2025 Respiratory Drug Development e-Book - New Devices & Drugs Enhance Compliance & Facilitate Improved Disease Management
In this sixth annual Respiratory e-book, learn more about several companies and their contributions to inhalation drug delivery and device design.
SPECIAL FEATURE- Outsourcing Formulation Development & Manufacturing: CDMOs Are Making Their Supply Chains More Resilient & Secure
Contributor Cindy H. Dubin speaks with many CDMO professionals to get their insights and perspectives on the current state of the industry.
FORMULATION FORUM - Manufacturing of Solid Oral Dosage Forms by Direct Compression
Jim Huang, PhD, and Shaukat Ali, PhD, say not all excipients are well suited for DC, so challenges remain to find excipients compatible to DC due to certain physicochemical properties associated with poor flowability, lack of plasticity, flexibility, and compressibility.
ESG STRATEGY - Sustainable Foundations: Embedding ESG Principles at Every Level
Benedicta A. Bakpa, MSc, says a robust environmental, social, and governance (ESG) strategy is increasingly important for businesses to align with stakeholder values.
OUTSOURCING - The Power of Partnerships Fueling Biopharma Progress With Advanced Tools & Expert Support
Lisa V. Sellers, PhD, says as biopharma moves faster and new drug approvals reach an all-time high, relationships with critical component suppliers and expert development and manufacturing partners cannot be an afterthought.
EXECUTIVE INTERVIEW - Adare Pharma Solutions: Fast, Flexible, and Focused: The Secrets of a Successful CDMO Partnership
Steven Facer, Senior Vice President of Sales and Marketing at Adare Pharma Solutions, shares practical insights on what makes CDMO partnerships work and what can cause them to fall short.
PROTEIN BARCODING - Streamlining mRNA Therapeutic & Vaccine Development
Meredith Carpenter, PhD, reviews how lipid nanoparticles have emerged as a powerful tool for delivery due to their low immunogenicity compared to viral vectors, along with their ability to encapsulate and protect nucleic acids and facilitate their entry into cells.
EXECUTIVE INTERVIEW - Sanner Group: Building a Suite of World-Leading Services for its Customers
Chris Gilmor, Vice President of Sales, Sanner of America, explains how Sanner’s Advance with Agility™ program helps its partners achieve faster development times and reduce time to market, and how the company embeds sustainable practices into its global business.
DRUG ADMINISTRATION - Protecting Patient Data in Cell & Gene Therapy: The Role of Tech Platforms
Matthew Lakelin, PhD, explores the unique data challenges in CGT, emphasizing the need for robust technology platforms to ensure patient privacy and security.
FACILITY DESIGN - Holistic Facility Design in Injectable Fill-Finish Operations
Chad Hafer believes companies need to consider a more comprehensive approach that not only ensures compliance but also incorporates cutting-edge technologies and prioritizes sustainability.
CLINICAL TRIALS - Solving Clinical Trial Challenges Through Sub-Population Optimization & Modeling Solution
Adrian Kizewski, MSc, MBA, says in recent years, a revolutionary approach known as Sub-population Optimization & Modeling Solution has emerged to transform the landscape of clinical trials and offer new hope for more efficient and successful studies.
SPECIAL FEATURE - PFS & Parenteral Delivery: Innovation Is Focused on Patient-Centric, Smart & Sustainable Solutions
Contributor Cindy H. Dubin speaks with several innovating companies to discuss trends in PFS as well as advancements in autoinjectors and innovations in parenteral delivery.
TRANSDERMAL DELIVERY - SkinJect’s Doxorubicin-Loaded Dissolvable Microneedle Array (D-MNA): A Revolutionary Approach to Transdermal Drug Delivery
Raza Bokhari, MD, Edward Brennan, MD, FACS, and Madison Weisz, MS, explore the D-MNA treatment, highlighting its drug delivery mechanisms, advantages over traditional treatments, and clinical potential.
EXECUTIVE INTERVIEW - PCI Pharma Services: Driving Precision, Agility & Partnership in Complex Drug Development
Anshul Gupte, PhD, RAC Drugs, VP of Pharmaceutical Development at PCI Pharma Services, talks about phase-appropriate development, technical hurdles in pharmaceutical sciences, building agile teams, and what sponsors should prioritize when planning their strategy for novel therapies.
FORMULATION FORUM - Self-Emulsifying Drug Delivery Systems for Improving Oral Bioavailability of Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say as more NCEs continue to be discovered with less options to find the appropriate excipients and solubilizers for Class II and IV drugs, the pharma industry has begun to evaluate liquid SEDDS for expediting drugs to market.
EXPERT CONTENT & RESOURCES
Whether you're a researcher, a pharmaceutical professional, or simply interested in the latest advancements in drug development and delivery technology, you'll find a wealth of insightful expertise and current resources here.
