The US Food and Drug Administration (FDA) has accepted Enzychem Lifescience’s investigational new drug application (IND) to assess its EC-18 therapeutic candidate for the prevention of acute respiratory disease syndrome (ARDS) due to Covid-19 pneumonia.
Boehringer Ingelheim announced that the first patient has enrolled in InPedILD, a global Phase III trial assessing the dosing and safety profile of nintedanib in children and adolescents between six and 17 years old with clinically significant fibrosing interstitial lung disease (ILD).
Bristol Myers Squibb announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.
SAB Biotherapeutics, a US-based clinical-stage company, has dosed the first participant of a phase 1 study of SAB-185, its therapeutic candidate for Covid-19, in healthy volunteers.
Appili Therapeutics, a biopharmaceutical company focused on anti-infective drug development, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to proceed after Appili’s filing of an investigational new drug (IND) application for broad-spectrum antiviral favipiravir.
Omeros Corporation reported the results of a compassionate-use study evaluating narsoplimab, Omeros’ investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), in the treatment of COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS), a severe and life-threatening symptom of COVID-19.
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it has entered into a clinical trial collaboration with AstraZeneca (LSE/STO/NYSE: AZN) to evaluate the combination of patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), and TAGRISSO (osimertinib), an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer (NSCLC).
Pfizer announced that the Phase 3 CROWN study of LORBRENA (lorlatinib) in people with previously untreated advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) met its primary endpoint by demonstrating significantly improved progression-free survival (PFS), as compared to XALKORI (crizotinib).
NeuroRx and Relief Therapeutics said that RLF-100 (aviptadil) delivered quick recovery from respiratory failure in the most critically ill patients suffering from Covid-19 in a phase 2/3 clinical trial.
AbCellera announced that LY-CoV555, a human antibody discovered by AbCellera in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC) and co-developed with Eli Lilly and Company (Lilly) as a potential treatment and prophylaxis for Covi-19, has progressed to Phase 3 clinical trials. A first-of-its-kind, the Lilly-sponsored trial will use customized mobile research units to conduct the study at long-term care facilities across the United States.
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