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RSS FeedPosted by Michael Wonder on 05 May 2020
EMA publishes minutes of joint meeting with EUnetHTA - November 2019
5 May 2020 - This was the 18th meeting between the EMA and representatives from the EUnetHTA and attended by the ...
Posted by Michael Wonder on 05 May 2020
Overlap weighting: a propensity score method that mimics attributes of a randomised clinical trial
5 May 2020 - Evidence obtained from clinical practice settings that compares alternative treatments is an important source of information about ...
Posted by Michael Wonder on 05 May 2020
GeneTx and Ultragenyx announce GTX-102 granted fast track designation by US FDA for treatment of Angelman syndrome
4 May 2020 - GeneTx Biotherapeutics and Ultragenyx today announced that the U.S. FDA has granted fast track designation to GTX-102 ...
Posted by Michael Wonder on 05 May 2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
5 May 2020 - In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International ...
Posted by Michael Wonder on 05 May 2020
Bill Gates donates $10 million to Australian trial of immune-boosting vaccine
5 May 2020 - Bill Gates has donated $10 million to an Australian trial of a vaccine that researchers hope ...
Posted by Michael Wonder on 05 May 2020
Teva and Celltrion Healthcare announce the launch of Truxima (rituximab-abbs) injection for rheumatoid arthritis, the only biosimilar to Rituxan (rituximab) available in the United States for this indication
4 May 2020 - Truxima is also now available for the treatment of granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis. ...
Posted by Michael Wonder on 05 May 2020
Gilead's drug pricing in the crosshairs again in wake of OK to use remdesivir against COVID-19
4 May 2020 - Gilead plans to spend $1 billion on its COVID-19 drug remdesivir. Now some members of Congress ...
Posted by Michael Wonder on 05 May 2020
COVID-19: Australia’s pledge to $12 billion virus fight, WHO issues vaccine warning
5 May 2020 - Scott Morrison has promised more than $352 million as part of a global coronavirus vaccine fundraiser, but ...
Posted by Michael Wonder on 05 May 2020
Acceleron receives PRIME Designation from EMA for sotatercept in pulmonary arterial hypertension
4 May 2020 - PRIME designation comes just three weeks after US FDA granted sotatercept breakthrough therapy designation. ...
Posted by Michael Wonder on 05 May 2020
Australia, Canada, Singapore, Switzerland Consortium regulators pledge support to tackle COVID-19
5 May 2020 - The Australia, Canada, Singapore, Switzerland Consortium (ACSS) regulatory authorities have pledged their collective support in countering ...
Posted by Michael Wonder on 04 May 2020
A future for regulatory science in the European Union: the European Medicines Agency’s strategy
4 May 2020 - After 3 years of co-design with stakeholders and EU regulatory partners, the European Medicines Agency’s Regulatory Science ...
Posted by Michael Wonder on 04 May 2020
Randomised clinical trials and COVID-19: managing expectations
4 May 2020 - Despite the millions of cases and hundreds of thousands of deaths that have occurred in this devastating ...
Posted by Michael Wonder on 04 May 2020
U.S. law makers question Jaguar Health on price hike of drug that may help treat COVID-19 patients
4 May 2020 - The chair of a House of Representatives committee and a fellow Democratic committee member on Monday ...
Posted by Michael Wonder on 04 May 2020
How remdesivir, new hope for COVID-19 patients, was resurrected
4 May 2020 - The drug failed as a treatment for hepatitis and Ebola. With federal funding, scientists trained it on ...
Posted by Michael Wonder on 04 May 2020
Two potential therapies for COVID-19 have some effect
4 May 2020 - Hope rears its head, but more information is needed. ...