Drugs

Boston Scientific to Divest Some Assets

The Federal Trade Commission (FTC) says Boston Scientific has agreed to divest certain assets to Varian Medical Systems to resolve FTC charges that the company’s proposed $4.2 billion acquisition of BTG would violate antitrust law. BTG is a medical equipment and pharmaceutical supplier.

FTC says that as originally structured, acquisition of BTG would harm consumers in the U.S. market for drug eluding beads (DEBs), used by interventional radiologists in combination with chemotherapy to treat certain liver cancers in a process known as transarterial chemoembolization. The agency complaint said Boston and BTG are the two largest suppliers of DEBs in the U.S.

The complaint said that new competition in this market is unlikely to occur in a timely manner to deter the anticompetitive effects of the proposed acquisition due to the length of time required for product development, FDA approval, and market adoption.

Under a proposed consent agreement with the FTC, within 10 days of closing of the BTG acquisition, Boston is required to divest to Varian its DEB business and its bland bead product line. FTC says bland beads are used in another type of procedure to block the flow of blood to a liver tumor.

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