Market News & Trends
Nemera Reinforces Commitment to Sustainability With First Integrated ESG Report
Designed as a snapshot of work over the years and a look into the future, the first ESG report is a new and important step…
First Wave BioPharma Announces First Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation
First Wave BioPharma, Inc. recently announced that the first patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of….
Catalent Expands UpTempo AAV Platform to Accelerate Development of Gene Therapies
Catalent recently announced the expansion of its UpTempo platform process for the development and CGMP manufacturing of adeno-associated viral (AAV) vectors. The platform now includes an…
Sermonix Pharmaceuticals Announces Initiation of Phase 3 ELAINE-3 Study of Lasofoxifene Plus Abemaciclib
Sermonix Pharmaceuticals Inc. and Guardant Health, Inc. recently announced the initiation of a registrational Phase 3 clinical study comparing targeted lasofoxifene in combination with the…
Ribon Therapeutics Doses First Patient in Phase 1 Clinical Study for Patients With Moderate-to-Severe Atopic Dermatitis
Ribon Therapeutics recently announced dosing the first patient in the open-label cohort of patients with moderate-to-severe atopic dermatitis to measure the pharmacodynamic activity of RBN-3143…
QSAM Biosciences Receives FDA Clearance to Expand Enrollment Criteria in its Phase 1 Study Targeting Metastatic Bone Cancer
QSAM Biosciences Inc. recently announced US FDA has cleared the Company’s amended clinical trial protocol increasing the maximum age of participants to 75 years old…
Lonza Upgrades Powder Characterization Capabilities at Tampa Site
Lonza recently announced a significant enhancement to its powder characterization capabilities at its Small Molecules site in Tampa, FL. The facility has been upgraded to…
Evonik Opens New Facility for Pharmaceutical Lipids at Site in Germany
Evonik is opening a new GMP facility to manufacture lipids for advanced, pharmaceutical drug delivery applications. The lipid launch facility is located at the company’s site in Hanau, Germany and….
Indaptus Therapeutics Doses First Subject in its Ongoing Phase 1 Open Label Clinical Trial of Decoy20 in Patients With Advanced Solid Tumors
Indaptus Therapeutics, Inc. recently announced the dosing of the first subject in INDP-D101, the company’s first-in-human, open label, dose escalation and expansion, multicenter Phase 1…
BioStem Technologies to Acquire Majority of Assets of Auxocell Laboratories, Inc.
BioStem Technologies Inc. recently announced it has entered into an agreement to acquire the majority of the assets of Auxocell Laboratories, Inc., a leading solid tissue processing equipment manufacturer…..
Certara Announces Release of Simcyp PBPK Simulator Version 22, Expanding Ability to Simulate Untested Scenarios for New Patient & Therapeutic Types
Certara, Inc. recently announced the release of Simcyp Simulator Version 22, which includes new capabilities and updated features to the company’s population-based modeling and simulation…
Dyadic Provides Phase 1 Clinical Trial Update for its COVID-19 Recombinant Protein RBD Booster Vaccine Candidate
Dyadic International, Inc. recently provided an update regarding its Phase 1 Clinical Trial for its DYAI-100 COVID-19 recombinant protein receptor binding domain (RBD) booster vaccine…
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…
Choosing the Best Drug Stability Solution for a Parental Product
The development of an injectable drug product always comes with the question of the best approach to retaining the product’s stability. We asked Dr. David Brett, Product and Service Manager at Vetter, what must be considered to deal with the….
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….
