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RSS FeedPosted 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 ...
Posted by Michael Wonder on 25 Nov 2020
Pfizer vaccine distribution could kick off within weeks pending FDA approval, Azar says
24 November 2020 - A FDA panel will meet on 10 December to consider Pfizer’s emergency use authorisation application for its ...
Posted by Michael Wonder on 25 Nov 2020
EU drug regulator could rule on COVID-19 vaccines by year end
24 November 2020 - The EMA could produce a scientific opinion on COVID-19 vaccines seeking regulatory approval by the end ...
Posted by Michael Wonder on 25 Nov 2020
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as second-line treatment for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
24 November 2020 - First immunotherapy to be approved for a gastro-esophageal cancer in the European Union. ...
Posted by Michael Wonder on 24 Nov 2020
Australia's coronavirus vaccination program to start from March
25 November 2020 - The federal government says Australia is on track to deliver the first vaccines in March. ...
Posted by Michael Wonder on 24 Nov 2020
Doctors say CDC should warn people the side effects from COVID vaccine shots won’t be ‘a walk in the park’
23 November 2020 - The CDC must be transparent about the side effects people may experience after getting their first shot ...