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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All eyes on a hurdle race for a SARS-CoV-2 vaccine

19 October 2020 - Leading COVID-19 vaccine candidates have progressed through laboratory tests at record speed.  ...

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Investigators propose different measures for biosimilar equivalence

12 May 2020 - Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence ...

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COVID-19: world needs a global approach to fight: Bill Gates

12 April 2020 - Over the past few weeks, I’ve spoken to dozens of experts about COVID-19, and there’s clear ...

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Biosimilars and interchangeable biosimilars: licensure for fewer than all conditions of use for which the reference product has been licensed guidance for industry

5 February 2020 - This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service Act ...

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Bristol-Myers Squibb announces submission of biologics license application for CAR T-Cell therapy lisocabtagene maraleucel (liso-cel) to FDA

18 December 2019 - Submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory ...

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Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakvi

17 August 2019 - Roche has priced its personalised cancer treatment, Rozlytrek, at about $17,050 per month, nearly half of ...

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Was it really a smart move for the FDA to approve a ‘smart pill’ for treating schizophrenia?

18 July 2019 - In late 2017, the FDA approved the first so-called smart pill, ushering in a new era ...

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FDA approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma

22 April 2019 - Approval based on results of KEYNOTE-426, where Keytruda in combination with axitinib reduced the risk of death ...

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CytoDyn reaches historical milestone, submits first of three sections of BLA to FDA for leronlimab (PRO 140) as a combination therapy for HIV

18 March 2019 - FDA previously granted rolling review for BLA. ...

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Janssen submits application to U.S. FDA seeking approval of Darzalex (daratumumab) combination therapy for patients with newly diagnosed multiple myeloma who are transplant ineligible

12 March 2019 - Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot ...

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Esperion announces submissions of two NDAs and official completion of two MAA validations for both bempedoic acid and the bempedoic acid/ezetimibe combination tablet

28 February 2019 - Esperion today announced that the company has successfully completed important and key global marketing applications including ...

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FDA grants fast track designation for AMG 420

3 December 2018 - Amgen today announced the first clinical results from studies evaluating investigational novel bi-specific T cell engager (BiTE) ...

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AbbVie announces Imbruvica (ibrutinib) plus rituximab approval by U.S. FDA as first chemotherapy-free combination treatment in adults with Waldenström's macroglobulinemia, a rare type of blood cancer

27 August 2018 - Milestone represents ninth FDA approval for Imbruvica in less than five years since its initial approval. ...

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FDA expedites review of Novartis drug Promacta for first-line severe aplastic anaemia

30 May 2018 - Regulatory action underscores the treatment potential of Promacta for a rare and serious blood condition. ...

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