Fractyl Health’s Post

Advancements in cellular and molecular biotechnology have led to the introduction of 26 ATMPs in the EU market, showcasing their transformative potential across various medical areas. 🧬 🌎 Recent safety signals are reshaping patient access to #ATMPs, marking a pivotal moment in medical innovation and regulation. Click the link to explore the 𝐜𝐫𝐢𝐭𝐢𝐜𝐚𝐥 𝐜𝐨𝐧𝐬𝐢𝐝𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬 posed by these signals in our latest blog written by Market Access Analyst Manahill Baig 👉 https://lnkd.in/grZXVjYk #marketaccess #patientaccess #genetherapy #advancedtherapies #medicalinnovation #pharma #healthcare

🎬 Resolian Video Series Finale: Chapter 9 🌟   The final of our video series featuring our CEO Patrick Bennett with Chris Conner from Life Science Marketing Radio. 🔍 “Unveiling the Heartbeat - Bringing Benefits to Patients!”   In this final instalment, we explore Resolian's impact on patients' experiences in clinical trials. Unlike central labs or clinical diagnostics, bioanalysis often involves unique methods, limiting optimal locations for sample analysis. Resolian's global network, with laboratories in multiple geographies, provides our pharma clients the leverage to strategically choose where they run analyses in alignment with their clinical trials. This not only expands the options for clients but, more importantly, broadens the reach of clinical trials, benefiting a larger population of patients around the globe. Missed a chapter? Watch all the chapters on our YouTube channel: https://lnkd.in/e7B9SGCG   #Resolian #VideoSeries #CompanyCulture #LabInnovation #WatchNow #Bioanalytics #bioanalyticalservices #AnalyticalSciences #ContractResearchOrganization #CRO #biotech #lifescience #pharma #drugdevelopment 🎥

#Orphandiseases are often chronic or life-threatening, yet most don’t have an effective treatment. Research for these is incentivised by #orphandrugdesignation which requires robust evidence. Read our case study to learn how we have supported this at http://bit.ly/3kdfWh9. -Orphan drug designation for a new investigative treatment of idiopathic pulmonary fibrosis (IPF) was granted by both the FDA and EMA. “The Company was “very pleased” to receive orphan drug designation (ODD) in both the US and EU. The EMA cited clinically relevant biomarker data as a justification for the ODD designation. The data presented provided evidence of a “clinically relevant advantage” over existing treatments, offering the potential to “address a significant unmet medical need.” Biotech CEO #rarediseases #biotech #lifesciences #IPF

Integrated drug substance, drug product and clinical services to accelerate your molecule pipeline...

Positive pre-clinical results of long-acting PAS-nomacopan for geographic atrophy (GA), including an advanced high yielding manufacturing process, support the anticipated submission of an IND in 2024 to begin clinical development with Phase 1 single and multiple ascending dose (SAD/MAD) testing to evaluate safety and pharmacokinetics/pharmacodynamics (PK/PD). Our poster, presented by Chief Scientific Officer Miles Nunn, at the 4th Annual Dry AMD Therapeutic Development conference can be found here: https://lnkd.in/evazJDn3

Macroeconomic forces can only carry the biotech sector so far—innovative new drugs, and the study data that supports them, are what sustains investors’ attention. Here are 10 imminent clinical trial readouts to watch as we open up the New Year.

Macroeconomic forces can only carry the biotech sector so far—innovative new drugs, and the study data that supports them, are what sustains investors’ attention. Here are 10 imminent clinical trial readouts to watch as we open up the New Year.

Macroeconomic forces can only carry the biotech sector so far—innovative new drugs, and the study data that supports them, are what sustains investors’ attention. Here are 10 imminent clinical trial readouts to watch as we open up the New Year.

Macroeconomic forces can only carry the biotech sector so far—innovative new drugs, and the study data that supports them, are what sustains investors’ attention. Here are 10 imminent clinical trial readouts to watch as we open up the New Year.

Macroeconomic forces can only carry the biotech sector so far—innovative new drugs, and the study data that supports them, are what sustains investors’ attention. Here are 10 imminent clinical trial readouts to watch as we open up the New Year.