Closing the Access Gap in Pediatric Oncology & Why Neuroblastoma Families Are Still Struggling
Neuroblastoma is a rare pediatric solid tumor that arises from immature nerve cells. It accounts for roughly 15% of childhood cancer deaths, despite being only 6%-10% of diagnoses. Nearly half of children are diagnosed with…
Kindeva e-Book: A Bridge to the Future: Our World-Class Site in Bridgeton
In this e-Book, you will learn about, the integrated capabilities of Bridgeton, MO, which eliminate the risks of fragmentation, the breadth of projects that Kindeva can support, our continuous investment in the facility to ensure it meets today’s demands and the needs of tomorrow, and the benefits of partnering with Kindeva.
EXECUTIVE INTERVIEW - Plus Therapeutics: Advancing Targeted Radiotherapeutics for Rare & Difficult-to-Treat Cancers
Dr. Marc Hedrick, CEO of Plus Therapeutics, discusses the company’s targeted radiotherapeutic platform for central nervous system and solid tumor cancers and why internal radiation therapy offers patients a more advanced drug delivery solution compared to traditional external radiation therapy.
Exploring New Potential Through 505(b)(2)
When filing for a drug product approval via the 505(b)(2) regulatory pathway rather than a traditional development pathway, companies are afforded several advantages.
Ionizable Lipids in LNPs: A Selection Guide
Finding the right ionizable lipid is critical for optimal formulations. This guide helps navigate the wide range of ionizable lipids for specific therapeutic needs. Explore lipids by target or cargo type.
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EXCLUSIVE WHITEPAPERS
WHITEPAPER - 3D Reconstructed Skin Models: Transforming Clinical & Safety Testing
Targeted at researchers, toxicologists and formulation scientists in the clinical and dermatological fields, the white paper provides essential insights into how advanced in vitro skin and mucosal tissue systems are reshaping research and development practices.
WHITEPAPER - OXYCAPT™: Multilayer Plastic Vial: An Optimal Primary Container for Drug Products Transported With Dry Ice
OXYCAPT™ vial is the multilayer primary container with the distinctive structure that includes the gas barrier layer in the middle layer. They offer optimal features for the transport and storage of advanced therapeutics, such as cell and gene therapy products.
WHITEPAPER - Container Selection for a Highly Sensitive Drug Product: A Success Story
When Stevanato Group is involved from the early stages, before the container is even chosen, we can support the client with a comprehensive data-driven analysis so the client can make an informed choice and select the optimal solution for their drug product.
WHITEPAPER: Partnering With Gattefossé to Tackle Veterinary Medicine Challenges
Veterinary medicines face unique challenges due to species diversity, physiology, and dosing needs. Animals can’t be instructed to take medicine, so palatability, safety, and bioavailability are key.
WHITEPAPER - 3D SCREEN Printing: Enabling a New Generation of Complex Formulations
By overcoming key challenges 3D screen printing is unlocking new possibilities in drug development and manufacturing.
EXCLUSIVE WEBINARS
ON-DEMAND WEBINAR: Drug Product Design for Delivery of Challenging Molecules
In this talk we illustrate several case studies demonstrating how a fundamental understanding of molecular properties combined with a strategic vision for drug product design can lead to effective and advanceable formulations for even the most challenging drug products.
WEBINAR - Vytal: The RTU Snap-Fit System for Container Closure Solutions – Setting the Standard for the Future
In recent decades, the landscape of parenteral drug production has undergone significant transformation, driven by the emergence of novel molecules and advanced therapies. The pharmaceutical industry has witnessed a notable shift towards biologics, mAbs, and cell-based therapies, which now represent some of the most successful pharmaceutical products globally.
WEBINAR ON DEMAND: Precision at Scale: Enabling Novel Therapeutics With Nanoparticle Manufacturing
Watch this on-demand webinar to learn about the key steps and considerations in bringing novel nanoparticle-based therapeutics from early R&D to commercial stages. Drawing from our 20 years of experience in the CDMO space, we cover critical topics unique to nanomaterials…..
WEBINAR: Introducing Key Concepts in Tableting Research: Unleashing Essential Concepts and Strategies for Enhanced Formulation Development
Tableting can present a series of challenges, particularly when dealing with formulations that have poor flowability, low compressibility, or high cohesivity. These issues can lead to manufacturing inefficiencies….
WEBINAR ON DEMAND: Advantages of Carbopol® Polymers in Oral Formulations
In this video, the Lubrizol team together with the IMCD US team takes you through formulation aspects of Carbopol® polymers as well as the results of a case study on an Acetaminophen oral suspension formulation.
