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 20 Sep 2021
Melinta Therapeutics announces two key milestones expanding reimbursement and access for Kimyrsa (oritavancin)
20 September 2021 - Kimyrsa receives product specific J code and transitional pass through status from CMS. ...
Posted by Michael Wonder on 20 Sep 2021
Marinus Pharmaceuticals announces FDA acceptance for filing and priority review of new drug application for ganaxolone in CDKL5 deficiency disorder
20 September 2021 - FDA indicated that it is not currently planning to hold an advisory committee meeting for the ...
Posted by Michael Wonder on 20 Sep 2021
FDA approves first biosimilar to treat macular degeneration disease and other eye conditions
17 September 2021 - The U.S. FDA today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the ...
Posted by Michael Wonder on 20 Sep 2021
FDA clears first technology to distinguish between bacterial and viral infections using the body’s immune response – the MeMed BV test and MeMed key platform
20 September 2021 - MeMed BV is a first-of-its kind test that decodes the immune response to accurately distinguish between bacterial ...
Posted by Michael Wonder on 20 Sep 2021
U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for LAG-3-blocking antibody relatlimab and nivolumab fixed dose combination as treatment for patients with unresectable or metastatic melanoma
20 September 2021 - The application is based on Phase 2/3 RELATIVITY-047 trial, in which the relatlimab and nivolumab fixed-dose combination ...
Posted by Michael Wonder on 20 Sep 2021
AbbVie submits regulatory application to FDA for risankizumab-rzaa (Skyrizi) for the treatment of patients 16 years and older with moderate to severe Crohn's disease
20 September 2021 - In three pivotal Phase 3 trials, risankizumab-rzaa demonstrated significant improvements in clinical remission and endoscopic response as ...
Posted by Michael Wonder on 20 Sep 2021
Vertex announces letter of intent with pan-Canadian Pharmaceutical Alliance for public reimbursement of CFTR modulators Extended to Include Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor)
17 September 2021 - Vertex Pharmaceuticals today announced that it has signed a letter of intent with the pan-Canadian Pharmaceutical ...
Posted by Michael Wonder on 20 Sep 2021
EU panel rejects Pfizer’s tanezumab for osteoarthritis pain
19 September 2021 - Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor ...
Posted by Michael Wonder on 20 Sep 2021
Medicare bulk billing rates at all time high
18 September 2021 - The latest Medicare data showing that almost nine out of 10 visits to the GP in 2020-21 ...
Posted by Michael Wonder on 19 Sep 2021
Manufacturers’ perceptions of the decision-making process for new drug reimbursement in South Korea
17 September 2021 - This study aimed to evaluate manufacturers’ perceptions of the decision-making process for new drug reimbursement and to ...
Posted by Michael Wonder on 19 Sep 2021
Highlights from the CHMP 13-16 September 2021 meeting
17 September 2021 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting. ...
Posted by Michael Wonder on 19 Sep 2021
Should regulatory authorities approve drugs based on surrogate outcomes?
16 September 2021 - The aducanumab controversy is the latest example of surrogate outcomes failing to predict clinically important outcomes. ...
Posted by Michael Wonder on 19 Sep 2021
GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil driven diseases
17 September 2021 - If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases. ...
Posted by Michael Wonder on 19 Sep 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...
Posted by Michael Wonder on 19 Sep 2021
BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia
17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...