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 Jan 2023
FDA grants priority review for nalmefene pre-filled syringe for the treatment of known or suspected opioid overdose
18 January 2023 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new ...
Posted by Michael Wonder on 18 Jan 2023
Avidity Biosciences granted FDA fast track designation for AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy
18 January 2023 - Avidity Biosciences today announced that the US FDA has granted fast track designation to AOC 1020 for ...
Posted by Michael Wonder on 18 Jan 2023
FDA’s breakthrough program: faster drug OKs without sacrificing safety
18 January 2023 - A FDA program markedly cut the time and cost of bringing to market new drugs, without ...
Posted by Michael Wonder on 18 Jan 2023
PHARMAC seeking feedback on funding a second spinal muscular atrophy treatment
19 January 2023 - PHARMAC is initiating a consultation today, seeking feedback on a proposal to fund of risdiplam (Evrysdi) for ...
Posted by Michael Wonder on 18 Jan 2023
Major purchasers predict expensive new therapies will keep driving drug price hikes
17 January 2023 - More than two dozen big buyers of prescription medicines expect that prices will rise by an ...
Posted by Michael Wonder on 18 Jan 2023
Paratek Pharmaceuticals announces inclusion of Nuzyra (omadacycline) in China’s National Reimbursement Drug List (NRDL)
18 January 2023 - National Healthcare Security Administration adds Nuzyra to NRDL for treatment of community-acquired bacterial pneumonia and acute bacterial ...
Posted by Michael Wonder on 18 Jan 2023
Voxelotor for the treatment of patients with sickle cell disease
11 January 2023 - The Department of Health and Social Care has asked NICE to produce guidance on using voxelotor ...
Posted by Michael Wonder on 18 Jan 2023
Forge Biologics receives PRIME designation from the EMA for novel gene therapy FBX-101 for the treatment of patients with Krabbe disease
17 January 2023 - FBX-101 is granted priority medicines (PRIME) designation by the EMA after review of Phase 1/2 RESKUE clinical ...
Posted by Michael Wonder on 18 Jan 2023
Medunik Canada obtains new Notice of Compliance from Health Canada for Ruzurgi (amifampridine) following a favourable Canadian Federal Court of Appeal ruling
17 January 2023 - Medunik Canada is pleased to announce that on 9 January 2023, the Federal Court of Appeal of ...
Posted by Michael Wonder on 18 Jan 2023
Maribavir for the treatment of patients with a refractory cytomegalovirus infection after transplant
18 January 2023 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...
Posted by Michael Wonder on 18 Jan 2023
Ultomiris approved in Canada for adults with generalied myasthenia gravis
17 January 2023 - First and only long acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised ...
Posted by Michael Wonder on 18 Jan 2023
Modernising the Prostheses List Committee process
17 January 2023 - The Australian Government will modernise the existing committee process for prostheses applications through the new Medical ...
Posted by Michael Wonder on 17 Jan 2023
California sues largest US insulin manufacturers and PBMs for overpricing
16 January 2023 - Eli Lilly, Novo Nordisk and Sanofi produce over 90% of the global insulin supply. ...
Posted by Michael Wonder on 17 Jan 2023
Vutrisiran in hereditary transthyretin amyloidosis: hint of minor added benefit
17 January 2023 - Vutrisiran is approved for the treatment of patients with hereditary transthyretin amyloidosis with stage 1 or ...
Posted by Michael Wonder on 17 Jan 2023
Innovative Medicines Canada proposes framework for innovative agreements for drug reimbursement
16 January 2023 - Pharmaceutical manufacturers in Canada often enter into product listing agreements, particularly with public payers, to facilitate their ...