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RSS FeedPosted by Michael Wonder on 15 Oct 2020
FDA approves expanded indication for Merck’s Keytruda (pembrolizumab) in adult patients with relapsed or refractory classical Hodgkin lymphoma
15 October 2020 - Keytruda is the first anti-PD-1 therapy approved for adult patients with relapsed or refractory classic Hodgkin lymphoma ...
Posted by Michael Wonder on 15 Oct 2020
Taysha Gene Therapies receives rare paediatric disease designation and orphan drug designation for TSHA-102 as a treatment for Rett syndrome
14 October 2020 - Program leverages novel miRARE platform technology used to control transgene expression on a cellular basis. ...
Posted by Michael Wonder on 14 Oct 2020
FDA approves first treatment for Ebola virus
14 October 2020 - Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three ...
Posted by Michael Wonder on 14 Oct 2020
U.S. FDA accepts Biohaven's supplemental new drug application of Nurtec ODT for the preventive treatment of migraine
14 October 2020 - Acceptance marks critical milestone in Biohaven's efforts to develop Nurtec ODT as a unique dual therapy for ...
Posted by Michael Wonder on 14 Oct 2020
Harmony Biosciences receives FDA approval for expanded use of Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy
13 October 2020 - Wakix is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult ...
Posted by Michael Wonder on 14 Oct 2020
Bayer submits supplemental new drug application to the FDA for intrauterine device Mirena (levonorgestrel releasing intrauterine system) 52 mg
14 October 2020 - Application seeks to extend duration of use up to seven years for Mirena. ...
Posted by Michael Wonder on 14 Oct 2020
CTI BioPharma initiates rolling submission of new drug application for pacritinib in myelofibrosis patients with severe thrombocytopenia
13 October 2020 - Completion of submission expected in first quarter 2021. ...
Posted by Michael Wonder on 13 Oct 2020
Roche to launch laboratory SARS-CoV-2 antigen test to support high-volume testing of suspected COVID-19 patients
13 October 2020 - The Elecsys SARS-CoV-2 Antigen test is an automated laboratory assay intended as an aid in the diagnosis ...
Posted by Michael Wonder on 13 Oct 2020
PMV Pharma granted FDA fast track designation of PC14586 for the treatment of advanced cancer patients that have tumours with a p53 Y220C mutation
13 October 2020 - PMV Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to its lead product ...
Posted by Michael Wonder on 13 Oct 2020
COVID-19 vaccines are chance at salvation, financial and beyond, for drug makers
13 October 2020 - Big profits beckon for pharmaceutical companies, which are already using their work on vaccines to fight efforts ...
Posted by Michael Wonder on 13 Oct 2020
Oxular receives rare paediatric disease and orphan drug designations for retinoblastoma treatment
12 October 2020 - Provides furthered momentum for OXU-003 development programme. ...
Posted by Michael Wonder on 12 Oct 2020
Inventiva receives FDA breakthrough therapy designation for lead drug candidate lanifibranor in NASH
12 October 2020 - Inventiva today announced that the U.S. FDA has granted breakthrough therapy designation to lanifibranor, the Company’s lead ...
Posted by Michael Wonder on 12 Oct 2020
Efficacy trials cost more, take longer for biosimilars than originators
11 October 2020 - Average clinical efficacy testing cost millions of dollars more for Phase 3 biosimilar studies than for ...
Posted by Michael Wonder on 12 Oct 2020
Pfizer trying to defuse critics amid push for vaccine before Election Day
10 October 2020 - The company behind President Donald Trump’s last hope for a vaccine by Election Day has quietly ...
Posted by Michael Wonder on 12 Oct 2020
Alexion receives FDA approval for new advanced formulation of Ultomiris (ravulizumab-cwvz) with significantly reduced infusion time
12 October 2020 - New 100 mg/mL formulation will reduce infusion time by approximately 60 percent, lessening the burden on patients. ...