COVID-19 has changed how the world does science, together

1 April 2020 - Never before, scientists say, have so many of the world’s researchers focused so urgently on a single ...

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Developing COVID-19 vaccines at pandemic speed

30 March 2020 - Rapid publication of a perspective co-authored by former head of Australian Department of Health. ...

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Clinical trial processes

31 March 2020 - The TGA has received a number of enquiries about processes for clinical trials relating to COVID-19 ...

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EMA validates marketing authorisation application for oral, once-daily berotralstat (BCX7353) to prevent HAE attacks

30 March 2020 - BioCryst Pharmaceuticals announced that the EMA has validated its marketing authorisation application submission for approval of ...

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Is it worthwhile having private health insurance during the coronavirus epidemic?

31 March 2020 - Major private health funds have delayed scheduled premium hikes and offered fee relief for policyholders who ...

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Trump administration in talks with India to avoid U.S. drug supply shortage

31 March 2020 - India, the top source of generic drugs and ingredients, has restricted exports but the U.S. wants exemptions ...

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U.S. regulator approves limited use of malaria drugs for COVID-19

30 March 2020 - A limited emergency-use authorisation for two antimalarial drugs touted as game-changers by President Donald Trump has ...

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New WHO guide to help countries expand access to essential medicines

30 March 2020 - WHO’s new user guide for countries, ‘Selection of medicines at country level’, is based ...

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PHARMAC eases restrictions on cancer drugs during COVID-19 pandemic

31 March 2020 - PHARMAC will ease restrictions on at least nine cancer drugs, including Keytruda, for the treatment of advanced ...

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Johnson & Johnson announces a lead vaccine candidate for COVID-19; landmark new partnership with U.S. Department of Health & Human Services; and commitment to supply one billion vaccines worldwide for emergency pandemic use

30 March 2020 - Company Expects to Initiate Phase 1 Human Clinical Studies of Vaccine Candidate at Latest by September 2020. ...

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FDA guidance on conduct of clinical trials of medical products during the COVID-19 pandemic

30 March 2020 - The U.S. FDA today issued an updated guidance, “Conduct of Clinical Trials of Medical Products during ...

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FDA on signing of the COVID-19 Emergency Relief Bill, including landmark over-the-counter drug reform and user fee legislation

30 March 2020 - On Friday, the President signed into law a $2 trillion emergency relief bill that will continue ...

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EMA to issue electronic certificates for medicines

30 March 2020 - EMA has implemented a new system to issue electronic certificates for human and veterinary medicines.  ...

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FDA approves durvalumab for extensive-stage small cell lung cancer

30 March 2020 - On 27 March 2020, the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with etoposide and either ...

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Lilly's Taltz (ixekizumab) receives U.S. FDA approval for the treatment of paediatric patients with moderate to severe plaque psoriasis

30 March 2020 - Taltz is the first and only IL-17A antagonist approved to treat this population. ...

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Daiichi Sankyo submits application for CAR T therapy axicabtagene ciloleucel for treatment of patients with certain relapsed/refractory B-cell lymphomas in Japan

30 March 2020 - Submission based on previous pivotal trial data and a phase 2 study in Japan in patients ...

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