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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Congress loves a big pharma villain. But will that lead to any real policy changes on drug prices?

21 May 2021 - There's a funny cycle that resurfaces every now and then within the life sciences industry.  ...

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COVID-19 vaccine rollout: Aussies could get COVID-19 jabs by Christmas

23 May 2021 - The federal government has made a major change to the Pfizer rollout, and it could see Australians ...

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US biotech Novavax could make COVID vaccine onshore in Australia

20 May 2021 - American biotechnology company Novavax has outlined plans to make doses of its coronavirus vaccine in Australia ...

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Health insurers ‘sit on pot of gold’, say private hospitals

21 May 2021 - Private hospitals say health insurers must promise to reduce premium hikes or pay cash back to ...

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EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19

21 May 2021 - EMA’s CHMP has completed its review on the use of the monoclonal antibody sotrovimab (also known as ...

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Vaxzevria: further advice on blood clots and low blood platelets

21 May 2021 - EMA has provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria ...

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FDA grants accelerated approval to amivantamab-vmjw for metastatic non-small cell lung cancer

21 May 2021 - Today, the FDA granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen), a bispecific antibody directed against epidermal ...

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U.S. FDA grants priority review of maribavir for the treatment of post-transplant recipients with cytomegalovirus infection in those resistant and/or refractory to prior anti-CMV treatment

21 May 2021 - New drug application based on Phase 3 trial of maribavir which met its primary outcome of superiority ...

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New listings for opioid medications on the Palliative Care Schedule for the management of severe disabling pain from 1 June 2021

21 May 2021 - Commencing 1 June 2021, the Palliative Care Schedule will include new and amended listings for opioid ...

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Biosimilar bevacizumab on the PBS - information for health professionals and patients

21 May 2021 - A biosimilar brand of bevacizumab (Mvasi) will be listed on the PBS on 1 June 2021. Information ...

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TGA evaluating first monoclonal antibody treatment for COVID-19 sotrovimab - GlaxoSmithKline

21 May 2021 - The Therapeutic Goods Administration granted a provisional determination to GlaxoSmithKline in relation to the monoclonal antibody ...

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PHARMAC to work with others to improve communication

21 May 2021 - PHARMAC accepts the Coroner’s comments that not all information about the brand change reached patients. ...

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Government calls for pitches for mRNA vaccine production facilities

21 May 2021 - Plans to build a new Australian vaccine facility will be launched on Friday in a call ...

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Thousands of AstraZeneca shots pile up in federal-run clinics as GPs wait

20 May 2021 - Thousands of AstraZeneca doses are sitting unused in federal government-run clinic refrigerators across Sydney and regional ...

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Omeros announces extension of FDA review period for narsoplimab in HSCT-TMA

20 May 2021 - PDUFA date is 17 October 2021. ...

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