GSK’s Post

We’re pleased to share an update on the supplemental biologics license application for the intravenous maintenance dosing regimen of our treatment for early #Alzheimersdiease. Read more: https://ow.ly/C7Rl50UNpJ6

This MAPP 6010.8 Rev. 2 establishes procedures for informing applicants of the target dates for communicating comments and feedback for labeling and anticipated post-marketing requirements (PMRs) and 506B post-marketing commitments (PMCs) for original new drug applications (NDAs), biologics license applications (BLAs), and efficacy supplements submitted to the Center for Drug Evaluation and Research (CDER). #CDER #NDAs #BLAs #PMCs #PMRs #CBER #USFDA #NEONS #NEOPLUS #NEOCUBES #ELEARNING

FDA is issuing this guidance to collate recommendations for appropriate reporting categories and the content of postapproval change submissions across numerous FDA guidance documents.2 This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved3 sterile drug products, including biological products, administered parenterally. This guidance also discusses pathways available to application holders to obtain Agency feedback. Additionally, this guidance discusses risk-based tools available to facilitate the implementation of changes to CCSs consisting of glass vials and stoppers. This guidance does not apply to CCS types other than glass vials and stoppers.

#LEQEMBI (Eisai x Biogen) is accepted by FDA for Biologics License Application (BLA) for subcutaneous maintenance dosing, against early #Alzheimer's disease with mild #cognitiveimpairment and mild #dementia. If it is approved, LEQEMEI will be the only treatment for #AD that can be administrated subcutaneously at home and the whole injection process would only be about 15 seconds. https://lnkd.in/gx5mTvgd

Navigating the Biologics CDMO Landscape We’d like to offer you exclusive access to an online resource with useful tools and practical information on navigating the biologics CDMO landscape. Access all resources: https://ow.ly/QUVa50ToC0F

Ionis Pharmaceuticals, Inc. #olezarsen has become the first FDA-approved drug therapy for adults with familial chylomicronaemia syndrome (FCS), an ultra-rare disease that leads to elevated triglyceride levels in the blood. https://lnkd.in/gvbaQjc7. #RegulatoryAffairs raredisease #RegulatoryIntelligence

For NDAs and BLAs, the USFDA review team completes the review and acts on Class 1 resubmissions within 2 months and on Class 2 resubmissions within 6 months of the receipt date. Eager to know how the USFDA's internal team work, go through this presentation. If you want to ask any question on this, write to me on dhaval.sheth@neocubespharma.com For more such presentations, follow Neoplus Translation & Neocubes Pharma For any business or service related inquires (Global Regulatory/Pharmacovigilance/Medical Writing/e-CTD Publishing/Translation/Artworks/Branding/Medico marketing), write to us on bd-neo@neocubespharma.com, dhaval.sheth@neocubespharma.com, jbl@neocubespharma.com, arnab.majumder@neocubespharma.com and info@neocubespharma.com #NDA, #BLA, #USFDA, #ELEARNING, #NEONS, #NEOPLUS, #NEOCUBES, #REGULATORYAFFAIRS, #PHARMACOVIGILANCE

Biosimilars for Regeneron’s aflibercept 2mg are coming to the US. The FDA has given two drugs, Yesafili (Biocon Biologics) and Opuviz (Biogen and Samsung Bioepis), the thumbs up with an interchangeability designation. The FDA has indicated that the drugs’ performance and safety profile were similar according to a battery of comparative measures, including clinical trials. The announcement and its impacts are now reverberating through the American anti-VEGF market for retinal diseases. What will the implications be for both patients and caregivers? https://lnkd.in/g5CvXYND #antiVEGF #Biosimilars #MediaMICE

#Biosimilars are key to lowering drug costs - Biologics are the largest driver of prescription drug spending - making up 40% of all drug spending, but only accounting for 2% of prescriptions filled. Learn more here: https://lnkd.in/gU8_9RgB

This Manual of Policies and Procedures (MAPP) 6020.4, Rev. 3 describes how the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) classifies resubmissions of original new drug applications (NDAs), original biologics license applications (BLAs) for originator biological products and related biological products, and efficacy supplements to NDAs and BLAs for originator biological products and related biological products, received in response to complete response letters as Class 1 or Class 2 resubmissions.