Phase 3 Trial

Israel Institute for Biological Research (IIBR) has posted scientific results from an initial sample of Phase 2 vaccinated patients to assess the BriLife vaccine against the COVID-19 Delta variant. Blood (Sera) from an initial sample of 11 trial participants demonstrated effective...

Merck & Co Inc (NYSE: MRK) said that its experimental COVID-19 pill, molnupiravir, reduced the risk of hospitalization and death by 30% in a study, according to data from all the patients enrolled in a late-stage study (n=1433). The Company said that molnupiravir data, developed...

The FDA has issued a clinical hold on Ocugen Inc's (NASDAQ: OCGN) Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152 (known as Covaxin outside the U.S.). The FDA plans to identify the specific deficiencies that are the basis for...

The FDA has approved Takeda Pharmaceutical Co Ltd's (NYSE: TAK) Livtencity (maribavir) for a common type of viral infection occurring in patients after organ transplant. The infection is caused by a type of herpes virus called cytomegalovirus (CMV). It can have a major...

Athenex Inc's (NASDAQ: ATNX) abstract for subgroup analysis of its Phase 3 study of oral paclitaxel and encequidar (Oral Paclitaxel) for metastatic breast cancer has been accepted for poster presentation at the 2021 San Antonio Breast Cancer Symposium. The abstract and poster provide data...

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 Vaccine in individuals 12 through 15 years of age. The updated findings from the Phase 3 trial show that a two-dose...

Gilead Sciences Inc (NASDAQ: GILD) has submitted a marketing application to FDA for bulevirtide for injection (2 mg) for chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Chronic HDV infection is the most severe form of viral hepatitis....

Cassava Sciences Inc (NASDAQ: SAVA) has initiated a second Phase 3 study of simufilam in patients with Alzheimer's disease.  The second Phase 3 study is designed to evaluate the safety and efficacy of oral simufilam 100 mg and 50 mg over 78 weeks over 78 weeks in...

AstraZeneca Plc (NASDAQ: AZN) has shared new data from two Phase 3 trials of AZD7442, its long-acting antibody (LAAB) combination, in COVID-19 patients. In an analysis of the ongoing PROVENT trial evaluating a median of six months of participant follow-up, one 300mg intramuscular (...

Molecular Partners AG (NASDAQ: MOLN) has announced that a planned futility analysis of ensovibep in the Phase 3 ACTIV-3 study has not met the thresholds required to continue enrollment of hospitalized adults with COVID-19. The independent Data and Safety Monitoring Board (DSMB) ...

PhaseBio Pharmaceuticals Inc (NASDAQ: PHAS) has announced interim results from the REVERSE-IT Phase 3 trial of bentracimab to reverse the antiplatelet effects of ticagrelor. The trial included patients with urgent surgery or an invasive procedure or experiencing uncontrolled major...

Mesoblast Limited (NASDAQ: MESO) presented new results from the landmark Phase 3 study of rexlemestrocel-L in 565 patients with chronic heart failure (CHF) with reduced ejection fraction (HFrEF). Data were shared at the American Heart Association annual Scientific Sessions. A single...

Aditxt Inc (NASDAQ: ADTX) has announced data from Phase 3 PRESECO trial evaluating oral Avigan/Reeqonus (favipiravir) as a potential at-home therapy for mild-to-moderate COVID-19, run by Appili Therapeutics Inc. The trial did not achieve statistical significance on the primary...

GlaxoSmithKline plc (NYSE: GSK) and Vir Biotechnology Inc (NASDAQ: VIR) have announced topline data from COMET-TAIL Phase 3 trial evaluating sotrovimab delivered via Intramuscular (IM) administration compared to IV administration in high-risk COVID-19 patients. The trial achieved...

​​​​​​Biogen Inc (NASDAQ: BIIB) and Eisai Co Ltd (OTC: ESALY) have new data released for Aduhelm (aducanumab-avwa) in Alzheimer's disease. Related: Biogen Posts Just $300K Sales From Aduhelm In Q3, Though Earnings Beat Estimates. The analysis comes from...