Market News & Trends
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.
Enable Injections Enters Strategic Partnerships With UCB & Apellis
Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, recently announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB.
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…
Alligator Bioscience & Aptevo Therapeutics Present New Preclinical Data
Alligator Bioscience and Aptevo Therapeutics Inc. recently announced new preclinical data for ALG.APV-527 at the Society for Immunotherapy of Cancer's (SITC) 33rd Annual Meeting being…
Moleculin Announces New Independent Study Expands Potential Use of Its Pancreatic Drug Candidate
Moleculin Biotech, Inc. recently announced that a new mechanism of action may have been uncovered expanding the potential use of its inhibitor of glycolysis, WP1122.…
Entera Bio Reports Positive Results from Part 1 of a Phase 2 PK/PD Study
Entera Bio Ltd. recently announced it has received positive results from the first part of its pharmacokinetic (PK) and pharmacodynamic (PD) study in patients with…
Intensity Therapeutics Highlights Data in Advanced Solid Tumors
Intensity Therapeutics, Inc. recently announced additional data from a Phase 1/2 clinical study of INT230-6, the company’s novel lead product candidate designed for direct intratumoral injection,…
Codexis Announces Results of Phase 1a Clinical Trial
Codexis, Inc. recently announced top-line results from its Phase 1a single ascending-dose study in healthy volunteers with CDX-6114, its orally administered enzyme candidate for the…
Enable Injections’ First Closing of Series B Round to Include New Investor
Enable Injections, Inc. recently announced it has completed a first closing of a Series B round that will raise up to $50 million, led by…