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RSS FeedPosted by Michael Wonder on 29 Jul 2021
Cancer patients, advocates 'gobsmacked' PHARMAC declining funding application for life-changing drug
29 July 2021 - Ovarian cancer patients and advocates are "utterly gobsmacked" Pharmac has proposed to decline a funding application ...
Posted by Michael Wonder on 29 Jul 2021
GSK and Vir Biotechnology announce Joint Procurement Agreement with European Commission for COVID-19 treatment sotrovimab
28 July 2021 - GSK and Vir Biotechnology today announced they have signed a Joint Procurement Agreement with the European ...
Posted by Michael Wonder on 28 Jul 2021
Controversy and progress in Alzheimer’s disease — FDA approval of aducanumab
28 July 2021 - The FDA’s accelerated approval of aducanumab represents a landmark moment, though the drug’s road to the clinic ...
Posted by Michael Wonder on 28 Jul 2021
Revisiting FDA approval of aducanumab
28 July 2021 - Given the scientific, regulatory, and clinical implications of the accelerated FDA approval of aducanumab for Alzheimer’s disease, ...
Posted by Michael Wonder on 28 Jul 2021
FDA approves first interchangeable biosimilar insulin product for treatment of diabetes
28 July 2021 - Availability of insulin products will help increase access and potentially lower the cost of insulin for people ...
Posted by Michael Wonder on 28 Jul 2021
PHARMAC releases drug wish-list to be more 'transparent' but advocates say it gives false hope
28 July 2021 - PHARMAC has for the first time released a list of all the drugs it wants to ...
Posted by Michael Wonder on 28 Jul 2021
U.S. FDA grants breakthrough therapy designation to Takeda’s investigational compound, TAK-994, an oral orexin agonist in clinical development for narcolepsy Type 1
29 July 2021 - If approved, investigational TAK-994 may provide a future treatment option targeting the orexin deficiency underlying narcolepsy ...
Posted by Michael Wonder on 28 Jul 2021
Mycovia Pharmaceuticals announces U.S. FDA acceptance and priority review of new drug application for oteseconazole for the treatment of recurrent vulvovaginal candidiasis
28 July 2021 - Six month priority review granted for oteseconazole with PDUFA target action date set for 27 January 2022. ...
Posted by Michael Wonder on 28 Jul 2021
Apic Bio receives FDA fast track designation for APB-102 for the treatment of patients with SOD1 ALS
28 July 2021 - Apic Bio today announced that the U.S. FDA has granted fast track designation to APB-102, the ...
Posted by Michael Wonder on 28 Jul 2021
'New regulation limiting generic drugs will change industrial paradigm'
27 July 2021 - The Korea Pharmaceutical and Bio-pharma Manufacturers Association said the revision of the Pharmaceutical Affairs Act to ...
Posted by Michael Wonder on 28 Jul 2021
FDA says its 'working as quickly as possible' to review for full approval of vaccines
27 July 2021 - Some say full approval could sway hesitant Americans to get the vaccine. ...
Posted by Michael Wonder on 28 Jul 2021
Agenda for the November 2021 PBAC meeting
28 July 2021 - The agenda for the November 2021 PBAC meeting is now available. ...
Posted by Michael Wonder on 28 Jul 2021
Advisory panel to develop a framework for a pan-Canadian prescription drug list
27 July 2021 - An Advisory Panel has been convened by CADTH to provide Health Canada with a recommended framework ...
Posted by Michael Wonder on 28 Jul 2021
PHARMAC commits to being more transparent
28 July 2021 - For the first time, PHARMAC is sharing its priority lists for all funding applications for medicines ...
Posted by Michael Wonder on 28 Jul 2021
Lyndra Therapeutics’ investigational oral, weekly opioid use disorder treatment LYN-014 granted fast track designation by FDA
27 July 2021 - LYN-014 has the potential to address significant public health concerns about access to opioid use disorder treatment and ...
Posted by Michael Wonder on 27 Jul 2021
J&J and Pfizer quietly resolve Remicade biosimilar lawsuit
27 July 2021 - In 2017, Pfizer filed a lawsuit against J&J alleging that the company undertook anticompetitive practices in a ...