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RSS FeedPosted by Michael Wonder on 08 Jan 2023
Otsuka and Lundbeck announce FDA acceptance and priority review of sNDA for brexpiprazole for the treatment of agitation associated with Alzheimer’s dementia
7 January 2023 - The FDA target date (PDUFA date) for completion of the review is 10 May 2023. ...
Posted by Michael Wonder on 07 Jan 2023
Eisai submits supplemental biologics license application to FDA for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease
7 January 2023 - Submission for traditional approval follows FDA accelerated approval of Leqembi on the same day, and is ...
Posted by Michael Wonder on 07 Jan 2023
Novan submits new drug application to the US FDA for berdazimer (SB206) 10.3% topical gel for the treatment of molluscum contagiosum
6 January 2023 - Potential FDA approval anticipated in first quarter 2024, assuming the filing is accepted by the FDA and ...
Posted by Michael Wonder on 07 Jan 2023
Eisai's approach to US pricing for Leqembi (lecanemab), a treatment for early Alzheimer's disease, sets forth out concept of "societal value of medicine" in relation to "price of medicine"
6 January 2023 - Maximising our value for all stakeholders while giving back value to society. ...
Posted by Michael Wonder on 07 Jan 2023
FDA grants priority review to Genentech’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma
5 January 2023 - Results from the pivotal Phase 1/2 NP30179 study showed glofitamab induced durable response rates in people with ...
Posted by Michael Wonder on 06 Jan 2023
US new drug price exceeds $200,000 median in 2022
5 January 2023 - After setting record high US prices in the first half of 2022, drug makers continued to ...
Posted by Michael Wonder on 06 Jan 2023
FDA grants accelerated approval for Alzheimer’s disease treatment
6 January 2023 - Today, the US FDA approved Leqembi (lecanemab-irmb) via the accelerated approval pathway for the treatment of Alzheimer’s ...
Posted by Michael Wonder on 06 Jan 2023
Infex's novel AMR drug candidate MET-X receives FDA QIDP designation
5 January 2023 - Infex Therapeutics is pleased to announce that the US FDA has granted qualified infectious disease product ...
Posted by Michael Wonder on 06 Jan 2023
UCB announces rozanolixizumab BLA for the treatment of generalised myasthenia gravis filed with US FDA and designated for priority review
6 January 2023 - Biologic license application designated priority review by FDA and seeks approval for rozanolixizumab for the treatment ...
Posted by Michael Wonder on 06 Jan 2023
AUM Biosciences receives US FDA rare paediatric disease designation for AUM302 for treatment of neuroblastoma
5 January 2023 - AUM Biosciences announced today that the US FDA has granted a rare paediatric disease designation for its ...
Posted by Michael Wonder on 06 Jan 2023
Bicycle Therapeutics announces FDA fast track designation granted to BT8009 for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer
4 January 2023 - Bicycle Therapeutics today announced that the US FDA has granted fast track designation to Bicycle’s BT8009 ...
Posted by Michael Wonder on 06 Jan 2023
Azafaros receives fast track designation for lead asset AZ-3102
5 January 2023 - Azafaros today announced that the FDA has granted fast track designation for the investigation of AZ-3102 for ...
Posted by Michael Wonder on 05 Jan 2023
Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months
5 January 2023 - Submission supported by comprehensive clinical trial programme, which demonstrated protection against RSV disease through the RSV ...
Posted by Michael Wonder on 05 Jan 2023
Checkpoint Therapeutics submits biologics license application to FDA for cosibelimab as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma
4 January 2023 - Positive and clinically meaningful pivotal clinical results announced in 2022 in both metastatic and locally advanced indications. ...
Posted by Michael Wonder on 05 Jan 2023
Sedana Medical receives FDA fast track designation in the US
4 January 2023 - Sedana Medical today announces that the US FDA has granted fast track designation for the evaluation of ...