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RSS FeedPosted by Michael Wonder on 26 Nov 2020
TGA announces approval of new medicine from ASX listed company
26 November 2020 - Afamelanotide acetate (Scenesse) was approved on 22 October 2020. ...
Posted by Michael Wonder on 26 Nov 2020
After admitting mistake, AstraZeneca faces difficult questions about its vaccine
25 November 2020 - Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures ...
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
Moderna signs deal with EU for 160 million COVID-19 vaccine doses
26 November 2020 - The European Commission has signed a supply deal with Moderna which will see it secure an ...
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
AstraZeneca gears up to vaccinate the world against COVID-19
24 November 2020 - Among the front-runners racing to deliver a COVID-19 shot, has the least vaccine experience. But it has ...
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 ...
Posted by Michael Wonder on 25 Nov 2020
Third major COVID-19 vaccine shown to be effective and cheaper
24 November 2020 - Drugmaker AstraZeneca said late-stage trials showed its COVID-19 vaccine is highly effective, buoying the prospects of a ...