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.
The Value of Expertise in Aseptic Fill Finish Manufacturing of Biologics
One way to mitigate the risk associated with aseptic fill finish manufacturing of biologics is to partner with a contract manufacturing organization (CMO) demonstrating proven expertise in all aspects of biologics production.
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.
Have expert content to share? Contact us
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
Esperion’s Bempedoic Acid Receives Level 1a Recommendation in Updated ESC/EAS Guidelines for Management of Dyslipidaemias
Esperion welcomed the inclusion of bempedoic acid as the only non-statin newly recommended for LDL-C lowering and cardiovascular risk reduction in the 2025 Focused Update…
Common Intracellular Toxin Could Help Fight Leukemia
All cells naturally produce formaldehyde as a byproduct of metabolism. To survive this toxic stress, both healthy and cancerous blood-forming cells rely on a built-in…
TOLREMO Therapeutics Receives Two FDA Fast Track Designations
TOLREMO therapeutics AG recently announced its lead candidate, TT125-802, received two Fast Track designations from the US FDA for the treatment of non-small cell lung…
Wugen Secures $115 Million to Advance Pivotal Study of First-in-Class Allogeneic CAR-T Therapy
Wugen, Inc. recently announced the closing of $115 million equity financing led by Fidelity Management & Research Company, with participation from RiverVest Venture Partners, Lightchain Capital,…
TREOS Bio Partners With Charité Berlin & Junshi Biosciences to Launch Pivotal Phase 2 Clinical Trial in Refractory MSS Colorectal Cancer
TREOS Bio Ltd. recently announced the execution of clinical collaboration agreements with Charité – Universitätsmedizin Berlin and Junshi Biosciences for the initiation of OBERTO-202, a…
MannKind Announces Expansion of United Therapeutics Collaboration for Second Inhaled Therapy
MannKind Corporation recently announced United Therapeutics Corporation has exercised its option—granted under the companies’ 2018 license and collaboration agreement—to develop a second dry powder inhalation…
Moleculin Issues New Positive AML Overall Survival Data
Moleculin Biotech, Inc. recently announced the completion of its Phase 1B/2 (MB-106) clinical trial evaluating Annamycin in combination with Cytarabine (also known as Ara-C and…
Bio-Rad Expands Range of StarBright Dyes to Enhance Panel Design Capabilities for Spectral Flow Cytometry
Bio-Rad Laboratories, Inc. recently announced the introduction of a new range of StarBright Dyes, providing greater choice and flexibility for spectral flow cytometry in immunology…
Cereno Scientific Granted FDA Fast Track Designation for CS1 in Rare Disease Pulmonary Arterial Hypertension
Cereno Scientific recently announced the US FDA has granted Fast Track designation to its lead program, CS1, for the treatment of pulmonary arterial hypertension (PAH).…
Hongene to Supply exNA Oligonucleotide Technology Under New Licensing Deal
Hongene Biotech Corporation recently entered a non-exclusive licensing agreement with the UMass Chan Medical School to produce and supply extended nucleic acid (exNA) monomers and…
Scenic Enters License & Research Agreement With Alnylam
Scenic Biotech recently announced a license and research agreement with Alnylam Pharmaceuticals, Inc. to leverage Scenic's Cell-Seq platform for discovering novel targets for RNAi therapeutics.…
Vitalant & UPMC Expand Partnership to Advance Cell & Gene Therapy Initiatives
Vitalant is deepening its partnership with UPMC to support and enhance the health system’s cell and gene therapy initiatives through medical leadership and laboratory operations.…
Allarity Therapeutics Granted FDA Fast Track Designation for Stenoparib for the Treatment of Advanced Ovarian Cancer
Allarity Therapeutics, Inc. recently announced the US FDA has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian cancer. The…
Clearside Biomedical Announces Multiple Presentations on Suprachoroidal Delivery
Clearside Biomedical, Inc. recently announced its SCS delivery platform and CLS-AX program will be highlighted in multiple presentations at the 25th EURETINA Congress from September…
CDT Equity Identifies New Biological Target Validating AI-Driven Repurposing Strategy
CDT Equity Inc. recently announced it has successfully identified a new biological target and novel therapeutic indication for its lead program, AZD1656 (and its derivatives),…
Newly Published Paper Unveils Breakthrough Enzyme That Expands Possibilities for Peptide Drug Discovery
A team of researchers from the University of Utah and Sethera Therapeutics has uncovered a powerful new way to build more stable and drug-like peptides,…
Terumo to Acquire OrganOx Limited, a Leading Innovator in Organ Preservation Devices
Terumo Corporation recently announced it has entered into a definitive agreement dated August 3, 2025, with OrganOx Limited, a leading innovator in organ preservation devices,…
MannKind to Acquire scPharmaceuticals, Accelerating Revenue Growth & Emerging as a Patient-Centric Leader in Cardiometabolic & Lung Diseases
MannKind Corporation and scPharmaceuticals Inc. recently announced the signing of a definitive merger agreement for MannKind to acquire scPharmaceuticals. This proposed acquisition marks MannKind’s strategic…
Artelo Biosciences Announces New Data From Initial Food Effect Investigation With a Novel Non-Opioid Treatment Candidate for Persistent Pain
Artelo Biosciences, Inc. recently announced encouraging results from its preliminary food effect evaluation with ART26.12. This assessment was conducted as a part of the successful single…
Immuneering Announces Clinical Supply Agreement With Lilly to Evaluate Atebimetinib in Combination With Olomorasib
Immuneering Corporation recently announced a clinical supply agreement with Eli Lilly and Company for its second-generation KRAS G12C inhibitor, olomorasib (LY3537982). The supply agreement supports…
