October 18, 2021
Specialty Pharmacy SmartBrief
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Leading News
Exceptional clinical gains with CAR-T therapy treatment for B-cell lymphoma has increased its use, even though Medicare reimbursement for CAR-T therapy does not meet the astronomical hospital costs. The push to move CAR-T treatment to outpatient settings using newer agents with fewer side effects may make CAR-T therapy more accessible for patients and providers.
Full Story: Pharmacy Practice News (free registration) (10/2021) 
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Specialty Pharmacy Update
All batches of irbesartan and irbesartan/hydrochlorothiazide tablets from Lupin Pharmaceuticals are being recalled in the US over concerns that they may contain N-nitrosoirbesartan, a potential carcinogen. The Indian firm received four adverse event reports linked to irbesartan use from October 2018 to September 2021.
Full Story: FDAnews (10/18) 
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An FDA advisory panel meeting has been scheduled for Nov. 30 to evaluate Merck's antiviral pill molnupiravir, developed in partnership with Ridgeback Biotherapeutics, to treat mild-to-moderate COVID-19. Should the panel back its approval, the oral pill would be used in recently diagnosed COVID-19 patients at high risk for developing severe illness, becoming hospitalized or dying from a coronavirus infection.
Full Story: The Hill (10/14) 
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Unvaccinated people are 11 times more likely to die from COVID-19 than people who are fully vaccinated against the disease, and those who have not been vaccinated are six times more likely to test positive, according to a CDC analysis. The report documented 665 cases per 100,000 unvaccinated people as of as of Aug. 29, while there were 150 cases per 100,000 of those who had received the Johnson & Johnson vaccine, 125 per 100,000 among those who received the Pfizer/BioNTech vaccine, and 86 per 100,000 of those who received Moderna's vaccine.
Full Story: The Hill (10/15) 
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Merck, Pfizer, AstraZeneca and Teva are partnering with the Israel Biotech Fund on a new AI-based incubator for startups. "We have competitors that are working together...because the challenge of harnessing AI and computational capabilities for pharma is so immense and it really hasn't been tapped into," said AION Labs CEO Mati Gill.
Full Story: Endpoints News (free registration) (10/13) 
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Legislation & Regulation
The FDA has approved Merck's Keytruda, or pembrolizumab, as a first-line treatment for recurrent, persistent or metastatic cervical cancer with tumors that express PD-L1. The treatment is combined with chemotherapy and may be administered with or without bevacizumab.
Full Story: PharmaTimes online (UK) (10/14) 
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The FDA's Vaccines and Related Biological Products Advisory Committee has recommended a second dose of the Johnson & Johnson COVID-19 vaccine for people age 18 and older who received the single-dose vaccine at least two months ago, according to Reuters. Some advisory panel members also asked whether the initial single-dose of the J&J vaccine should be considered a two-dose regimen.
Full Story: Reuters (10/15) 
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Clinical & Research News
Six weeks of treatment with budesonide orodispersible tablets was linked to increased esophageal distensibility for patients with eosinophilic esophagitis, when compared with a placebo, according to a study presented by Alfredo J. Lucendo, MD, PhD, of General Hospital in Tomelloso, Spain, and presented at the United European Gastroenterology's annual meeting. Improvements in esophageal distensibility continued during a 48-week maintenance period, researchers said.
Full Story: Healio (free registration) (10/15) 
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Patients taking vonoprazan had a higher risk for Clostridioides difficile but it was no greater than the risk associated with the use of proton pump inhibitors, according to a study led by Katsunori Iijima, of the Akita University Graduate School of Medicine in Japan, and published in The American Journal of Gastroenterology. The study included 4,466 cases of Clostridioides difficile and 13,220 non-CDI controls. Read the abstract.
Full Story: Infectious Disease Advisor (10/15) 
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Trends & Technology
US mortality from drug overdoses has hit another record high, climbing by 29.6% to 96,779 from March 2020 to March 2021, the CDC's National Center for Health Statistics reports. Opioids accounted for the largest share of overdose deaths, followed by synthetic opioids, excluding methadone.
Full Story: The Hill (10/13),  CNN (10/13) 
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