Deals Shaping The Medical Industry, February 2015
Executive Summary
Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Dealmaking column is a survey of recent health care transactions listed by relevant industry segment – In Vitro Diagnostics, Medical Devices, Pharmaceuticals, and Research/Analytical – and then categorized by type – Acquisition, Alliance, or Financing. This month’s column covers deals announced December 2014-January 2015.
You may also be interested in...
Medovex Plans US IDE Trial For Its DenerveX Spine Surgery Device
DenerveX is a unique surgical tool used to ablate the nerve and capsular tissue on the posterior surface of the facet joint. preventing the nerve from reattaching with the goal of creating lasting relief from back pain that otherwise might require spinal fusion and/or treatment with opiate drugs.
Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process And For Consumers
“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.
After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway
Publication of "ACNU" proposed rule wasn’t reached in straight line and featured coining another term with more of a regulatory sound, “NSURE,” and detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.