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 21 Apr 2022
What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.
21 April 2022 - The word breakthrough carries a kind of weight: it’s a dramatic step forward, a critical advance in ...
Posted by Michael Wonder on 21 Apr 2022
ICER to assess treatments for multiple sclerosis
21 April 2022 - Report will be subject of New England CEPAC meeting in January 2023; draft scoping document open ...
Posted by Michael Wonder on 21 Apr 2022
AbbVie’s Crohn’s disease drug given green light by MHRA
21 April 2022 - An estimated 217,000 people aged 16 and over live with the condition in the UK. ...
Posted by Michael Wonder on 21 Apr 2022
Are high cost prescription drugs the price of innovation? Disclose the costs of clinical trials.
21 April 2022 - With 40% of Americans struggling to afford prescription medicines and many rationing or delaying initiation of lifesaving ...
Posted by Michael Wonder on 21 Apr 2022
Astellas announces reimbursement for Xospata (gilteritinib) in most provinces for patients with relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
21 April 2022 - Having access to an additional treatment option offers hope for Canadian adult AML patients with relapsed ...
Posted by Michael Wonder on 21 Apr 2022
Revance receives FDA acceptance of BLA resubmission for daxibotulinumtoxinA for injection for glabellar lines
21 April 2022 - PDUFA goal date set for 8 September 2022. ...
Posted by Michael Wonder on 21 Apr 2022
Zambon receives U.S. FDA breakthrough therapy designation for CMS I-neb in patients with non-cystic fibrosis bronchiectasis
21 April 2022 - CMS I-neb is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients ...
Posted by Michael Wonder on 21 Apr 2022
COVID-19 vaccine weekly safety report (24 April 2022)
24 April 2022 - To 17 April 2022, the TGA has received 534 reports which have been assessed as likely to ...
Posted by Michael Wonder on 21 Apr 2022
Ontario family forced to fight for life-saving drug highlights need for national rare disease strategy
21 April 2022 - Beth Vanstone doesn’t want anyone else to have to fight for access to life saving medications. ...
Posted by Michael Wonder on 21 Apr 2022
Hansa Biopharma granted added benefit ASMR 3 by French Transparency Commission for Idefirix (imlifidase) as desensitisation treatment for highly sensitised kidney transplant patients
20 April 2022 - The opinion by the Transparency Commission follows after Idefirix was granted a funded Early Access Program by ...
Posted by Michael Wonder on 20 Apr 2022
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 years with at least one F508del mutation
20 April 2022 - Vertex has submitted this indication to CADTH & INESSS for health technology assessments. ...
Posted by Michael Wonder on 20 Apr 2022
Otsuka announces Health Canada approval of Tavneos (avacopan) for ANCA associated vasculitis
20 April 2022 - Launch is expected in Canada in the fourth quarter of 2022. ...
Posted by Michael Wonder on 20 Apr 2022
Extrapolation of drug indications from study populations by FDA is ‘common’
19 April 2022 - Extrapolation of indications in new drug approvals by the U.S. FDA to populations not originally studied ...
Posted by Michael Wonder on 20 Apr 2022
Making #MedicinesMatter for all Australians
21 April 2022 - Medicines Australia has launched a social media campaign to highlight key policy issues for the election ...
Posted by Michael Wonder on 20 Apr 2022
New drug application resubmission update
20 April 2022 - Polarean Imaging announces that further to the RNS issued on 31 March 2022, the Company can confirm ...