Formulation Development
Vironexis Biotherapeutics Launches With FDA Clearance of IND Application for First-Ever Clinical Trial of an AAV-delivered Cancer Immunotherapy
Vironexis Biotherapeutics launched from stealth, unveiling its TransJoin AAV Gene Therapy Platform and a pipeline of more than ten product candidates for blood-based cancers, solid…
Monopar Announces Positive Early Human Clinical Data Validating the Tumor Targeting Ability of MNPR-101-Zr
Monopar Therapeutics Inc. recently announced positive early data from its ongoing open-label MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial confirming MNPR-101-Zr’s tumor targeting ability…
Cellares & Sony Announce a Joint Development Collaboration to Integrate Flow Cytometry-Based Sorting & Online Analysis Into an Automated, High-Throughput Cell Therapy Manufacturing Platform
Cellares and Sony Corporation recently announced a collaboration to jointly develop and integrate advanced flow cytometry-based cell analysis and sorting solutions into the Cellares Cell…
TFF Pharmaceuticals Announces Positive Preclinical Data From Bivalent Universal Influenza Vaccine Candidates
TFF Pharmaceuticals, Inc recently announced positive preclinical data advancing a multivalent universal influenza vaccine manufactured by TFF to protect against seasonal and pandemic viruses. The…
Agios Announces FDA Orphan Drug Designation Granted for Treatment of Myelodysplastic Syndromes
Agios Pharmaceuticals, Inc. recently announced the US FDA has granted orphan drug designation to the company’s novel pyruvate kinase (PK) activator tebapivat (AG-946) for the…
Ilya Pharma Receives Rare Pediatric Disease Designation From US FDA
Ilya Pharma recently announced that it has received a Rare Pediatric Disease Designation by the US FDA. About SAVI: STING-associated vasculopathy with onset in infancy…
BriaCell Reports Positive Overall Survival in Metastatic Breast Cancer
BriaCell Therapeutics Corp. recently announced positive overall survival data of its Phase 2 clinical study of Bria-IMT in combination with an immune check point inhibitor…
Evonik Starts Operation of New Spray Drying Facility for Pharmaceutical Oral Excipients
Evonik has officially opened a new facility for drying aqueous dispersions of EUDRAGIT polymers at its site in Darmstadt. The new double-digit million-euro excipient manufacturing…
Roivant Unveils New Pipeline Program of a Potential First-in-Class & Best-in-Category Inhaled Once-Daily Soluble Guanylate Cyclase Activator
Roivant recently announced its previously undisclosed pipeline program mosliciguat, a potential first-in-class, inhaled, once-daily sGC activator with targeted delivery to the lungs via dry powder…
Quotient Sciences & Vasa Therapeutics Announce Dosing of First Subjects With Novel Heart Failure Treatment
VS-041, a novel and potentially life-saving treatment for heart failure, developed by Vasa Therapeutics, a San Diego-based biotechnology company, has reached a major clinical milestone…
Incendia Therapeutics Enrolls First Patient in Phase 1c Clinical Trial of a Novel DDR1 Inhibitor
Incendia Therapeutics, a precision oncology company discovering and developing a novel class of therapies that reprogram the tumor microenvironment (TME), recently announced the first patient…
Belite Bio Announces First Patient Dosed in Phase 2/3 Trial of Tinlarebant for the Treatment of Stargardt Disease
Belite Bio, Inc recently announced that the first patient has been dosed at the Tokyo Medical Center in the Phase 2/3 portion of its DRAGON…
Incannex Healthcare Announces Strategic Financing for up to $60 Million
Incannex Healthcare Inc. recently announced it has entered into an agreement to issue up to $10 million in secured convertible notes to Arena Investors, LP…
Tanvex Appoints Biopharma Industry Veteran as New CEO
Tanvex BioPharma, Inc., the biosimilar-focused biopharmaceutical company and CDMO, recently announced its Board of Directors has appointed Stephen Lam as the company's Chief Executive Officer,…
Cartesian Therapeutics Receives FDA Rare Pediatric Disease Designation for Descartes-08 for the Treatment of Juvenile Dermatomyositis
Cartesian Therapeutics, Inc. recently announced the US FDA has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). Descartes-08, Cartesian’s…
Hongene Biotech Corporation & ReciBioPharm Establish a Gene Editing Development Partnership
Hongene Biotech Corporation and ReciBioPharm have announced a strategic collaboration that will enhance gene editing drug manufacturing capabilities. Hongene, renowned for its expertise in the…
GRIN Therapeutics Announces Positive Topline Data from Honeycomb Trial of Radiprodil in GRIN-Related Neurodevelopmental Disorder
GRIN Therapeutics, Inc. recently reported topline results from the its ongoing two-part global Phase 1b open-label trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of…
Protara Therapeutics Announces Completion of First Cohort in Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients With Lymphatic Malformations
Protara Therapeutics, Inc. recently announced completion of the first cohort of the Phase 2 STARBORN-1 trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment…
Serán More Than Doubles Clinical Manufacturing Capacity in Bend, OR
Serán BioScience, LLC, the science-driven drug development partner, recently announced it has completed an expansion to increase the number of process manufacturing suites at its…
ENA Respiratory Announces Extension of US Department of Defense Funding for Novel Prophylactic Antiviral
ENA Respiratory has been awarded an additional $3.13 million contract from the U.S. Department of Defense (DOD). The new funding extends the $8.18 million already…
