Tamas Sohajda’s Post

You're all cordially invited to read “Rational Design and Synthesis of HSF1-PROTACs for Anticancer Drug Development” 👉https://ow.ly/TyaQ50PQ0u3 #mdpimolecules #molecules_mdpi

𝐅𝐃𝐀'𝐬 𝐌𝐨𝐝𝐞𝐥-𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐞𝐝 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞 (𝐌𝐈𝐄) 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐌𝐞𝐞𝐭𝐢𝐧𝐠 𝐏𝐢𝐥𝐨𝐭 𝐏𝐫𝐨𝐠𝐫𝐚𝐦 𝐟𝐨𝐫 𝐆𝐞𝐧𝐞𝐫𝐢𝐜 𝐃𝐫𝐮𝐠𝐬 𝐀𝐩𝐩𝐥𝐢𝐜𝐚𝐧𝐭𝐬🤝💊 𝘎𝘦𝘵 𝘍𝘋𝘈 𝘱𝘳𝘦-𝘢𝘱𝘱𝘳𝘰𝘷𝘢𝘭 𝘧𝘰𝘳 𝘺𝘰𝘶𝘳 𝘪𝘯 𝘴𝘪𝘭𝘪𝘤𝘰 𝘮𝘰𝘥𝘦𝘭𝘪𝘯𝘨 𝘢𝘯𝘥 𝘴𝘪𝘮𝘶𝘭𝘢𝘵𝘪𝘰𝘯 𝘢𝘱𝘱𝘳𝘰𝘢𝘤𝘩𝘦𝘴 𝘧𝘰𝘳 𝘨𝘦𝘯𝘦𝘳𝘪𝘤 𝘥𝘳𝘶𝘨 𝘥𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵. The FDA, based on the #success of the MIDD (Model Informed Drug Development) program for #discovery that started in 2018, has now launched a similar program for #generics. The "Model-Integrated Evidence" (MIE) Industry Meeting Pilot Program for Generic Drugs, which was launched on 🗓️ October 1st, 2023. If you are thinking about using in silico for your generic #drugdevelopment program the MIE meeting is a new and essential program to help #validate your plan with the FDA and get pre-approvals. 🔗𝘊𝘭𝘪𝘤𝘬 𝘩𝘦𝘳𝘦 𝘵𝘰 𝘳𝘦𝘢𝘥 𝘵𝘩𝘦 𝘧𝘶𝘭𝘭 𝘣𝘭𝘰𝘨 𝘱𝘰𝘴𝘵 𝘢𝘯𝘥 𝘭𝘦𝘢𝘳𝘯 𝘮𝘰𝘳𝘦 𝘢𝘣𝘰𝘶𝘵 𝘵𝘩𝘦 𝘔𝘐𝘌 𝘗𝘪𝘭𝘰𝘵 𝘗𝘳𝘰𝘨𝘳𝘢𝘮. https://lnkd.in/ds74smFg FDA InSilicoTrials #FDA #GenericDrugs #MIEPilotProgram #InSilico #Modeling #Simulation #RegulatoryUpdates

We will show some applications of Gastro Intestinal Simulator(GIS) which are really helpful for the new formulation studies of BCS class II drugs to investigate those in vivo performance. For BE study, GIS will be an extremely useful in vitro dissolution system for BCS classII drugs! About the drtail, please contact us:) GIS-α will be helpful for your drug formation study. #dissolution #formulation #GIS-α #madeinjapan #bioavailability #biologicalequivalencestudy

Delve into a discussion with experts from FDA and industry about MIDD Strategies in RNA-Based Oligonucleotide Drug Development in this upcoming #ASCPTwebinar. 4/24 at 12 pm ET: https://bit.ly/49MdUxw

As a CRDMO supporting the development of innovative therapies using new modalities such as oligonucleotides and peptides, our scientists safely handle new molecules in the lab everyday. To manage risk of occupational exposure, we always seek the best solutions. In a 2020 article, Jessica Graham et. al. proposed an Occupational Exposure Control Banding (ECB) system to for oligonucleotides and peptides, helping our scientists to safely handle new modalities. Read more👇 Graham JC, Hillegass J, Schulze G. Considerations for setting occupational exposure limits for novel pharmaceutical modalities. Regul Toxicol Pharmacol. 2020 Dec;118:104813. doi: 10.1016/j.yrtph.2020.104813. Epub 2020 Nov 2. PMID: 33144077; PMCID: PMC7605856.

