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RSS FeedPosted by Michael Wonder on 09 Jun 2020
Insmed receives FDA breakthrough therapy designation for brensocatib in patients with non-cystic fibrosis bronchiectasis
8 June 2020 - Full results from phase 2 WILLOW study of brensocatib in non-cystic fibrosis bronchiectasis to be presented at ...
Posted by Michael Wonder on 08 Jun 2020
NICE publishes appraisal consultation for isatuximab in combination with pomalidomide and dexamethasone for treating patients with relapsed and refractory multiple myeloma
4 June 2020 - The appraisal committee has considered the evidence submitted by the company and the views of non-company consultees ...
Posted by Michael Wonder on 08 Jun 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #7
8 June 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 08 Jun 2020
EMA receives application for conditional authorisation of first COVID-19 treatment in the EU
8 June 2020 - EMA has now received an application for conditional marketing authorisation of the antiviral medicine remdesivir for ...
Posted by Michael Wonder on 08 Jun 2020
CytoDyn receives BLA acknowledgment letter from the FDA
8 June 2020 - PDUFA date could be set by the FDA on 10 July. ...
Posted by Michael Wonder on 08 Jun 2020
U.K. lab to sidestep pharma industry to sell potential virus vaccine
7 June 2020 - Imperial College aims to develop a vaccine that is cheaper and easier to manufacture and is forming ...
Posted by Michael Wonder on 08 Jun 2020
The quest for a vaccine could restore faith in big pharma
4 June 2020 - The boffins of AstraZeneca are showing the way forward ...
Posted by Michael Wonder on 07 Jun 2020
The University of Queensland, CEPI and CSL partner to advance development and manufacture of COVID-19 vaccine candidate
5 June 2020 - A vaccine is anticipated to be available in 2021 if clinical trials are successful. ...
Posted by Michael Wonder on 07 Jun 2020
Bayer submits vericiguat for marketing authorization in the EU and Japan for the treatment of chronic heart failure
5 June 2020 - Regulatory submissions based on positive data from Phase III VICTORIA study recently published in the New England ...
Posted by Michael Wonder on 07 Jun 2020
Lilly bags expanded EU approval for Taltz
5 June 2020 - The European Medicines Agency has expanded the reach of Lilly's Taltz (ixekizumab) to include the treatment ...
Posted by Michael Wonder on 06 Jun 2020
AiCuris was granted breakthrough therapy designation by U.S. FDA for pritelivir for the treatment of HSV infections in immunocompromised patients
5 June 2020 - AiCuris is currently preparing to add a pivotal Phase 3 trial part to the ongoing Phase 2 ...
Posted by Michael Wonder on 05 Jun 2020
Genmab announces European marketing authorisation for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of patients with multiple myeloma
4 June 2020 - Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies. ...
Posted by Michael Wonder on 04 Jun 2020
FDA re-evaluates user fees for biosimilar reviews
4 June 2020 - Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. ...
Posted by Michael Wonder on 04 Jun 2020
Trump Administration selects five coronavirus vaccine candidates as finalists
3 June 2020 - The Trump administration has selected five companies, including Moderna, AstraZeneca and Pfizer, as the most likely ...
Posted by Michael Wonder on 04 Jun 2020
The Lancet, New England Journal retract COVID-19 studies, including one that raised safety concerns about malaria drugs
4 June 2020 - The Lancet, one of the world’s top medical journals, on Thursday retracted an influential study that ...