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# Since Our Last Issue...
- URL: https://www.fdaweb.com/since-our-last-issue-116/
- Published: 2019-03-31T12:00:00.000Z
- Updated: 2026-09-15T01:16:55.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135324

**Pfizer Inc**. and **Allergan** say they are not going forward with their $160 billion merger, in part because of new U.S. Treasury rules aimed at thwarting tax inversions. Pfizer has agreed to pay Allergan $150 million for reimbursement of expenses associated with the transaction.

The National Institutes of Health has awarded **Profusa, Inc.** a $1.75 million grant under the Small Business Innovation Research to support fast-tracked Phase 1 and Phase 2 studies of its Lumee tissue-integrated biosensors for continuous monitoring of oxygen for patients with peripheral artery disease. The company says Phase 2 will concentrate on verifying the biocompatibility of the biosensors and Phase 2 will include a 50-patient clinical trial to be conducted at the University of California San Francisco.

**Eli Lilly** and **AstraZeneca** report that their AMARANTH Phase 2/3 study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor being developed as a potential treatment for early Alzheimer’s disease, will continue to Phase 3 of the Phase 2/3 seamless trial. According to the companies, AZD3293 has been shown in Phase 1 studies to reduce levels of amyloid beta in the cerebro-spinal fluid of persons with Alzheimer’s disease and healthy volunteers.

**Regeneron Pharmaceuticals** and **Intellia Therapeutics** have entered a licensing and collaboration agreement to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development. Under the terms of the agreement, Regeneron has the exclusive right to discover and develop CRISPR-based products against up to 10 targets, focused primarily on therapies for a broad range of diseases that may be treated by editing genes in the liver.

**VSP Global** has invested $2 million with California-based **Vizzario Inc**. to develop eye care technologies to track visual acuity, eye strain, traumatic brain injury, and sports vision performance. According to the companies, Vizzario operates as a sensory data exchange platform that allows for value creation around data generated from technologies, including smart devices, wearables, eye-tracking tools, electroencephalogram systems, virtual reality and augmented reality via head-mounted displays.