Moderna announces new supply agreement with Australia for 25 million doses of its COVID-19 vaccine

12 May 2021 - 25 million doses includes 10 million doses of mRNA-1273 to begin delivery in 2021 and 15 ...

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Australia secures Moderna vaccines

13 May 2021 - The Australian Government has secured 25 million doses of the Moderna COVID-19 vaccine to further diversify our ...

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Eisai Korea to stop supply of blood cancer drug Symbenda this year

13 May 2021 - Symbenda (bendamustine), a treatment for blood cancer, is expected to become unavailable in Korea within this ...

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Daiichi Sankyo submits application for additional indication of mirogabalin in Japan

13 May 2021 - Daiichi Sankyo  today announced that it has submitted a supplemental new drug application for mirogabalin besylate ...

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Fulcrum Therapeutics announces U.S. FDA grants fast track designation to losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy

12 May 2021 - Fulcrum Therapeutics today announced that the U.S. FDA has granted fast track designation to losmapimod for ...

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COVID-19 vaccine weekly safety report

13 May 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with thrombocytopenia ...

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Provisional determination granted to Pfizer in relation to COVID 19 vaccine (Comirnaty) - for use in individuals 12 years of age and older

13 May 2021 - On 11 May 2021, the Therapeutic Goods Administration granted a provisional determination to Pfizer Australia in ...

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Agenda items scheduled for review by the PBAC under the process for reviewing recommendations not accepted by applicants

13 May 2021 - The revised agenda for the July 2021 PBAC meeting notes seven medicines/medicinal preparations for review under ...

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TGA approves Octapharma's Cutaquig

12 May 2021 - The TGA has deemed it to be a new biological entity. Others will beg to differ. ...

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BioCryst receives UK approval of Orladeyo (berotralstat), first oral, once daily therapy to prevent attacks in hereditary angioedema patients

12 May 2021 - BioCryst Pharmaceuticals today announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency has granted ...

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Allow Medicare to negotiate on behalf of patients to lower drug prices

12 May 2021 - President Biden’s speech announcing his American Families Plan reaffirmed his strong support for legislation to lower ...

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Evofem Biosciences receives fast track designation for EVO100 for prevention of gonorrhoea in women

12 May 2021 - Potential for expedited NDA review of EVO100 by FDA. ...

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Alume Biosciences granted FDA fast track designation of ALM-488 for surgical nerve visualisation

12 May 2021 - Fast track designation highlights the urgent need for improved intra-operative nerve identification. ...

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Liquidia resubmits new drug application for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension

10 May 2021 - Liquidia Corporation announced today that on 7 May 2021, it resubmitted its new drug application for LIQ861 ...

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Astellas’ Xtandi bags additional MHRA approval in prostate cancer

12 May 2021 - Japanese pharma company Astellas has announced that its prostate cancer therapy Xtandi has gained an approval ...

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