Formulation Development
Quotient Sciences Announces Installation of World's First GMP Biofoundry-in-a-Box From Centillion Technology
Quotient Sciences recently announced the installation of Centillion’s proprietary Biofoundry-in-a-Box (BiaB), the first multi-product GMP platform technology for end to end RNA manufacture. BiaB is…
AlveoGene Receives Rare Pediatric Disease Designation Novel, Inhaled Gene Therapy for Lethal Neonatal Surfactant Protein B Deficiency
AlveoGene recently announced it has been granted a Rare Pediatric Disease Designation (RPDD) by the US FDA for AVG-002, its novel, inhaled gene therapy for…
NurExone Biologic Secures EMA Orphan Status for ExoPTEN in Spinal Cord Injury
NurExone Biologic Inc. recently announced the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation for the its ExoPTEN therapy, marking a significant step…
PTC Therapeutics Announces FDA Approval of AADC Deficiency Gene Therapy
PTC Therapeutics, Inc. recently announced the US FDA accelerated approval of its gene therapy for the treatment of AADC deficiency, the first-ever gene therapy approved…
Aravax Establishes Pharmaceutical Development Base on the Oxford Science Park With a Focus on Developing Manufacturing Capabilities in the UK
Aravax recently announced it has established a UK subsidiary, based on the Oxford Science Park, as the company continues its development into an international leader…
Khondrion Receives FDA Clearance of INDA for Pivotal Phase 3 Trial of Sonlicromanol for Treatment of Primary Mitochondrial Disease
Khondrion recently announced it has received clearance from the US FDA for its Investigational New Drug (IND) application for sonlicromanol. The IND supports the initiation…
AC Immune Reports Positive Interim Results From Phase 2 Trial of Active Immunotherapy in Early Parkinson’s Disease
AC Immune SA recently announced positive interim safety and immunogenicity data from the Phase 2 VacSYn clinical trial evaluating ACI-7104.056, its wholly owned anti-alpha-synuclein (a-syn)…
Nxera Pharma’s Partner Centessa Initiates Phase 2 Trial of a Novel Orexin Receptor 2 Agonist
Nxera Pharma Co., Ltd. recently announced Centessa Pharmaceuticals has initiated a Phase 2 trial of ORX750, an investigational, orally administered, highly potent and selective orexin…
Microbiotica Announces First Patient Dosed in its Phase 1b Trial of a Precision Microbiome Medicine in Ulcerative Colitis Patients
Microbiotica recently announced the first patient has been dosed in its Phase 1b First-in-Human trial, COMPOSER-1, of MB310 in ulcerative colitis (UC) patients. This international…
BioNTech to Acquire Biotheus to Boost Oncology Strategy
BioNTech SE and Biotheus recently announced the signing of a definitive agreement for the acquisition of Biotheus, a clinical-stage biotechnology company dedicated to the discovery and…
Nippon Shinyaku & Atsena Therapeutics Enter Exclusive Strategic Collaboration
Nippon Shinyaku Co., Ltd. and Atsena Therapeutics, Inc. have entered into an exclusive license agreement for the commercialization of ATSN-101 in the territory of the…
Entero Therapeutics Announces Proposed Reverse Merger With Journey Therapeutics
Entero Therapeutics, Inc. recently announced it has entered into a binding term sheet for a reverse merger transaction with Journey Therapeutics, Inc. Upon completion of…
CAR T Cell Therapies to Pave Way for Drug-Free Remission in Lupus Care
Bristol Myers Squibb and Cabaletta Bio are set to present promising Phase 1 data on CD19-directed CAR T therapies for severe, refractory lupus at the…
Kane Biotech Announces Agreement to Acquire FB Dermatology
Kane Biotech Inc. recently announced it has entered into a binding term sheet setting out the key terms and conditions relating to the acquisition of…
Attralus Therapeutic AT-02 Receives Orphan Drug Designation for the Treatment of ATTR Amyloidosis
Attralus, Inc. recently announced the US FDA has granted orphan drug designation for AT-02 for the treatment of transthyretin-associated amyloidosis (ATTR), a rare, progressive, debilitating…
Zenas BioPharma Completes Targeted Enrollment of the Phase 3 INDIGO Trial of Obexelimab in Immunoglobulin G4-Related Disease
Zenas BioPharma, Inc. recently announced the completion of its targeted enrollment for the Phase 3 INDIGO trial of its lead product candidate, obexelimab, for the…
Adragos Pharma Completes Expansion With New Ampoule Fill & Finish Line in Livron
Adragos Pharma has significantly enhanced its production capabilities with the completion of a new ampoule filling line at its Livron-sur-Drôme site in France. Adragos invested…
Araris Biotech Publishes Foundational Science Behind its Novel Antibody-Drug Conjugate Platform
Araris Biotech AG recently announced the publication of a new technology for ADC generation that supports its foundational technology platform. The publication in ChemBioChem showcases,…
Enlivex Announces Enrollment & Dosing of the First 10 Patients in the Randomized Phase 2 Stage of its Allocetra Trial
Enlivex Therapeutics Ltd. recently announced the enrollment and dosing of the first 10 patients in the randomized Phase 2 stage of the company’s multi-country Phase…
Lonza to Expand Bioconjugation in Visp (CH) With Two Additional Manufacturing Suites
Lonza recently announced it will invest in additional bioconjugation capabilities in Visp (CH). The expansion will add two multipurpose 1,200L manufacturing suites and manufacturing-related infrastructure…
