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RSS FeedPosted by Michael Wonder on 20 Aug 2020
U.S. FDA grants rare paediatric disease designation to AmideBio’s glucagon analog for the treatment of congenital hyperinsulinism
20 August 2020 - AmideBio announced today that the US FDA Offices of Pediatric Therapeutics and Orphan Products Development granted a ...
Posted 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 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
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
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 ...
Posted by Michael Wonder on 18 Aug 2020
Adding sickle cell disease to FDA’s priority review voucher list of neglected tropical diseases
18 July 2020 - On 16 July, Putting Rare Diseases Patients First! filed a citizen’s petition to add sickle cell ...
Posted by Michael Wonder on 18 Aug 2020
FDA finalises penalties for clinical trial sponsors that don’t share data, but critics say they fall short
18 August 2020 - After a year of deliberation, the FDA released final guidelines for penalising clinical trial sponsors that ...
Posted by Michael Wonder on 18 Aug 2020
The FDA response to COVID-19 at six months: regulatory innovation in the face of a pandemic
18 August 2020 - The COVID-19 pandemic has significantly impacted American society, with more than 160,000 deaths and 5 million cases ...
Posted by Michael Wonder on 18 Aug 2020
FDA initiatives to accelerate the development of COVID-19 therapeutics
18 August 2020 - More than 750,000 deaths have occurred worldwide as a result of the novel coronavirus as of ...