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 08 Sep 2022
Launch prices: tackling the next drug pricing challenge
8 September 2022 - The passage of the Inflation Reduction Act brings a new era to drug pricing in the ...
Posted by Michael Wonder on 08 Sep 2022
Is IQWiG's 15% threshold universally applicable in assessing the clinical relevance of patient reported outcomes changes? An ISPOR Special Interest Group report.
8 September 2022 - To assess the clinical relevance of patient reported outcomes, a response threshold of ≥ 15% of the ...
Posted by Michael Wonder on 08 Sep 2022
Esketamine: NICE’s appraisal was unfair, appeal panel rules
8 September 2022 - The decision by the UK National Institute for Health and Care Excellence not to recommend esketamine ...
Posted by Michael Wonder on 08 Sep 2022
British Colombia expands children’s access to ‘transformational’ cystic fibrosis drug
7 September 2022 - A week after a B.C. family went public with its plea for a life-changing drug for ...
Posted by Michael Wonder on 08 Sep 2022
Ceribell receives FDA breakthrough device designation for delirium indication
8 September 2022 - Breakthrough device designation recognizes Ceribell's point of care EEG as a first of its kind technology ...
Posted by Michael Wonder on 08 Sep 2022
Submitting documents using real world data and real world evidence to FDA for drug and biological products
8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real ...
Posted by Michael Wonder on 08 Sep 2022
MHRA approves olaparib for high-risk, early stage breast cancer
7 September 2022 - The Institute of Cancer Research, London, celebrates the news that the precision medicine olaparib has been ...
Posted by Michael Wonder on 08 Sep 2022
Revance announces FDA approval of Daxxify (daxibotulinumtoxinA-lanm) for injection, the first and only peptide formulated neuromodulator with long-lasting results
8 September 2022 - Based on the data from SAKURA, Daxxify has the ability to deliver year long results with as ...
Posted by Michael Wonder on 08 Sep 2022
ViewRay announces China NMPA approval of its MRIdian MRI guided radiation therapy for cancer patients
7 September 2022 - This approval expands MRIdian's global reach and offers cancer patients a new radiation therapy option—MRIdian SMART. ...
Posted by Michael Wonder on 08 Sep 2022
COVID-19 vaccine safety report (8 August 2022)
8 September 2022 - To 4 September 2022, the TGA has received 699 reports which have been assessed as likely to ...
Posted by Michael Wonder on 08 Sep 2022
Silence Therapeutics announces FDA fast track designation for SLN124, a novel investigational siRNA therapy for the treatment of polycythemia vera
8 September 2022 - Designation provides potential for expedited drug development path. ...
Posted by Michael Wonder on 08 Sep 2022
Grifols enters into agreement with Canadian Blood Services to accelerate self-sufficiency in immunoglobulins for Canada
7 September 2022 - The country, with an increasing immunoglobulin usage rate, currently imports about 85% of its immunoglobulin demand for ...
Posted by Michael Wonder on 08 Sep 2022
Health Canada approves Pluvicto as first targeted radioligand therapy for progressive PSMA positive metastatic castration-resistant prostate cancer
7 September 2022 - Novel mechanism of action of Pluvicto binds to target PSMA positive cancer cells, delivering radiation treatment directly ...
Posted by Michael Wonder on 08 Sep 2022
Pharmac issues RFP for intravenous trastuzumab, a medicine used to treat breast cancer
8 September 2022 - PHARMAC is seeking commercial bids from pharmaceutical suppliers for the supply of intravenous trastuzumab, a ‘biologic’ ...
Posted by Michael Wonder on 07 Sep 2022
FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program
7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program. ...