Blog
RSS FeedPosted by Michael Wonder on 26 Oct 2020
Spectrum Pharmaceuticals announces that the FDA is deferring its action on the BLA for Rolontis (eflapegrastim)
26 October 2020 - Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel ...
Posted by Michael Wonder on 26 Oct 2020
European Union would apply lower threshold in assessing COVID-19 vaccine
25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less ...
Posted by Michael Wonder on 24 Oct 2020
FDA approves FoundationOneCDx as companion diagnostic for Vitrakvi (larotrectinib) to aid in identifying NTRK fusion positive patients
23 October 2020 - Detection of genomic alterations that drive the growth and spread of the tumour can guide treatment decisions ...
Posted by Michael Wonder on 24 Oct 2020
FDA shows signs of cold feet over emergency authorisation of COVID-19 vaccines
23 October 2020 - There are serious signs the FDA is getting cold feet over the notion of issuing emergency ...
Posted by Michael Wonder on 24 Oct 2020
Medicago signs agreements with the Government of Canada to supply up to 76 million doses of its recombinant plant-derived COVID-19 vaccine
23 October 2020 - Canadian government to provide $173M in funding for vaccine research and development, and domestic manufacturing capacity. ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...
Posted by Michael Wonder on 22 Oct 2020
FDA approves first treatment for COVID-19
22 October 2020 - Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult ...
Posted by Michael Wonder on 22 Oct 2020
Oxford developed COVID-19 vaccine, then scholars clashed over money
21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...
Posted by Michael Wonder on 22 Oct 2020
Remdesivir’s hefty price tag ignores NIH investment in its creation
22 October 2020 - Throughout the Democratic presidential primary, candidates cast a spotlight on the broken U.S. health care system ...
Posted by Michael Wonder on 22 Oct 2020
Leo Pharma announces U.S. FDA approval for Enstilar (calcipotriene and betamethasone dipropionate) foam U.S. Prescribing Information update to include data in long-term use in plaque psoriasis treatment
22 October 2020 - U.S. Prescribing Information updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly ...
Posted by Michael Wonder on 22 Oct 2020
F2G receives second US FDA breakthrough therapy designation for Olorofim
22 October 2020 - In Phase 2b development for the treatment of life-threatening fungal infections. ...
Posted by Michael Wonder on 22 Oct 2020
AppliedVR receives FDA breakthrough device designation to treat pain with digital therapeutic
21 October 2020 - AppliedVR today announced its EaseVRx product received breakthrough device designation from the U.S. FDA for treating ...
Posted by Michael Wonder on 21 Oct 2020
FDA approves fewer generics in FY2020, ending record streak
21 October 2020 - After four straight years of posting record numbers of abbreviated new drug application approvals, the US ...
Posted by Michael Wonder on 21 Oct 2020
U.S. FDA grants fast track designation for ASP0367/MA-0211, a selective PPARδ modulator being developed for the treatment of primary mitochondrial myopathies
20 October 2020 - Astellas Pharma today announced that the U.S. FDA has granted fast track designation for the development ...
Posted by Michael Wonder on 21 Oct 2020
COVID-19 vaccines to be stored secretly under tight security
21 October 2020 - Drug makers and others plan to use fake shipments and GPS trackers to prevent potential thefts. ...