Formulation Development
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…..
Wearable Drug Delivery Provider Sorrel Medical Partners With Leading Global Pharmaceutical Manufacturer
Sorrel Medical recently announced it has entered into a strategic partnership with one of the world’s leading pharmaceutical companies to advance the development and introduction of next-generation wearable drug delivery solutions….
NGM Bio Announces Initiation of Phase 2 CATALINA Study
NGM Biopharmaceuticals, Inc. recently announced it has initiated the Phase 2 CATALINA study, a multicenter, randomized, double-masked, sham-controlled clinical trial, to evaluate the safety and efficacy of….
Emerald Health Pharmaceuticals Begins Enrollment in Phase 2a Study
Emerald Health Pharmaceuticals Inc. has recently begun enrollment and has dosed its first patients with diffuse cutaneous systemic sclerosis (dcSSc) in its Phase 2a clinical…
Daré Bioscience Announces Initiation of Phase 1 Clinical Trial of Novel Intravaginal Ring Designed to Deliver Non-oral, Bio-identical Hormone Therapy
Daré Bioscience, Inc. recently announced the initiation of a Phase 1 clinical trial of DARE-HRT1, designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over…
LGM Pharma Acquires Pharmaceutical Development & Manufacturing Unit of Nexgen Pharma
LGM Pharma recently announced it has acquired the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. The combination brings together LGM…
Oculis Announces Successful End-of-Phase 2 Meeting With the FDA
Oculis S.A. recently announced it has successfully completed an End-of-Phase 2 meeting with the US FDA for OCS-01 in two indications: for the treatment of…
Sterling Signs Deal to Produce Potential COVID-19 Drug Candidate for Moleculin
Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions has recently signed an agreement with Moleculin Biotech, Inc., to support the company’s expanded development…
