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RSS FeedPosted by Michael Wonder on 27 Apr 2020
Lokelma US label updated to include dosing guidance for the treatment of hyperkalaemia in patients with end-stage renal disease on haemodialysis
27 April 2020 - Label update is based on data from Phase IIIb DIALIZE trial ...
Posted by Michael Wonder on 27 Apr 2020
Takeda announces U.S. FDA breakthrough therapy designation for mobocertinib (TAK-788) for the treatment of NSCLC patients with EGFR exon 20 insertion mutations
27 April 2020 - Designation represents positive progress for a unique patient population in need of targeted therapy options. ...
Posted by Michael Wonder on 27 Apr 2020
CytoDyn submits completed biologics license application to the FDA for leronlimab as a combination therapy for highly treatment experienced HIV patients
27 April 2020 - During the FDA’s review period, the Company will dedicate all resources to ensure availability of leronlimab for ...
Posted by Michael Wonder on 27 Apr 2020
Health Canada issues warning against use of hydroxychloroquine for COVID-19
26 April 2020 - Health Canada is warning the public of the possible side effects of a drug that U.S. ...
Posted by Michael Wonder on 27 Apr 2020
Ousting vaccine chief ‘is going to set us back,’ former FDA head says
26 April 2020 - Scott Gottlieb says Rick Bright’s departure is likely to be counterproductive. ...
Posted by Michael Wonder on 27 Apr 2020
America needs to win the coronavirus vaccine race
26 April 2020 - Other countries might not be quick to share. Time to speed up trials and ramp up manufacturing ...
Posted by Michael Wonder on 27 Apr 2020
Medicines Australia welcomes COVID-19 tracking app
27 April 2020 - Medicines Australia has today welcomed the COVID-19 tracking app COVIDSafe, which will help keep the community ...
Posted by Michael Wonder on 27 Apr 2020
Prescriptions surged as Trump praised drugs in coronavirus fight
25 April 2020 - Prescriptions for two antimalarial drugs jumped by 46 times the average when the president promoted them on ...
Posted by Michael Wonder on 26 Apr 2020
Janssen announces submission of two applications to U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
24 April 2020 - Submissions demonstrate Janssen’s commitment to developing new options for young patients. ...
Posted by Michael Wonder on 25 Apr 2020
FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems
24 April 2020 - Close supervision is strongly recommended. ...
Posted by Michael Wonder on 25 Apr 2020
CSL's blood payments in US under the microscope
25 April 2020 - CSL has been forced to defend the way it runs its blood plasma collection business in ...
Posted by Michael Wonder on 25 Apr 2020
Merck resubmits supplemental biologics license applications for Keytruda (pembrolizumab) six week dosing schedule
23 April 2020 - Additional applications filed across all approved adult indications. ...
Posted by Michael Wonder on 25 Apr 2020
EU actions to support availability of medicines during COVID-19 pandemic – update #3
24 April 2020 - The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual ...
Posted by Michael Wonder on 25 Apr 2020
FDA’s Woodcock on authorising the emergency use for hydroxychloroquine: ‘we did the best we could’
24 April 2020 - Over the past few weeks, the FDA has been criticised for some of the steps taken – ...
Posted by Michael Wonder on 25 Apr 2020
Maker of drug touted as coronavirus cure accuses China of gouging
24 April 2020 - Hydroxychloroquine controversially pushed by Trump as COVID-19 remedy. ...