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RSS FeedPosted by Michael Wonder on 30 Jul 2021
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 ...
Posted by Michael Wonder on 30 Jul 2021
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 ...
Posted by Michael Wonder on 30 Jul 2021
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 ...
Posted by Michael Wonder on 30 Jul 2021
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 ...
Posted by Michael Wonder on 29 Jul 2021
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 ...
Posted by Michael Wonder on 29 Jul 2021
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 ...
Posted by Michael Wonder on 29 Jul 2021
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 ...
Posted by Michael Wonder on 29 Jul 2021
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. ...
Posted by Michael Wonder on 29 Jul 2021
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. ...
Posted by Michael Wonder on 29 Jul 2021
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 ...
Posted by Michael Wonder on 29 Jul 2021
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 ...
Posted by Michael Wonder on 29 Jul 2021
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 ...
Posted by Michael Wonder on 29 Jul 2021
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 ...
Posted by Michael Wonder on 28 Jul 2021
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 ...
Posted by Michael Wonder on 28 Jul 2021
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, ...