Anti-viral drug should not be first choice in treating COVID-19

3 December 2022 - The most widely prescribed anti-viral drug in Australia, molnupiravir, should no longer be routinely given for ...

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Libtayo (cemiplimab) approved by the European Commission as the first immunotherapy in second-line recurrent or metastatic cervical cancer irrespective of PD-L1 expression level or tumour histology

22 November 2022 - Approval based on a Phase 3 trial that demonstrated significant survival benefit in patients with recurrent or ...

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Junshi Biosciences announces approval of supplemental application for additional indications of adalimumab injection

22 November 2022 - Shanghai Junshi Biosciences announced today that the supplemental application for additional indications of adalimumab injection (UBP1211) for ...

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argenx announces US FDA acceptance of biologics license application for subcutaneous efgartigimod in generalised myasthenia gravis with priority review

22  November 2022 - PDUFA target action date is 20 March 2023. ...

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NICE recommends Sobi’s Doptelet to treat thrombocytopenia

18 November 2022 - Primary ITP is a rare autoimmune condition characterised by high platelet destruction ...

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Carfilzomib in combination with daratumumab and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma

22 November 2022 - NICE is unable to make a recommendation on the use of carfilzomib in combination with daratumumab and ...

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Tisagenlecleucel for the treatment of patients with follicular lymphoma after two or more therapies

22 November 2022 - NICE is unable to make a recommendation on the use of tisagenlecleucel for the treatment of adults ...

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Kiwi myeloma cancer sufferers don’t have access to daratumumab, a drug available in Australia

21 November 2022 - Kiwi cancer sufferers are being denied a drug that saves lives in other countries, including Australia ...

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TLV subsidises anti-viral treatment of COVID-19 to risk groups

21 November 2022 - Paxlovid, which treats patients who are at risk of becoming seriously ill from COVID-19, will be ...

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Medicare 2.0 - a vision for the future of America’s health insurance plan

21 November 2022 - Medicare is one of the great successes in American social policy. It provides universal health insurance to ...

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TLV subsidises drugs against cystic fibrosis

18 November 2022 - The Dental and Pharmaceutical Benefits Agency, TLV, has decided that the drugs Kaftrio, Kalydeco and Symkevi, ...

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US FDA accepts for priority review the biologics license application for epcoritamab (DuoBody-CD3xCD20) for the treatment of relapsed/refractory large B-cell lymphoma

21 November 2022 - The application is supported by data from EPCORE NHL-1 Phase 1/2 trial evaluating the safety and preliminary ...

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New Quality Innovation Expert Group supports medicine innovation

21 November 2022 - The EMA has established a Quality Innovation Expert Group to support innovative approaches for the development, ...

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Moderna applies to Swissmedic for authorisation of a second bivalent COVID-19 vaccine

18 November 2022 - Application submitted for Spikevax Bivalent Original / Omicron BA.4-5 (mRNA-1273.222) ...

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Adjustment for baseline characteristics in randomised clinical trials

17 November 2022 - The purpose of randomisation in clinical trials is to ensure that there are no systematic differences between ...

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Bristol Myers Squibb warns US price reforms will dent drug development

20 November 2022 - Biggest shake-up in pharma pricing in decades prompts companies to shelve some potential therapies. ...

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