2021 October price disclosure cycle – indicative prices

30 August 2021 - Indicative 1 October 2021 prices resulting from the 2021 October Cycle of Price Disclosure have now ...

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GSK announces FDA approval for Nucala (mepolizumab) for use in adults with chronic rhinosinusitis with nasal polyps

29 July 2021 - First IL-5 therapy approved as an add-on treatment in the US for adults with chronic rhinosinusitis with ...

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Erytech granted U.S. FDA fast track designation for Eryaspase in hypersensitive ALL

29 July 2021 - Fast track designation for eryaspase underscores the need for new treatment options for patients who developed ...

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Announcement of the National Medicines Policy Review Committee and Terms of Reference

30 August 2021 -  The Minister for Health has established an Expert Advisory Committee to lead the Review of the National ...

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Ardelyx receives complete response letter from U.S. FDA for new drug application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis

29 July 2021 - Ardelyx today announced that it has received a complete response letter from the U.S. FDA regarding ...

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Congress presses the FDA to move faster on ALS drugs

29 July 2021 - Lawmakers pressed a top FDA official Thursday for answers on why the agency has balked at approving ...

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FDA approves expanded Botox (onabotulinumtoxinA) label to include eight new muscles to treat adults with upper limb spasticity

29 July 2021 - Botox has demonstrated efficacy and has an established safety profile with over 10 years of clinical ...

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Arrowhead Pharmaceuticals receives breakthrough therapy designation from U.S. FDA for ARO-AAT for the treatment of alfa-1 anti-trypsin deficiency associated liver disease

29 July 2021 - Full enrollment reached in Phase 2 SEQUOIA study of ARO-AAT. ...

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Advanz and private equity groups fined for 1,000 per cent drug price hike

29 July 2021 - Regulator penalises pharma company and buyout firms Cinven and Hg after NHS hit by ‘unfair’ rises. ...

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FDA accepts application for Genentech’s faricimab for the treatment of wet age-related macular degeneration and diabetic macular oedema

28 July 2021 - Across four Phase 3 studies, approximately half of patients receiving faricimab could extend treatment time to every ...

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Cancer patients, advocates 'gobsmacked' PHARMAC declining funding application for life-changing drug

29 July 2021 - Ovarian cancer patients and advocates are "utterly gobsmacked" Pharmac has proposed to decline a funding application ...

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FDA authorizes baricitinib alone as treatment for COVID-19

28 July 2021 - Today, the U.S. FDA revised the Emergency Use Authorisation for baricitinib (Olumiant) now authorising baricitinib alone for ...

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GSK and Vir Biotechnology announce Joint Procurement Agreement with European Commission for COVID-19 treatment sotrovimab

28 July 2021 - GSK and Vir Biotechnology today announced they have signed a Joint Procurement Agreement with the European ...

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Controversy and progress in Alzheimer’s disease — FDA approval of aducanumab

28 July 2021 - The FDA’s accelerated approval of aducanumab represents a landmark moment, though the drug’s road to the clinic ...

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Revisiting FDA approval of aducanumab

28 July 2021 - Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, ...

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