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market access in Japan

Implementation of Cost-Effectiveness Analysis in Japan’s Health Technology Assessment Process

Japan’s evolving approach to market access includes a formal cost-effectiveness analysis (CEA) requirement for certain new medicines and medical devices. Introduced as part of a broader health technology assessment (HTA)...

Petauri Evidence

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Bayer’s Kerendia granted FDA approval for new heart failure indication

Approximately 55% of the 6.7 million adults in the US with HF have an LVEF of at least 40%

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Bayer’s Vitrakvi receives full FDA approval for NTRK gene fusion-positive tumours

The US regulator first approved the TRK inhibitor in 2018 under its accelerated approval pathway

- PMLiVE

Sobi receives NICE recommendation for Altuvoct in severe haemophilia A

Approximately 7,700 people in England are living with the genetic bleeding disorder

- PMLiVE

FDA grants RMAT designation to AskBio’s Parkinson’s gene therapy candidate

The progressive neurodegenerative disease affects more than ten million people worldwide

- PMLiVE

Sobi receives MHRA approval for Altuvoct in severe or moderate haemophilia A

The factor VIII replacement therapy has been authorised to treat and prevent bleeding in children and adults

- PMLiVE

Novo Nordisk’s haemophilia A therapy Mim8 shows promise in late-stage study

The inherited bleeding disorder accounts for up to 85% of the 1,125,000 global haemophilia cases

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Bayer UK launches digital educational hub to improve menopause support

An estimated 13 million women in the UK are currently perimenopausal or menopausal

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Bayer’s non-hormonal menopause drug shows promise in phase 3 breast cancer trial

Breast cancer patients can experience vasomotor symptoms as a result of adjuvant endocrine therapy

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Bayer presents positive results for Kerendia in late-stage heart failure study

Approximately 55% of the 6.7 million heart failure patients in the US have an LVEF of at least 40%

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Bayer and NextRNA Therapeutics enter oncology partnership worth $547m

The companies will advance small molecule therapeutics against a new class of targets for cancer

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Bayer shares promising results for Kerendia in phase 3 heart failure study

Approximately 55% of heart failure patients have an LVEF of at least 40%

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