FDA Still Reviewing Clot Risk for Birth Control Pills
Four months after announcing that it was reviewing the safety of certain drospirenone-containing oral contraceptives, following reports of heightened risk for blood clots, the FDA said Monday that it still had not reached a conclusion. Data from a large FDA-funded epidemiologic study have now undergone preliminary analysis and suggest a 1.5-fold increase in venous thromboembolism […]
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FDA Panel, Bayer Birth Control Pills & Blood Clots
Nearly six months after a pair of studies found that women taking birth control pills containing a hormone called drospirenone are more likely to develop blood clots than those who take an older oral contraceptive, the FDA has decided to hold an advisory panel meeting in December to review the risks and benefits. Meanwhile, the […]
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Cephalon Gets Subpoena For Treanda Marketing
The other shoe has dropped in the probe into Cephalon and its Treanda medication, which is used to treat chronic lymphocytic leukemia. The drugmaker has officially received a subpoena from the US Attorney in New Yrok requesting documents “pursuant to its authority†under the Health Insurance Portability and Accountability Act, according to a filing with […]
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The 340B Drug Pricing Program Needs A Big Fix
Is the 340B Drug Pricing Program broken? Maybe not entirely, but a big fix may be in order, according to a new report released by the US Government Accountability Office. After interviewing 61 participants, including drugmakers and hospitals, the GAO says the Health Resources and Services Administration Agency relies too heavily on self-policing to ensure […]
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Op-Ed: Pharma Layoffs & Small-Minded Survivors
As pipelines shrink and investors demand better yields, the downsizing has caused tens of thousands of pharma employees to lose their jobs over the past several years. These severe cutbacks, however, may yet take their toll on the pharmaceutical industry in another, more pernicious way. In the view of Dan Hoffman, big drugmakers are now […]
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Why The Little Biotech Dismissed Its CEO
A few weeks ago, Oxygen Biotherapeutics mysteriously dismissed ceo Chris Stern after stock market trading finished one day. There was little explanation offered at the time, other than an investigation by the board’s audit committee found problems with his “conduct†and its potential impact on the biotech, which is developing various products that would deliver […]
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Recall of contaminated pads not required
A potentially deadly bacterium was detected on alcohol prep pads produced by a New York medical manufacturer three months ago, but the product was not recalled until this week because federal regulators didn’t require it, the company said Wednesday. A day after the recall was launched Tuesday, word of it was slowly dribbling out to […]
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AMRI Receives FDA Notification on Proposed Corrective Actions
AMRI today announced the receipt of a letter from U.S. Food and Drug Administration (FDA) regarding its Burlington, Massachusetts aseptic finish-and-fill facility, acquired in June 2010. The letter pertained to AMRI’s written responses to a August 2010 warning letter and a June 2011 Form 483, and stated that corrective actions proposed by AMRI, once fully […]
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Mela Sciences surges on FDA nod
The FDA issues an “approvable letter” to Mela Sciences after its years-long battle for a U.S. green light for its hand-held skin cancer detection device, the MelaFind, sending the company’s shares up more than 90 percent in pre-market trading. Mela Sciences Shares of Mela Sciences (NSDQ:MELA) are on a tear today in pre-market trading on […]
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The Johnson & Johnson Recalls Just Keep on Coming
Just as Johnson & Johnson finally resumes shipments of one of its Tylenol over-the-counter meds, the healthcare giant is once again beset by manufacturing problems that have hurt sales and its venerable corporate image. This time, thousands of prefilled syringes containing its Eprex anemia drug have been recalled from 17 countries due to inconsistent potency. […]
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