Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 18 Oct 2022
AvroBio granted ILAP designation from UK MHRA for first in class gene therapy for Gaucher disease
18 October 2022 - ILAP intended to accelerate regulatory review process and facilitate patient access in UK for seriously debilitating and ...
Posted by Michael Wonder on 18 Oct 2022
Tissue agnostic drug development in oncology
17 October 2022 - This guidance provides recommendations to sponsors regarding considerations for tissue agnostic drug development in oncology. ...
Posted by Michael Wonder on 18 Oct 2022
Kite’s Yescarta first CAR T-cell therapy to receive European marketing authorisation for use in second-line diffuse large B-cell lymphoma and high-grade B-cell lymphoma
17 October 2022 - First treatment in 30 years to improve upon standard care for second-line treatment of DLBCL. ...
Posted by Michael Wonder on 17 Oct 2022
Minerva Neurosciences receives refusal to file letter from FDA for its new drug application for roluperidone for the treatment of negative symptoms in schizophrenia
17 October 2022 - Minerva Neurosciences today announced that the company has received a refusal to file letter from the ...
Posted by Michael Wonder on 17 Oct 2022
Can state prescription drug affordability boards address high cost drug prices?
11 October 2022 - State law makers, like their federal counterparts, are focused on addressing the high and growing cost of ...
Posted by Michael Wonder on 17 Oct 2022
Biogen announces FDA’s 3 month extension of review period for the new drug application for tofersen
17 October 2022 - The new Prescription Drug User Fee Act action date set by the FDA is 25 April ...
Posted by Michael Wonder on 17 Oct 2022
Calls for TGA to withdraw Covid drug approval
17 October 2022 - The medicines regulator is facing calls to withdraw its provisional approval for the antiviral drug molnupiravir ...
Posted by Michael Wonder on 17 Oct 2022
Amryt receives reimbursement approval from the Dutch Ministry of Health for Myalepta (metreleptin)
17 October 2022 - Amryt receives reimbursement approval from the Dutch Ministry of Health for Myalepta (metreleptin). ...
Posted by Michael Wonder on 17 Oct 2022
Gene therapy Luxturna now reimbursed in Quebec for people with previously untreatable inherited vision loss
17 October 2022 - Quebec leads the way as the first province to reimburse Luxturna (voretigene neparvovec) for previously untreatable inherited ...
Posted by Michael Wonder on 17 Oct 2022
FDA pushes to remove pregnancy drug, company pushes back
18 October 2022 - The maker of a drug intended to reduce premature births is making a last-ditch effort to keep ...
Posted by Michael Wonder on 17 Oct 2022
ICER releases draft evidence report on treatments for multiple sclerosis
17 October 2022 - Public comment period now open until 11 November 2022; requests to make oral comment during public ...
Posted by Michael Wonder on 17 Oct 2022
Medicare rorts expose inflated bulk billing rates
18 October 2022 - Systemic rorting of Medicare is artificially inflating official statistics that claim almost nine out of 10 ...
Posted by Michael Wonder on 17 Oct 2022
Mereo BioPharma receives FDA fast track designation for alvelestat for treatment of alpha-1 antitrypsin deficiency-associated lung disease
17 October 2022 - Mereo BioPharma today announced that the US FDA has granted fast track designation for its investigational oral ...
Posted by Michael Wonder on 17 Oct 2022
US FDA approves Menveo in a new single vial presentation to help prevent disease caused by meningococcal bacteria serogroups A, C, Y, and W
17 October 2022 - Single vial presentation option removes the need for reconstitution of Menveo before use in individuals 10 ...
Posted by Michael Wonder on 17 Oct 2022
Medicare reports
17 October 2022 - Minister for Health and Aged Care, Mark Butler has issued the following statement regarding Medicare reporting. ...