Formulation Development
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…..
Recipharm Announces Commercial Manufacturing to Support Drug Launch Following FDA Approval
Recipharm, the contract development and manufacturing organisation (CDMO), recently announced ongoing large-scale commercial manufacturing of RedHill Biopharma’s drug, Talicia (omeprazole magnesium,…..
ChemoCentryx & VFMCRP Announce Positive Topline Data From Pivotal Phase 3 Trial
ChemoCentryx, Inc. and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) recently announced positive topline data from the pivotal Phase 3 ADVOCATE trial of avacopan, an…
Avadel Pharmaceuticals Achieves Enrollment Target in REST-ON Phase 3 Pivotal Trial
Avadel Pharmaceuticals plc recently announced it has achieved its patient enrollment target of 205 patients in the REST-ON Phase 3 clinical trial for its once-nightly…
TFF Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial
TFF Pharmaceuticals, Inc. recently announced the initiation of its Phase 1 clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of…
Akcea & Ionis Announce Initiation of NEURO-TTRansform Phase 3 Clinical Trial
Akcea Therapeutics, Inc., a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. recently announced initiation of the NEURO-TTRansform Phase 3 clinical trial for…
2020 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
CDMO SELECTION - Ready to Launch: Developing Your Biologic With an Eye Toward Commercial Supply
Stacey Treichler, PhD, believes the development process for new biologics is complex and requires a substantial amount of time and resources, and reviews some of the areas where careful choice of CDMO is key, including cell line development and cGMP manufacturing capabilities, and how an integrated approach can be beneficial.
