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RSS FeedPosted by Michael Wonder on 22 Mar 2023
HTA reform gets underway – terms of reference released today
22 March 2023 - Medicines Australia acknowledges the Health Technology Assessment Review Terms of Reference – released today – and ...
Posted by Michael Wonder on 22 Mar 2023
Advancing regulatory science in the EU – mid-point report published
22 March 2023 - The EMA has published a report summarising the mid-term achievements of its regulatory science strategy to ...
Posted by Michael Wonder on 22 Mar 2023
Nivolumab in combination with chemotherapy for the neo-adjuvant treatment of patients with resectable non-small-cell lung cancer
22 March 2023 - NICE has published evidence based recommendations on the use of nivolumab (Opdivo) in combination with chemotherapy ...
Posted 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
Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...
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 22 Mar 2023
Terms of reference for the Health Technology Assessment Policy and Methods Review
22 March 2023 - The terms of reference for the Health Technology Assessment Policy and Methods Review is now available. ...
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 21 Mar 2023
Lobbying firms earning hundreds of thousands from contracts with Government agencies
20 March 2023 - The government drug buying agency PHARMAC made extensive use of Wellington firm Draper Cormack Group. ...
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 ...