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RSS FeedPosted by Michael Wonder on 11 Aug 2022
aTyr Pharma receives FDA fast track designation for efzofitimod (ATYR1923) for treatment of pulmonary sarcoidosis
11 August 2022 - Company is investigating efzofitimod in global pivotal Phase 3 EFZO-FIT study in pulmonary sarcoidosis patients. ...
Posted by Michael Wonder on 11 Aug 2022
Genentech announces FDA approval of Xofluza to treat influenza in children aged five and older
11 August 2022 - The FDA also approved Xofluza to prevent influenza in children aged five and older following contact with ...
Posted by Michael Wonder on 11 Aug 2022
Understanding the Democrats’ drug pricing package
10 August 2022 - On Sunday, the Senate passed the Inflation Reduction Act (IRA) of 2022, which includes comprehensive reforms to ...
Posted by Michael Wonder on 11 Aug 2022
Amgen's acute lymphoblastic leukaemia drug Blincyto passes reimbursement review
11 August 2022 - Amgen's acute lymphoblastic leukaemia treatment Blincyto (blinatumomab) passed the reimbursement review about two years after expanding ...
Posted by Michael Wonder on 11 Aug 2022
Menarini Group’s elacestrant granted priority review by the US FDA for patients with ER+/HER2- advanced or metastatic breast cancer
11 August 2022 - US FDA has assigned a Prescription Drug User Fee Act date of 17 February 2023. ...
Posted by Michael Wonder on 11 Aug 2022
European Commission approves Imbruvica (ibrutinib) fixed duration combination for adult patients with previously untreated chronic lymphocytic leukaemia
9 August 2022 - It is the first all oral, fixed duration, once daily treatment based on a Bruton's tyrosine kinase ...
Posted by Michael Wonder on 10 Aug 2022
Real-world data can help expedite drug approvals for serious diseases with few options
10 August 2022 - My grandmother was diagnosed with dementia in the early 2000s. We started taking it seriously when she ...
Posted by Michael Wonder on 10 Aug 2022
Cure Rare Disease receives FDA approval to administer first in human CRISPR therapeutic
10 August 2022 - Cure Rare Disease announces the approval from the US FDA to administer its very first therapeutic. ...
Posted by Michael Wonder on 10 Aug 2022
Overall survival, progression-free survival and tumour response benefit supporting initial US FDA approval and indication extension of new cancer drugs, 2003-2021
10 August 2022 - Clinical trial evidence is routinely evaluated for initial drug approvals, yet the benefit of indication extensions remains ...
Posted by Michael Wonder on 10 Aug 2022
Few U.S. patients with hepatitis C get timely treatment, CDC says
9 August 2022 - Few U.S. adults diagnosed with hepatitis C virus infection receive timely treatment with anti-viral drugs, the ...
Posted by Michael Wonder on 09 Aug 2022
Has the innovative pharmaceutical industry essential given up trying to list new medicines in New Zealand?
10 August 2022 - Upon examining the agenda for this month's PTAC meeting, one would think that it has. ...
Posted by Michael Wonder on 09 Aug 2022
Challenges of health technology assessment in pluralistic healthcare systems: an ISPOR Council report
9 August 2022 - Health technology assessment has been growing in use over the past 40 years, especially in its impact ...
Posted by Michael Wonder on 09 Aug 2022
Paladin Labs announces Health Canada's filing acceptance of cenobamate tablets as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy
8 August 2022 - Paladin Labs announced today that Health Canada has accepted its new drug submission for cenobamate tablets as ...
Posted by Michael Wonder on 09 Aug 2022
Relmada Therapeutics receives FDA fast track designation for REL-1017 as a monotherapy for the treatment of major depressive disorder
9 August 2022 - Relmada Therapeutics today announced that the U.S. FDA has granted fast track designation to REL-1017, the Company's ...
Posted by Michael Wonder on 09 Aug 2022
CorMedix announces regulatory and manufacturing updates
8 August 2022 - CorMedix today announced a second complete response letter was received from the FDA stating that the DefenCath ...