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 07 Mar 2024
Pharmaceutical reform agreement review report
6 March 2024 - The Department of Health and Aged Care has conducted a review of Pharmaceutical Reform Agreements (PRAs), to ...
Posted by Michael Wonder on 07 Mar 2024
Biden says Medicare should negotiate prices for at least 50 drugs each year, up from a target of 20
6 March 2024 - That proposal is one of several new health care policy plans Biden will outline during his State ...
Posted by Michael Wonder on 07 Mar 2024
Early impact of the Inflation Reduction Act on drug discovery
6 March 2024 - Despite the concerns of the biopharma industry, the Inflation Reduction Act has been enacted and with it, ...
Posted by Michael Wonder on 07 Mar 2024
Ivosidenib with azacitidine for untreated acute myeloid leukaemia with an IDH1 R132 mutation
28 February 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 07 Mar 2024
FDA approves nivolumab in combination with cisplatin and gemcitabine for unresectable or metastatic urothelial carcinoma
7 March 2024 - On 6 March 2024, the FDA approved nivolumab (Opdivo, Bristol-Myers Squibb) in combination with cisplatin and gemcitabine ...
Posted by Michael Wonder on 07 Mar 2024
Johnson & Johnson submits application to the EMA for Darzalex (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma
6 March 2024 - Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly ...
Posted by Michael Wonder on 06 Mar 2024
Trellis Bioscience's TRL1068 receives FDA fast track and QIDP designations, amplifying commitment to combat infectious diseases
6 March 2024 - Trellis Bioscience is thrilled to announce that its lead antibody candidate, TRL1068, has been granted fast ...
Posted by Michael Wonder on 06 Mar 2024
Epcoritamab for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma after two or more systemic treatments
6 March 2024 - NICE has published final evidence-based recommendations on the use of epcoritamab (Tepkinly) for the treatment of ...
Posted by Michael Wonder on 06 Mar 2024
FDA approves inotuzumab ozogamicin for paediatric patients with acute lymphoblastic leukaemia
6 March 2024 - Today, the FDA approved inotuzumab ozogamicin (Besponsa, Pfizer) for paediatric patients 1 year and older with ...
Posted by Michael Wonder on 06 Mar 2024
Vanda Pharmaceuticals announces FDA update for supplemental NDA for Hetlioz in the treatment of insomnia
6 March 2024 - Vanda Pharmaceuticals today announced that on 4 March 2024, it received a complete response letter from ...
Posted by Michael Wonder on 06 Mar 2024
NICE publishes final draft guidance on Enhertu after commercial discussions conclude without a price to make it a cost-effective use of NHS resources
6 March 2024 - NICE has published final draft guidance that does not recommend Enhertu (trastuzumab deruxtecan; Daiichi Sankyo) for treating ...
Posted by Michael Wonder on 06 Mar 2024
Camurus announces FDA acceptance of NDA submission for Oclaiz for treatment of acromegaly
5 March 2024 - PDUFA set to 21 October 2024. ...
Posted by Michael Wonder on 06 Mar 2024
Wezlana (ustekinumab), a biosimilar to Stelara, now available in Canada for certain chronic inflammatory diseasee
4 March 2024 - Wezlana is the first biosimilar to Stelera to be available for Canadian patients in all indications. ...
Posted by Michael Wonder on 06 Mar 2024
Updated agenda for March 2024 PBAC meeting (6 March 2024)
6 March 2024 - The agenda for this March 2024 meeting has been updated. ...
Posted by Michael Wonder on 06 Mar 2024
CymaBay announces EMA accepts for review the marketing authorisation application for seladelpar for the treatment of primary biliary cholangitis
5 March 2024 - MAA validation follows recent applications for seladelpar to the UK MHRA and US FDA. ...