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
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
Nanexa Signs Continuation of Feasibility Agreement With Major Pharmaceutical Company to Investigate PharmaShell Long-Acting Formulations in a Multi-Billion US Market
Nanexa has recently announced the signing of an extension of a feasibility agreement with a major pharmaceutical company to investigate the use of Nanexa´s proprietary…
Assembly Biosciences Reports Positive Interim Results From Phase 1b Clinical Study of Long-Acting Helicase-Primase Inhibitor Candidate Showing Reductions in Viral Shedding Rate & Genital Lesion Rate in Recurrent Genital Herpes
Assembly Biosciences, Inc. recently announced positive interim antiviral activity, clinical outcomes, safety, and pharmacokinetic (PK) results from a Phase 1b study evaluating ABI-5366, an investigational…
Genmab Announces Phase 3 Trial Met Dual Primary Endpoints in Patients With Relapsed/Refractory Follicular Lymphoma
Genmab A/S recently announced positive results of the Phase 3 EPCORE FL-1 trial evaluating subcutaneous epcoritamab, a bispecific antibody, in combination with rituximab andlenalidomide (R2) versus…
Almirall & Absci Expand AI Drug Creation Collaboration Adding a Second Dermatology Target
Almirall and Absci Corporation recently announced the expansion of their ongoing AI Drug Discovery collaboration with Almirall’s selection of a second target aimed at dermatological indications.…
Parkinson’s Disease Market to Grow to $7 Billion by 2033
The Parkinson’s disease (PD) market across the seven major markets (7MM) is forecast to grow at a compound annual growth rate (CAGR) of 7.6% from…
Aragen Appoints Aniel Khubchandani as CEO of Development & Manufacturing Solutions Business
Aragen recently announced the appointment of Aniel Khubchandani as CEO of its Development & Manufacturing Solutions business. Aniel will be a member of Aragen’s Management…
Sanofi Completes Acquisition of Vigil Neuroscience
Sanofi recently announced the completion of its acquisition of Vigil Neuroscience, Inc. This acquisition strengthens Sanofi’s early stage pipeline in neurology with VG-3927, a novel,…
Evoke Pharma Announces Issuance of New Patent for GIMOTI With Extended Exclusivity to Late 2038
Evoke Pharma, Inc. recently announced the official issuance of a new US patent related to its product GIMOTI. The patent, US Patent No. 12,377,064, covers…
Cardurion Pharmaceuticals Completes Enrollment in Phase 2 Trials Evaluating a Novel PDE9 Inhibitor in Heart Failure
Cardurion Pharmaceuticals, Inc. recently announced it has completed enrollment in two global, multi-center, Phase 2 clinical trials assessing the safety and efficacy of CRD-750 in…
Moleculin Biotech Reports Promising Preclinical Data of Annamycin in Liver Cancer Treatment
Moleculin Biotech, Inc. recently announced the presentation of encouraging preclinical data for its lead drug candidate, Annamycin, also known by its non-proprietary name of naxtarubicin, which…
Porosome Therapeutics Announces Breakthrough Alzheimer's Discoveries
Porosome Therapeutics, Inc. recently announced key advancements in its first-in-class, disease-modifying neurological platform, which will transform Alzheimer’s Disease (AD) research and treatment by offering a…
Polpharma Biologics & Fresenius Kabi Sign Licensing Agreement for Proposed Vedolizumab Biosimilar
Polpharma Biologics S.A. recently announced a global (except for Middle East & North Africa) licensing agreement with Fresenius Kabi for the commercialization of PB016, a…
Axplora Announces Significant Investment at Vizag Site & FDA Inspection Success Across Indian Operations
Axplora recently announced a significant investment at its Vizag site in India to expand production capacity and reinforce supply chain resilience. This announcement follows the…
Elicio Therapeutics Announces Positive Recommendation to Continue ELI-002 7P Randomized Phase 2 Study in Pancreatic Cancer Without Modifications to Final Analysis
Elicio Therapeutics, Inc. recently announced that following the Independent Data Monitoring Committee’s (IDMC) pre-specified interim review of the unblinded safety and efficacy data in the…
Pioneering LNP Expert Dr. Pieter Cullis Joins Hongene’s Scientific Advisory Board
Hongene, a global CDMO focused on nucleic acid raw materials and medicines, has appointed Dr. Pieter Cullis, a renowned innovator in lipid nanoparticle…
SERB Pharmaceuticals Agrees to Acquire Y-mAbs Therapeutics
SERB Pharmaceuticals and Y-mAbs Therapeutics, Inc. recently announced they have entered into a definitive merger agreement under which SERB will acquire Y-mAbs, including its lead…
Yatiri Bio Acquires NGeneBioAI to Expand AI-Powered Proteomics Platform & Advance Precision Biomarker Discovery
Yatiri Bio, Inc. recently announced the successful acquisition of NGeneBioAI, Inc., a San Diego-based company specializing in plasma proteomics and AI-powered diagnostics. The acquisition strengthens Yatiri…
Freya Pharma Solutions Announces Launch of Phase 2 Clinical Dose-Response Study Testing its Lybrido Concept Targeting Female Sexual Dysfunction
Freya Pharma Solutions recently announced the initation of a Phase 2 clinical study evaluating its Lybrido concept. The study will investigate two dose-combinations of testosterone…
Microbiotica Announces Completion of Recruitment in its Phase 1b Trial of a Precision Microbiome Medicine in Ulcerative Colitis Patients
Microbiotica recently announced patient recruitment is complete in its Phase 1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis (UC) patients. This international trial has…
Medicus Pharma Announces MoU With Helix Nanotechnologies to Develop Thermostable Infectious Disease Vaccines
Medicus Pharma Ltd. and Helix Nanotechnologies Inc. recently announced they have entered into a non-binding memorandum of understanding (MoU) in respect of their shared mutual interest…
