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 13 Dec 2020
Though promising, gene therapies face durability and reimbursement headwinds
11 December 2020 - The promise of gene therapy is to cure diseases associated with faulty or missing genes. There’s enormous ...
Posted by Michael Wonder on 13 Dec 2020
Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries
10 December 2020 - Zisis and colleagues performed a literature review to identify published guidance for the conduct and assessment ...
Posted by Michael Wonder on 13 Dec 2020
Walgreens statement regarding FDA emergency use authorisation of COVID-19 vaccine
11 December 2020 - Walgreens is preparing to immediately bring vaccines to high priority populations, as determined by the Centers ...
Posted by Michael Wonder on 13 Dec 2020
First coronavirus vaccines head to states, starting historic effort
12 December 2020 - Distributing supplies is a daunting logistical challenge, involving sophisticated tracking equipment, military contingencies and tight security. ...
Posted by Michael Wonder on 13 Dec 2020
Reimbursement from pharmaceutical companies decreases by 288 million
11 December 2020 - The rebate from side agreements between regions and pharmaceutical companies is estimated according to the forecast ...
Posted by Michael Wonder on 12 Dec 2020
CHMP recommends the approvals of Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and ankylosing spondylitis
10 December 2020 - If approved, Rinvoq will be the first oral, selective and reversible JAK inhibitor approved in three rheumatologic ...
Posted by Michael Wonder on 12 Dec 2020
FDA takes key action in fight against COVID-19 by issuing emergency use authorisation for first COVID-19 vaccine
11 December 2020 - Action follows thorough evaluation of available safety, effectiveness, and manufacturing quality information by FDA career scientists, input ...
Posted by Michael Wonder on 12 Dec 2020
Lexicon Pharmaceuticals receives fast track designation from the FDA for LX9211 for diabetic peripheral neuropathic pain
11 December 2020 - Lexicon Pharmaceuticals announced today that it has received Fast Track designation from the U.S. FDA for ...
Posted by Michael Wonder on 11 Dec 2020
Bavencio (avelumab) receives positive CHMP opinion for first-line maintenance treatment of locally advanced or metastatic urothelial carcinoma
11 December 2020 - Merck and Pfizer today announced that the CHMP of the EMA adopted a positive opinion recommending approval ...
Posted by Michael Wonder on 11 Dec 2020
Alunbrig scores NICE backing for ALK positive lung cancer
11 December 2020 - Takeda’s Alunbrig (brigatinib) has been recommended by the UK’s NICE for patients with ALK positive advanced ...
Posted by Michael Wonder on 11 Dec 2020
Pfizer and BioNTech receive FDA Advisory Committee vote supporting potential first emergency use authorisation for vaccine to combat COVID-19 in the U.S
10 December 2020 - FDA expected to make a decision on Emergency Use Authorization in the coming days. ...
Posted by Michael Wonder on 11 Dec 2020
CSL, University of Queensland coronavirus vaccine trials halted
11 December 2020 - CSL and University of Queensland researchers knew of the potential for false HIV positives in the ...
Posted by Michael Wonder on 10 Dec 2020
SoniVie receives FDA breakthrough device designation for the TIVUS system for renal artery denervation
9 December 2020 - SoniVie acquires new intellectual property and other assets from Cardiosonic Moving TIVUS into new therapeutic areas beyond ...
Posted by Michael Wonder on 10 Dec 2020
Atox Bio announces FDA acceptance to file the NDA for reltecimod to treat suspected organ dysfunction or failure in patients with necrotising soft tissue infection ("flesh eating disease")
10 December 2020 - Atox Bio today announced that the U.S. FDA has accepted to file the new drug application ...
Posted by Michael Wonder on 10 Dec 2020
Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug
9 December 2020 - A federal watchdog is being asked to investigate the FDA for an “inappropriate collaboration” with Biogen ...