Phase 3 Trial

Amgen Inc (NASDAQ: AMGN) announced new data from the NAVIGATOR Phase 3 trial evaluating tezepelumab in patients who also have nasal polyps, a common complication of respiratory disease. New data demonstrated that tezepelumab reduced exacerbations and improved lung function and nasal...

RedHill Biopharma Ltd (NASDAQ: RDHL) has announced new Movantik (naloxegol) Phase 3 study data analyses. The three analyses included pooled data from two Phase 3 studies involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 446 patients in the...

The FDA has granted a new 510(k) clearance to RenovoRx Inc's (NASDAQ: RNXT) RenovoCath Delivery System.  The RenovoCath Delivery System is the device component of the Company's initial product, RenovoGem.  The drug/device combination used in RenovoRx'...

Pfizer Inc (NYSE: PFE) has initiated a Phase 3 clinical trial evaluating its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older. The Phase 3 RENOIR trial will enroll approximately 30,000...

Takeda Pharmaceutical Co Ltd (NYSE: TAK) announced topline data from the Phase 3 PANTHER study evaluating pevonedistat in blood cancer indications. The trial did not achieve the pre-defined statistical significance for the primary endpoint of event-free survival (EFS). Patients were...

Merck & Co Inc (NYSE: MRK) and Ridgeback Biotherapeutics have initiated the Phase 3 MOVe-AHEAD trial to evaluate molnupiravir, an investigational oral antiviral therapeutic, for the prevention of COVID-19 infection.  The global study enrolls individuals who are at least 18...

The FDA has accepted Teva Pharmaceutical Industries Ltd (NYSE: TEVA) and MedinCell's marketing application seeking approval for TV-46000/mdc-IRM in schizophrenia.  TV-46000/mdc-IRM is a risperidone extended-release injectable suspension for subcutaneous use. The...

GlaxoSmithKline Plc (NYSE: GSK) has started Phase 3 clinical study for a COVID-19 vaccine candidate designed by South Korean drugmaker SK Bioscience Co. The study will enroll 4,000 participants and compare the shot to Oxford University - AstraZeneca Plc (NASDAQ: AZN...

Pfizer Inc (NYSE: PFE) announced topline data from the JADE DARE Phase 3 trial comparing abrocitinib with Sanofi SA (NASDAQ: SNY) - Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) Dupixent (dupilumab), in moderate to severe atopic dermatitis. The study met its...

Eli Lilly And Co (NYSE: LLY) and Boehringer Ingelheim have rolled out full results of EMPEROR-Preserved phase 3 trial of Jardiance (empagliflozin) for heart failure with preserved ejection fraction (HFpEF).  The data was delivered at the annual meeting of the European...

Amgen Inc (NASDAQ: AMGN) has announced positive data from the HUYGENS Phase 3 study assessing if Repatha (evolocumab) could increase the thickness of the fibrous caps to improve a feature of plaque stability. The data were presented at the oral presentation at ESC Congress 2021....

AstraZeneca plc (NASDAQ: AZN) reported high-level results from the FoCus Phase 3 trial evaluating ALXN1840 in Wilson disease. The study met the primary goal of improving the daily mean copper mobilized from tissues over 48 weeks. Wilson disease is a genetic condition in which the...

Edesa Biotech Inc (NASDAQ: EDSA) issued an update for the Phase 2/3 study evaluating its monoclonal antibody candidate, EB05, as single-dose therapy for hospitalized COVID-19 patients. Edesa reported that more than 525 subjects had been randomized into the study. Approximately 35 of...

The regulatory authority of Brazil has signed off Inovio Pharmaceuticals Inc's (NASDAQ: INO) global Phase 3 segment of its INNOVATE Phase 2/3 trial for INO-4800, DNA COVID-19 vaccine candidate. Related Content: Inovio's DNA COVID-19 Vaccine Candidate Triggers Immune...

Amneal Pharmaceuticals Inc (NYSE: AMRX) announced topline data from the Phase 3 RISE-PD trial evaluating IPX-203 in patients with Parkinson's disease who have motor fluctuations.  Amneal plans to submit a marketing application for IPX-203 with the FDA in mid-2022. The study...