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.
Pfizer announced positive results from two Phase III trials, one in moderate-to-severe atopic dermatitis and another in pneumococcal disease.
Investigators with the National Institutes of Health conducted research on monkeys that injected a bacilli Calmette-Guerin (BCG) vaccine directly into the bloodstream, producing dramatically improved effectiveness compared to injecting the vaccine into the muscle or skin.
Vaccines: A Healthcare Revolution and High Return on Investment
Business, Chickenpox Virus, Clinical Trials, Deals, Dengue Fever, Diphtheria, Diseases, Haemophilus influenza type B, Hepatitis A, Hepatitis B, Infectious Diseases, Influenza, Measles, Mumps & Rubella, pertussis, Pharmaceutical Research and Manufacturers of America (PhRMA), PhRMA, Pneumococcal Disease, Polio, Product Pipelines, R&D, Rotavirus, Smallpox, tetanus, U.S. Centers for Disease Control and Prevention, Vaccines, Viruses, Whooping Cough, World Health OrganizationAccording to the Pharmaceutical Research and Manufacturers of America (PhRMA), there are 264 vaccines in development to prevent and treat diseases.
RedHill Biopharma Ltd.’s three-drug combination therapy to treat Helicobacter pylori bacterial infections was approved by the U.S. Food and Drug Administration.