Formulation Development
FDA Approves Intra-Cellular Therapies’ Novel Treatment of Schizophrenia in Adults
Intra-Cellular Therapies, Inc. recently announced that CAPLYTA (lumateperone) has been approved by the US FDA for the treatment of schizophrenia in adults. The company expects…
Bioiberica Launches Natural Origin Thyroid
Bioiberica, a world reference in the identification, extraction, and development of animal-derived APIs, recently announced the launch of its natural thyroid active pharmaceutical ingredient (API) for the treatment of…..
Tetra Bio-Pharma Provides Update on its Hepatocellular Carcinoma Drug
Tetra Bio-Pharma Inc. recently announced it will be requesting a meeting with the US FDA to discuss the drug development program for its Orphan Drug candidate HCC011….
Catalent Partners With Bridge Therapeutics on Formulation, Development & Production of New Opioid Addiction Treatment
Catalent recently announced it has completed clinical production of Bridge Therapeutics Inc.’s (Bridge) opioid addiction development therapeutic product, BT-219, and executed an….
Tonix Pharmaceuticals Enrolls First Patient in Phase 3 RELIEF Study
Tonix Pharmaceuticals Holding Corp. recently announced that the first patient was enrolled in the Phase 3 RELIEF study (TNX-CY-F304)……
Inceptua Medicines Access & Onconova Therapeutics Announce Pre-Approval Access Collaboration
Onconova Therapeutics, Inc. and Inceptua Medicines Access (a business unit of the Inceptua Group) recently announced they have entered into a collaboration to make available…
Fate Therapeutics Presents its First Off-the-Shelf, iPSC-Derived CAR T-Cell Immunotherapy Program
Fate Therapeutics, Inc. recently announced new in vivo preclinical data for FT819, its first off-the-shelf, iPSC-derived chimeric antigen receptor (CAR) T-cell product candidate, at the…
Retrogenix & Resonant Therapeutics Announce Strategic Alliance
Retrogenix and Resonant Therapeutics, Inc. recently announced they have entered into a non-exclusive strategic partnership to identify the targets of Resonant antibodies directed against the…
Navigen Announces FDA Clearance of its IND Application
Navigen, Inc. recently announced the US FDA has cleared its Investigational New Drug application (IND) for the initiation of a Phase 1 study in healthy…
Bioncotech Therapeutics Announces Oncology Clinical Trial Collaboration With MSD
Bioncotech Therapeutics recently announced it has entered into a Phase 2 clinical trial collaboration with a subsidiary of Merck & Co., Inc., Kenilworth, NJ, known…
Appili Therapeutics Enters Commercial Agreement With Saptalis Pharmaceuticals
Appili Therapeutics Inc. recently announced it has entered into a commercialization agreement with Saptalis Pharmaceuticals LLC on ATI-1501, Appili’s liquid suspension reformulation of the…..
Biogen Announces Positive Phase 2 Study Results
Biogen Inc. recently announced positive top-line results from the Phase 2 LILAC study evaluating the efficacy and safety of BIIB059, a fully humanized….
OWP Pharmaceuticals Announces Second IND Approval & Patent Application for First-Ever Liquid Oral Suspension Formulation
OWP Pharmaceuticals, Inc. recently announced today that it has received Investigational New Drug (IND) approval from the US FDA, and has submitted for US patent protection, for the first-ever liquid formulation of….
Dermavant Announces First Patient Dosed in Phase 2a Clinical Trial
Dermavant Sciences recently announced that the first patient has been dosed in its Phase 2a vitiligo clinical trial for topical cerdulatinib. Cerdulatinib is a dual…
CicloMed Expands Fosciclopirox Phase 1 Trial
CicloMed LLC recently announced the expansion of its fosciclopirox clinical development program. The fosciclopirox first-in-human Phase 1 trial has been expanded to include patients with…
Soligenix Completes Enrollment in its Pivotal Phase 3 Clinical Trial
Soligenix, Inc. recently announced it has completed patient enrollment in its Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin) in…
Cara Therapeutics Announces Positive Topline Data From Phase 2 Trial
Cara Therapeutics, Inc. recently announced positive topline results from its Phase 2 dose-ranging trial of Oral KORSUVAT (CR845/difelikefalin) for the treatment of pruritus in patients…
Vivera Pharmaceuticals Enters Agreement Clinical Study Agreement With Parexel Biotech
Vivera Pharmaceuticals, Inc. recently announced it has signed an agreement for Clinical Development Services with Parexel International, a leading provider of solutions to accelerate the…
IONTAS & Adaptate Biotherapeutics Enter Collaboration Agreement
IONTAS Limited recently announced it has entered into a collaboration agreement with Adaptate Biotherapeutics to generate and optimize antibodies for novel immuno-oncology targets, including access…
PPD Expands Special Patient Capabilities in Early Development Research
PPD, Inc. has expanded its early development research services by adding significant neuroscience and ethno-bridging expertise, broadening its capabilities to provide increased access to…..