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 ...

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Recell System insurance coverage begins in Japan for treatment of acute burns

1 September 2022 - Reimbursement in Japan will be similar to that of pricing in the United States. ...

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Health Canada authorises first bivalent COVID-19 booster for adults 18 years and older

1 September 2022 - Today, Health Canada authorised an adapted version of the Moderna Spikevax COVID-19 vaccine.  ...

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Vabysmo (faricimab injection) receives positive CADTH recommendation for the treatment of neovascular (wet) age-related macular degeneration in adults

1 September 2022 - Provincial jurisdictions will make the final decision on public reimbursement. ...

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What “negotiating” with Medicare means for drug makers: a mixture of price controls and actual negotiations

1 September 2022 - In the debate on the drug pricing provisions contained in the Inflation Reduction Act, critics call the ...

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First adapted COVID-19 booster vaccines recommended for approval in the EU

1 September 2022 - The EMA’s CHMP has recommended authorising two vaccines adapted to provide broader protection against COVID-19.  ...

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Critical kidney disease medication listed on the PBS

1 September 2022 - A life changing treatment for chronic kidney disease will be made available to thousands of Australians through ...

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Janssen's Stelara gets insurance benefits as first-line therapy for ulcerative colitis

1 September 2022 - Janssen Korea said its ulcerative colitis Stelara (ustekinumab) won health insurance benefits as the primary treatment ...

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Antengene announces Xpovia included for reimbursement by the PBS in Australia for the treatment of patients with relapsed and/or refractory multiple myeloma

1 September 2022 - Xpovio (selinexor) is the first and only selective inhibitor of nuclear export (SINE) inhibitor approved by the ...

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Availability of new medicines in the US and Germany (2004 - 2018)

30 August 2022 - In this cohort study comparing 599 medicine approvals in the US and Germany between 2004 and 2018, ...

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ACE publishes another tranche of technology guidances (August 2022)

31 August 2022 - Six technology guidance documents were published yesterday. ...

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PBS listing for ovarian cancer and kidney disease

1 September 2022 - From 1 September 2022, Australians will have access to new and expanded medicines on the Pharmaceutical Benefits ...

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Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions

31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...

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Amneal announces submission of new drug application to the US FDA for IPX203 for the treatment of Parkinson’s disease

31 August 2022 - IPX203 is a novel, extended-release oral formulation of carbidopa and levodopa that if approved, would offer patients ...

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Governor Ron DeSantis announces lawsuit against Biden Administration’s reckless delay of Canadian Prescription Drug Importation Program

31 August 2022 - Today, Governor Ron DeSantis announced a lawsuit against the US FDA in response to their unreasonable delay ...

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Kidney disease drug dapagliflozin added to Pharmaceutical Benefits Scheme

31 August 2022 - Lachlan Ross describes his more than a decade-long battle with kidney failure as "very long, and very ...

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