FDA Law Blog: Biosimilars
APRIL 8, 2025
Since 2019, when DPD took over this process, the Division has published more than 600 ANDA withdrawals at the request of generic drug manufacturers. Processing voluntary ANDA withdrawals under 21 C.F.R. 314.150(c). Managing the process of issuing Covered Product Authorizations (CPAs) under the CREATES Act.
PharmaVoice
JUNE 23, 2025
The combo therapy topped $10 billion in revenue last year for the first time since its approval in 2019. But Stelara, which became a megablockbuster in 2023, will leave a revenue gap that J&J has yet to fill as biosimilar competition heats up.
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pharmaphorum
JUNE 12, 2025
Skip to main content Thursday 12 June 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)
Pharmacy Times
JUNE 27, 2025
November 21, 2019. Effect of acalabrutinib in combination with bendamustine plus rituximab on survival endpoints in older patients with mantle cell lymphoma: insights from the ECHO trial. healthbook TIMES Onco Hema. 2024;22(4):22-29. doi:10.36000/HBT.OH.2024.22.163 ClinicalTrials.gov. Updated February 19, 2025. Accessed May 14, 2025.
Pharmacy Times
JULY 12, 2025
May 9, 2019. Presented at: McKesson ideaShare 2025. Nashville, TN; July 11, 2025. Pharmacist-prescribed birth control reaches new users, saves Oregon $1.6M. News release. Oregon Health and Science University. Accessed July 11, 2025. Arkansas Maternal Mortality Review Committee. Legislative Report. December 2022. Accessed July 11, 2025.
Pharmacy Times
JULY 16, 2025
million deaths in 2019 alone. This post hoc secondary analysis, published by investigators in JAMA Network , aims to determine if this intervention had a spillover effect on antibiotic prescribing across the entire patient population. 1 Image credit: I Viewfinder | stock.adobe.com According to WHO, AMR accounted for 1.27
Pharmacy Times
JULY 1, 2025
1,2 Tafamidis in the Treatment of ATTR-CM Initially approved in 2019 3 , tafamidis (Vyndamax; Pfizer) is a selective transthyretin (TTR) kinetic stabilizer that binds to thyroxine-binding sites on TTR tetramers, which prevents dissociation into monomers, or the breakdown into amyloid deposits that damage the heart in ATTR-CM. May 6, 2019.
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