Planned launches of generic Claritin-D, Mucinex and Prevacid 24HR are expected to help Perrigo reach 12% to 14% consumer health care growth in fiscal 2012. Opportunities to gain from J&J and Novartis OTC recalls likely are minimal going forward, the private labeler says on its Q2 earnings call.
Perrigo Co. PLC expects its back-end-loaded new product launches will pick up what so far has been a modest fiscal 2012 for the firm’s consumer health care segment.
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New plan to encourage alternatives to animal testing seeks interagency cooperation to meet more aggressive targets for transformational change than the US FDA’s long-standing program.
HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.
Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.
The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.
Jonathan Blum, who was principal deputy administrator during the Biden Administration, explained the agency’s approach to setting up the price negotiation program and said changes likely will be implemented by the Trump Administration.
The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.
