Blog
RSS FeedPosted by Michael Wonder on 26 Nov 2020
Bowel disease patients to march on PHARMAC and Parliament to present 30,000+ signature petition
27 November 2020 - On 2 December 2020, Crohn’s and Colitis NZ will lead a march of patients, supporters and medical ...
Posted by Michael Wonder on 26 Nov 2020
Takhzyro is not included in the high-cost protection
26 November 2020 - Takhzyro (lanadelumab) is a subcutaneous injection intended for routine prevention of recurrent hereditary seizures, angioedema in patients ...
Posted by Michael Wonder on 26 Nov 2020
European Medicines Agency validates application for tepotinib for the treatment of advanced NSCLC with METex14 skipping alterations
26 November 2020 - Merck today announced that the EMA has validated for review, the application for tepotinib for the ...
Posted by Michael Wonder on 26 Nov 2020
FDA defers approval of daxibotulinumtoxinA for injection in glabellar lines due to COVID-19 related travel restrictions impacting manufacturing site inspection
25 November 2020 - Revance Therapeutics today announced that the United States FDA has deferred a decision on the biologics license ...
Posted by Michael Wonder on 26 Nov 2020
European Commission approves Janssen’s Tremfya (guselkumab), a first-in-class treatment for active psoriatic arthritis
25 November 2020 - Guselkumab is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of psoriatic arthritis ...
Posted by Michael Wonder on 26 Nov 2020
Bio-Thera Solutions submits marketing authorisation application for BAT1706, a proposed biosimilar to Avastin, to European Medicines Agency
25 November 2020 - Bio-Thera Solutions today announced that it has submitted the marketing authorisation application for BAT1706, a proposed biosimilar ...
Posted by Michael Wonder on 26 Nov 2020
Lynparza (olaparib) receives Health Canada approval for the treatment of BRCA or ATM gene-mutated metastatic castration-resistant prostate cancer
25 November 2020 - On 21 August 2020, Health Canada approved Lynparza (olaparib), for the treatment of adult patients with deleterious ...
Posted by Michael Wonder on 25 Nov 2020
FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow
25 November 2020 - On 24 November 2020, the FDA granted accelerated approval to naxitamab (Danyelza, Y-mAbs Therapeutics) in combination with ...
Posted by Michael Wonder on 25 Nov 2020
RhoVac's prostate cancer drug candidate RV001 is granted fast track designation by the FDA
25 November 2020 - RhoVac, a clinical stage company today announced that the American FDA has granted Fast Track Designation to ...
Posted by Michael Wonder on 25 Nov 2020
Merck racks up another NICE recommendation for Keytruda
25 November 2020 - That makes it number 12. ...
Posted by Michael Wonder on 25 Nov 2020
Rinvoq continues to be part of the high-cost protection with limited subsidy after reconsideration
25 November 2020 - TLV has reconsidered the subsidy for Rinvoq (upadacitinib monohydrate) and decided that the drug should continue to ...
Posted by Michael Wonder on 25 Nov 2020
NICE publishes final guidance on Nubeqa
25 November 2020 - NICE has completed its assessment of darolutamide for use in combination with androgen deprivation therapy for ...
Posted by Michael Wonder on 25 Nov 2020
Liquidia receives complete response letter from FDA for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
25 November 2020 - Complete response letter does not cite need for additional clinical studies. ...
Posted by Michael Wonder on 25 Nov 2020
Remdesivir (Veklury) approval for the treatment of COVID-19—the evidence for safety and efficacy
26 November 2020 - Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of ...
Posted by Michael Wonder on 25 Nov 2020
Medical trial delays see Australians wait for rare disease treatment
25 November 2020 - Patients with rare diseases are entering ‘random lottery’ draws for clinical trials because Australia is too slow ...