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 approves Coherus’ Cimerli (ranibizumab-eqrn) as the first and only interchangeable biosimilar to Lucentis for all five indications, with 12 months of interchangeability exclusivity

2 August 2022 - First Cimerli product sales expected in October 2022. ...

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PHARMAC tells MPs medicine buying agency undergoing 'substantial change'

3 August 2022 - PHARMAC has undergone “substantial change” in the past few years, even before a hard hitting review ...

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Bupa, Ramsay fight puts pressure on customers and Health Minister Mark Butler

3 August 2022 - Mark Butler finds himself in an uncomfortable position after Australia’s biggest private hospital operator Ramsay terminated ...

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COVID-19 vaccines undergoing evaluation (3 August 2022)

3 August 2022 - The TGA has published a list (table) of the COVID-19 vaccines currently under evaluation by the agency. ...

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Pralsetinib for treating advanced RET fusion positive non-small-cell lung cancer

3 August 2022 - NICE has published evidence-based recommendations on the use of pralsetinib (Gavreto) for the treatment of adults ...

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TGA commences evaluation of Pfizer's COVID-19 vaccine (Comirnaty) for children aged 6 months to less than 5 years

3 August 2022 - The TGA has commenced evaluation of an application from Pfizer to extend the use of its ...

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Patient reported outcome measures in clinical research

 2 August 2022 - Health conditions may cause patients to feel ill and have impaired functioning in their daily lives. Thus, ...

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Critics decry drug pricing provisions in Inflation Reduction Act, say they will stifle innovation

2 August 2022 - The push back against the prescription drug pricing provisions in the Inflation Reduction Act is relentless and ...

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Marius Pharmaceuticals receives FDA approval of Kyzatrex, an oral testosterone replacement therapy

2 August 2022 - Marius Pharmaceuticals today announced the approval of Kyzatrex (testosterone undecanoate) by the U.S. FDA.  ...

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FDA official: patients play an increasing role in rare disease drug development

1 August 2022 - Patients have a critical role in drug development, from identifying unmet medical needs to assessing meaningful ...

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Novo Nordisk receives FDA approval for Rebinyn for routine prophylaxis to prevent bleeding in people living with haemophilia B

29 July 2022 - Novo Nordisk announced today that the US FDA has approved the supplemental biologics license application for Rebinyn, ...

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PHARMAC scrutiny a win for transparency

2 August 2022 - “PHARMAC’s appearance before the Health Select Committee tomorrow morning is a triumph for transparency and the ...

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Delay of Evrysdi reimbursement review denies SMA patients' right to drug choice

2 August 2022 - The Government has been dragging its feet to review insurance benefits for Roche's new spinal muscular ...

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Korea's first gene treatment for SMA Zolgensma gets insurance benefits

2 August 2022 - Novartis Korea said Monday that it released Zolgensma, the nation's first gene replacement treatment for spinal ...

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Characteristics of key patents covering recent FDA approved drugs

1 August 2022 - New drugs are protected by patents that block generic competition and allow manufacturers to charge high prices. ...

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