Formulation Development
GigaGen Announces Publication of Research Describing a New Class of Drugs, Recombinant Hyperimmunes, Including its Novel COVID-19 Therapy, GIGA-2050
GigaGen presents a novel technology for producing a new class of drug, which it calls recombinant hyperimmunes…..
Multiple Headlands Research Sites Selected for AstraZeneca’s Phase 3 COVID-19 Vaccine Trial
Headlands Research recently announced its research centers have been selected to participate in AstraZeneca’s upcoming Phase 3 COVID-19 vaccine trial. Headlands has built an industry-leading…
FDA Clears Appili Therapeutics to Expand its Phase 2 Clinical Trial of Favipiravir for the Potential Prevention of COVID-19
Appili Therapeutics Inc. recently announced the US FDA has granted the company clearance to proceed after Appili’s filing of an investigational new drug (IND) application…
Eyenovia & Arctic Vision Announce Exclusive Collaboration & License Agreement
Eyenovia, Inc. and Arctic Vision recently announced they have entered into an exclusive license agreement for Arctic Vision to develop and commercialize MicroPine for the…
Immutep Granted US Patent for Eftilagimod Alpha in Chemo-Immunotherapy Combination
Immutep Limited, a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune disease, recently announced the grant of a new patent (number 10,736,940) titled…
Clearside Biomedical Announces US FDA Acceptance of IND Application
Clearside Biomedical, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for CLS-AX (axitinib injectable suspension), enabling initiation of a…
Arcturus Therapeutics Announces Dosing of its COVID-19 Vaccine Candidate in Phase 1/2 Study
Arcturus Therapeutics Holdings Inc. recently announced that all subjects in the first cohort have been dosed in the Phase 1/2 clinical study with its ARCT-021…
Biogen & Denali Sign Co-Development/Co-Commercialization Agreement
Biogen Inc. and Denali Therapeutics Inc. recently announced they have signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for….
RedHill Biopharma’s Phase 2/3 COVID-19 Study Approved in Mexico
RedHill Biopharma Ltd. recently announced approval from the Mexican Federal Committee for the Protection against Sanitary Risks (COFEPRIS) for the company’s Clinical Trial Authorization (CTA) application for….
Immatics Extends Cell Therapy Manufacturing Collaboration With UTHealth
Immatics N.V. recently announced the extension of its cell therapy manufacturing collaboration with The University of Texas Health Science Center at Houston (UTHealth)….
Catalent Adds Potent Manufacturing Capabilities at its Buenos Aires Site
Catalent recently announced that it will expand its Argentinian site in Loma Hermosa, Buenos Aires. The expansion, which will add over….
Immunic, Inc. Reports Positive Top-line Data From Phase 2 EMPhASIS Trial
Immunic, Inc. recently announced positive top-line data from its phase 2 EMPhASIS trial of lead asset, IMU-838, the company’s selective oral DHODH inhibitor, in patients…
FDA Approves Two Emergency INDs for COVID-19 Outpatient Therapy
Organicell Regenerative Medicine, Inc. recently announced the US FDA approved two outpatient Emergency Investigational New Drug Applications (eINDs) for treating mild-to-moderate respiratory distress due to…
Corbus Pharmaceuticals Completes Enrollment in Phase 3 Study
Corbus Pharmaceuticals Holdings, Inc. recently announced the completion of subject enrollment in DETERMINE, a Phase 3 study assessing the efficacy and safety of lenabasum for…
Rafael Pharmaceuticals Achieves Target Enrollment of 500 Patients in Pivotal Phase 3 Trial
Rafael Pharmaceuticals, Inc. recently announced it has reached its target enrollment of 500 patients in its pivotal Phase 3 clinical trial for metastatic pancreatic cancer…
Catalent Gene Therapy Facility Receives FDA Approval as an Additional Manufacturing Site for AveXis' Gene Therapy
Catalent recently announced that it was approved by the US FDA to produce commercial drug substance intermediate for AveXis’ spinal muscular atrophy (SMA) gene therapy…
BioAegis Therapeutics Initiates Phase 2 Clinical Trial of its Inflammation Regulator for COVID-19 Treatment
BioAegis Therapeutics Inc. recently announced it enrolled its first patient in its Phase 2 study of hospitalized patients with severe COVID-19 pneumonia. This study assesses…
Editas Medicine Enters Into Strategic Partnership With Catalent to Support Gene-Editing Medicine Pipeline
Editas Medicine, Inc. and Catalent recently announced they have entered into a strategic partnership whereby Catalent will provide support for the development, manufacturing, and clinical supply of….
Arrowhead Pharmaceuticals Earns $20-Million Milestone Payment From Amgen
Arrowhead Pharmaceuticals Inc. recently announced it has earned a $20-million milestone payment from Amgen following the administration of the first dose of….
PMI BioPharma Solutions Rebrands to August Bioservices, Closes Investment From Oak HC/FT to Accelerate Growth
PMI BioPharma Solutions recently announced new funding from Oak HC/FT to expand its capabilities to become a specialized, one-stop-shop CDMO for clinical and commercial injectable therapies…..
