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 22 Dec 2020
Jazz Pharmaceuticals announces initiation of biologics license application submission for JZP-458 for the treatment of acute lymphoblastic leukaemia or lymphoblastic lymphoma
21 December 2020 - Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 21 Dec 2020
The FDA grants IO Biotech breakthrough therapy designation for IO102 and IO103 in combination with anti-PD-1 in unresectable/metastatic melanoma
15 December 2020 - IO Biotech today announced that the U.S. FDA has granted breakthrough therapy designation for a combination ...
Posted by Michael Wonder on 21 Dec 2020
Price disclosure 2021 April cycle outcomes summary
21 December 2020 - The summary of price disclosure price reductions for the 2021 April Cycle has now been published. ...
Posted by Michael Wonder on 21 Dec 2020
Janssen initiates rolling submission of a biologics license application to U.S. FDA for BCMA CAR-T therapy ciltacabtagene autoleucel (cilta-cel) for the treatment of relapsed and/or refractory multiple myeloma
21 December 2020 - Janssen announced today the initiation of a rolling submission of its biologics license application to the ...
Posted by Michael Wonder on 21 Dec 2020
Sesen Bio submits completed biologics license application to the FDA for Vicineum and has requested priority review
21 December 2020 - BLA supported by strong Phase 3 VISTA trial data and positive analytical comparability data. ...
Posted by Michael Wonder on 21 Dec 2020
Vertex announces FDA approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for use in people with cystic fibrosis with certain rare mutations
21 December 2020 - More than 600 people with certain rare cystic fibrosis mutations are now eligible for Trikafta, Symdeko or ...
Posted by Michael Wonder on 21 Dec 2020
Private health insurance: families hit with 127 dollar a year premium lift
21 December 2020 - Private health insurers have got their Christmas wish, with Health Minister Greg Hunt granting premium price ...
Posted by Michael Wonder on 21 Dec 2020
EMA recommends first COVID-19 vaccine for authorisation in the EU
21 December 2020 - EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, ...
Posted by Michael Wonder on 21 Dec 2020
European Commission approves Aimmune’s Palforzia as first-ever treatment for peanut allergy in the EU
21 December 2020 - Peanut allergy is one of the most common food allergies in Europe. ...
Posted by Michael Wonder on 21 Dec 2020
Swissmedic approves Buvidal for the treatment of opioid dependence
18 December 2020 - Camurus announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ...
Posted by Michael Wonder on 21 Dec 2020
PBS website updates for Stage 2 PBS process improvements
21 December 2020 - The PBS website has been updated to support implementation of Stage 2 PBS process improvements from ...
Posted by Michael Wonder on 21 Dec 2020
Kiwis going into debt to pay for drugs other countries fund
21 December 2020 - An internal stoush at the drug-buying agency PHARMAC has blocked funding for a life-extending drug for bowel ...
Posted by Michael Wonder on 21 Dec 2020
Oyster Point Pharma submits new drug application to the U.S. FDA for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease
18 December 2020 - The new drug application submission is based on efficacy and safety results from a comprehensive clinical trial ...
Posted by Michael Wonder on 21 Dec 2020
PHARMAC to fund new diabetes medicines with amended Special Authority criteria
21 December 2020 - PHARMAC has approved funding for two new medicines with substantial health benefits for around 53,000 New Zealanders ...
Posted by Michael Wonder on 21 Dec 2020
Health Canada approves expanded indication for Soliqua
18 December 2020 - New indication for Soliqua offers an alternative approach for Canadians living with type 2 diabetes requiring treatment ...