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.
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.
How to Choose the Right CDMO for Your Pharmaceutical Project
This guide outlines the fundamental considerations to ensure your CDMO selection aligns with your project goals.
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EXCLUSIVE WHITEPAPERS
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.
WHITEPAPER - Formulating Custom Viscosity Blends With POLYOX™ Polyethylene Oxide
Excipient variability plays a critical role in pharmaceutical product design. A risk-based, scientific approach to Quality by Design (QbD) is essential to ensure consistent drug…
EXCLUSIVE WEBINARS
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.
WEBINAR - ABISOL Emulsion Preconcentrate Kit & ABISORB-DC Excipient System for Tableting Lipids
ABITEC Technical Business Director, John Tillotson, RPh, PhD, discusses ABITEC’s latest products: The ABISOL Emulsion Preconcentrate kit for the easy formulation of emulsified drug delivery systems and the….
MARKET NEWS & TRENDS
Pancreatic Cancer Phase 2a Study With Can-Fite’s Namodenoson Achieved Over 50% Enrollment Milestone
Can-Fite BioPharma Ltd. recently announced that it achieved the over 50% enrollment milestone in its Phase 2a trial of Namodenoson for pancreatic cancer. The Phase…
Incannex Reports Positive Topline Results From RePOSA Phase 2 Trial of IHL-42X
Incannex Healthcare Inc. recently announced positive topline results from its RePOSA Phase 2 clinical trial evaluating IHL-42X, a novel oral drug candidate for obstructive sleep…
FDA Provides Trethera Clearance to Initiate Clinical Trial in Healthy Volunteers to Study Food Effect & Biomarkers
Trethera Corporation recently announced the US FDA has cleared a clinical trial evaluating its novel drug, TRE-515, in healthy volunteers. TRE-515, a clinical-stage drug in…
Merck Advances Neuroscience Pipeline With Novel Therapies in Phase 2 Studies for Treatment of Alzheimer’s Disease
Merck, known as MSD outside of the US and Canada, a premier research-intensive biopharmaceutical company, is initiating two Phase 2 clinical studies for MK-2214 and…
Ofichem Expands Drug Substance Capabilities With Acquisition of Meribel Pharma Solutions’ Uppsala Site in Sweden
Ofichem recently announced the acquisition of Meribel Pharma Solutions’ site in Uppsala, Sweden. This strategic step enhances Ofichem’s ability to support early phase, IP-driven drug…
Centauri Therapeutics Receives an Additional $5.1 Million From CARB-X to Progress ABX-01 Lead Compound to First-in-Human Clinical Trials
Centauri Therapeutics Limited recently announced CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) has provided an additional $5.1 million in funding for the development of their lead…
BriaPro Therapeutics Files Patent Application for Immuno-Oncology Platform With Novel Multitargeting Agents
BriaCell Therapeutics Corp. and its majority owned subsidiary, BriaPro Therapeutics Corp., recently announce BriaPro is developing novel multivalent agents for cancer treatment. BriaPro has filed…
Therini Bio Announces First Patient Dosed in Phase 1b Trial of THN391 in Alzheimer’s Disease
Therini Bio, Inc. recently announced the first patient has been dosed in a Phase 1b trial evaluating THN391 for the treatment of Alzheimer's disease (AD).…
Veranova Appoints New Vice President of Bioconjugation
Veranova, a global leader in the development and manufacturing of specialty and complex active pharmaceutical ingredients (API) for the pharmaceutical and biotech sectors, is pleased….
Breakthrough Study From UCLA Demonstrates Can-Fite’s Piclidenoson as a Treatment for Vascular Dementia
Can-Fite BioPharma Ltd. recently announced a leading group from University of Los Angeles (UCLA) demonstrates that Piclidenoson showed efficacy in an experimental model of vascular…
LENZ Therapeutics Announces NMPA Submission of ND for LNZ100 for Presbyopia Treatment
LENZ Therapeutics, Inc. recently announced CORXEL Pharmaceuticals has submitted the New Drug Application (NDA) for LNZ100 to the Center for Drug Evaluation (CDE) of the…
Radiopharm Theranostics Receives IND Approval to Initiate Phase 1 Therapeutic Clinical Study to Target B7H3 With Betabart
Radiopharm Theranostics recently announced the US FDA has provided clearance of the Company’s Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody…
Deciphera Announces Positive CHMP Opinion for ROMVIMZA for the Treatment of Tenosynovial Giant Cell Tumor
Deciphera Pharmaceuticals, LLC and Ono Pharmaceutical Co., Ltd. recently announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a…
Inmagene Biopharmaceuticals Announces Completion of Merger With Ikena Oncology & Concurrent Private Placement of $75 Million
Inmagene Biopharmaceuticals recently announced the completion of its previously announced merger with Ikena Oncology, Inc. The combined company will operate under the name ImageneBio, Inc.…
Simtra BioPharma Solutions Announces Strategic Purchase to Expand US Manufacturing Capacity for Injectable Medicines
Simtra BioPharma Solutions recently announced the purchase from Cook Group of a 65-acre property (301 N. Curry Pike) with more than 300,000 square feet of…
Candel Therapeutics Receives EMA Orphan Designation for CAN-2409 for the Treatment of Pancreatic Cancer
Candel Therapeutics, Inc. recently announced the European Medicines Agency (EMA) has granted Orphan Designation for CAN-2409 (aglatimagene besadenovec) for the treatment of pancreatic cancer. This…
Rheumatologists Eye AbbVie’s Rinvoq, Roche/Genentech’s Gazyva & Bristol Myers Squibb’s Sotyktu as Front-Runners to Address Persistent Gaps in Systemic Lupus Erythematosus Care
Biologic use in systemic lupus erythematosus (SLE) is steadily rising, with US rheumatologists now treating close to 40% of their moderate-to-severe patients with biologics. Most…
Jupiter Neurosciences Highlights Critical Advancement of JOTROL Over Traditional Resveratrol With Breakthrough Bioavailability & CNS-Targeted Science
Jupiter Neurosciences, Inc. spotlights the scientific and clinical advantages of its proprietary resveratrol platform, JOTROL, over conventional resveratrol formulations. Resveratrol is one of the world’s most…
Roquette Unveils POLYOX ES Packaging to Advance Excipient Stability & Sustainability
Roquette has recently launched POLYOX Extended Stability (ES) packaging, a customer-driven innovation that delivers measurable improvements in excipient stability, handling, and environmental impact. POLYOX Water…
BD Announces First Pharma-Sponsored Clinical Trial Using BD Libertas Wearable Injector Technology for Biologic Drugs
BD (Becton, Dickinson and Company) recently announced the first pharma-sponsored combination product clinical trial using the BD Libertas Wearable Injector for subcutaneous delivery of complex…
