Positive Outcomes for SDOH Interventions: A Q&A With Kate Sommerfeld
May 18th 2022Kate Sommerfeld, president of the Social Determinants of Health Institute, spoke about efforts to address social determinants of health (SDOH) gaining traction, taking an interconnected approach and using data analytics to understand the value of the efforts to address SDOH.
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FDA Updates for Week of May 9, 2022
May 14th 2022In COVID-19 news, the FDA has approved Olumiant for new COVID-19 indication, but had limited Janssen’s COVID-19 vaccine. The agency has launched a new program for rare disease drug development and approved a new oral form of ALS therapy. Regulators have also extended the review time for both a new Pompe disease therapy and the sNDA for Myfembree for endometriosis. Additionally, Eisai has completed its submission of lecanemab for Alzheimer’s disease.
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NIH Partners with WHO to Make COVID-19 Tech Available Worldwide
May 13th 2022The partnership will allow international manufacturers to use the technologies for the potential development of COVID-19 vaccines, treatments and diagnostics to benefit people living in low- and middle-income countries.
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“Patent Thickets” on Biologics and What Could Be Done To Chop Them Down to Size
May 10th 2022Multiple patents on original biologics delay when biosimilars get on the market in the US. University of Denver Sturm College of Law legal experts argue in a preprint that changes in how the original patents are written could reduce the number of duplicative patents and legal gamesmanship.
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Will Cyltezo Be Accepted As Interchangeabe With Humira? Researchers Sow Some Doubt.
May 10th 2022A Cleveland Clinic researcher anticipates that the FDA’s definition of strength of formulation could impair acceptance of Boehringer Ingelheim’s biosimilar to Humira (adalimumab), even though the FDA has approved the biosimilar as “interchangeable” to Humira.
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Removing Subset of T Cells Reduces Chronic Graft-Versus-Host Disease
May 10th 2022Findings from phase 2 trials reported in Journal of Clinical Oncology seed hopes that winnowing out certain types of T cells from peripheral blood stem-cell transplants will make chronic graft-versus-host disease less common. Randomized trials are underway to test the proposition.
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FDA Updates for the Week of May 2, 2022
May 7th 2022The FDA has approved a rare disease therapy and an additional indication for Enhertu, and grants priority review for Imfinzi in biliary tract cancer. Regulators have issued complete response letters for three therapies. The agency also has scheduled an advisory committee for Nuplazid in Alzheimer’s psychosis.
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2022 Asembia Specialty Pharmacy Summit: Attendees Feasted on a Buffet of Topics
May 6th 2022Politics and policies were among the main topics at the meeting in Las Vegas. But the 6,000 attendees also heard about biosimilars, the gross-to-net price gap and the ripple effects of the CMS’ Aduhelm coverage decision.
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At the 2022 Asembia Specialty Pharmacy Summit, healthcare policy experts at Avalere shared insights into the politics of a less ambitious Build Back Better bill and the healthcare provisions it might include. If a "skinny bill" doesn't get passed, the healthcare action of the Biden administration might shift to CMS Innovation Center and payment models, including a successor to the Oncology Care Model, they said.
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Biden Administration’s Healthcare Priorities and the Build Back Better Act, per Ryan Urgo of Avalere
May 6th 2022Ryan Urgo, Managing Director, Health Policy at Avalere addressed the Biden administration’s healthcare priorities and if the Build Back Better legislation will include provisions that deal with drug prices? Urgo spoke at this year's annual Asembia Specialty Pharmacy Summit in Las Vegas on the subject, as well.
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There Remains an Unmet Need for EoE Treatments That Provide Effective, Long-term Disease Control
May 5th 2022Patients with eosinophilic esophagitis (EoE) are faced with delayed diagnosis, burdens related to symptoms, quality of life and cost, but lack targeted systemic therapies to improve long-term disease control.
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Drugmakers’ Reputation on the Line in the 340B Donnybrook: 2022 Asembia Specialty Pharmacy Summit
May 4th 2022Drug manufacturers are challenging the discounted drug program, but if they are blamed for the closing of rural hospitals that depend on 340B funds, the challenge may have a serious downside, warned an expert on the program.
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