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BMS strikes $14bn deal for Karuna Therapeutics

European Pharmaceutical Review

The deal includes Karuna’s lead asset KarXT (xanomeline-trospium), a potential first-in-class treatment for schizophrenia. KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile.

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FDA accepts Ardelyx’s NDA resubmission for XPHOZAH

Pharma Leaders

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmitted New Drug Application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adult patients with chronic kidney disease on dialysis who have had an insufficient response or intolerance to a phosphate binder therapy.

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The internet enables misinformation on COVID

World of DTC Marketing

While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. The major concerns for hesitancy included worries over side effects and that the vaccine is too new. Also cited was a lack of trust in the government to ensure the vaccines’ safety and effectiveness.

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ANeuroTech shares plans for major depressive disorder pivotal programme

Pharmaceutical Technology

Belgium-headquartered ANeuroTech is participating in a Series B round, which will raise up to $150m to power the pivotal programme of its lead candidate ANT01 for use as an adjunctive treatment for major depressive disorder (MDD). The company aims to run an interim analysis of the trial by mid-2024 at the very latest.

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Three-dose vaccine prevents HIV patients getting hepatitis B

European Pharmaceutical Review

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B.

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Developing a new treatment paradigm for chronic kidney disease

European Pharmaceutical Review

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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Developing a new treatment paradigm for IgAN

European Pharmaceutical Review

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).