Life Sciences Voice’s Post

Sagesse Bio is an early stage pharmaceutical company utilizing RNAi technology to accelerate the clinical development of novel solutions to destroy or remodel undesirable pockets of fat. The company's lead compound, SGY-101, is IND-enabled and currently in Phase II clinical trials for other indications. Sagesse Bio will promptly begin clinical evaluation of SGY-101 with comprehensive scientific and technical support from Sirnaomics which specializes in the development of RNAi technology. Initial indications of interest include body contouring and fat reduction. The strategic goal of Sagesse Bio is to become the leading provider of therapeutic solutions for targeted fat reduction in both medical dermatology and aesthetic medicine. 

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

𝐅𝐨𝐫 400,000 𝐰𝐨𝐦𝐞𝐧 𝐰𝐨𝐫𝐥𝐝𝐰𝐢𝐝𝐞, 𝐡𝐨𝐩𝐞 𝐭𝐮𝐫𝐧𝐞𝐝 𝐭𝐨 𝐡𝐨𝐫𝐫𝐨𝐫 𝐰𝐢𝐭𝐡 𝐏𝐨𝐥𝐲 𝐈𝐦𝐩𝐥𝐚𝐧𝐭 𝐏𝐫𝐨𝐭𝐡è𝐬𝐞 (𝐏𝐈𝐏) 𝐛𝐫𝐞𝐚𝐬𝐭 𝐢𝐦𝐩𝐥𝐚𝐧𝐭𝐬. Imagine facing a life-altering decision: surgery after breast cancer or cosmetic enhancement for confidence. This incident is a disregard for safety in pursuit of profit. The PIP scandal highlights the crucial need for stringent medical device regulation, exemplified by the Medical Device Regulation (2017/745). This crisis exposed the consequences of lax oversight in the industry. Check the Comments Section to Read the Complete Article ⬇  #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

Promising News: Vertex's Non-Opioid Painkiller Shows Positive Results! Vertex Pharmaceuticals announces encouraging late-stage trial results for its experimental painkiller, VX-548. Designed as a non-addictive alternative to opioids, VX-548 significantly reduced post-surgery pain. Vertex plans to seek FDA approval for treating moderate-to-severe acute pain by mid-year. This breakthrough offers hope in addressing the opioid crisis and providing safer pain management options. Learn more about this milestone: https://lnkd.in/gaipmm6u #VertexPharmaceuticals #NonOpioidPainkiller #MedicalInnovation

RespireRx Pharmaceuticals Inc.: A Biopharmaceutical Company (OTC:RSPI) said a case study demonstrating positive results from the treatment of an epilepsy patient involving its therapeutic KRM-II-81 has been published in a peer-reviewed journal. The company said that the 19-year-old patient in the case study had pharmaco-resistant epilepsy and required a craniotomy to remove the brain tissue generating seizures. Cortical brain tissue surgically resected from the patient exhibited epileptiform bursting with microelectrode recordings but once KRM–II–81, one of RespireRX’s GABAkines, was added to the incubation fluid, the epileptiform activity in the excised brain tissue was fully suppressed, the company highlighted.  A year after the surgery, the patient remains seizure-free but on medication. More at #Proactive #ProactiveInvestors #OTC #RSPI http://ow.ly/PwO21057PZT

We’ve been asked how does it work: Cytogel Pharma, LLC’s lead compound, CYT-1010 has a novel mechanism of action, preferentially activating the endomorphin receptor, which in nonclinical studies is associated with powerful pain relief and a greater margin of safety than is seen from activation of the traditional opioid receptor.  CYT-1010 is an analogue of a naturally occurring peptide, endomorphin 1, produced in the human body. The chemical structure of CYT-1010 is unrelated to traditional pain drugs, and therefore cannot be chemically converted to known drugs of abuse. Read more on our website https://lnkd.in/g28dGM5p

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 

Sandoz has received marketing authorization from the European Commission for Pyzchiva® (biosimilar ustekinumab), developed by Samsung Bioepis. Pyzchiva® is approved for use in treating chronic inflammatory diseases within gastroenterology, dermatology, and rheumatology. This approval marks a significant advancement in Sandoz's growth strategy, offering European patients an additional treatment option. The regulatory submission included extensive data from analytical, preclinical, and clinical studies. Sandoz entered a development and commercialization agreement with Samsung Bioepis in 2023, granting Sandoz commercialization rights in various regions while Samsung Bioepis retains responsibilities for development, registration, and manufacturing. Pyzchiva® matches the reference medicine, a monoclonal antibody targeting interleukin (IL)-12/23, for treating autoimmune disorders. #marketintelligence #competitiveintelligence #marketsmind #pharmaceutical #sandoz #ustekinumab

🔸 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

InFormed Consent introduces remote procedural consent and platform expansion to clinical research and pharmaceutical markets. Read more at https://bit.ly/3WhaNIj. #informedconsent #remoteproceduralconsent #remoteinformedconsent #CRO #clinicalresearch #readmore #learnmore #painmanagement #spine #spineprocedure #spinesurgery #plasticsurgery #orthopedicsurgery