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 ...

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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 ...

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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 ...

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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, ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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'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 ...

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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. ...

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Agenda for the November 2021 PBAC meeting

28 July 2021 - The agenda for the November 2021 PBAC meeting is now available. ...

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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 ...

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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 ...

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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 ...

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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 ...

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