VBL Therapeutics announces second successful pre-planned interim analysis with a positive data safety monitoring committee review looking at OS - the primary endpoint of the OVAL Phase III potential registration study of VB 111 in Ovarian Cancer.
Guardant360 CDx first FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers. Guardant Health, Inc.
REGN 1500 filed with the FDA for homozygous familial hypercholesterolemia.- Regeneron Pharmaceuticals
China National Medical Products Administration (NMPA) approves Truvada for pre-exposure prophylaxis (PrEP). Gilead Sciences.
CheckMate -577, a phase III trial evaluating Opdivo as adjuvant therapy for resected esophageal or gastroesophageal junction cancer, meets primary endpoint of disease-free survival.- BMS
No FDA decision yet on EM 100 treatment for ocular itching.- Eton Pharma + Bausch & Lomb
Health Canada approves Opdivo + Yervoy with chemo for metastatic non-small cell lung cancer.- BMS
Phase III trial of NT 300 starts for mild or moderate COVID-19.- Romark
Phase III ECOSPOR III study of SER 109 shows efficacy in C. difficile infection.- Seres Therapeutics
Omeros Corporation reports recovery and survival of all
patients in a study evaluating narsoplimab with acute respiratory distress syndrome associated with COVID-19.
Mixed results from phase III trial of RG 7413 in ulcerative colitis.- Genentech/Roche
Gilead Sciences files NDA at FDA Veklury, an investigational antiviral for the treatment of patients with COVID-19.
Vaxart announces that its COVID-19 investigational new drug (IND) application for an oral vaccine has been filed with the FDA.
FDA accepts BLA from Eisai and Biogen for aducanumab, a proposed treatment for Alzheimer’s disease.
FDA approves supplemental indication of Spravato for major depressive disorder with acute suicidal ideation or behavior. Johnson & Johnson
Phase III ORIENT-11 trial of Tyvyt plus Alimta shows efficacy in NSCLC.- Innovent Biologics + Eli Lilly
FDA approves Evrysdi (risdiplam) for treatment of spinal muscular atrophy (SMA) in adults and children 2 months and older. Genentech/Roche
Genentech/Roche provides update on phase III study Of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer.
FDA grants accelerated approval for Blenrep to treat relapsed or refractory multiple myeloma for those who have received at least four prior therapies .- GSK
AEGIS-H2H study reanalysis shows that Feraccru/Accrufer is a credible alternative to IV therapy for iron deficiency anaemia. -Shield Therapeutics.
Bausch will spin off its eye care business into a separate publicly traded company
NEJM publishes Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis.- Novartis
Novartis announces Kymriah meets primary endpoint at interim analysis of pivotal study in follicular lymphoma.
Complete Response from FDA for Viaskin Peanut patch to treat peanut allergies in children ages 4 to 11 years. DBV Technologies
FDA accepts sNDA submission for Exparel postsurgical analgesia in children.- Pacira Biosciences
Eli Lilly initiates phase III trial of LY-CoV555 for prevention of COVID-19 at long-term care facilities in partnership with NIAID.
FDA accepts Vanda's applications for Hetlioz in the treatment of Smith-Magenis Syndrome.
The future of organ transplantation
Complications of stem cell transplants
Treating rejection in organ transplants
Challenges in transplant organ rejection
Biologic efficacy for complications associated with moderate-to-severe psoriasis
Moderate-to-severe psoriasis: treatment for young women
Migraine treatments: On the horizon
An independent review of current treatments for migraine
Migraine: The forgotten epidemic?
NEW: Moderate to Severe Asthma Learning Zone launches on Medthority.com
Senolytics: Can we treat age-related diseases with a single drug
Long-term disease control in Psoriasis: announcing a new project
Senolytics: an emerging therapeutic for the prevention and treatment of cardiovascular disease
Targeted therapies in triple negative breast cancer
Targeted therapies in HER2 negative breast cancer
Targeted therapies in HER2 positive breast cancer
Breast Cancer- Targeted therapies