Clinical Trials: Shifting Direction in Drug Development

Join FDA on August 27 for the virtual workshop, “Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs.” https://lnkd.in/edahF9RP Topics: ▪️ An overview of MIE submissions received by FDA and key takeaways for the field.  ▪️Up-to-date regulatory expectations and lessons learned for population pharmacokinetics (popPK) modeling, locally acting physiologically based pharmacokinetic (PBPK) modeling, and oral PBPK modeling in generic drug submissions.  ▪️The role of MIE in shaping FDA product-specific and general guidance development across a range of drug products, including orally inhaled drug products, long-acting injectables, ophthalmic drug products, and oral drug products. ▪️An update on the ICH M15 guidance on “General Principles for Model-Informed Drug Development”.

This workshop sounds interesting!! As #quantitative #modeling continues to play an increasingly important role in evidence generation and regulatory decision-making, this could be a valuable opportunity to explore emerging scientific and regulatory perspectives! For instance, how modeling and #simulation can generate #pivotal #evidence and support regulatory decision-making in generic drug development!

SDBN Feed: Acadia Pharmaceuticals Receives FDA Fast Track Designation for Remlifanserin in Alzheimer's Disease Psychosis https://lnkd.in/g5WNRwNA SAN DIEGO–(BUSINESS WIRE)–Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to remlifanserin, an investigational, highly selective, 5-HT2A receptor inverse agonist, for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions a Click here to view original post Click Here to Publish/Feature Your Company or Product News with Biotech Networks

🚨 BREAKING News from Clival Database!| WEEK 3 | 16th July 2026 🚨 Clinical Update: Lingke Completes Enrollment | Atrium Secures FDA IND Approval 🔹 Lingke Pharmaceuticals completes patient enrolment in phase III trial of zaprixitinib for the treatment of ankylosing spondylitis 🔹 US FDA clears Atrium Therapeutics’ IND application for ATR 1072 to treat of PRKAG2 syndrome 🚀 These breakthroughs highlight how innovation, advanced clinical strategies, and global expansion are reshaping the future of healthcare and patient outcomes. 🎥 Watch complete analysis & expert insights on our YouTube channel: 👉 https://lnkd.in/g655VA-J 📰 Explore more verified clinical and pharma updates anytime: 👉 https://clival.com/news 📊 Want deeper clinical intelligence, pipeline tracking, competitor benchmarking, and real-time pharma insights? 📅 Book a demo with Clival Database today: 👉 https://lnkd.in/dSdbxTJF 📡 Daily updates. Verified insights. Real-time research breakthroughs — only on Clival Database. 🌐 Visit: www.clival.com 📞 Toll-Free: 1800 4190 155 . . . #Clival #ClivalDatabase #ClinicalResearch #PharmaNews #BiotechNews #ClinicalTrials #MedicalResearch #PharmaInnovation #BiotechInnovation #LifeSciences #DrugDevelopment #HealthcareInnovation #PharmaTrends #LifeScienceIntellipedia

Could a promising drug candidate get a second chance through a different delivery route? Drug repurposing is creating new market opportunities as developers reformulate existing compounds for inhaled and nasal delivery. These approaches can potentially improve bioavailability, accelerate onset of action, reduce systemic exposure and overcome limitations that stalled earlier programs. This exclusive seventh annual Drug Development & Delivery eBook explores development, including: - Inhaled formulations designed to rescue struggling oral drug candidates - Nasal sprays advanced through the 505(b)(2) pathway - Nose-to-brain delivery for CNS therapies - High-payload pulmonary delivery for complex and repurposed drugs - New formulation and device technologies supporting development Thank you to Kindeva Drug Delivery, Bespak, Aptar, and MedPharm for their support and insights.. Read the full article: https://lnkd.in/gRA9ghz7 #DrugRepurposing #DrugDelivery #InhalationDrugDelivery #NasalDrugDelivery #PharmaceuticalDevelopment #505b2 #PulmonaryDelivery #NoseToBrain #PharmaInnovation

