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RSS FeedPosted by Michael Wonder on 02 Jul 2020
Gilead donates COVID-19 drug remdesivir to Australia’s medical stockpile after US buys up supply
2 July 2020 - The US pharmaceutical giant Gilead has donated a supply of the anti-viral medication remdesivir to Australia’s ...
Posted by Michael Wonder on 24 Jun 2020
Big pharma is taking big money from U.S. tax payers to find a coronavirus vaccine — and charge whatever they want for it
24 June 2020 - Congress must act now to ensure that COVID-19 vaccines and treatments are affordable. ...
Posted by Michael Wonder on 24 Jun 2020
Mayne Pharma announces FDA filing acceptance of new drug application for E4/DRSP in the US
24 June 2020 - Mayne Pharma is pleased to announce the new drug application for E4/DRSP to prevent pregnancy has been ...
Posted by Michael Wonder on 24 Jun 2020
NICE begins phased restart of non-COVID-19 guidance
24 June 2020 - NICE has begun a phased restart of publishing non-COVID-19 guidance as the NHS and wider health ...
Posted by Michael Wonder on 24 Jun 2020
Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24 June 2020 - Under the umbrella of the International Coalition of Medicines Regulatory Authorities, international regulators discussed COVID-19 vaccine ...
Posted by Michael Wonder on 24 Jun 2020
Renibus Therapeutics receives FDA fast track designation for RBT-9 treatment in COVID-19
23 June 2020 - Renibus Therapeutics announced today that it has been granted fast track designation by the FDA for RBT-9 ...
Posted by Michael Wonder on 23 Jun 2020
Polynoma receives FDA fast track designation for its melanoma cancer vaccine seviprotimut-L
23 June 2020 - Polynoma announces that the U.S. FDA has granted its application for fast track designation of seviprotimut-L, ...
Posted by Michael Wonder on 23 Jun 2020
The case for using novel value elements when assessing COVID-19 vaccines and therapeutics
23 June 2020 - In the span of mere weeks, the novel coronavirus (COVID-19) has upended modern life. Schools and businesses ...
Posted by Michael Wonder on 23 Jun 2020
Unfunded drug the final lifeline for 27 year old with bowel cancer
23 June 2020 - Tiana Scott has spent two years living with cancer, and she'd happily do it all again, as ...
Posted by Michael Wonder on 23 Jun 2020
FDA maintains the pace of meeting its goals on applications for medical products during the pandemic
23 June 2020 - One of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the ...
Posted by Michael Wonder on 23 Jun 2020
MHRA extends access to Santhera's DMD drug via the EAMS
23 June 2020 - The UK’s Medicines and Healthcare products Regulatory Agency has renewed for a further year the Early ...
Posted by Michael Wonder on 23 Jun 2020
Academia developing medicines for rare diseases to receive free EMA scientific advice
23 June 2020 - To further encourage the development of treatments for rare diseases, EMA will waive all fees for ...
Posted by Michael Wonder on 23 Jun 2020
FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials
23 June 2020 - The U.S. FDA today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence. ...
Posted by Michael Wonder on 23 Jun 2020
Law makers push COVID-19 bills to prevent price gouging, track federal funds used to discover drugs
22 June 2020 - Amid ongoing concern that COVID-19 therapies and vaccines may be unaffordable, a bipartisan group of lawmakers ...
Posted by Michael Wonder on 23 Jun 2020
Pricing remdesivir: a domestic reference price approach
23 June 2020 - As COVID-19 continues to ravage US communities, the costs in terms of lives and lost wages are ...
Posted by Michael Wonder on 23 Jun 2020
Imbruvica (ibrutinib) seeks to expand U.S. label with long-term data in Waldenström's macroglobulinaemia
23 June 2020 - Submission is based on results of more than five years of follow-up data from the Phase 3 ...