Blog
RSS FeedPosted by Michael Wonder on 03 Dec 2018
Novartis announces FDA filing acceptance and priority review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1
3 December 2018 - The AVXS-101, now known as Zolgensma (onasemnogene abeparvovec-xxxx), filing is supported by data from the START trial ...
Posted by Michael Wonder on 03 Dec 2018
FDA faulted for lapses in orphan drug program
30 November 2018 - The FDA has failed to ensure that drugs given prized rare-disease status meet the intent of ...
Posted by Michael Wonder on 01 Dec 2018
AbbVie announces Humira (adalimumab) global patent license with Pfizer
30 November 2018 - AbbVie announced today patent license agreements with Pfizer over its proposed biosimilar adalimumab product. ...
Posted by Michael Wonder on 01 Dec 2018
‘A loss for the rest of us’: An FDA approval is a boon for a drug maker, but could come at a major cost for patients
30 November 2018 - Vickie Moored can walk again. Her words don’t slur, her vision isn’t blurred, and she no ...
Posted by Michael Wonder on 01 Dec 2018
FDA accepts filing of new oestrogen-free oral contraceptive developed by Exeltis
29 November 2018 - This new method of contraception could offer an improved bleeding profile and greater flexibility for female population. ...
Posted by Michael Wonder on 30 Nov 2018
FDA announces pilot program with WHO to expedite review of HIV drug applications
30 November 2018 - The U.S. FDA today announced a plan to work with the WHO to pilot a process to ...
Posted by Michael Wonder on 29 Nov 2018
Acceleron receives FDA fast track designation for ACE-083 in Charcot-Marie-Tooth disease
28 November 2018 - Acceleron Pharma today announced that the United States FDA has granted fast track designation to ACE-083, the ...
Posted by Michael Wonder on 29 Nov 2018
Galapagos receives fast track designation from FDA for GLPG1972/S201086 in osteoarthritis
27 November 2018 - Galapagos announced today that the FDA has granted GLPG1972/S201086 Fast Track designation for the treatment of ...
Posted by Michael Wonder on 29 Nov 2018
FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare auto-immune disorder
28 November 2018 - The U.S. FDA today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome in adults. ...
Posted by Michael Wonder on 29 Nov 2018
FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukaemia with a certain genetic mutation
28 November 2018 - The U.S. FDA today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed ...
Posted by Michael Wonder on 28 Nov 2018
FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
28 November 2018 - The agency has now approved 15 biosimilars and is advancing new policies to improve the efficiency of ...
Posted by Michael Wonder on 28 Nov 2018
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy and fast track designations for RP-L102 gene therapy for Fanconi anaemia
27 November 2018 - Global trial of RP-L102 utilising no conditioning and “Process B” on track for early 2019. ...
Posted by Michael Wonder on 27 Nov 2018
HighTide Therapeutics receives fast track designation from the U.S. FDA for HTD1801 treating non-alcoholic steatohepatitis
27 November 2018 - HighTide Therapeutics announced that the U.S. FDA has granted fast track designation to its investigational new drug, ...
Posted by Michael Wonder on 27 Nov 2018
Statement from FDA Commissioner on how modern predicates can promote innovation and advance safety and effectiveness of medical devices that use 510(k) pathway
27 November 2018 - Earlier this week, the FDA announced new steps to modernise FDA’s 510(k) clearance pathway, used for ...
Posted by Michael Wonder on 27 Nov 2018
FDA promised a ‘lower-cost option’ to EpiPen, but the price isn’t any lower
27 November 2018 - Teva's alternative to Mylan's authorised generic EpiPen is no cheaper. ...