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EMA committee says AB Science’s Masitinib should not be approved in light of GCP failings

AB Science’s candidate cancer drug Masitinib (masitinib) should not be approved according to an EMA committee, which cited concerns about data and failings identified in a 2015 trial.

Aduro and Merck & Co to test Keytruda and CRS-207 in second cancer study

Merck & Co and Aduro Biotech have announced plans to test Keytruda combined with CRS-207 in patients suffering malignant pleural mesothelioma as a result of exposure to asbestos.

US triples indications for Kalydeco without needing new clinical data

The US FDA has approved Vertex’s cystic fibrosis drug Kalydeco (ivacaftor) to treat a further 23 genetic mutations based solely on in vitro data.

Synlogic takeover secures Mirna’s NASDAQ listing + $40m cash

Synlogic has announced it will conduct a reverse merger with failed Mirna Therapeutics, to focus on metabolic and inflammatory diseases and cancer.

CEFIC: members will only sell GHB intermediate to legitimate industry users

Cefic has agreed to make sure its members only sell the intermediate gamma butyrolactone (GBL) to legitimate users to stop it being abused or used in “date rape” drug GHB.

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