Nogra Pharma’s Post

🔬 Join us for an insightful webinar on March 6, 2024, from 10:00 am - 11:00 pm ET (4:00 - 5:00 pm CET)! 👉🏼 Learn more & Register: https://buff.ly/3uxcXtq 👩🔬 The SxP SIG and Biopharmaceutical Section of the ASA invites you to explore "Maximizing on minimal data using pharmacometric modeling to estimate the probability of technical success." 👩💼 Dermatomyositis, a rare disease affecting skin and muscle tissues, poses unique challenges for clinical trials. Learn how exposure-response modeling helped overcome data limitations in a Phase 2 study of an investigational IFNβ monoclonal antibody, paving the way for further development. 📈 Don't miss this opportunity to dive into innovative approaches in pharmacometrics. Register now! #Pharmacometrics #ClinicalTrials #Research #Webinar

Thoughts on this? >> Regeneron and Genentech battle for ophthalmologists’ affinity in Eylea HD, Vabysmo matchup >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #healthcare #productmarketing #biotech

Thoughts on this? >> Regeneron and Genentech battle for ophthalmologists’ affinity in Eylea HD, Vabysmo matchup >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #pharma #biotech #productmarketing #healthcare

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% (eye drops), a generic therapeutic equivalent version of the Reference Listed Drug (RLD), from Alcon Research LLC. Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% is indicated to dilate the pupil of the eyes. According to IQVIATM (IMS Health), Phenylephrine hydrochloride Ophthalmic Solution USP 2.5% and 10% had US sales of approximately $32 million for the 12-month period ending Mar 2024. Click on link for Press Release : https://lnkd.in/gchk95D9 #ANDA #caplinpointlaboratories #caplinpoint #caplinsteriles #caplinone #caplinonelabs #caplinapprovals #sterilemanufacturing #pharmamanufacturing #injectables #formulations #RandD #solidorals #cancertreatment #oncology #ANDAapproval #phenylephrine #phenylephrinehydrochloride #ophthalmic #ophthalmicsolution

Farisogullari, et al. present their results of their meta-analysis of trials that investigated the relationship between pharmacokinetic intervention and the reduction of fatigue symptoms in patients with inflammatory rheumatic and musculoskeletal disease. 📈 They found that the majority of pharmaceutical interventions significantly reduced fatigue symptoms. You can find the full paper summary on the IMID Forum completely free along with the latest updates in #RhematoidArthritis https://ow.ly/jQRM50Qz70y

BioCity Biopharma Provides Update on P-II (2-SUCCEED) Trial of SC0062 to Treat IgA Nephropathy #biocity #sc0062 #chronickidneydisease #igan #diabetickidneydisease #phase2trial #2succeedstudy #sglt2inhibitors #etaantagonist #renalbloodflow #inflammation #fibrosis #adverseevents #fluidretention

Brittany L. Hayes, Ph.D. speaks at DCAT 2024 about our Highly Potent & Oncology Platform Highlights, focused on 3 main areas: In the past year we launched our Drug Product Innovation Centre of Excellence at our CordenPharma Plankstadt (DE) facility, where we added bioavailability technologies like Hot Melt Extrusion (HME), spray drying, nanomilling and micronization. In addition, we have capabilities to take gram quantities of APIs to make small-scale prototypes for tablets or capsules, and using our Accelerated Stability Assessment Program, quickly identify and predict stability to bring your project rapidly into First-in-Human (FIH). Secondly, we anticipate the opening of our new clinical trial area in Plankstadt, where we have the capacity to produce 5-60 Kilo batches of tablets and capsules using technologies such as wet and dry granulation, compression coating, and a state-of-the-art encapsulator with filling modules for direct API into individually weighed capsules, as well as powders, granules, pellets, and minitablets. Lastly, in conjunction with our bioavailability enhancement technologies for non-GMP and long track record of experience with complex formulations, we are expanding into the oral solid dosage formulation of peptides. This exciting area provides oral ingestion of peptides via capsules or tablets, which offers definite advantages over traditional auto-injectors for your patients. Click here for more information on: Highly Potent & Oncology Platform: https://lnkd.in/ekPYiREv Bioavailability Enhancement: https://lnkd.in/e-Q5nWQZ Early-Phase Drug Product Services:  https://lnkd.in/ed8K4Hqm API Crystallization Solid-State Services:  https://lnkd.in/eekWNwjZ #CordenPharma #tablets #capsules #bioavailability #drugproducts #pharmaceuticals #clinicalmanufacturing #firstinhuman #osd #oralpeptides #stabilityassesment #cdmo #oncology

We’re excited to be at the Peptide Therapeutics Symposium in sunny San Diego, California! 🌟 Visit the AnaSpec table to discover how our expertise in manufacturing of peptides and peptidomimetics— from research use to clinical applications— can accelerate your drug development timeline. Let’s chat about how we can support your innovations! #PeptideTherapeutics #PeptideResearch #CustomPeptides #Peptidomimetics #PeptideSynthesis

Amgen has launched Pavblu, its aflibercept biosimilar, adding another player to the competitive landscape for treatments targeting wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The road to market for aflibercept biosimilars has been marked by ongoing legal disputes, including patent litigation with Regeneron, the maker of the original aflibercept (Eylea®). These legal proceedings have delayed market entry for several biosimilars, as companies challenge patent exclusivity and regulatory hurdles. Despite this, the approval and launch of Pavblu reflects the growing momentum for biosimilars in addressing high-cost biologic therapies. As legal issues continue to shape the future of this space, the broader impacts on drug pricing, competition, and patient access will be closely watched. Spherix will be tracking ophthalmologists’ perceptions and uptake of Pavblu. Read more here: https://lnkd.in/gSRkY2Tk #Ophthalmology #Biosimilars #Aflibercept #Pavblu #RetinalTherapies #Amgen #Regeneron #Eylea #AMD #DME

𝐀𝐁𝐈𝐎𝐍𝐘𝐗 𝐏𝐡𝐚𝐫𝐦𝐚 𝐀𝐜𝐤𝐧𝐨𝐰𝐥𝐞𝐝𝐠𝐞𝐬 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐨𝐟 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐀𝐄𝐆𝐈𝐒-𝐈𝐈 𝐒𝐭𝐮𝐝𝐲 𝐨𝐧 𝐂𝐒𝐋 𝐁𝐞𝐡𝐫𝐢𝐧𝐠'𝐬 𝐂𝐒𝐋𝟏𝟏𝟐 ABIONYX Pharma ABIONYX Pharma, a pioneering biotech company focused on innovative therapies, acknowledges the outcomes of the Phase 3 AEGIS-II study evaluating the efficacy and safety of CSL Behring's human-plasma-derived apoA-I, CSL112. Key Insights: The study aimed to assess CSL112's effectiveness in reducing major adverse cardiovascular events (MACE) in patients following acute myocardial infarction (AMI). Unfortunately, the study did not meet its primary efficacy endpoint of MACE reduction at 90 days. About CER-001: CER-001 is an engineered recombinant human apoA-I designed to mimic natural HDL, crucial for lipid elimination. It mirrors the Reverse Lipid Transport pathway (RLT), facilitating the removal of cholesterol, lipids, and bacterial endotoxins from tissues. CER-001 enhances HDL particles, promoting lipid elimination via the liver. While the results may not have met expectations, the ongoing pursuit of innovative therapies like CER-001 demonstrates the commitment of companies like ABIONYX Pharma to address critical medical needs. #Biotech #MedicalResearch #CardiovascularHealth #Innovation #ABIONYXPharma #CSL112 #AEGISII #ClinicalResearch