A Teleflex subsidiary is voluntarily recalling one of its tracheal tubes because of reports that it can kink during use and cut off a patient's air supply. The FDA slapped its Class I recall designation on the Pennsylvania company's action, meaning the defect carries with it a risk of major injury or death.
After an uncommonly bipolar review from FDA staff, The Medicines Co.'s cangrelor got an icy reception from a panel of agency advisers, who voted against granting approval for the company's blood-thinning treatment.
Johnson & Johnson and Pharmacyclics' new drug Imbruvica won the expanded approval it needed to go beyond a rare disease treatment and reach the blockbuster status it was conceived for. The FDA Wednesday gave Imbruvica accelerated approval for treating chronic lymphocytic leukemia in patients who have received at least one previous therapy.
An FDA warning letter told a Hong Kong-based API seller that inspectors found serious quality issues at its distribution facility there and at one in Tempe, AZ. One reason for the lapses, the agency said, appears to be that the ingredient maker has no quality control unit to make sure it meets GMP standards.
You're trying to jump-start sales of a drug that never has hummed on all cylinders, but now, you're seeing signs of life. Then the feds show up, digging into the study data that justified that drug's FDA approval. That's the conundrum facing AstraZeneca and its Brilinta blood thinner, now under investigation by the Justice Department.
F. Michael Ball has spent many earnings calls talking almost entirely about the quality problems at the company's plants and its long-running efforts to get past them. Wednesday he spent very little, an indication, executives said, that four years of effort and more than $375 million in investments are paying off.
California biopharmaceutical giant Amgen got smacked with an FDA warning letter alleging quality system manufacturing violations in some of its drug/device combo products. These prefilled syringes and related devices are prepped for osteoporosis and autoimmune treatments.
A Baxter Healthcare plant in Illinois failed to put in place adequate quality control practices in the manufacture of HomeChoice dialysis and iPump pain management systems, the FDA tells the company in a warning letter.
Bayer's painkiller Aleve carries the same heart-risk warning as other nonsteroidal anti-inflammatories, or NSAIDs, like Motrin and Advil. And as far as an FDA review panel of experts is concerned, it should continue to.
AstraZeneca's diabetes drug Onglyza is under the FDA's microscope. The agency said it would review possible heart risks associated with the medication, which is one of the cornerstone products in the U.K.-based drugmaker's diabetes business.