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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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.  ...

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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 ...

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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 ...

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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 ...

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