BioSpace’s Post

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 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/gg5sFUhW #antiVEGF #Biosimilars #MediaMICE

#AACR24 BridgeBio BBO-8520 KRASG12C (ON) inhibitor Great talk from Pedro J. Beltran at New Drugs on the Horizon. BBO-8520 is an orally bioavailable and highly potent small molecule direct inhibitor of KRASG12C (ON) state. BBO-8520 binds covalently to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRASG12C, leading to rapid and robust inhibition of KRASG12C activity. Look forward to seeing more clinical data! #pharmaceuticals #healthcare BridgeBio

Dear LinkedIn Family, I would like to discuss the following update. FDA decides to withdraw Pepaxto (melphalan flufenamide) On 23rd February 2024, the FDA made a significant announcement regarding the withdrawal of Pepaxto (melphalan flufenamide), a formulation developed by Oncopeptides AB. Pepaxto had previously received accelerated approval for its combined use with dexamethasone in treating certain individuals afflicted with multiple myeloma. The FDA's Center for Biologics Evaluation and Research (CBER) division outlined the reasons behind the withdrawal of Pepaxto: 1. Following a comprehensive review of data from the OCEAN confirmatory studies and extensive deliberation by the Oncologic Drugs Advisory Committee (ODAC), it was determined that Pepaxto did not demonstrate clinical benefit. The ODAC voted 14 to 2 against Pepaxto's favorable benefit-risk profile. 2. The available data did not support Pepaxto's clinical safety and efficacy for its indicated use. The FDA intends to publish this decision as a notice in the Federal Register and remove Pepaxto from the Orange Book. #fda #FDAupdates #oncopeptides #pepaxto #CBER

Importance of life cycle management - Regeneron has been taking steps to minimize the hit from incoming biosimilars of its drug Eylea, by pivoting to Eylea HD. The higher-dose version of the drug was approved by the US FDA in August of last year. The new version of the drug has the same indications as the previous version, but a longer dosing gap brings in new IP around the higher-dose version. Regeneron could switch over patients taking the standard dose to the HD version, which would be protected by IP and potential regulatory exclusivity, and cushion the impact from biosimilar drugs expected for the standard dose in 2024. The new dosing also allows Regeneron to take on competition with Roche’s Vabysmo

Today, the U.S. FDA acknowledged the Biologics License Application (BLA) resubmission for our investigational first-in-class CLDN18.2-targeted therapy:  https://lnkd.in/gKcJtfcV This recognition brings us one step closer to making an impact for people in the U.S. living with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Hello everyone, I'm excited to share that my first review article, corresponding author with Dhananjay S. Yadav , titled "A Review on Adverse Drug Reactions of Antidiabetic Drugs for Type II Diabetes," has been published in the International Journal of Modern Pharmaceutical Research (IJMPR). Check it out here:https://lnkd.in/exAaRku8

Top 200 Drugs 2023 #medicine Wanted to highlight the recent poster Jon Njardarson and team just published on their website. Top 200 Brand Name Drugs By 2023 Sales. Keytruda (Pembroluzimab) the best selling drug in 2023. 25 Billion in Sales. Ozempic (Semaglutide) now the 3rd best selling drug in 2023. Expect to see this go to top spot in 2024. The next decade to be dominated by the GLP-1 receptor agonists? The wonder drug. The poster is freely available here - https://lnkd.in/dRVsaNfE Also the Top 200 Small molecule drugs by 2023 sales here #pharmaceuticals #healthcare

FDA Committee Evaluates the Future of Psychedelic Therapy FDA’s Examination of MDMA-Assisted Therapy In recent discussions within the healthcare and pharmaceutical sectors, the FDA’s Psychopharmacologic Drugs Advisory Committee has taken a significant step by examining the potential use of MDMA-assisted therapy for treating post-traumatic stress disorder

#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