Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2023
FDA approves first in class Evkeeza (evinacumab-dgnb) for young children with ultra rare form of high cholesterol
22 March 2023 - Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolaemia, an inherited condition characterised ...
Posted by Michael Wonder on 22 Mar 2023
Drug repurposing during the COVID-19 pandemic: lessons for expediting drug development and access
20 March 2023 - The COVID-19 pandemic created a large, sudden unmet public health need for rapid access to safe and ...
Posted by Michael Wonder on 22 Mar 2023
Sandoz receives US FDA approval for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
21 March 2023 - Biosimilar Hyrimoz (adalimumab-adaz) high-concentration formulation approved for seven indications of reference medicine Humira. ...
Posted by Michael Wonder on 22 Mar 2023
Techdow USA announces FDA approval of generic Lovenox (enoxaparin sodium – preservative free) in pre-filled syringes
20 March 2023 - Techdow today announced the FDA approval of enoxaparin sodium (preservative free) in pre-filled syringes for the US ...
Posted by Michael Wonder on 22 Mar 2023
Moderna expects to price its COVID vaccine at about $130 in the US
20 March 2023 - Moderna expects to price its COVID-19 vaccine at around $130 per dose in the US going ...
Posted by Michael Wonder on 21 Mar 2023
Top FDA official: agency needs to start using accelerated approval for gene therapies
20 March 2023 - A top FDA official said Monday that the agency needs to start using accelerated approval, a ...
Posted by Michael Wonder on 21 Mar 2023
Prestige Biopharma receives FDA fast track designation for PBP1510 in the treatment of pancreatic cancer
21 March 2023 - Prestige Biopharma has received fast track designation from the US FDA for PBP1510 (ulenistamab), in the ...
Posted by Michael Wonder on 20 Mar 2023
Diabetes treatment can be incredibly costly. But the biggest cost is (surprisingly) not insulin.
19 March 2023 - Millions of Americans with diabetes have cheered as drug makers slashed the price of insulin, the ...
Posted by Michael Wonder on 20 Mar 2023
Opioid settlement hinders patients’ access to a wide array of drugs
13 March 2023 - An agreement between attorneys general and major drug distributors increased scrutiny on medications for ADHD, addiction, anxiety ...
Posted by Michael Wonder on 20 Mar 2023
Arrowhead receives FDA fast track designation for ARO-APOC3
20 March 2023 - Arrowhead Pharmaceuticals today announced the US FDA has granted fast track designation to ARO-APOC3 for reducing ...
Posted by Michael Wonder on 19 Mar 2023
Deciphera Pharmaceuticals announces FDA grants breakthrough therapy designation for Qinlock in second-line GIST patients with mutations in KIT exon 11 and 17/18
14 March 2023 - Breakthrough therapy designation is based on results from ctDNA analysis of INTRIGUE Phase 3 clinical trial demonstrating ...
Posted by Michael Wonder on 19 Mar 2023
Prestige Biopharma's pancreatic cancer drug candidate put on FDA fast track
17 March 2023 - Prestige Biopharma said on Thursday that its new pancreatic cancer antibody drug candidate, PBP1510, (ulenistamab), was ...
Posted by Michael Wonder on 17 Mar 2023
FDA approves dabrafenib with trametinib for paediatric patients with low grade glioma with a BRAF V600E mutation
16 March 2023 - Today, the FDA approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for paediatric patients 1 year ...
Posted by Michael Wonder on 16 Mar 2023
First drugs facing Medicare price penalty are named
15 March 2023 - US lists 27 medications whose prices rose faster than inflation, triggering rebates under new law. ...
Posted by Michael Wonder on 16 Mar 2023
Sanofi cuts US list price of Lantus, its most prescribed insulin, by 78% and caps out of pocket Lantus costs at $35 for all patients with commercial insurance
16 March 2023 - Sanofi announces that it will cut the list price of Lantus (insulin glargine injection) 100 units/mL, ...