Category: Clinical trials

Apexigen, Inc. Announces First Patient Dosed in Phase 1b/2 Clinical Trial of APX005M in Combination with Opdivo (nivolumab) in Advanced Solid Tumors

San Carlos, CA – July 17, 2017 – Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing antibody-based therapeutics for the treatment of cancer with an emphasis on new Immuno-Oncology (I-O) agents, today...

Paratek Announces Phase 3 Study of Oral-Only Dosing of Omadacycline Met All Primary and Secondary FDA and EMA Efficacy Endpoints in Acute Bacterial Skin Infections

BOSTON, July 17, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today positive top-line results from a pivotal Phase 3 clinical study comparing its once-daily, oral investigational antibiotic, omadacycline, to...

FDA Grants Orphan Drug Designation to Mallinckrodt Development Product MNK-1411 for Potential Treatment of Duchenne Muscular Dystrophy

STAINES-UPON-THAMES, United Kingdom, July 12, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to MNK-1411,...

Alnylam and Sanofi Genzyme Report Positive Results from Ongoing Phase 2 Open-Label Extension Study with Investigational RNAi Therapeutic Fitusiran in Patients with Hemophilia A and B With or Without Inhibitors

CAMBRIDGE, Mass. & PARIS--(BUSINESS WIRE) July 10, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today new positive...

Alnylam and Sanofi Genzyme Report Positive Results from Ongoing Phase 2 Open-Label Extension Study with Investigational RNAi Therapeutic Fitusiran in Patients with Hemophilia A and B With or Without Inhibitors

CAMBRIDGE, Mass. & PARIS--(BUSINESS WIRE) July 10, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today new positive...

Alnylam and Sanofi Genzyme Initiate ATLAS Phase 3 Program with Investigational RNAi Therapeutic Fitusiran in Patients with Hemophilia A and B with or without Inhibitors

CAMBRIDGE, Mass.--(BUSINESS WIRE) July 7, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today the initiation of the ATLAS...

Alnylam and Sanofi Genzyme Initiate ATLAS Phase 3 Program with Investigational RNAi Therapeutic Fitusiran in Patients with Hemophilia A and B with or without Inhibitors

CAMBRIDGE, Mass.--(BUSINESS WIRE) July 7, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today the initiation of the ATLAS...