Covid-19 delta outbreak: major PHARMAC review report delayed by lockdown

22 September 2021 - Act says it is "not good enough" an interim report for a much touted independent PHARMAC ...

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Highlights from the CHMP 13-16 September 2021 meeting

17 September 2021 - The EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2021 meeting. ...

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Should regulatory authorities approve drugs based on surrogate outcomes?

16 September 2021 - The aducanumab controversy is the latest example of surrogate outcomes failing to predict clinically important outcomes.  ...

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GSK receives CHMP positive opinions recommending approval of Nucala (mepolizumab) in three additional eosinophil driven diseases

17 September 2021 - If approved in Europe, mepolizumab would be the only treatment indicated for use in four eosinophil-driven diseases. ...

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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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Pharmacist substitution of PBS medicines without a prescription during shortages (Serious Scarcity Substitution Instrument)

18 September 2021 - Where a Serious Scarcity Substitution Instrument has been issued by the TGA, community pharmacists can substitute specific ...

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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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Keytruda made available on the NHS for certain oesophageal cancer patients

17 September 2021 - NICE has recommended MSD’s Keytruda (pembrolizumab) combined with chemotherapy for the first-line treatment of certain oesophageal ...

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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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ICER releases draft evidence report on therapies for severe asthma

16 September 2021 - Public comment period now open until 14 October 2021; requests to make oral comment during public ...

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