Another antisense-RNA drug just crossed the finish line, and it's worth pausing on why that matters. The FDA approved Ionis's TRYNGOLZA (olezarsen) — the first and only treatment to lower triglycerides and reduce acute pancreatitis risk in severe hypertriglyceridemia. It's an oligonucleotide that silences APOC3 at the RNA level, and it's Ionis's second independent launch. The headline is a new therapy for a serious metabolic disease. The subtext is more important: RNA-targeting medicines are now routinely delivering approvals, not just pipeline optimism. Every one of these de-risks the modality for the entire field — regulators build precedent, payers get comfortable, and clinicians gain reps with oligonucleotide drugs. What strikes us most is how the path from target biology to approved RNA drug keeps getting shorter. Identify the transcript that drives disease, design a molecule to silence or correct it, prove it in the clinic. That's a discovery loop that rewards deep functional-genomics insight into which RNAs actually matter. 🔗 TRYNGOLZA (olezarsen) approved by the FDA — Ionis Pharmaceuticals, 2026 https://lnkd.in/gsWdiKYu #RNAtherapeutics #FunctionalGenomics #Biotech #RNAbiology #DrugDiscovery

Eli Lilly and Company just committed $3.8 billion to a psychedelic depression drug. On July 16, Lilly announced it would acquire AtaiBeckley, gaining BPL-003, an intranasal 5-MeO-DMT that produced antidepressant response in 66.7% of patients by Day 2 in Phase 2a. This is not a one-off bet. In the past 12 months, Otsuka Pharmaceutical Companies (U.S.) paid $1.2 billion for Transcend. AbbVie paid $1.2 billion for Gilgamesh Pharma. Total big pharma commitment to psychedelic assets: over $5 billion. The commercial proof is already here. J&J's Spravato is annualizing $2.3 billion in revenue with 7,000 certified administration sites, up from 2,800 two years ago. Here is the part the deal announcements skip. BPL-003 produces an altered state of consciousness. Administration requires supervised clinical settings, REMS protocols, and real-time patient monitoring. Scaling that from trial sites to thousands of commercial locations requires a governance infrastructure that does not exist yet. Four things to watch: 1) How Lilly plans to standardize supervised administration across certified sites. 2) Whether the FDA publishes AI monitoring guidance for psychedelic REMS programs. 3) How fast Lilly can scale site certification (J&J took years to reach 7,000). 4) Whether Phase 3 data on BPL-003 holds the Day 2 response signal through longer follow-up. The molecule is not the hard part. The supervised delivery framework at commercial scale is. Is your organization watching the operational governance of psychedelic medicine? #elililly #pharmaai #abbvie #otsuka #aigovernance #mentalhealth #drugdevelopment

In recent months, shortages of several essential cancer medicines have highlighted the challenges facing the global pharmaceutical supply chain. Geopolitical tensions disrupting supply chains, rising platinum prices increasing API costs, and higher raw material and operational expenses have made production financially challenging for many manufacturers. Together, these factors have contributed to reduced availability of critical oncology medicines. At GloBio Pharma, we remain committed to supporting a resilient pharmaceutical ecosystem and improving access to life-saving treatments worldwide. Because every patient deserves uninterrupted access to essential medicines. #GloBioPharma #Connectingtheworldtocare #Oncology #PharmaceuticalIndustry #SupplyChain #API #Healthcare #DrugShortage #GlobalHealth #CancerCare

Biosimilars are entering a new phase in the U.S. market. Recent uptake around products tied to Humira, Stelara, and Eylea shows growing momentum, but the path forward still comes with major challenges, including reimbursement complexity, patent barriers, interchangeability policy, and the cost of development. For patient access and support leaders, this evolution matters. As more biologics approach loss of exclusivity, biosimilar competition could expand treatment access, but only if patients, providers, payers, and support teams can navigate the transition clearly. The opportunity is not just more alternatives. It is better education, stronger access pathways, and more coordinated support around complex therapies. Worth a read:  https://lnkd.in/efE-yeYa  #Biosimilars #PatientAccess 

🚀 Pharma & Healthcare News | July 25, 2026 From EU approvals, FDA Fast Track designations, AI-powered clinical platforms, and oncology breakthroughs to cold-chain innovations and supply chain investments, today's updates reflect the rapid pace of transformation across the global pharmaceutical industry. Stay informed. Stay compliant. Stay ahead. #Pharma #Healthcare #ClinicalResearch #Biotech #RegulatoryAffairs #DrugDevelopment #FDA #EMA #Oncology #AIInHealthcare #MedicalDevices #PharmaNews #PharmaWithSahil