Market News & Trends
Advicenne Receives Positive Feedback From US FDA on Pathway to Approval & Amended Phase 3 Study Protocol
Advicenne recemtly announced the US FDA acceptance of the amended protocol of the company’s US-based Phase 3 pivotal trial of ADV7103 (Sibnayal) for the treatment…
BD to Build New Manufacturing Facility in Spain to Support Ongoing Strong Growth of Prefilled Drug Delivery Business
BD (Becton, Dickinson and Company) recently announced will build a $200-million high-tech manufacturing facility in city of Zaragoza, located in the Aragon region of Spain,…
NovAliX Expands Cryo-Electron Microscopy Capabilities for Drug Development Offering
NovAliX recently announced the expansion of its cryogenic electron microscopy (cryo-EM) technology capability. NovAliX will benefit from the implementation at its premises of Thermo Fisher…
AC Immune Announces Expansion of Phase 1b/2a Phospho-Tau Alzheimer’s Vaccine Trial & Provides a Program Update
AC Immune SA recently announced the company and its strategic partner Janssen Pharmaceuticals, Inc. have expanded the ongoing Phase 1b/2a clinical trial of the companies’…
AzurRx BioPharma Announces Positive Interim Data in Phase 2 Clinical Trial
AzurRx BioPharma, Inc. recently announced positive interim data from the first 18 out of 20 patients in its Phase 2 trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy (PERT),….
Checkpoint Therapeutics Announces Completion of Enrollment in the Registration-Enabling Trial of Cosibelimab
Checkpoint Therapeutics, Inc. recently announced the completion of enrollment for the metastatic cutaneous squamous cell carcinoma (cSCC) cohort in its registration-enabling clinical trial of….
New Adjuvanted Vaccine Candidate Using IDRI Formulation Demonstrates Coronavirus Pan-Vaccine Potential
The Infectious Disease Research Institute (IDRI), Duke Human Vaccine Institute, and 3M have collaborated to create a vaccine candidate with potential to provide protection against multiple variants of SARS-CoV-2….
Centogene Extends Global Parkinson’s Disease Study
Centogene N.V. recently announced it has extended the Rostock International Parkinson’s Disease (ROPAD) Study…..
Cybrexa Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial
Cybrexa Therapeutics recently announced the first patient has been dosed in a Phase 1/2 clinical trial evaluating CBX-12 (alphalex-exatecan), the company’s lead therapeutic candidate. The…
OncoTEX & Sterling Pharma Solutions Sign Clinical Manufacturing Agreement
OncoTEX Inc and Sterling Pharma Solutions recently announced that they had signed a clinical development agreement for the manufacture of OncoTex’s novel platinum-resistant oncology drug…
Fortress Biotech Announces Exclusive License Agreement With Fuji Yakuhin
Fortress Biotech, Inc. recently announced it has entered into an exclusive licensing agreement with Fuji Yakuhin Co. Ltd. to develop Dotinurad in the US, UK,…
Biosight Completes Enrollment in Phase 2b Study for First-Line Acute Myeloid Leukemia Therapy
Biosight Ltd. recently announced it has completed enrollment in the company’s ongoing Phase 2b trial evaluating aspacytarabine (BST-236) as a single-agent first-line acute myeloid leukemia…
Altimmune Announces New Preclinical Data for AdCOVID Demonstrating Sterilizing Immunity After a Single Intranasal Dose
Altimmune, Inc. recently announced positive results from a preclinical study of AdCOVID in a SARS-CoV-2 challenge model of infection. In this study, a single intranasal…
Proveris Laboratories Announces Expanded Services for Spray & Aerosol Characterization of Unit-Dose Nasal Drugs
Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, recently announced the expansion of contract…
Nemera’s Preservative-Free Multi-Dose Eyedropper Approved in Brazil for Aché’s NSAIDs & Dry Eye Formulations
Nemera is excited to announce that its multidose eye dropper Novelia has been approved by ANVISA for the preservative-free formulations CLILON [1] (Ketorolac 0,4% and 0,5%), a nonsteroidal anti-inflammatory drug….
Vectura & Inspira Pharmaceuticals Sign Agreement to Develop Potential Inhaled Treatment for COVID-19
Vectura Group plc and Inspira Pharmaceuticals Limited recently announced an agreement to develop an inhaled formulation of Inspira’s lead drug candidate for the potential treatment of….
Takara Bio Europe AB & PanCryos Announce Licensing Agreement to Enable Development of Cell-Based Therapy for Diabetes
Takara Bio Europe AB (TBEAB) and PanCryos recently announce they have reached a licensing agreement surrounding TBEAB’s clinical-grade human embryonic stem (hES) cell lines…..
Gerresheimer Presents Innovative SensAIR Platform for First Drug Delivery Device for Biologics
With SensAIR, Gerresheimer presents for the first time a new platform for on-body infusion pumps that can deliver drugs of higher viscosity, such as monoclonal antibodies (mAbs), with precise dosing and safety….
Catalent Acquires Additional Facility at its Gosselies, Belgium, Campus for Commercial-Scale Plasmid DNA Manufacturing
Catalent and Promethera Biosciences recently announced that Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its….
The FDA Expands Collaboration With CN Bio to Investigate Lung-on-a-Chip Model for Inhaled Drug Evaluation Applications
CN Bio recently announced the US FDA has extended its research collaboration for an additional 3 years. The scope of the research carried out with…
