Ophthalmology Times Europe’s Post

The Food and Drug Administration (FDA) announced its approval of 2 biosimilars as interchangeable with aflibercept 2 mg (Eylea). The agency approved aflibercept-jbvf (Yesafili, Biocon Biologics) and aflibercept-yszy (Opuviz, Samsung Bioepis, Biogen). All 3 products are anti-vascular endothelial growth factor (VEGF) agents, administered intravitreally for neovascular age-related macular degeneration (nAMD). Aflibercept-jbvf and aflibercept-yszy are the first interchangeable biosimilars to aflibercept 2 mg. Read more: https://lnkd.in/ea8K3wnN

📢 Announcing Volume 29, Issue 44 of Current Pharmaceutical Design! Stay updated with the latest in pharmaceutical research. This issue covers crucial topics, from bone infection treatment to drug delivery systems for anti-cancer drugs. 📘 Featured Articles: 👉Trends in Nanofibers for Bone Infection Treatment 👉Pharmaceutical Aspects of Nanoformulation Based Drug 👉Delivery Systems 🔗 Explore the Issue: https://bit.ly/3LjUd66 #CurrentPharmaceuticalDesign #PharmaceuticalResearch #OpenAccess

#LongboardPharmaceuticals Inc shares surged 181% to $16.96 in late-morning trading on Tuesday after the clinical-stage biopharmaceutical company revealed positive topline data from its PACIFIC Study evaluating bexicaserin, which reduced seizures by 53.3% across a population of patients with developmental and epileptic encephalopathies (DEE).  Longboard noted the phase 1b/2a study included 52 patients ages 12 to 65 years old with different seizure disorders, including Lennox-Gastaut syndrome and Dravet syndrome.  Bexicaserin led to a 72.1% mean reduction in Dravet-related seizures, 48.1% in Lennox-Gastaut and 61.2% in DEE other, according to the company.   "We are continuing our Phase 3 preparations as we evaluate the broader dataset," Longboard Pharmaceuticals CEO Kevin Lind said in a statement.   The company added that bexicaserin exhibited favorable safety and tolerability results.      More at #Proactive #ProactiveInvestors http://ow.ly/jSg71057Boj

Ventyx Biosciences Inc shares sank as much as 20% in pre-market trading on Tuesday after the clinical-stage #biopharmaceutical company announced results from the Phase 2 trial of VTX002, a novel oral S1P1 receptor modulator, in patients with moderate-to-severely active ulcerative colitis (UC).  Ventyx said 28% of patients on the 60 milligram (mg) dose and 24% of patients on the 30 mg dose achieved the primary endpoint of clinical remission at week 13 compared to 11% of patients on placebo.  "The positive Phase 2 data for VTX002 establish a highly attractive profile for an oral agent in moderate-to-severely active UC, with the 60 mg dose achieving a compelling clinical remission rate, an unprecedented rate of complete endoscopic remission, and an excellent safety and tolerability profile," Ventyx Biosciences chief medical officer William Sandborn said in a statement.   More at #Proactive #ProactiveInvestors http://ow.ly/St63104XkAP

The FDA has approved two biosimilars to Regeneron Pharmaceuticals’ blockbuster eye injection Eylea (aflibercept)—Biocon Biologics’ Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy). Yesafili and Opuviz also have the FDA’s interchangeability designation, which means they may be used in place of the reference branded product without needing to consult the prescriber, according to the FDA’s announcement. Key patent protections for Eylea are set to expire this year, and Regeneron has been fending off would-be competitors with a spate of lawsuits. In December 2023, it won a case against Viatris keeping the biotech’s biosimilar out of the U.S. until 2027. Regeneron also has a case against Samsung Biologics. #biotech #biopharma #Eylea #biosimilar

Soliris, used for treating rare conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), is an ultra-expensive biopharmaceutical with an annual treatment cost of about 400 million won ($295,857) for an adult. Samsung Bioepis launches Epysqli (ingredient: eculizumab), a biosimilar referencing Soliris at 30% lower price than original to expand access and decrease financial burden of the patients suffering from PNH and aHUS. https://lnkd.in/dBsf6DM3

📣 NEW! Amylyx Pharmaceuticals announces acquisition of hyperinsulinemic hypoglycemia drug Avexitide with FDA Breakthrough Therapy Designation. Avexitide, a phase-3 ready GLP-1 receptor antagonist, was initially developed by Eiger BioPharmaceuticals. While the drug is currently moving forward for post-bariatric hypoglycemia (PBH), it has also completed Phase 2 studies for congenital hyperinsulinism (HI). 📣 Amylyx reports that they are “actively engaging in discussions with the broader congenital HI community, including experts in the field, to develop a path forward based on promising Phase 2 study results conducted at Children's Hospital of Philadelphia” - you can find more information about this development in Amylyx Pharmaceutical’s recent press release here: https://lnkd.in/eNE9D-Uh 🔗 #hyperinsulinism #raredisease #congenitalhyperinsulinism #hypoglycemia | Hyperinsulinism | Congenital | HI | Hypoglycemia | Rare Disease

Another step towards advancing patient care with #Biosimilars, together with our license partner Formycon: The FDA has accepted for review the Biologics License Application for our proposed ustekinumab biosimilar candidate FYB202. FYB202 is a human monoclonal antibody that targets interleukin 12 and interleukin 23 for the treatment of immune-mediated disorders such as plaque psoriasis, Crohn’s disease, ulcerative colitis as well as active psoriatic arthritis. Read the full release: https://lnkd.in/dUCUbYeT #Vision2026 #FutureFresenius #AdvancingPatientCare #FreseniusKabi

𝐆𝐥𝐚𝐧𝐝 𝐏𝐡𝐚𝐫𝐦𝐚 𝐫𝐞𝐜𝐞𝐢𝐯𝐞𝐬 𝐔𝐒𝐅𝐃𝐀 𝐚𝐩𝐩𝐫𝐨𝐯𝐚𝐥 𝐟𝐨𝐫 𝐄𝐫𝐢𝐛𝐮𝐥𝐢𝐧 𝐌𝐞𝐬𝐲𝐥𝐚𝐭𝐞 𝐢𝐧𝐣𝐞𝐜𝐭𝐢𝐨𝐧 📌Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Eribulin Mesylate Injection, 0.5 mg/mL Single Dose Vial (Product). 📌Eribulin mesylate is approved to treat: Breast cancer that has metastasized (spread to other parts of the body). It is used in patients who have already been treated with at least 2 types of chemotherapy for metastatic disease, including an anthracycline and a taxane #usfda #glandpharma

With likely US approval of Merck’s #sotatercept for the treatment of pulmonary arterial hypertension (PAH), we are fielding a poll to #cardiologists and #pulmonologists who treat PAH to ask get their thoughts. Learn more here: https://lnkd.in/d5q8ywhf #clinicalresearch #drugdevelopment #PAH #pharmaceuticals #pulmonaryhypertension #regulatoryaffairs