MARKET NEWS & TRENDS
Trethera Awarded $3-Million NIH Grant to Advance First-In-Class Drug for the Treatment of Lupus
Trethera Corporation recently announced it has been awarded a $3-million Small Business Innovation Research (SBIR) grant from the National Institute of Health (NIH). The award…
BioMed X & Novo Nordisk Launch New Collaboration in Oral Peptide Drug Delivery
BioMed X recently announced the launch of a new collaboration with Novo Nordisk, a leading global healthcare company headquartered in Denmark. This partnership aims to…
Memo Therapeutics Publishes Phase 1 Study for Neutralizing Antibody Targeting BKPyV Infection in Clinical & Translational Science
Memo Therapeutics AG has published Phase 1 clinical data in Clinical and Translational Science, highlighting the safety, tolerability, and pharmacokinetics (PK) of its lead clinical…
Rein Therapeutics Wins Approval to Launch Phase 2 Clinical Trial of LTI-03 in Idiopathic Pulmonary Fibrosis
Rein Therapeutics recently announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the company to initiate its Phase 2 RENEW clinical trial…
ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors
ALX Oncology Holdings Inc. recently announced the first patient has been dosed in the company’s Phase 1 clinical trial for ALX2004, a potential best- and…
BiomX Provides Update on BX004 Phase 2b Trial for the Treatment of Patients with Cystic Fibrosis
BiomX Inc. recently announced the US FDA has placed a clinical hold on the Phase 2b trial of BX004 for the treatment of patients with…
Invivyd Announces Continued Neutralizing Activity of PEMGARDA & VYD2311 Against Currently Dominant SARS-CoV-2 Variant XFG
Invivyd, Inc. recently announced positive, continued, clinically meaningful in vitro neutralization data for PEMGARDA (pemivibart) against the currently dominant and growing XFG variant of SARS-CoV-2.…
Upperton Pharma Solutions Awarded VaxHub Sustainable Grant to Advance Oral Vaccine Delivery in Partnership With the University of Oxford’s Pandemic Sciences Institute
Upperton Pharma Solutions, a leading UK-based contract development and manufacturing organisation (CDMO), has been awarded a grant as part of the first VaxHub Sustainable Platform…
Ascentage Pharma Announces Global Registrational Phase 3 Study of Lisaftoclax for First-line Treatment of Patients With Higher-Risk Myelodysplastic Syndrome Cleared by FDA & EMA
Ascentage Pharma recently announced it has received clearance by the US FDA and the European Medicines Agency (EMA) to conduct GLORA-4 study (NCT06641414), a global…
Valneva’s Chikungunya Vaccine Now Authorized in Canada for Individuals Aged 12 & Older
Valneva SE recently announced Health Canada has granted marketing authorization for its single-dose vaccine, IXCHIQ, for the prevention of disease caused by the chikungunya virus…
Traws Pharma Receives Approval to Proceed With Phase 2 COVID Studies With Ratutrelvir
Traws Pharma, Inc. recently announced receipt from the Human Research Ethics Committee (HREC) of approval to proceed with a Phase 2 study to evaluate ratutrelvir, a…
Reunion Neuroscience Announces Positive Topline Results From Phase 2 Clinical Trial of RE104 for the Treatment of Postpartum Depression
Reunion Neuroscience, Inc. recently announced positive topline results from its RECONNECT Phase 2 clinical trial evaluating RE104 in adult female patients with moderate-to-severe postpartum depression…
Opus Genetics Announces FDA Clearance of IND Application for Gene Therapy Candidate
Opus Genetics recently announced the US FDA has accepted its Investigational New Drug (IND) application for OPGx-BEST1, a gene therapy for the treatment of bestrophin-1…
Halda Therapeutics Receives FDA Fast Track Designation for Metastatic Castration-Resistant Prostate Cancer Treatment
Halda Therapeutics recently announced the US FDA granted Fast Track designation to HLD-0915, the company’s lead development candidate, for the treatment of patients with metastatic…
Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab for Multiple System Atrophy
Tiziana Life Sciences, Ltd. recently announced the first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients…
Fifty 1 Labs & The Gates Foundation Lead Largest-Ever Sickle Cell Disease Study
Fifty1 AI Labs, Inc. recently announced the completion of the largest and most comprehensive study of Sickle Cell Disease (SCD) ever undertaken. Leveraging a decade's worth…
Superluminal Medicines Announces Collaboration With Eli Lilly to Advance Small Molecule Therapeutics for Cardiometabolic Diseases & Obesity
Superluminal Medicines recently announced a collaboration with Eli Lilly and Company to advance small molecule therapeutics targeting undisclosed GPCR targets relevant to cardiometabolic diseases and…
Veranova’s Devens Site Successfully Passes FDA Inspection With Zero Observations
Veranova recently announced that a routine current Good Manufacturing Practice (cGMP) surveillance inspection of Veranova’s Devens, Massachusetts site, completed by the Food and Drug Administration…
Colorcon Ventures Invests in Phytolon to Advance the Future of Natural Colorants
Colorcon Ventures, the corporate venture fund of Colorcon Inc., has invested in Phytolon, a startup company offering natural food coloring via precision fermentation of modified…
BriaCell Selected for MSK’s 2025 Therapeutics Accelerator Program for Bria-OTS+ for Cancer
BriaCell Therapeutics Corp. recently announced its acceptance into Memorial Sloan Kettering Cancer Center’s (MSK’s) Therapeutics Accelerator 2025 Cohort program. This project aims to accelerate the…
