FDA Policy/General

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McKesson has signed a definitive agreement to purchase RxCrossroads, a provider of tailored services to pharmaceutical and biotechnology manufacturers, from CVS Health for $735 million. The acquisition is intended to enhance McKesson’s existing commercialization solutions for manufacturers of branded, specialty, generic and biosimilar drugs, including comprehensive patient support services, custom pharmacy solutions and third-party logistics.

Biopharmaceutical company Cerenis Therapeutics has agreed to acquire Lypro Biosciences’ portfolio of drug delivery nanotechnology for an undisclosed amount. Lypro’s NanoDisk technology will be combined with Cerenis’ HDL technology to build the first HDL particle delivery platform for the oncology market. The NanoDisk technology is based on self-assembling, targetable, nanometer-scale bioparticles, incorporating active drugs into NanoDisk.

Boehringer Ingelheim and MiNA Therapeutics have signed an agreement to develop new compounds to treat fibrotic liver diseases such as NASH, based on the latter’s small activating RNA therapeutics platform. Under the agreement, MiNA will receive up an upfront cash payment and committed research funding, as well as potential research, development and regulatory milestone payments.

Factory CRO, a contract research firm focused on medical devices and IVDs, has acquired MileStone Research Organization (San Diego), which specializes in clinical research and reimbursement solutions for the medical device and biologics industries. Since 1992, Factory says it has completed more than 450 projects in Class 2 and 3 medical devices in a wide range of therapeutic areas for some of the top global medical device manufacturers.

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