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EMA clears Janssen to make HIV drug using continuous manufacturing approach

The EMA has cleared Janssen to make the HIV drug Prezista using a continuous manufacturing process as well as the previously approved batch method.

US FDA rejects Pfizer's Epogen biosimilar citing McPherson site warning

Concerns about Pfizer’s fill/finish plant in McPherson, Kansas have prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

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Clinical hold for Seattle Genetics’ frontline myeloid leukaemia drug

The US Food and Drug Administration (FDA) has put Seattle Genetics’ investigational new drug application for vadastuximab talirine (SGN-CD33A) on clinical hold .

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Zynerba starts Ph I study of cannabinoid pain patch

Zynerba Pharmaceuticals Inc has begun a Phase I trial of cannabinoid patch it is developing for fibromyalgia and peripheral neuropathic pain.

US FDA slams Chinese API maker over data breaches

Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.

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