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RSS FeedPosted by Michael Wonder on 20 Aug 2020
Genmab announces Janssen granted U.S. FDA approval for Darzalex (daratumumab) in combination with carfilzomib and dexamethasone in relapsed or refractory multiple myeloma
20 August 2020 - Approval marks eighth U.S. FDA approval for Darzalex. ...
Posted by Michael Wonder on 20 Aug 2020
FDA approves Novartis Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
20 August 2020 - Approval based on two Phase III ASCLEPIOS studies demonstrating significant reductions in risk of relapses, confirmed disability ...
Posted by Michael Wonder on 20 Aug 2020
Polaryx Therapeutics receives FDA fast track designation to PLX-200 for the treatment of patients with juvenile neuronal ceroid lipofuscinosis
20 August 2020 - Polaryx Therapeutics announced today that the U.S. FDA has granted fast track designation to PLX-200 for ...
Posted by Michael Wonder on 20 Aug 2020
Precision BioSciences receives fast track disease designation from U.S. FDA for PBCAR0191 investigational allogeneic CAR T-cell therapy
19 August 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to Precision for PBCAR0191, the ...
Posted by Michael Wonder on 20 Aug 2020
US FDA awards fast track designation to paxalisib for glioblastoma
20 August 2020 - Kazia Therapeutics is pleased to announce that the United States FDA has granted fast track designation to ...
Posted by Michael Wonder on 20 Aug 2020
Health Canada grants market authorization for Tecentriq in combination with bevacizumab, the first immunotherapy combination treatment, for the most common form of liver cancer
19 August 2020 - Tecentriq in combination with bevacizumab improved overall survival and progression-free survival compared to the previous standard of ...
Posted by Michael Wonder on 19 Aug 2020
'Be prepared for anything': CSL boss warns of key unknowns on vaccine
19 August 2020 - CSL chief executive Paul Perreault has cautioned that more details need to be ironed out before ...
Posted by Michael Wonder on 19 Aug 2020
Inquiry into approval processes for new drugs and novel medical technologies in Australia
19 August 2020 - Following a referral on 13 August 2020 from the Minister for Health, The Hon Greg Hunt ...
Posted by Michael Wonder on 19 Aug 2020
BioMarin receives complete response letter from FDA for valoctocogene roxaparvovec gene therapy for severe haemophilia A
19 August 2020 - FDA introduces new recommendation for 2 year annualised bleeding rate as primary outcome for on-going Phase 3 ...
Posted by Michael Wonder on 19 Aug 2020
Scott Morrison announces free COVID-19 vaccines for Australians, backtracks on ‘mandatory’ comments
19 August 2020 - Prime Minister Scott Morrison has backtracked on comments that a free COVID-19 vaccine would be ‘as mandatory ...
Posted by Michael Wonder on 19 Aug 2020
Financing drug innovation in the US: current framework and emerging challenges
19 August 2020 - The current US drug innovation financing framework rests on the notion that a defined period of marketing ...
Posted by Michael Wonder on 19 Aug 2020
Coronavirus: CSL reveals delivery date for COVID-19 vaccine as it progresses with clinical trials
19 August 2020 - Australia’s biggest health care company, CSL, expects to start delivering “emergency doses” of a COVID-19 vaccine ...
Posted by Michael Wonder on 19 Aug 2020
The antibiotic paradox: why companies can’t afford to create life-saving drugs
19 August 2020 - Paratek Pharmaceuticals successfully brought a new antibiotic to the market. So why is the company’s long-term survival ...
Posted by Michael Wonder on 19 Aug 2020
Mylan brings critical access to the multiple sclerosis community by launching a more affordable treatment option through a first generic to Tecfidera
19 August 2020 - Mylan today announced the launch of the first FDA approved therapeutically equivalent, substitutable generic of Biogen's ...
Posted by Michael Wonder on 19 Aug 2020
Galapagos announces that Gilead received a complete response letter for filgotinib for the treatment of moderately to severely active rheumatoid arthritis
19 August 2020 - Galapagos announces today that Gilead Sciences received a complete response letter from the U.S. FDA for the ...