Drugs

Multilateral Working Group on Pharmaceutical Mergers

The Federal Trade Commission (FTC) says it is joining with the Justice Department, state attorneys general, the Canadian Competition Bureau, European Commission Directorate General for Competition, and the UK Competition and Markets Authority to form a working group to update their approach to analyzing the effects of pharmaceutical mergers. An FTC statement says the project taps expertise from competition authorities with whom the FTC cooperates frequently, as well as others with relevant experience, to ensure the most effective enforcement in this crucial market. The working group’s goal is to identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers, FTC says.

The issues to be considered, it says, are:

how to expand and refresh current theories of harm;
determining the full range of a pharmaceutical merger’s effect on innovation;
how to consider in merger review pharmaceutical conduct such as price-fixing, reverse payments, and other regulatory abuses;
the evidence needed to challenge a transaction based on any new or expanded theories of harm;
the types of remedies that would work in the cases to which the new or expanded theories are applied; and
· what has been learned about the scope of assets and characteristics of firms that make successful divestiture buyers.

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