Intavis Peptide Services’ Post

Neurogenic Detrusor Overactivity Treatment Market Size in the 7MM is expected to witness a major change in the study period 2020-2034: Neurogenic Detrusor Overactivity Treatment Market is projected to witness substantial growth over the next few years, driven by advancements in treatment modalities and increasing awareness of the condition. The pipeline for Neurogenic Detrusor Overactivity Therapeutics includes promising candidates that aim … Continue reading → #PharmaceuticalsBiotech

Rani Therapeutics has released positive Phase I clinical trial results for RT-111, a biosimilar to ustekinumab (marketed as Stelara by Johnson & Johnson) for psoriasis treatment. RT-111 combines the biosimilar CT-P43 with Rani's non-invasive, 'robotic' RaniPill capsule for drug delivery through the intestinal wall. The study, involving 55 healthy subjects in three cohorts, demonstrated safety and met primary pharmacokinetic endpoints without serious adverse events. Celltrion Inc supplied CT-P43 under a licence and supply agreement with Rani, granting Celltrion first negotiation rights globally. Ustekinumab, an IgG1қ monoclonal antibody, is approved in the US for various conditions, including psoriasis and psoriatic arthritis. Earlier this month, STADA Group and Alvotech won the first EU approval for its Stelara biosimilar Uzpruvo (AVT04), opening the door for more competition to enter the regional ustekinumab market. In addition, Amgen scored the first US Food and Drug Administration (FDA) for its interchangeable biosimilar version of Stelara, dubbed Wezlana (ustekinumab-auub) in November 2023.  #marketintelligence #competitiveintelligence #marketsmind #pharmaceutical #ustekinumab

🚀 Kicking off Day 2 of the 20th BioPharma Drug Discovery Nexus Conference with a bang! Join Mauro Mileni Founder and CEO, Abilita Therapeutics, Inc. as he unveils insights into 'Enabling the Discovery of Therapeutic Antibodies Targeting Challenging Membrane Proteins'. Don't miss out on this enlightening session! #BioPharma #DrugDiscovery #Innovation #Antibodies #Therapeutics #Membraneproteins #Epitopes #Conformational #Protiens #NexusConference #SanDiego #USconference #ScientificConference

#AACR24 BMS-986365, a Ligand Directed Androgen Receptor Degrader (AR LDD) #medicine First time disclosure from Shuichan Xu at New Drugs on the Horizon. Complete degradation! BMS-986365 (CC-94676) is an oral drug selectively targeting AR and induces effective and durable suppression of AR signaling, overcomes resistance to existing AR pathway inhibitors therapies and shows promising clinical activity in heavily pre-treated patients with mCRPC across wildtype, amplified and mutant AR status, highlighting this asset as the best-in-class AR-ligand directed degrader that may help overcome resistance to standard of care ARPIs in patients with mCRPC, a difficult-to-treat tumor type. #pharmaceuticals #healthcare Bristol Myers Squibb

𝐅𝐃𝐀 𝐆𝐫𝐚𝐧𝐭𝐬 𝐅𝐚𝐬𝐭 𝐓𝐫𝐚𝐜𝐤 𝐃𝐞𝐬𝐢𝐠𝐧𝐚𝐭𝐢𝐨𝐧 𝐭𝐨 𝐀𝐫𝐭𝐡𝐫𝐨𝐬𝐢 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬’ 𝐀𝐑𝟖𝟖𝟐 𝐟𝐨𝐫 𝐆𝐨𝐮𝐭 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 Arthrosi Therapeutics Arthrosi Therapeutics, Inc. announced that the FDA has granted Fast Track Designation to AR882, a next-generation URAT1 inhibitor, for the treatment of clinically visible tophi in gout patients. This significant milestone underscores the FDA's recognition of the serious and disabling nature of gout in patients with visible tophi. The Fast Track Designation reflects the potential of AR882 to meet this critical medical need. With our pivotal Phase 3 clinical program now underway, we are committed to working closely with the FDA to accelerate the development of AR882 and bring it to patients as quickly as possible. #ArthrosiTherapeutics #GoutTreatment #URAT1Inhibitor #FDAFastTrack #Biotech #Pharma #ClinicalTrials #HealthcareInnovation #GoutResearch #ArthritisTreatment

