Generic Celebrex Dispute Shows Hatch-Waxman’s Legal Wrath
Ongoing battle over 180-day exclusivity shows just how complex life under the 1984 amendments to the FD&C Act can get.
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Pfizer sues five generic firms alleging their celecoxib ANDAs infringe a reissued method-of-use patent, which protects the blockbuster COX-2 inhibitor until December 2015, 18 months longer than had been expected.
COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers
First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.
Although US FDA wants sponsors to maintain blinded Phase III follow-up as long as possible after emergency use authorization or licensure, vaccine researcher Larry Corey says it will become ‘untenable’ to keep individuals in placebo arm once they qualify for vaccine access under the allocation framework.