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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FDA grants breakthrough device designation for ImpediMed's SOZO digital health platform for renal failure

30 August 2021 - FDA recognises potential of SOZO digital health platform to assist clinicians in measuring exact fluid volume of ...

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Australia is ending its zero-covid strategy

28 August 2021 - “This is not a sustainable way to live in this country,” declared Scott Morrison, Australia’s prime minister, ...

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Health Canada approves Myinfla (colchicine 0.5 mg extended release tablets), a new repurposed treatment for cardiovascular disease

27 August 2021 - A unique partnership between Pharmascience and the Montreal Heart Institute leads to the approval of Myinfla (colchicine ...

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Roche to withdraw 2 Parkinson’s drugs from Korean market

27 August 2021 - Roche said it would withdraw Parkinson’s syndrome treatment Madopar 125 mg and 250 mg tablets from ...

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FDA orphan drug approval: Octapharma’s Octagam 10% receives 7 years of market exclusivity for adult dermatomyositis

30 August 2021 - Octagam 10% expected to become the first treatment option for adults with rare immune-mediated inflammatory disease. ...

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Evrysdi (risdiplam) receives CADTH reimbursement recommendation for some patients with spinal muscular atrophy

30 August 2021 - Roche Canada today announced that the CADTH Canadian Drug Expert Committee has issued its final recommendation ...

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Biogen offers free Alzheimer's drug as Medicare payment uncertainty remains

30 August 2021 - Biogen is providing its controversial and expensive new Alzheimer's drug free of charge for some patients amid ...

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Review of the National Medicines Policy – call for submissions

30 August 2021 - The National Medicines Policy Review Committee is now welcoming submissions to support the review of the National Medicines ...

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Public Summary Documents – May 2021 PBAC meeting

27 August 2021 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the May 2021 PBAC ...

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Moderna COVID-19 vaccine gets Health Canada approval for kids 12+

27 August 2021 - As the Delta variant rages through unvaccinated populations in Canada ahead of the back-to-school season, children ...

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COVID-19 vaccine claims scheme

29 August 2021 - Medicines Australia commends the Australian Government on the COVID-19 Vaccine Claim Scheme for anyone who experiences ...

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Breakthrough PBS listings to benefit thousands of Australians

29 August 2021 - From 1 September 2021, thousands of Australians living with schizophrenia, liver disease, lymphoma and anaphylaxis will have ...

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European Medicines Agency grants Marinus Pharmaceuticals accelerated assessment of ganaxolone for treatment of CDKL5 deficiency disorder

26 August 2021 - Marinus Pharmaceuticals today announced that the CHMP of the EMA has granted its request for accelerated ...

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Merck’s Keytruda (pembrolizumab) receives two new approvals in Japan

26 August 2021 - Keytruda now approved for the treatment of patients with PD-L1 positive, hormone receptor negative and HER2 negative, ...

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Incyte and MorphoSys announce the European Commission approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma

26 August 2021 - In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL. ...

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