• AstraZeneca has won a recommendation for its closely-watched hyperkalemia drug ZS-9 from the EMA’s Committee for Medicinal Products for Human Use. AstraZeneca bought the drug from ZS Pharma in a $2.7 billion deal, but was hit with a CRL from the FDA due to manufacturing concerns. A formal European approval for the drug should follow in a few months.
• San Diego-based Tocagen has won the FDA’s breakthrough therapy designation, giving them quick access to regulators as they advance Toca 511 and Toca FC for patients with recurrent high grade glioma. “Receiving Breakthrough Therapy Designation from the FDA for recurrent HGG, the first time it has been granted for this type of brain cancer, highlights the urgent need for new treatment options for this deadly disease,” said Marty Duvall, chief executive officer of Tocagen. “Based on the encouraging safety and efficacy data we have seen to date, advancing the development of Toca 511 & Toca FC continues to be our team’s top priority.”
• Merck CEO Ken Frazier and J&J chief Alex Gorsky joined a White House lineup of Fortune 500 execs brainstorming ways to create new manufacturing jobs in the US.
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