By offering these end-to-end services across the drug lifecycle, an integrated CRDMO platform,Chinese Peptide Company can provide a seamless and efficient pathway for the development, manufacturing, and commercialization of peptide and oligonucleotide therapeutics, ultimately helping clients bring their innovative treatments to market faster and more effectively. For more information, please visit：https://lnkd.in/gmNEVsqk #Peptide #oligonucleotides #manufacturing #CPC #Chinesepeptidecompany #cgmp #peptides #cdmo #api #drugdevelopment #peptidesynthesis #peptidetherapeutics #GMP

𝐁𝐫𝐚𝐢𝐧𝐒𝐭𝐨𝐫𝐦 𝐂𝐞𝐥𝐥 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐥𝐢𝐠𝐧𝐬 𝐰𝐢𝐭𝐡 𝐅𝐃𝐀 𝐨𝐧 𝐂𝐌𝐂 𝐀𝐬𝐩𝐞𝐜𝐭𝐬 𝐟𝐨𝐫 𝐍𝐮𝐫𝐎𝐰𝐧® 𝐏𝐡𝐚𝐬𝐞 𝟑𝐛 𝐓𝐫𝐢𝐚𝐥 BrainStorm Cell Therapeutics (NASDAQ: BCLI) Brainstorm Cell Therapeutics has reached alignment with the FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its Phase 3b trial for NurOwn®, its investigational therapy for ALS. This follows the positive momentum from April 2024, when the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement, providing clarity on the trial's design and endpoints. "This in-person Type C meeting with the FDA was crucial as we finalize preparations for our pivotal Phase 3b trial of NurOwn. We are very pleased with the outcome and are now aligned on resolving all previously outstanding CMC questions," said Chaim Lebovits Chaim Lebovits, President & CEO of BrainStorm. "We are committed to working closely with the FDA and are excited to move forward with the Phase 3b trial to address the unmet needs of ALS patients." #ALS #StemCellTherapy #ClinicalTrials #FDA #NurOwn #BrainStormCellTherapeutics #Biotech #NeurodegenerativeDiseases

📢PTC Therapeutics, Inc. today announced promising 12 month results from their Phase 2 PIVOT-HD study of oral PTC518. At Month 12, mutant Huntingtin (mHTT) in the blood was lowered by 22% and 43% respectively for 5mg and 10mg doses. A similar result was seen in cerebrospinal fluid, where mHTT was lowered by 21% and 43% respectively, for 5mg and 10mg doses. 👉In addition PTC518 treatment resulted in a notable slowing in progression of motor symptoms at month 12, as assessed by the Total Motor Score (2.0 points worsening for 5mg and 1.3 points worsening for 10mg vs. 4.9 points worsening for placebo). Read the full release to learn more 🔗 https://bit.ly/3KTYSL6 

Congrats to Abbisko Therapeutics for achieving a major milestone! They have successfully completed patient enrollment for pivotal Phase III MANEUVER (ABSK021-301) STUDY, which aims to evaluate the safety and efficiency of pimicotinib in managing patients with tenosynovial giant cell tumor (TGCT). The study was conducted across over 30 investigational sites globally, with European and North American patients accounting for over half of total enrollment. Pimicotinib is a path-breaking, orally available, highly selective and potent small molecule inhibitor of CSF-1R, independently discovered and developed by Abbisko Therapeutics. Pimicotinib has received the Breakthrough Therapy Designation (BTD) from the China NMPA and the U.S. FDA, along with the PRIME designation from the EMA. The U.S. FDA also granted Fast Track Designation (FTD), and the EMA granted Orphan Drug Designation (ODD) in January 2024, further underlining the potential of this game-changing drug. Additionally, back in December 2023, Abbisko teamed up with Merck, granting them exclusive license to commercialize the product. #QMportfolio #QMhealthcare #milestone #clinicalstudy#AbbiskoTherapeutics #TGCT #PhaseIIITrial #HealthcareInnovation #Merck #Pimicotinib #BreakthroughTherapy 

🔬 Poseida Therapeutics, Inc. Responds Swiftly to FDA Safety Review with Preliminary Data on P-BCMA-ALLO1! 🩸💉 In response to the FDA's recent safety review of approved CAR-T therapies, Poseida Therapeutics presents preliminary data for its allogeneic CAR-T candidate, P-BCMA-ALLO1, developed in collaboration with Roche. 💡 Distinguished by its nonviral approach, this candidate holds the potential for a more favorable safety profile compared to conventional methods. The phase 1 trial primarily targets patients facing relapsed or refractory multiple myeloma. #PoseidaTherapeutics #CAR-T #clinicaltrials