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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Government races to secure more vaccines but stares down AstraZeneca critics

13 January 2021 - The Morrison government is seeking new deals to vaccinate millions of Australians by the middle of ...

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Swissmedic authorises COVID-19 Vaccine Moderna for use in Switzerland

12 January 2021 - Swiss Federal Government has secured 7.5 million doses and first deliveries expected to begin in January. ...

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Regeneron announces U.S. Government agreement to purchase additional COVID-19 antibody cocktail doses

12 January 2021 - New agreement covers 1.25 million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential ...

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Chronocort marketing authorisation application submitted to the UK MHRA

12 January 2021 - Independent UK (MHRA) application to run in parallel with ongoing European (EMA) application, following end of Brexit ...

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Health Canada approves Onureg (azacitidine tablets), first maintenance therapy for patients in remission from acute myeloid leukaemia

12 January 2021 - Onureg has shown clinically meaningful increase in overall survival for patients. ...

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MorphoSys and Incyte announce acceptance by Health Canada of the new drug submission for tafasitamab

12 January 2021 - MorphoSys and Incyte today announced that Health Canada has accepted the new drug submission for tafasitamab, an ...

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Health Canada approves Lundbeck's Vyepti (eptinezumab)--the first and only intravenous preventive treatment for migraine

12 January 2021 - Lundbeck is pleased to announce that Vyepti (eptinezumab) has been approved by Health Canada for the preventive ...

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Further insights from the agenda for the 2021/1 PBAC meeting

13 January 2021 - The case for improved clarity and transparency gets stronger. ...

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STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies

12 January 2021 - In alignment with the International Council of Harmonization’s strategic goals, a public private consortium has developed a ...

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Middlemen sue to block a signature Trump drug pricing proposal

12 January 2021 - The Pharmaceutical Care Management Association, which represents drug middlemen in Washington, filed a lawsuit Tuesday to ...

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U.S. FDA accepts for priority review the biologics license application for V114, Merck’s investigational 15 valent pneumococcal conjugate vaccine, for use in adults 18 years of age and older

12 January 2021 - Merck today announced the U.S. FDA accepted for priority review a biologics license application for V114, Merck’s ...

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U.S. FDA grants priority review to new drug application for finerenone to treat patients with chronic kidney disease and type 2 diabetes mellitus

12 January 2021 - Bayer announced today that the U.S. FDA has accepted its new drug application and granted priority review ...

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ICER identifies most significant 2019 US drug price hikes — even after rebates — that were not supported by new clinical evidence

12 January 2021 - Out of 10 identified drugs that had substantial 2019 price increases on top of already high current ...

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Vaccine ‘is not good enough’ to stop the virus

13 January 2021 - Doctors are calling for a re-evaluation of Australia’s vaccine strategy, saying that herd immunity cannot be ...

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Janssen's ulcerative colitis treatment to receive reimbursement

12 January 2021 - Janssen Pharmaceutical said Tuesday that the Ministry of Health and Welfare would begin to reimburse Stelara, ...

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