Researchers at Northwestern University identified a compound that appears to reverse the ongoing degeneration of upper motor neurons associated with amyotrophic lateral sclerosis (ALS).
The U.S. Food and Drug Administration accepted for priority review a Biologics License Application (BLA) for Merck’s 15-valent pneumococcal conjugate vaccine V114.
BioSpace Global Roundup: Ipsen Wins Fast Track Designation for Cancer Drug and More
3D, Antibody-Drug Conjugates (ADCs), Business, Clinical Trials, Collaborations, Coronavirus Disease 2019 (COVID-19), Data, E. Coli, Fast Track Designation, FDA, Gene Editing, Joint Ventures, Licensing, Metastatic pancreatic cancer, Neurological Disorders, R&D, Series A, Small cell lung cancer, Staphylococcus aureus infections, Therapeutics, Ulcerative Colitis, VaccinesParis-based Ipsen secured Fast Track designation from the U.S. Food and Drug Administration for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen.
The widely used BCG tuberculosis vaccine will be tested on frontline care workers in Britain for its effectiveness against Covid-19, researchers running the UK arm of a global trial said.
The U.S. National Institutes of Health launched a clinical trial of fostamatinib, currently used to treat a blood platelet-destroying autoimmune disorder, in patients hospitalized with severe Covid-19.
Merck reported positive results regarding the safety, tolerability and immunogenicity in two Phase III studies for V114, the company’s investigational 15-valent pneumococcal conjugate vaccine.
Atox Bio had positive results in the company’s Phase III ACCUTE trial for reltecimod for early treatment of severe Necrotizing Soft Tissue Infection (NSTI), a so-called flesh-eating disease.
FDA Action Alert
Atopic Dermatitis (Eczema), Auto-Injection Therapy, B Cells, Biologics License Application (BLA), Complicated Urinary Tract Infections (cUTI), Diabetic Gastroparesis, Eosinophilic Asthma, FDA, FDA/Regulatory, Follicular Lymphoma, Inflammatory Diseases, Monoclonal Antibodies, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Pediatric Asthma, Prescription Drug User-Fee Act (PDUFA), Priority Review Status, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA)A look at upcoming PDUFA dates for the U.S. Food and Drug Administration, including Viela Bio’s inebilizumab for NMOSD.
Foster City, California-based SutroVax closed on a Series D preferred stock financing worth $110 million, which was co-led by new investors RA Capital Management and Janus Henderson Investors.
Roche Holding AG Chief Executive Officer Severin Schwan said in an interview with CNBC it could take at least a couple of weeks, if not months, for the United States to implement broad testing for coronavirus.