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 28 Oct 2022
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment
28 October 2022 - Application based on positive pivotal Phase 3 data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract ...
Posted by Michael Wonder on 28 Oct 2022
Public Summary Documents – July 2022 PBAC meeting
28 October 2022 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the July 2022 PBAC ...
Posted by Michael Wonder on 28 Oct 2022
Gilead receives complete response letter from US FDA for bulevirtide for the treatment of adults with hepatitis delta virus
27 October 2022 - The US FDA has issued a complete response letter for the biologics license application for bulevirtide, ...
Posted by Michael Wonder on 28 Oct 2022
TGA provisionally approves Pfizer bivalent COVID-19 vaccine for use as a booster dose in adults
28 October 2022 - On 27 October 2022, the TGA provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron ...
Posted by Michael Wonder on 28 Oct 2022
Health Canada approves Rebinyn (coagulation factor IX (recombinant), pegylated) for the treatment of routine prophylaxis to prevent or reduce frequency of bleeding episodes in children with haemophilia B
27 October 2022 - Expanded indication for Rebinyn will continue to support Canadian paediatric patients living with haemophilia B. ...
Posted by Michael Wonder on 27 Oct 2022
Myeloid Therapeutics announces FDA fast track designation for MT-101 for the treatment of CD5 positive relapsed/refractory PTCL
27 October 2022 - MT-101 is the first mRNA engineered CAR monocyte therapy to be dosed in humans. ...
Posted by Michael Wonder on 27 Oct 2022
Health technology assessment review – frequently asked questions
27 October 2022 - The Department of Health & Aged Care has produced a two page summary on the upcoming ...
Posted by Michael Wonder on 27 Oct 2022
Evidence based drug delivery for rare diseases: the role of digitisation
25 October 2022 - Digitisation has potential when it comes to making clinical development for the care of rare diseases more ...
Posted by Michael Wonder on 27 Oct 2022
FDA continues to advance medicines for children
27 October 2022 - Increasing the availability of safe and effective medicines for children is a key priority for the US ...
Posted by Michael Wonder on 27 Oct 2022
Drug maker raises the price of an old chemo medicine tenfold amid persistent shortages
27 October 2022 - Amid sporadic shortages of a drug that is essential in preparing patients for lifesaving, cancer-fighting treatments, ...
Posted by Michael Wonder on 27 Oct 2022
PMPRB finds ultra-rare drug Procysbi is excessively priced
26 October 2022 - On 1 September 2022, a Panel of the Patented Medicine Prices Review Board issued a decision that ...
Posted by Michael Wonder on 27 Oct 2022
MSD's Zerbaxa becomes Korea's newest antibiotic to receive reimbursement
27 October 2022 - MSD Korea is strengthening its position in the local antibiotic market with Zerbaxa (ingredient: ceftolozane/tazobactam) after ...
Posted by Michael Wonder on 27 Oct 2022
AvroBio receives rare paediatric disease designation from the US FDA for first in class gene therapy for Gaucher disease
27 October 2022 - AVR-RD-02 has previously received fast track status from FDA, orphan drug designation in the US and EU, ...
Posted by Michael Wonder on 27 Oct 2022
ITM receives FDA fast track designation for radionuclide therapy candidate ITM-11 (Lutetium Lu 177 edotreotide) in neuroendocrine tumours (GEP-NETs)
27 October 2022 – ITM Isotope Technologies today announced that the US FDA has granted the company fast track designation ...
Posted by Michael Wonder on 27 Oct 2022
Santhera and ReveraGen complete NDA submission to FDA for vamorolone in Duchenne muscular dystrophy
27 October 2022 - Santhera Pharmaceuticals and ReveraGen BioPharma announce that they have completed the rolling submission of a new drug ...