Koselugo approved in the EU for children with neurofibromatosis type 1 and plexiform neurofibromas. - AstraZeneca + Merck Inc.
GSK and Vir Biotechnology announce continuing progress of the COMET clinical development programme for sotrovimab for COVID 19.
Gilead’s Veklury is associated with a reduction in mortality rate in hospitalized patients with COVID-19 across three analyses of large retrospective real-world data sets.
EU approves extended approval of Aubagio for pediatric patients with relapsing-remitting multiple sclerosis.- Sanofi/Genzyme
EMA approves Onureg for acute myeloid leukemia.- BMS
Health Canada approves Trikafta for cystic fibrosis patients ages 12 and older who have at least one F508del mutation.-Vertex Pharma
Avenue Therapeutics receives Complete Response Letter from the FDA for IV Tramadol.
Novavax NVX-CoV2373 vaccine demonstrates 90% overall efficacy and 100% protection against moderate and severe COVID 19 disease in PREVENT-19 Phase III trial
NMPA (China) gives conditional approval for Brukinsa to treat adult patients with Waldenström’s macroglobulinemia .- BeiGene Ltd.
Phase III SPR1NT and STR1VE-EU trials show efficacy in spinal muscular atrophy.- Novartis
Complete Response Letter for arimoclomol, a heat shock protein amplifier intended for the treatment of Niemann-Pick disease type C.- Orphazyme A/S
Phase III AP-003-C trial of Ampion shows efficacy out to 12 weeks in osteoarthritis of the knee.- Ampio Pharma
BeiGene announces first patient dosed in phase III trial of anti-TIGIT antibody, ociperlimab + tislelizumab in NSCLC.
First patient dosed in APOLLOE4 phase III trial of oral ALZ 801 in patients with early Alzheimer’s
CureVac provides update on phase IIb/III HERALD study of first generation COVID 19 candidate,CVnCoV.
First patient dosed in phase III TOPAZ-1 study to treat systemic lupus erythematosus - Biogen Inc.
FDA accepts Alymsys filing for metastatic colorectal cancer.- Amneal Pharma
Topline results from phase II study of gosuranemab, an anti-Tau antibody, for Alzheimer’s disease. Biogen.
FDA approves Ayvakit to treat advanced systemic mastocytosis.-Blueprint Medicines Corpn.
Pivotal trial data for narsolimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy HSCT-TMA).- Omeros Corporation.
REGEN-COV phase III RECOVERY trial meets primary outcome, improving survival in hospitalized COVID-19 patients lacking an immune response to SARS-CoV-2. Regeneron Pharma/Roche
Mallinckrodt announces FDA approval of StrataGraft to treat thermal burns.
Health Canada approves Rinvoq for the treatment of adults with active psoriatic arthritis- AbbVie Canada
Paladin Labs Inc. announces approval of Wakix in Canada for the treatment of excessive daytime sleepiness or cataplexy.
Entresto approved in China to treat essential hypertension. - Novartis
Update on STORM CHASER trial
assessing AZD 7442 in post-exposure prevention of symptomatic COVID-19.- AstraZeneca.
FDA approves Rezipres for the treatment of clinically important hypotension occurring in the setting of anesthesia. Eton Pharma.
Clinical value beyond price alone: biosimilars improve patient access to treatment
Long-term topical management of psoriasis: the road ahead
Over the horizon: early stage trials for NASH
Phase II trials and stem cell therapies
The next global epidemic
The latest treatments in NASH
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