Drugs

Mixed Reaction to Mexico Biological Drug Trade Deal

Branded drug companies are cautiously supportive of a bullet point in the Trump Administration’s new trade understanding with Mexico that would extend drug patent exclusivity for 10 years and would expand the scope of products eligible for protection. However, generic drug manufacturers say the move would delay biosimilar competition.

Axios quotes Senate Finance Committee chair Orrin Hatch that the provision is a step in the right direction but does not provide a long enough period of exclusivity. Current U.S. law protects drug patents for 12 years, but NAFTA is silent on drug exclusivity protection for biologics. The Trans Pacific Partnership that was never approved included five years of market exclusivity.

The U.S.-based Association for Accessible Medicines was joined by Canadian and Mexican generic drug trade groups in saying the proposal “will harm patients who seek more affordable medicines…. The U.S., Mexico, and Canada should reject these provisions, which would benefit brand name drug companies to the detriment of public health and the affordability of medical care.”

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