Yan Kugel’s Post

🔸 Sofdra™ NDA accepted, target approval date confirmed 🔸   Botanix Pharmaceuticals has today announced the company’s resubmission of the new drug application (NDA) for Sofdra™ has been accepted as a complete response by FDA. FDA also confirmed that the resubmission of the Sofdra NDA is a Class 2 response (i.e., a 6-month review period from the resubmission in late December 2023), with the result that approval remains on target for late June 2024. Botanix CEO, Dr Howie McKibbon, said:   “We are pleased that FDA has confirmed that the resubmission of the Sofdra NDA is acceptable as a complete response and that the anticipated approval date in late June 2024 remains on target.   “This clarity means that our commercialisation activities in preparation for launch can be appropriately designed to ensure a rapid launch of Sofdra, following successful approval from FDA.”   Read today’s ASX release 👉 https://lnkd.in/g3f8RcRU   $BOT #ASX #pharma #innovation #dermatology #hyperhidrosis #FDA

𝐈𝐧𝐜𝐲𝐭𝐞 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐀𝐜𝐪𝐮𝐢𝐬𝐢𝐭𝐢𝐨𝐧 𝐨𝐟 𝐄𝐬𝐜𝐢𝐞𝐧𝐭 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬: 𝐀𝐝𝐯𝐚𝐧𝐜𝐢𝐧𝐠 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐯𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐟𝐨𝐫 𝐌𝐚𝐬𝐭 𝐂𝐞𝐥𝐥-𝐌𝐞𝐝𝐢𝐚𝐭𝐞𝐝 𝐃𝐢𝐬𝐞𝐚𝐬𝐞𝐬 Incyte (Nasdaq:INCY) Incyte has entered into a definitive agreement to acquire Escient Pharmaceuticals Escient Pharmaceuticals, including their innovative drug candidates EP262 and EP547. Hervé Hoppenot Herve Hoppenot, CEO of Incyte, stated, “This acquisition aligns with our strategy to develop differentiated medicines. EP262 has shown promise in treating mast cell-mediated diseases, with preclinical studies demonstrating improvements in atopic dermatitis. Additionally, Phase 1 results indicate its safety and tolerability.” Joshua A. Grass Joshua Grass, President and CEO of Escient, expressed confidence in Incyte’s ability to translate their research into valuable medicines. The acquisition, valued at $750 million plus Escient’s net cash, is subject to customary conditions and expected to close by the third quarter of 2024. #Incyte #EscientPharmaceuticals #DrugDiscovery #MastCellDisorders #Pharmaceuticals #Investing #Acquisition #ClinicalTrials #InflammatoryDiseases #Dermatology

𝗡𝗮𝗻𝗼𝘀𝘂𝘀𝗽𝗲𝗻𝘀𝗶𝗼𝗻𝘀 𝗶𝗻 𝗼𝗽𝗵𝘁𝗵𝗮𝗹𝗺𝗼𝗹𝗼𝗴𝘆: 𝗢𝘃𝗲𝗿𝗰𝗼𝗺𝗶𝗻𝗴 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗲𝗻𝗵𝗮𝗻𝗰𝗶𝗻𝗴 𝗱𝗿𝘂𝗴 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗳𝗼𝗿 𝗲𝘆𝗲 𝗱𝗶𝘀𝗲𝗮𝘀𝗲𝘀 This review article provides a comprehensive overview of the advancements in using nanosuspensions for controlled drug delivery in ophthalmology. It highlights the significance of ophthalmic drug delivery due to the prevalence of eye diseases and delves into various aspects of this field. The article explores molecular mechanisms, drugs used, and physiological factors affecting drug absorption. It also addresses challenges in treating both anterior and posterior eye segments and investigates the role of mucus in obstructing micro- and nanosuspensions. Read more in the article. #pharmaceutical #nanosuspensions #ophthalmology

