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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.

Repacker Fagron pulls three lots of Pfizer-made anaesthetic

Repackaging firm Fagron Sterile Services has recalled three lots of general anaesthetic made at Pfizer’s Rocky Mount facility in North Carolina.

Grace to start making fluorinated drug intermediates with tech from Valliscor

W.R Grace & Co has announced its intention to start making fluorinated pharmaceutical intermediates with technology obtained from Valliscor Llc.

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.

News in brief

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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