January 24, 2022
Specialty Pharmacy SmartBrief
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Leading News
The specialty pharmacy market continues to expand with the release of new products and the growing numbers of patients with chronic conditions, and 90% of large hospitals operate their own specialty pharmacies. Each hospital system will need solutions to support patients on specialty medications, and the integrated delivery network model can result in improved patient outcomes and lower medical costs.
Full Story: Pharmacy Times (1/2022) 
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Specialty Pharmacy Update
Scientists are working on a production method that would allow them to freeze-dry mRNA COVID-19 vaccines so that they can be stored and transported at room temperature. "Our goal is to develop a freeze-drying process that can be used for mRNA-based COVID-19 vaccines to make them more stable and extend their shelf life, as well as make them easier to transport, store and use," said Seongkyu Yoon, one of the lead scientists of the project.
Full Story: News Medical (1/21) 
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Pfizer CEO Albert Bourla said it would be better to have a COVID-19 vaccine booster once a year instead of every four to five months, something the company is already looking into. Bourla said Pfizer aims to seek approval for a revised COVID-19 vaccine to combat the Omicron variant, which they plan to mass produce possibly as soon as March.
Full Story: Reuters (1/22) 
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Bristol Myers Squibb said it will limit 340B discounts on all drugs dispensed at hospitals' contract pharmacies, except for its immunomodulatory imide drugs, effective March 1, making it the 12th drugmaker to do so. In a letter sent to hospitals, Bristol said it will only offer discounts to up to two contract pharmacies if the hospital does not have an in-house pharmacy.
Full Story: Healthcare Finance (1/19),  FierceHealthcare (1/19) 
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Legislation & Regulation
Robert Califf, President Joe Biden's nominee for FDA commissioner, agreed with other industry experts that confirmatory trial completion is key to the success of the FDA's accelerated approval program, and Califf said new legislation may be necessary to stimulate generation of confirmatory data. Speaking at a recent summit, Califf praised the program's design but said its biggest problem is "the failure to produce confirmatory evidence quickly and in a way that really gives us the information that we need as patients and clinicians to decide which treatments are most effective and in which order."
Full Story: Regulatory Focus (1/19) 
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The Biden administration has created the Pandemic Innovation Task Force, which it says will be responsible for preparing countermeasures against new coronavirus variants and future infectious disease threats. Established by the White House Office of Science and Technology Policy, the task force will focus on new therapies, vaccines, tests and other tools to combat pandemic threats, and it will be led by White House Science Adviser Eric Lander and HHS Assistant Secretary for Preparedness and Response Dawn O'Connell, according to officials with knowledge of the matter.
Full Story: Bloomberg Government (1/18) 
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The FDA is deliberating on limited authorization for some monoclonal antibody treatments that have not proven effective in combating the coronavirus' Omicron variant. The agency is expected to decide on whether it will control the use of antibody treatment developed by Eli Lilly and Co. and partner Regeneron after the NIH updated its guidelines advising clinics not to use these treatments for patients who have mild to moderate COVID-19 because of their diminished efficacy versus the Omicron variant.
Full Story: CNN (1/23) 
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Marker Therapeutics' investigational T-cell immunotherapy MT-601 was granted orphan drug status by the FDA. The T-cell immunotherapy was developed as a treatment for metastatic or advanced pancreatic adenocarcinoma.
Full Story: Healio (free registration)/HemOnc Today (1/22) 
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Trends & Technology
New COVID-19 cases declined in 19 states, Washington, D.C., and Puerto Rico for the week that ended Thursday, but weekly new case rates were up 11% in the Midwest, 2% in the South and 3% in Western states. The CDC reported Friday that the nationwide seven-day average for new COVID-19 cases fell 5% from the prior week to 744,616, while average daily deaths were down 0.3% to 1,749.
Full Story: Reuters (1/21),  Becker's Hospital Review (1/24) 
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