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 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
Posted by Michael Wonder on 12 Oct 2021
GenSight Biologics announces FDA grant of fast track designation for optogenetic therapy GS030 as treatment for retinitis pigmentosa
12 October 2021 - GenSight Biologics today announced that the U.S. FDA has granted fast track designation to GS030, which combines ...
Posted by Michael Wonder on 12 Oct 2021
Quanterix granted breakthrough device designation from U.S. FDA for blood based pTau 181 assay for Alzheimer’s disease
11 October 2021 - Quanterix Corporation announced today that its Simoa phospho-Tau 181 (pTau-181) blood test has been granted breakthrough ...
Posted by Michael Wonder on 12 Oct 2021
SMC - October 2021 decisions
11 October 2021 - The Scottish Medicines Consortium, which advises on newly licensed medicines for use by NHSScotland has today ...
Posted by Michael Wonder on 11 Oct 2021
Paying for cancer drugs that prove their benefit
11 October 2021 - The United States pays prices for brand name drugs that are estimated to be 256% higher than ...
Posted by Michael Wonder on 11 Oct 2021
Health economic assessment of Poteligeo in the treatment of mycosis fungoides or Sézary syndrome
11 October 2021 - TLV has produced a health economic assessment for the regions for the drug Poteligeo (mogamulizumab). ...
Posted by Michael Wonder on 11 Oct 2021
Merck and Ridgeback announce submission of emergency use authorisation application to the U.S. FDA for molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild to moderate COVID-19 in at risk adults
11 October 2021 - Submissions to regulatory agencies worldwide underway. ...
Posted by Michael Wonder on 11 Oct 2021
Consternation as NICE rejects Janssen MS drug Ponvory
8 October 2021 - NICE has delivered its first verdict on NHS funding of Janssen’s oral multiple sclerosis drug Ponvory, ...
Posted by Michael Wonder on 11 Oct 2021
Takeda's ovarian cancer drug Zejula gets expanded insurance benefit
1 October 2021 - Takeda Korea said its ovarian cancer treatment Zejula would receive expanded health insurance coverage as maintenance ...
Posted by Michael Wonder on 11 Oct 2021
Tegsedi receives innovative drug category pricing in Brazil
11 October 2021 - PTC Therapeutics today announced that Tegsedi (inotersen) has successfully received Category 1 classification from Câmara de ...
Posted by Michael Wonder on 11 Oct 2021
Medicare drug pricing debate pits savings against innovation
11 October 2021 - Proposal to allow Medicare to negotiate for lower prescription drug prices is central to Democrats’ health care, ...
Posted by Michael Wonder on 11 Oct 2021
Ocular Therapeutix announces FDA approval of supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for the treatment of ocular itching associated with allergic conjunctivitis
11 October 2021 - Approval represents the first primarily office-based indication for Dextenza. ...
Posted by Michael Wonder on 11 Oct 2021
EMA receives application for marketing authorisation for Ronapreve (casirivimab with imdevimab) for treatment and prevention of COVID-19
11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...
Posted by Michael Wonder on 11 Oct 2021
NICE backs Rinvoq for moderate active RA
11 October 2021 - AbbVie has announced that its oral therapy Rinvoq (upadacitinib) has received a positive recommendation from NICE ...
Posted by Michael Wonder on 11 Oct 2021
Belgium may remove step between paying doctors and reimbursement
8 October 2021 - Doctors and dentists could soon choose to only charge patients for co-payments – the non-refundable part ...