Pearce IP’s Post

Could this be the biggest week ever for the Pearce IP #BioBlast? We have reported global biosimilars developments weekly since 2015, but I do not recall a week this active! - Novo Nordisk's #Ozempic® - Samsung Bioepis's #adalimumab #ustekinumab interchangeability biosimilars; - Biocon's #aflibercept - Amgen's #Stelara® (#ustekinumab) - Sandoz's interchangeable #denosumab - Sandoz/Coherus BioSciences’ #CIMERLI® (#ranibizumab)     - Fresenius Kabi's #tocilizumab  Read more below   #bioblast #biosimilars #boutiquelawfirm #australia #patentlaw #awardwinning #patents #biopharma #lifesciences #femalefounder 

Thanks so much #LaurentGrassin and #Boursorama for having me on Le Journal des Biotech to start the year. On the agenda 2 French names: #Medincell (Uzedy and its new formulation of olanzapine partnered with Teva); #OSEImmuno: Phase 2 Top-line efficacy data with OSE-127/Lusvertikimab (anti-IL7) in ulcerative colitis are expected in mid-2024 (enrollment expected to close by the end of Q1 24): induction data at week 10. 2 doses are tested and they use the same efficacy criteria as Abivax: mean change from baseline on the modified Mayo score. It is always difficult to make cross-comparisons between molecules because the duration of the induction phase can vary from one study to another. For example, AbbVie conducted a Phase 3 program with Skyrizi (anti-IL23) with a 12-week induction, with Rinvoq (a JAK inhibitor), AbbVie conducted Phase 3 with an induction at 8 weeks. Abivax in its Phase 2b with ABX464 had an induction at 8 weeks (mean change from baseline was 3.2 points with the 50mg dose versus 1.9 points with placebo). The issue with these studies (OSE and Abivax) is that the primary efficacy endpoint is not the one use in Phase 3 for approval: which is clinical remission (secondary efficacy endpoint for OSE and Abivax). 

This week's Pearce IP #BioBlast features the following (and more!): - #omalizumab: Celltrion Inc submits BLA for interchangeable #omalizumab (#Xolair®) biosimilar - #omalizumab: CuraTeQ Biologics’ #omalizumab biosimilar (#BP11) Phase I completion - #pembrolizumab: A second challenge commenced by Merck (this time IPR) against four Johns Hopkins #pembrolizumab MOT patents - #ranibizumab: Formycon AG / MS PHARMA’s #ranibizumab biosimilar (#Ravegza®) approved in Saudi Arabia - #adalimumab / #semaglutide / #teriparatide: AU's November 2023 PBAC public summary documents feature biopharma developments Read more: https://lnkd.in/gZ_sxhrm   #bioblast #biosimilars #boutiquelawfirm #australia #patentlaw #awardwinning #pearceip #patents #biopharma #lifesciences #femalefounder

💉------------->💊 Shot to pill? For the very first time in Pakistan Getz Pharma has introduced an oral therapy For the treatment of CKD-induced anemia What is roxadustat ? • Roxadustat is a HIF-PH inhibitor (Hypoxia inducible factor prolyl hydroxylase inhibitor) • It promotes erythropoiesis which raises erythropoietin levels • Ultimately increases the production of RBCs in the body • Leading to normal Hb levels • This has great potential for the clinical treatment of anemia caused by CKD #Roxaget #GetzPharma

Ice Bear Therapeutics’ co-founder Christian Pfleger will be in San Francisco all week for the ‘2024 CSSi LifeSciences J.P.Morgan Healthcare Partnering Forum’ and external meetings with potential partners and investors.   We are a cutting edge biotherapeutic manufacturing platform that is championing continuous manufacturing processes through mammalian cell line technology to produce biotherapeutics faster and cheaper. The first two candidates manufactured with our technology are going to be biosimilar insulins Glargine and Lispro.   We chose biosimilar insulins because we see a huge opportunity in the market that is being accelerated by three factors: a) a rapidly growing global prevalence rate with currently 451m patients and $24M spending on insulins, b) an increase in demand globally for biosimilar drugs and c) a changing favorable regulatory landscape for faster biosimilar FDA clearances. The key to taking advantage of these factors is low cost, rapid manufacturing processes, which we now have.    We are currently looking for partners and investors that see the same opportunity to disrupt the current risk heavy centralized manufacturing model with a cutting-edge continuous manufacturing technology which will bring biosimilar insulins to everyone globally.   Attending the CSSi LifeSciences event? Find us on the online CSSi LifeSiences partnering system to request a meeting.   #JPMweek #JPM2024

