Formulation Development
Tenax Therapeutics Activates First Clinical Research Site for Phase 2 Clinical Trial
Tenax Therapeutics, Inc. recently announced that Stanford University School of Medicine has been activated as the first clinical research site for the company’s Phase 2…
Adial Pharmaceuticals Engages CRO to Begin Phase 3 Clinical Trials
Adial Pharmaceuticals, Inc. and Crown CRO recently announced Crown’s engagement to manage Adial’s Phase 3 clinical trial for AD04 for the treatment of alcohol use…
New Phase 1 Zika Vaccine Trial Meets Primary Endpoint
Emergent BioSolutions Inc. and Valneva SE (VLA) recently announced positive interim results for the Phase 1 study evaluating VLA1601, their vaccine candidate against the Zika virus. The…
Synthetic Biologics Announces Positive Outcome of End-of-Phase 2 Meeting with FDA
Synthetic Biologics, Inc. recently announced it has successfully completed an End-of-Phase 2 meeting with the US FDA to discuss development of SYN-004 (ribaxamase) for the…
Roivant Sciences & iNtRON Bio Sign Licensing Deal for Novel Anti-Superbugs Biologic; Deal Worth $667.5 Milllion
Roivant Sciences and iNtRON Biotechnology recently announced they have entered into a global licensing agreement for SAL200, a novel investigational biologic for the treatment of infectious diseases caused by antibiotic-resistant staphylococci. This licensing deal is worth a total of $667.5 million inclusive of milestone payments, with royalties on net sales in the low double digits.
CordenPharma Announces Successful SafeBridge Recertification
CordenPharma Colorado has successfully completed the Potent Compound Recertification Audit by SafeBridge Consultants. Certification has been maintained since first awarded in 2013.
Cadent Therapeutics Secures $40 Million Series B Financing to Advance Pipeline
Cadent Therapeutics recently announced it has raised $40 million in a Series B financing. In addition, the company has appointed Bob (Ibrahim) Dagher, MD, as…
Provectus Biopharmaceuticals Provides Drug Development Update
Provectus recently provided an update on the company’s small molecule clinical development program for its investigational immuno-dermatology drug PH-10 for the treatments of psoriasis and…
Synteract Acquires Pediatric CRO to Further Strengthen its Pediatric Center of Development
Synteract has acquired KinderPharm, a specialty pediatric CRO, focused on advancing pediatric drug development across all phases of clinical research. Like Synteract, KinderPharm has extensive experience in…
Fujifilm Announces Research Results for Novel Liposome Drug Candidate
FUJIFILM Corporation recently announced the drug release mechanism of continuous action in tumors for the anti-cancer agent FF-10832, currently undergoing Phase I clinical trials in…
Aptinyx Exploratory Clinical Studies Provide First Evidence that NYX-2925 Elicits Rapid, Persistent, NMDAr-Mediated Pharmacodynamic Activity in Humans
Aptinyx Inc. recently announced that exploratory clinical studies of its novel NMDA receptor (NMDAr) modulator, NYX-2925, provide the first evidence that oral dosing of the…
Commercial Prospects for Immuno-Oncology Development Across Oncology Indications in Untapped Cancer Types or in Combinations
Immuno-Oncology (IO) development is booming across the 8MM (US, France, Germany, Italy, Spain, UK, Japan, and China) with IO agents being investigated in most cancer…
Catalent to Open Second Clinical Supply Facility; Enables Broader Integrated Solutions for Global & Local Customers
Catalent Pharma Solutions recently announced its plans to invest $2.5 million in a new, second clinical supply facility in Shanghai, China, due to open in early 2019. When completed, the facility is expected to employ 100 people and will double Catalent’s total clinical storage capacity in China.
PCI Clinical Services Announces Site Expansion to Support Growth & Flexibility
PCI Pharma Services, a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global biopharmaceutical industry, recently announced the expansion of its Clinical site at Rockford, IL.
HUMAN MICROBIOME - Advancing New Frontiers in a Rapidly Emerging Market
Flo Orim, MD, PhD, focuses on biomedical aspects of research, development, and commercial endeavors in the human microbiome space, including essential background information, evolution of the field, and advances in basic research.
REGENERATIVE MEDICINE - Cell Therapy - The Quest for Finding the Cure
Aarti Chitale, MBA, believes as the therapeutic landscape evolves and transitions toward personalized and value-based care, regenerative medicine will play an increasingly important role, and moreover, the success of these therapies offers promising opportunities for previously untreated diseases areas.
GENETIC MODIFICATION THERAPIES - Clinical Applications & Technology Platforms
Laurie L. Sullivan and John Bergin, MS, MBA, say the growing interest on the part of large pharma or biotech companies is driving clinical development of genetic modification therapy candidates, and the rich late-stage pipeline for genetic modification therapy candidates is a driving force of growth.
THERAPEUTIC VACCINES - Exploring the Potential of Combining Cancer Vaccines With Immune Checkpoint Inhibitor Therapy
Nina Baluja, MD, believes advances in our understanding of tumor immunology are rekindling interest in cancer vaccines, particularly in combination with breakthrough immunotherapies, such as immune checkpoint inhibitors.
Organovo Partners With IIAM on Multi-Year Clinical Biomaterial Sourcing Agreement
Organovo Holdings, Inc. recently announced it has entered into a cell and tissue clinical sourcing agreement with the International Institute for the Advancement of Medicine (IIAM).
Nkarta Therapeutics Reports Potent Natural Killer Cell Anti-Cancer Activity in Preclinical Tumor Model
Nkarta Therapeutics recently announced preclinical data highlighting the anti-cancer activity of engineered NK cells in a presentation at the Society of Immunotherapy for Cancer meeting…
