Drugs

Sanofi Discontinuing TheraCys Bladder Cancer Therapy

Sanofi Pasteur has decided to discontinue making TheraCys (BCG live attenuated), indicated for treating non-muscle invasive bladder cancer. In an email sent to urologists late last week and obtained by Forbes contributor Benjamin Davies, the company notes how it brought the product back online after resolving GMP issues at a Canadian manufacturing plant. Unfortunately, the company said, all its efforts “cannot guarantee the long-term continuity and supply of the product.” Production is scheduled to stop mid-2017. Merck is the only other manufacturer of BCG and has had its share of manufacturing problems associated with its product, which led to earlier product shortages (see earlier story).

In 2012, FDA cited Sanofi Pasteur in a Warning Letter after two foreign inspections documented GMP deviations related to TheraCys. The agency said Sanofi failed to establish the accuracy, sensitivity, specificity, and reproducibility of test methods. For example, the letter said sterility for all TheraCys BCG Live lots manufactured in a certain building cannot be assured. Test method revalidation conducted from March through April “failed acceptance criteria for bacteriostasis/fungistasis testing,” it said. FDA also said there have been 58 documented non-conformances related to mold isolation within the BCG aseptic processing areas. And the firm failed to assure an adequate system for monitoring environmental conditions, and for cleaning and disinfecting aseptic processing areas and equipment.

In responding to FDA-483 inspection observations, Sanofi indicated that manufacturing had been suspended in order to renovate the Toronto BCG manufacturing facility to improve the environmental quality, according to the Warning Letter.

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