What’s in the #pipeline for #biopharma this year? We’ve analysed some of the biggest potential launches for 2024 and some of that analysis features in this new article from the team at MM+M. Well worth a look at some of these potentially disruptive therapies that may hit the market this year. 👉 https://ow.ly/Zt9x50QuO9G #biotech

The interstitial cystitis drugs market is on a robust growth trajectory, projected to reach $1.67 billion by 2028. This expansion is fueled by increased attention to rare diseases, innovations in biopharmaceuticals, and regulatory support for orphan drugs. Key trends include advancements in diagnostics and the rise of targeted therapies, enhancing patient care and outcomes. Learn more about the interstitial cystitis drugs market: https://lnkd.in/g-5vF2ee . . . #interstitial #cystitis #drugs #medications #tbrc #thebusinessresearchcompany #marketresearch #marketintelligence

Therapeutic Drug Monitoring Market worth $2.9 billion by 2027 Download PDF Brochure: https://lnkd.in/dwUEsB3s The global therapeutic drug monitoring market in terms of revenue was estimated to be worth $1.8 billion in 2022 and is poised to reach $2.9 billion by 2027, growing at a CAGR of 9.6% from 2022 to 2027. 𝐓𝐡𝐞 𝐜𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 𝐟𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐢𝐧 𝐭𝐡𝐢𝐬 𝐫𝐞𝐩𝐨𝐫𝐭 𝐢𝐧𝐜𝐥𝐮𝐝𝐞 Abbott Thermo Fisher Scientific Wohlfahrtsstiftung der F. Hoffmann-La Roche AG , Siemens Healthineers Danaher Corporation Bio-Rad Laboratories bioMérieux Theradiag SA. Grifols Exagen Inc. R-Biopharm AG ARK Diagnostics, Inc. apDia Immundiagnostik AG SEKISUI MEDICAL CO., LTD. #therapeuticdrugmonitoring #precisionmedicine #pharmacokinetics #clinicaldiagnostics #personalizedmedicine

-Biogen and Ionis announce the discontinuation of BIIB105, an investigational drug for ALS. -Despite successfully lowering ATXN2 protein, BIIB105 did not demonstrate effectiveness in slowing the disease process, prompting the decision to terminate its development. -Both companies express gratitude to study participants and investigators while affirming continued commitment to developing treatments for ALS. To know more, read the full article on #theenterprise #Biogen #IonisPharmaceuticals #ALSResearch #BIIB105 #ClinicalTrials#globalbusiness #theenterprisenews #followformore #global #finance

The Pharma News 2024 Stay Updated!   1.     JPM24: Novartis’ head start, FTC fallout and Bluebird’s price defense – 10 Jan - https://lnkd.in/gPWjY_Ru 2.     Gaucher disease market to reach $1.3 billion across 7MM in 2032 – 28 Dec - https://lnkd.in/gyJj6xgN 3.     GSK to buy asthma drug startup Aiolos for $1B – 9 Jan - https://lnkd.in/g_Y9iGzq 4.     Psychedelic Therapy Developer MAPS PBC Closes $100M Series A, Rebrands as Lykos Therapeutics - 10 Jan - https://lnkd.in/g6qXC4JC 5.     #JPM24 quick hits: Ionis on partnership’s pros and cons; Novo Ventures has $600M to spend; Are small molecules back? + more 10 Jan- https://lnkd.in/e9TTRgNb P.S. Comment below with the latest pharma/biotech news you came across #pharma #cdmo #biotech