Formulation Development
Minovia Therapeutics Announces Two New US Patents Granted, Strengthening its Mitochondrial Augmentation Therapy Platform
Minovia Therapeutics Ltd. recently announced it has been granted two new US patents that further expand and strengthen its global intellectual property portfolio supporting its…
Cellistic Launches Three New iPSC-Based GMP Manufacturing Platforms to Advance Immuno-Oncology & Regenerative Cell Therapies
Cellistic recently announced the launch of three new iPSC-derived GMP cell therapy manufacturing platforms: Echo-T, Echo-Cardio, and Echo-Endothelial. The new platforms are designed to advance…
Bionpharma Receives FDA Approval for Etravirine Tablets Developed in Collaboration With STEERLife
Marking a significant milestone in the global effort to expand access to advanced HIV therapies, STEERLife (the life sciences division of STEER World), and Bionpharma…
Cellares Expands Global Smart Factory Network With European Headquarters in the Netherlands; Announces IND Amendment Clearance Obtained for Clinical Manufacturing of Rese-Cel From Cabaletta Bio Using Cellares' Automated Platforms
Cellares recently announced it has secured a site and signed a long-term lease for a new IDMO Smart Factory at Leiden Bio Science Park (LBSP)…
Hongene Biotech Announces Grant to Expand Global Access to mRNA Vaccine Raw Materials
Hongene Biotech recently announced the receipt of a grant from the Gates Foundation to develop high-quality, affordable, and patent-free cap analogs for use in mRNA…
Bio-Sourcing & Zerion Pharma Join Forces to Develop First HER2 Oral Monoclonal Antibody Against Breast Cancer
Bio‑Sourcing and Zerion Pharma A/S recently announce their joint project to develop an oral formulation of Trastuzumab, the pioneer monoclonal antibody used to treat breast…
Codexis Expands Reach of Manufacturing Platform Through Evaluation Agreement With Axolabs for Oligonucleotide Therapeutics
Codexis, Inc. and Axolabs recently announced they have entered into an agreement under which Axolabs will evaluate Codexis’ ECO Synthesis Manufacturing Platform. This partnership provides…
Plus Therapeutics Announces Read Out of Type B Meeting With FDA With Goal of Accelerating Approval of REYOBIQ for Leptomeningeal Metastases
Plus Therapeutics, Inc. recently announced the completion of a Type B meeting with the US FDA on next steps on REYOBIQ pivotal trial strategy for…
ProMed Pharma Announces Agreement With Undisclosed Partner for Dedicated Manufacturing Suite at New Niagara Ln Facility
ProMed Pharma, a leading contract development and manufacturing organization (CDMO) specializing in long-acting injectable and implantable drug delivery systems, today announced it has entered into…
NRG Therapeutics Announces First Participants Dosed in its First-in-Human Phase 1 Clinical Trial of a Disease-Modifying Treatment for ALS/MND & Parkinson’s
NRG Therapeutics Ltd. recently announced the first participants have been dosed in its first-in-human Phase 1 clinical trial of its lead candidate NRG5051, which is…
Complement Therapeutics Announces FDA Fast Track Designation for CTx001 for the Treatment of Geographic Atrophy Secondary to AMD
Complement Therapeutics GmbH (CTx) recently announced the US FDA has granted Fast Track Designation for CTx001, the company’s lead gene therapy candidate for the treatment…
Atsena Completes Dosing in Part B of the Phase I/II/III LIGHTHOUSE Trial Evaluating ATSN-201 to Treat X-linked Retinoschisis and Announces Plans for Initiation of Pivotal Part C Cohort
Atsena Therapeutics recently announced dosing is complete in patients enrolled across all adult and pediatric cohorts in Part B of the Phase I/II/III Lighthouse Trial…
MedPharm Announces Successful FDA Inspection of its cGMP Commercial Manufacturing Facility
MedPharm recently announced its topical drug product manufacturing facility in Durham, NC, has successfully completed a US FDA inspection for commercial manufacture of drug products.…
SpliceBio Initiates Dose-Expansion Portion of Phase 1/2 ASTRA Clinical Trial for SB-007, a Dual-AAV Gene Therapy for Stargardt Disease
SpliceBio recently announced the first patient has been dosed in the Part B dose-expansion portion of the Phase 1/2 ASTRA clinical trial of SB-007, a…
Roswell Park Study Shows IL-36 Gamma "Armored" CAR T Cells Can Eradicate Solid Tumors
A laboratory study out of Roswell Park Comprehensive Cancer Center outlines a new way to boost the effectiveness of chimeric antigen receptor (CAR) T-cell therapy…
ProBioGen & Zag Bio Forge Strategic CMC Partnership to Advance Fc-Fusion Autoimmune Therapy
ProBioGen recently announced the signing of a Master Service Agreement (MSA) with Zag Bio, Inc., a biotechnology company developing thymus-targeted therapies to induce central immune…
Autolus Therapeutics to Evaluate Automated Manufacturing of AUCATZYL (obe-cel) on the Cellares Cell Shuttle Platform
Autolus Therapeutics plc and Cellares Corp recently announced that Autolus will assess the feasibility of Cellares’ Cell Shuttle platform to complement its commercial manufacturing operations…
Nimbus Therapeutics Announces Research Collaboration & License Agreement With Lilly for Novel Oral Obesity Treatment
Nimbus Therapeutics, LLC recently announced it has entered into a multi-year research collaboration and exclusive, worldwide license agreement with Eli Lilly and Company to develop…
FDA Approves New 2-Gram Presentation of Fibryga, Enhancing Convenience & Precision in Treating Acquired Fibrinogen Deficiency
Octapharma USA, Inc. recently announced the US FDA has approved a new 2-gram presentation of Fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement…
Zenas BioPharma Announces Positive Results from Phase 3 Trial of Obexelimab in Immunoglobulin G4-Related Disease
Zenas BioPharma, Inc. recently announced positive results from the Phase 3 INDIGO trial of obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). Obexelimab met the primary endpoint,…
