April 21, 2021
Specialty Pharmacy SmartBrief
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Leading News
The growth of high-touch specialty pharmacy services is outpacing traditional pharmacies as over half of new drug approvals are for specialty medications. Specialty pharmacies are specifically equipped to handle greater levels of complexity and the time needed for prior authorizations, in-depth patient education, and adherence support.
Full Story: Drug Topics (4/21) 
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Specialty Pharmacy Update
The use of metformin, as well as newer types of glucose-lowering medications like glucagonlike peptide 1 receptor agonists, dipeptidyl peptidase 4 inhibitors and sodium-glucose cotransporter 2 inhibitors, significantly increased among patients with type 2 diabetes and chronic kidney disease from 2007 to 2016. The findings published in the journal Kidney Medicine also revealed that the most greatly used single medication class was insulin, and its use was especially high among patients with a low-income subsidy.
Full Story: Healio (free registration)/Nephrology News & Issues (4/19) 
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Teva Pharmaceutical Industries, Johnson & Johnson, AbbVie's Allergan unit and Endo International faced a virtual trial on Monday over their alleged role in fueling the country's opioid epidemic. Several California counties have accused the firms of deceptive marketing to downplay the addiction risks of their drugs and boost their sales, and they could pay billions plus penalties if they are found liable.
Full Story: Reuters (4/16) 
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New advanced therapy medicinal products, such as cell and gene therapies, are changing how treatments are manufactured and delivered, and while the US FDA and EMA have issued some guidance, "our industry must create the manufacturing model," write biotechnology engineers Herman Bozenhardt and Erich Bozenhardt. The relationship between suppliers and hospitals will transition to manufacturing partnerships, with expectations that vary "from site to site that will require an assessment of best practices to find the appropriate solution," they write.
Full Story: BioProcess International (4/19) 
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With the success of Moderna's COVID-19 vaccine, the company is advancing towards phase 1 clinical trials for its messenger-RNA-based HIV vaccines mRNA-1644 and mRNA-1574. mRNA-1644 is being developed with the support of the International AIDS Vaccine Initiative and the Bill and Melinda Gates Foundation, while mRNA-1574 is a being developed in partnership with the NIH.
Full Story: Seeking Alpha (free registration) (4/19) 
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Legislation & Regulation
Ten senators sent a letter to President Joe Biden last week urging the administration to support the waiver of COVID-19 vaccine patents "[t]o bring the pandemic to its quickest end and save the lives of Americans and people around the world." Backers of the effort, which include several House lawmakers, major unions and outside groups such as Doctors Without Borders, believe that waiving vaccines' intellectual property protections could help prevent the emergence of new, potentially vaccine-resistant COVID-19 variants.
Full Story: The Hill (4/16) 
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A Kaiser Family Foundation analysis found 50 drugs accounted for 80% of Medicare Part B drug spending, and the 250 top-selling Medicare Part D drugs with a sole manufacturer and no generic or biosimilar version accounted for 60% of net Part D spending in 2019. The findings show that Medicare drug spending is "highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors," according to the report.
Full Story: Kaiser Family Foundation (4/19) 
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Curis' investigational drug CA-4948 was granted orphan drug status by the FDA as a treatment for myelodysplastic syndrome and acute myeloid leukemia. The drug is also being tested as a monotherapy as well as in combination with Janssen and Pharmacyclics' Imbruvica, or ibrutinib, as a treatment for non-Hodgkin lymphoma.
Full Story: Healio (free registration)/HemOnc Today (4/19) 
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Clinical & Research News
Preliminary data from an early-stage trial testing a chimeric antigen receptor T-cell therapy to treat diffuse midline glioma found that three out of four patients experienced improvements in their neurologic symptoms as well as tumor regression. Details of the research by Stanford University School of Medicine scientists were presented at the annual meeting of the American Association for Cancer Research.
Full Story: Healio (free registration) (4/20) 
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Trends & Technology
The US will allocate $1.7 billion from the latest COVID-19 relief package to the CDC, state health departments and six university-affiliated centers of excellence as well as to set up a national system to detect, monitor, analyze and share data on emerging disease threats, including coronavirus mutations. "In order for us to even have the possibility of getting back to normal by the fall we need to massively scale up our genomic surveillance," said FasterCures Executive Director Esther Krofah, adding that the national pathogen surveillance network is "not just for COVID, but going forward for other pathogens of concern."
Full Story: The Associated Press (4/16) 
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Nothing is ever the same as they said it was.
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