#spine #biologics Market Size, Share & Trends Analysis Report By Product Type (Bone Graft Substitutes, Bone Grafts, Platelet Rich Plasma (PRP), Bone Marrow Aspirate Concentrate (BMAC) Therapy), By Surgery type (Anterior Cervical Discectomy and Fusion (ACDF), Transforamenal Lumbar Interbody Fusion (TLIF), Anterior Lumbar Interbody Fusion (ALIF), Lateral Lumbar Interbody Fusion (LLIF), Other Surgeries), Global Economy Insights, Regional Outlook, Growth Potential, Price Trends, Competitive Market Share & Forecast, 2023 - 2031 Buy This Report @ $2145: https://lnkd.in/d2c73vpv Top Key Players: AlloSource® ALPHATEC HOLDINGS LIMITED. Alphatec Spine. Arthrex Aziyo Biologics, Inc. Baxter International Inc. Bone Biologics Camber Spine Cerapedics Inc. ChoiceSpine LLC CoreLink Surgical DePuy Synthes Exactech Globus Medical Harvest Technologies Inc Induce Biologics USA Inc. Innovasis, Inc. Integra LifeSciences InVivo Therapeutics. Johnson & Johnson K2M. Derek A. Lawson LifeNet Health Medtronic. MTF Biologics NuVasive ORHUB, INC Orthofix International NV Orthofix RTI Surgical® SeaSpine Smith+Nephew Spinal Elements. Spine Wave, Inc. Stryker Tyber Medical, LLC Wright Medical Group N.V. Wright Medical Xtant Medical Zimmer Biomet

AM-Pharma B.V. has initiated Phase 2 clinical trials for its patented alkaline phosphatase, ilofotase alfa, as a preventive therapy for cardiac surgery-related renal damage (CSA-RD). This synthetic alkaline phosphatase has shown stability and high activity in various clinical trials. CSA-RD is a significant surgical complication for which there is currently no specific pharmaceutical treatment. #AMPharma #clinicaltrials #RenalDamage #cardiacsurgery #healthcare #lifesciences

MCRA is pleased to announce its role in the U.S. Food and Drug Administration’s (FDA) 510(k) clearance for 3D Systems’ 3D-printed, patient-specific cranial implant solution — VSP® PEEK Cranial Implant. MCRA’s biocompatibility team worked with 3D Systems to design and execute a biocompatibility strategy, including chemical characterization studies, that addressed FDA expectations and demonstrated that the device is biocompatible for patient use. The VSP PEEK Cranial Implant is now the world's first patient-specific and 3D-printed PEEK cranial implant using an extrusion platform to receive such clearance. Read the full press release here: https://lnkd.in/eYaVzHP3 #pressrelease #MCRA #biocompatibility #FDA #FDAapproval #FDAclearance #510k #FDAsubmission #cranialimplant #neurology #neurodevice #medtech #biotech #medicaldevices #medtechinnovation #medtechindustry 

COVID-19 has been associated with many thrombus related conditions like retinal vascular occlusions (RVOs).  Early in the pandemic, a young male without any known risk factors presented to our practice with a CRVO suggesting an association. Subsequent reports and a study from Kaiser suggested an increased rate of CRVOs after Covid-19 infections.  We looked to answer this question by using the American Academy of Ophthalmology IRIS Registry, the largest ophthalmic database in the world.  Through a sophisticated analysis, we found that the number of RVOs were LESS than expected after the COVID Pandemic.  However, patients with RVOs were a higher proportion of total patient visits (due to suppression of ophthalmic care) giving a perception, yet misleading, of an increase in incidence rates for RVOs.  This paper came out today in the April issue of Ophthalmology Retina. Flora Lum Charles Li #covid19 https://lnkd.in/gVcVHVnc

Exploring the Efficacy of Biologics in Knee Osteoarthritis: Ultrasound Evaluation of Cartilage Regeneration Effects https://bit.ly/3RmYCYO #OA #KneeOsteoarthritis #Osteoarthritis

A new 24-month study results showcase the remarkable efficacy of Trinity Elite in lumbar spinal fusion: • 95.3% fusion success, confirmed by independent review of thin-cut CT and lack of angular and translational motion • High rates of successful lumbar arthrodesis regardless of surgical approach or risk factors • Significant improvements in pain and disability scores With more than 15 years on the market and 350,000 procedures recorded, Trinity allografts have consistently demonstrated safety and performance in aiding bone repair. This latest study reinforces Trinity Elite an efficacious alternative to autograft for musculoskeletal defects. Tissues are exclusively processed by MTF Biologics. Read the full publication at https://lnkd.in/gtk2TSr8 and learn more about Trinity Elite at https://lnkd.in/gdr5VB9T #TrinityElite #LumbarSpinalFusion #SpineSurgery #BoneHealing #MTFBiologics #Orthofix

The US FDA Approves Biocon’s Yesafili (Biosimilar to Eylea) for Ophthalmology  #biocon #yesafili #agerelatedmaculardegeneration #biosmilar #eylea #aflibercept #ophthalmology #approval #usfda #phase3 #pharmacokinetics #safety #efficacy #immunogenicity