Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy for certain patients with locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)

17 September 2021 - Recommendation based on data from Phase 3 KEYNOTE-355 trial. ...

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BeiGene receives positive CHMP opinion for Brukinsa (zanubrutinib) for the treatment of adults with Waldenström’s macroglobulinaemia

17 September 2021 - The CHMP recommendation is based on results from the Phase 3 ASPEN trial, in which BRUKINSA ...

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Roche receives positive CHMP opinion for Gavreto (pralsetinib) for the treatment of adults with RET fusion positive advanced non-small-cell lung cancer

17 September 2021 - If approved, Gavreto will be the first and only targeted treatment approved by the EMA that ...

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Alvotech welcomes positive CHMP opinion for AVT02, a proposed biosimilar to Humira

17 September 2021 - Alvotech today welcomed the positive opinion of the EMA's CHMP recommending the approval of Alvotech‘s high-concentration AVT02 ...

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Incyte announces Health Canada conditional approval of Pemazyre (pemigatinib) as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma

17 September 2021 - Incyte today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre (pemigatinib), ...

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FDA advisory committee votes unanimously in favour of Comirnaty booster for emergency use in people 65 and older and certain high risk population

17 September 2021 - Committee reviewed clinical data showing a booster dose of Comirnaty elicits high neutralisation titres against SARS-CoV-2 and ...

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Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) for patients with previously treated radioactive iodine-refractory differentiated thyroid cancer

17 September 2021 - FDA approval based on Phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with ...

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Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full Health Canada approval for individuals 12 years and older

16 September 2021 - Health Canada Notice of Compliance is based on a comprehensive submission package including six month efficacy ...

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BridgeBio Pharma receives FDA fast track designation for investigational therapy for the treatment of limb-girdle muscular dystrophy type 2i (LGMD2i)

15 September 2021 - If successful, BridgeBio's drug could be the first approved therapy for patients with LGMD2i. ...

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Moderna announces Health Canada approves its COVID-19 vaccine

16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...

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ATAGI update following weekly COVID-19 meeting – 15 September 2021

16 September 2021 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 15 ...

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Raising the bar for using surrogate outcomes in drug regulation and health technology assessment

16 September 2021 - Surrogate outcomes provide no guarantee of clinical benefit, and Dalia Dawoud and colleagues argue they should ...

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Emergency use authorisation for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19

16 September 2021 - Expanded emergency use authorisation includes certain people who have been exposed to someone infected with SARS-CoV-2 ...

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AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) for the treatment of adults with moderately to severely active ulcerative colitis

16 September 2021 - AbbVie today announced that it has submitted applications seeking approval for upadacitinib (15 mg and 30 mg ...

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COVID-19 vaccine weekly safety report (16 September 2021)

16 September 2021 - To 12 September 2021, approximately 22.8 million vaccine doses have been given in Australia – 14 million ...

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