-
Sophiris Bio Receives Positive Feedback from EMA Regarding Prostate Cancer Clinical Trial Design
americanpharmaceuticalreview
June 21, 2019
Sophiris Bio has received formal scientific advice from the European Medicines Agency (EMA) regarding a proposed design of a Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate ris
-
Terns Pharmaceuticals Initiates Phase 1 Clinical Trial of TERN-101
americanpharmaceuticalreview
June 14, 2019
Terns Pharmaceuticals announced the initiation of a Phase 1 clinical trial of TERN-101, a farnesoid X receptor (FXR) agonist, being developed for the treatment of non-alcoholic steatohepatitis (NASH).
-
Lannett Initiates Human Clinical Trial of Biosimilar Insulin Glargine
americanpharmaceuticalreview
June 06, 2019
Lannett announced the commencement of a human clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC).
-
89bio Reports Positive Top-line Data from Phase 1 Single-Ascending Dose Clinical Trial of BIO89-100
americanpharmaceuticalreview
May 23, 2019
89bio LTD announced positive top-line results from a Phase 1 single ascending dose (SAD) study of its investigational medicine, BIO89-100, in healthy volunteers.
-
Rigel Enrolls First Patient in Phase 3 Clinical Trial of Fostamatinib Disodium Hexahydrate
americanpharmaceuticalreview
May 17, 2019
Rigel Pharmaceuticals has enrolled the first patient in a pivotal Phase 3 clinical trial of fostamatinib disodium hexahydrate (fostamatinib) in warm antibody autoimmune hemolytic anemia (AIHA).
-
SGS implements Veeva Vault clinical trial management system across its global network
cphi-online
May 07, 2019
SGS will implement the Veeva Vault CTMS (clinical trial management system) across its network of clinical operations sites for the management of its global clinical study services.
-
BREAKING NEWS Myoderm Announces Leadership Transition
contractpharma
April 04, 2019
CEO Michael Cohen to become Executive Chairman; COO James Lovett to be promoted to CEO
-
BriaCell Announces Clinical Trial Collaboration Agreement with Incyte
pharmafocusasia
April 03, 2019
BriaCell Therapeutics Corp., a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, today announced a clinical trial collaboration and supply agreement (the “Agreement”) with Incyte ...
-
J&J submits sNDA for Invokana after premature end to clinical trial
pharmatimes
April 02, 2019
Johnson & Johnson’s Janssen has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a new indication for Invokana (canagliflozin).
-
ISCR welcomes new drugs and clinical trial rules, 2019
expressbpd
March 27, 2019
New rules well balanced, focused on patient rights, safety and well-being