Formulation Development
WHITEPAPER - Purity is Paramount: Assessing N-Oxide Impurities in Lipids Used in Lipid Nanoparticle Delivery Systems
This study demonstrates that Evonik is capable of manufacturing high-quality lipids with a purity greater than 99% and a consistently low level of the N-Oxide impurity.
TCR² Therapeutics & Adaptimmune Announce Strategic Combination to Create a Preeminent Cell Therapy Company for Solid Tumors
TCR² Therapeutics Inc. and Adaptimmune Therapeutics recently announced entry into a definitive agreement under which Adaptimmune will combine with TCR² in an all-stock transaction to create a preeminent cell therapy company….
New Data Show CNM-Au8 Preserved ALS Patient Function & Slowed Disease Progression in the Open-Label Extension of the Phase 2 RESCUE-ALS Trial
Clene Inc. and its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, recently announced new results showing preserved ALS….
SciSparc Successfully Completed Production of its Proprietary Drug Candidate for its Upcoming Clinical Trial on Tourette Syndrome
SciSparc Ltd. recently announced it has successfully manufactured clinical batches of its top-tier drug candidate SCI-110 to be used in its upcoming multinational, multicenter, Phase…
NeOnc Technologies Engages Anova Enterprises to Pursue Pediatric Brain Tumor Indication & FDA Fast-Track Status
NeOnc Technologies Holdings, Inc. has recently expanded its engagement of Anova Enterprises to pursue a pediatric indication for NEO100, an enhanced method of delivering pharma-based…
Sermonix’s Lasofoxifene Improves Vaginal/Vulvar Symptoms Relative to Fulvestrant in ELAINE 1 Study of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation
Sermonix Pharmaceuticals Inc. recently announced that its lead drug candidate, lasofoxifene, improved vaginal/vulvar symptoms while fulvestrant worsened them in a study of postmenopausal women with locally…
Anti-Properdin Antibody Demonstrates Efficacy in a Primate Model of Wet-AMD & Dry-AMD
NovelMed Therapeutics recently announced NM3086, the lead clinical asset in its Properdin-associated Alternative Pathway (AP) program, demonstrated favorable efficacy in an animal model of neovascular…
Checkpoint Therapeutics Announces FDA Filing Acceptance of BLA for Cosibelimab in Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
Checkpoint Therapeutics, Inc. recently announced the US FDA has accepted for filing the Biologics License Application (BLA) for cosibelimab, Checkpoint’s investigational anti-PD-L1 antibody….
Avenue Therapeutics Enters Transformational License Agreement With AnnJi Pharmaceutical
Avenue Therapeutics, Inc. recently announced it has entered into an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. for AJ201, a first-in-class clinical asset currently…
SiSaf & the University of Leipzig Partner to Develop Bio-Courier Targeted miRNA for the Treatment of Pancreatic Cancer
SiSaf Ltd recently announced its collaboration with the University of Leipzig, Germany, to develop Bio-Courier targeted micro interfering RNAs (miRNA) for the treatment of….
EPO Decision to Grant European Patent for Rencofilstat Further Strengthens Hepion’s Patent Portfolio
Hepion Pharmaceuticals, Inc. recently announced the European Patent Office (EPO) has granted European Patent No. EP 3886813, covering the innovative formulation of Hepion’s lead cyclophilin…
SPECIAL FEATURE - Solubility & Bioavailability: Difficult Beasts to Tame
Contributor Cindy H. Dubin highlights the services many of these outsourced providers offer to enhance solubility and bioavailability and get their clients’ projects to market faster and cost effectively – while maintaining critical quality attributes.
DELIVERY TECHNOLOGY - NeuroDirect™ Ketamine: Novel, Non-Systemic Topical Therapy for PTSD & Associated Intractable Depression
Ronald Aung-Din, MD, and Chantelle G. Martin, MBChB, present scientific data demonstrating how with NeuroDirect technology, the benefits of psychedelic compounds may be achieved without concern for their potential systemic effects.
EXECUTIVE INTERVIEW - Purple Biotech Ltd.: Developing First-In-Class Oncology Therapies
Gil Efron, Chief Executive Officer of Purple Biotech, discusses the company’s focus on identifying and developing promising molecules that may offer first-in-class approaches to treating devastating cancers with large unmet medical needs.
FORMULATION FORUM - Changing the Landscape of Nanoparticles for Long-Acting Injectable Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say recently, there has been continued interest in parenteral NPs with sustained-release characteristics as more drugs discovered are poorly soluble and less bioavailable, and these challenges have led to enormous opportunities and launch of many drug products to market.
MARKET TRENDS - Emerging Trends in Injectable Drug Formulation & Delivery
Martin Gonzalez, PhD, details current trends in sterile injectable formulations and delivery devices and highlights the challenges pharma and its CDMO partners are facing bringing emerging parenteral breakthroughs to patients.
AUTOMATED SOLUTIONS - Automation & Shared Knowledge Pave the Way Into the Future
Luca Valeggia says by no means is automation a novel concept for most research labs, but its swift advancement and expansion into new fields such as synthetic biology have shown us that we are only witnessing the start of what is possible.
PAN-VARIANT INHIBITORS - How Pan-Variant Inhibition Can Outsmart Cancer Treatment Resistance
Tim Clackson, PhD, says the goal in targeted oncology is to achieve pan-variant inhibition and, ideally, pan-variant inhibition should be accomplished with a single agent, avoiding the potential complications and toxicities of drug combinations.
ImmunoGen Announces a Global, Multi-Target License & Option Agreement With Vertex for the Use of ImmunoGen's ADC Technology in the Development of Novel Targeted Conditioning Agents
ImmunoGen, Inc. recently announced a global, multi-target license and option agreement whereby it granted Vertex Pharmaceuticals rights to conduct research using ImmunoGen's ADC technology to…
Incannex Commences Phase 2 Clinical Trial Assessing IHL-675A for use in Treatment of Pain & Function in Rheumatoid Arthritis
Incannex Healthcare Limited recently announced it has commenced a Phase 2 clinical trial to assess the safety and efficacy of its proprietary anti-inflammatory combination drug….
