Medicago signs agreements with the Government of Canada to supply up to 76 million doses of its recombinant plant-derived COVID-19 vaccine

23 October 2020 - Canadian government to provide $173M in funding for vaccine research and development, and domestic manufacturing capacity. ...

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Strengthening global collaboration on COVID-19 real-world evidence and observational studies

23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...

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FDA approves first treatment for COVID-19

22 October 2020 - Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult ...

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Oxford developed COVID-19 vaccine, then scholars clashed over money

21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...

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Remdesivir’s hefty price tag ignores NIH investment in its creation

22 October 2020 - Throughout the Democratic presidential primary, candidates cast a spotlight on the broken U.S. health care system ...

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Leo Pharma announces U.S. FDA approval for Enstilar (calcipotriene and betamethasone dipropionate) foam U.S. Prescribing Information update to include data in long-term use in plaque psoriasis treatment

22 October 2020 - U.S. Prescribing Information updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly ...

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F2G receives second US FDA breakthrough therapy designation for Olorofim

22 October 2020 - In Phase 2b development for the treatment of life-threatening fungal infections. ...

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AppliedVR receives FDA breakthrough device designation to treat pain with digital therapeutic

21 October 2020 - AppliedVR today announced its EaseVRx product received breakthrough device designation from the U.S. FDA for treating ...

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FDA approves fewer generics in FY2020, ending record streak

21 October 2020 - After four straight years of posting record numbers of abbreviated new drug application approvals, the US ...

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U.S. FDA grants fast track designation for ASP0367/MA-0211, a selective PPARδ modulator being developed for the treatment of primary mitochondrial myopathies

20 October 2020 - Astellas Pharma today announced that the U.S. FDA has granted fast track designation for the development ...

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COVID-19 vaccines to be stored secretly under tight security

21 October 2020 - Drug makers and others plan to use fake shipments and GPS trackers to prevent potential thefts. ...

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Trump’s antibody ‘cure’ will be in short supply

20 October 2020 - All the weak points of American health care — testing delays, communication breakdowns, inequity — are working ...

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TG Therapeutics announces fast track designation granted by the FDA to ublituximab in combination with umbralisib for the treatment of adult patients with chronic lymphocytic leukaemia

21 October 2020 - TG Therapeutics today announced that the U.S. FDA has granted fast track designation to the combination of ...

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Zosano Pharma receives complete response letter from FDA for Qtrypta

21 October 2020 - FDA feedback consistent with FDA’s preliminary communication in September. ...

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Xeris Pharmaceuticals granted fast track designation by the FDA for its novel concentrated diazepam formulation (XP-0863) for injection

20 October 2020 - Xeris Pharmaceuticals today announced it was granted fast track designation by the FDA for the investigation ...

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