The Para IV Winners and Losers – May 2024   Track the Para IV space on a regular basis through our monthly report. The report is derived from our Para IV Insights – a database that covers all the Para IV litigations since 2012, both for Synthetic and Biosimilar drugs.   The report answers the following questions for the month of May 2024:   Which are the products were new Para IV filings have happened? Which products witnessed settlements and / or judgement? What opportunities emerge for companies based on the above developments? What are the key developments in the biosimilars space? For more information on the report and database – kindly contact us. #ParaIV #USgenerics #patent #505b(2) #settlement

#BREAKING: The FDA has cleared Cybin's investigational new drug application for CYB004 — our proprietary deuterated DMT molecule — allowing us to proceed with a Phase 2a GAD study of CYB004 in Q1 2024. "We have gathered important insights on dosing and preliminary efficacy signals from our extensive dataset of deuterated DMT and DMT studies that will inform our next steps," said Cybin CEO Doug Drysdale. "Exploratory analysis of data from the completed Phase 2a study of SPL026 (IV DMT) showed a reduction in anxiety symptoms in patients with major depressive disorder, de-risking the development of deuterated DMT in anxiety disorders as we further evaluate the efficacy and safety of CYB004." Read more: https://lnkd.in/gUVn4GfU #Cybin #CYB004 #FDAapproval #ClinicalTrials #MentalHealthResearch #AnxietyTreatment #InnovationInHealthcare #Pharmaceuticals #Biotech

As we're at the forefront of the ADC and bioconjugate industry (we don't do modesty as you can tell 😉), it is only right that we have the most up-to-date technology to go alongside that. ThioBridge™ embodies our objective to do just that! What is ThioBridge™ you may ask? ThioBridge™ is a technology which links antibodies and other proteins to drugs, however it is not just any old linker technology. It also has the ability to maintain the stability of the antibody and a consistent drug-to-antibody ratio (DAR), meaning the product is more uniform than if traditional methods were used. We did say we were at the forefront of the ADC and bioconjugate industry 😜 Find out more about our ADC services here: https://lnkd.in/eu68Ed89 #CDMO #Pharma #PharmaceuticalTechnology

As a vertically integrated CRDMO, we support customers from research up to cGMP manufacturing of modified phosphoramidites, oligonucleotides, GalNAc and oligonucleotide conjugates. This might be helpful to accelerate your new drug development program, so let's start working together. 👉Schedule an introductory meeting here: 📧crdmo@auriscopharma.com📧 #CRDMO #CDMO #GalNAc #oligonucleotides #tides #RNA #drugconjugates #drugdelivery #newmodalities #pharma #biotech

Another huge #AACR for #DDR therapies this year - 10% up on the total number of abstracts last year. Breaking this down: - Over 160 abstracts - Over 30 new drugs, with a significant number from Chinese biotech - Strong showing from novel targets as new #WRN, #PolTheta and #USP1 drugs make up half of the new drugs - First insight into Merck KGaA's #ATM + #ATR combination Keen to highlight the last point: the lack of additive toxicity reported feels like a really important result and it provides strong rationale for future combinations involving DDRi - in particular with over DDRi. The prior assumption was that these would be overly toxic but if respective toxicity does not overlap then it creates an interesting hypothesis for a given combo. Tracking toxicity data for over 1500 DDRi is not easy - this is where Beacon comes in. Message me to learn more!