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Clinical Trials

Sorrento Receives US FDA Clearance to Proceed With Phase 1 Clinical Trial of STI-1499 Neutralizing Antibody in COVID-19 Positive Patients

Sorrento Therapeutics, Inc. announced that it received a study may proceed letter from the FDA for its phase 1 clinical trial for COVI-GUARD (STI-1499) in hospitalized COVID-19 patients. As Sorrento previously announced, in preclinical studies, STI-1499 demonstrated 100% in vitro...

Pfizer and BioNTech Propose Expansion of Pivotal COVID-19 Vaccine Trial

Pfizer Inc. and BioNTech SE announced that they have submitted an amended protocol to the U.S. Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which...

Takeda Announces Results from Phase 3 Clinical Trial Evaluating NINLARO in Newly Diagnosed Multiple Myeloma

Takeda Pharmaceutical Company Limited announced results from the Phase 3 TOURMALINE-MM2 trial evaluating the addition of NINLARO™ (ixazomib) to lenalidomide and dexamethasone versus lenalidomide and dexamethasone plus placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem...

Phesi data show clinical trial suspensions continue to rise as COVID-19 impact on development persists

Analysis from Phesi shows the impact of COVID-19 on clinical development is continuing to mount, with many clinical trial sites unable to bounce back following suspension in March and April 2020. Phesi’s previous analysis in May 2020 found that...

Merck announces positive results phase 3 trials of gefapixant 45 mg twice daily in patients with refractory or unexplained chronic cough

Merck, known as MSD outside the United States and Canada, has announced the results from two pivotal phase 3 trials (COUGH-1 and COUGH-2) evaluating the efficacy and safety of gefapixant (MK-7264), an investigational, orally administered, selective P2X3 receptor antagonist,...

Sharp launches Clinventory Inventory Management System (IMS) for clinical trials

Sharp - part of UDG Healthcare plc, a global leader in contract packaging clinical supply services, has launched a new Inventory Management System (IMS) to support clinical trial sponsors in managing inventory and supplies. The new system - named Clinventory...

Sinovac Biotech’s COVID-19 vaccine enters phase 3 trial globally

A COVID-19 vaccine candidate developed by Beijing-based Sinovac Life Sciences Corp has obtained preliminary approval in Bangladesh for entering phase III clinical trials, the company. "Our vaccine has received approval from a national drug research council in Bangladesh and is...

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