Drugs

Cancer Drug Approvals Slower Outside U.S.: Study

University of Pittsburgh researchers say that cancer drugs are approved faster in the U.S. than in overseas countries. The study was reported in the Journal of Managed Care & Specialty Pharmacy.

The researchers looked at 45 oncology drugs approved by FDA between 2009 and 2013. They found that most treatments were approved first in the U.S., although 6.7% of approvals were faster outside this country. “Average time to approval is 10.6 months later in Europe, 14.9 months later in Canada, and 15.6 months later in Australia,” they write. The study also found that even if a drug is approved outside the U.S., it may be that insurers will not pay for it.

It says that before 12/21/13, 30 of the 45 drug indications were approved by the European Medicines Agency (EMA) and thus available (although possibly not covered) in the UK. France approved all 30 EMA-approved indications. In Canada and Australia, 24 of the 45 drug indications were approved. In the U.S., in contrast, all 45 indications were covered in some way by Medicare.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome