Public Health Service Act

• Based on the results of the LIBERTY UC and LIBERTY CD studies, ZYMFENTRA demonstrated superiority in the primary endpoints of clinical remission (UC and CD) and endoscopic response (CD) compared to placebo as maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD, over a 54-week study period.
• The overall safety profile of ZYMFENTRA was similar to that of placebo during maintenance period in both studies with no new safety signals seen.2,3
  “There remains an unmet need for patients who suffer from the day-to-day burden of living with moderately to severely active Crohn’s disease and ulcerative colitis,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA.
• “As someone dedicated to improving the lives of patients with IBD, I am excited to see data supporting the efficacy and safety of a new formulation offering convenience and improved access to a well-known and proven drug,” said Dr. Andres Yarur of Cedars-Sinai Medical Center.
• ZYMFENTRA will be under patent protection by 2037 for its dosage form and route of administration by 2040.

• The COVID-19 pandemic’s public health emergency status in the U.S. expires on May 11, 2023.
• And on May 5, the World Health Organization declared an end to the COVID-19 public health emergency of international concern, or PHEIC, designation that had been in place since Jan. 30, 2020.
• While the global emergency status has ended, COVID-19 is still an “established and ongoing health issue,” he said.

1. What does ending the national emergency phase of the pandemic mean?

• Ending the federal emergency reflects both a scientific and political judgment that the acute phase of the COVID-19 pandemic crisis has ended and that special federal resources are no longer needed to prevent disease transmission across borders.
• In practical terms, it means that two declarations – the federal Public Health Emergency, first declared on Jan. 31, 2020, and the COVID-19 national emergency that former President Donald Trump announced on March 13, 2020, are expiring.
• Declaring those emergencies enabled the federal government to cut through mountains of red tape to respond to the pandemic more efficiently.

2. What domestic policies are changing?

• Another analysis projected that as many as 24 million people will be kicked off the Medicaid rolls.
• Before the pandemic, states required people to prove every year that they met income and other eligibility requirements.
• In March 2020, Congress enacted a continuous enrollment provision in Medicaid that prevented states from removing anyone from their rolls during the pandemic.
• In a December 2022 appropriations bill, Congress passed a provision that ended continuous enrollment on March 31, 2023.
• The array of telehealth services that Medicare began covering during the pandemic will continue to be covered through December 2024.

3. What does this mean for the status of the pandemic?

• But declaring an end to the emergency doesn’t mean a return to business as usual.
• She called for more federally funded research into therapeutics and durable vaccines that protect against many variants.
• With the end of the emergency, the CDC is also changing the way it presents its COVID-19 data to a “sustainable national COVID-19 surveillance” model.

4. How will state and local pandemic measures be affected?

• Most U.S. states, however, have ended their own public health emergency declarations.
• Marian Moser Jones receives funding from the National Endowment for the Humanities and The American Public Health Association.
• In the past she has received funding from the National Institutes of Health and the American Association for the History of Nursing, as well as the State of Maryland.

• WASHINGTON, Jan. 31, 2023 /PRNewswire-PRWeb/ -- Healthcare Ready has released a report to Congress calling for greater federal oversight, and increased communication, coordination and preparedness among those responsible for organizing and responding to public health emergencies.
• The nonprofit organization works to strengthen the U.S. health care system and assist all communities in planning for, responding to, and recovering from disasters and disease pandemics.
• Launched in 2019, the evaluation includes lessons learned from the COVID-19 pandemic as well as prior public health emergencies.
• Increase funding for federal preparedness and response to strengthen national and regional capabilities, help to achieve better outcomes after disasters, and contribute to ensuring our nation's health security against future public health threats.

• His consulting firm, Vista Consulting Team, has been "behind the green curtain" of more than 200 plaintiff firms across the United States and Canada.
• "These firms are listening to the business people that are creeping into the law firm space, just as the banks and accountants did.
• The impending change, McKey said, means that law firms should concentrate on running a law practice as a business.
• Tim McKey is the owner and co-founder of Vista, a consulting group aimed at helping plaintiff law firms improve operations, culture, and leadership.