side before a panel of seven Commonwealth Court justices on Wednesday, in a case involving allegations that Johnson & Johnson defrauded Pennsylvania out of millions of taxpayer dollars.
At issue is whether the company misled Medicaid officials about the risks of antipsychotic drug Risperdal and marketed it for unapproved uses, duping the state into improperly paying millions more for the drug ...
continue reading...
