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Regulatory & Safety: Top Headlines

US FDA rejects Pfizer's Epogen biosimilar citing McPherson plant warning letter

Pfizer site in McPherson, Kansas

23-Jun-2017 - Concerns about Pfizer’s fill/finish plant in McPherson, Kansas prompted the US FDA to reject the firm’s biosimilar version of Amgen’s anaemia drug Epogen.

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US FDA slams Chinese API maker over data breaches

22-Jun-2017 - Qinhuangdao Zizhu omitted, deleted and manipulated manufacturing data at its active pharmaceutical ingredient plant in Hebei, China according to the US FDA.

Germany’s Merck invests in immune-oncology in Switzerland

21-Jun-2017 - Merck KGaA’s corporate venture division has created an immune-oncology company based on a mixture of small and large molecule drugs, including Merck and Pfizer’s Bavencio (avelumab). 

Patient deaths end Seattle Genetics leukaemia Phase III trial

21-Jun-2017 - Seattle Genetics announced it has discontinued its Phase III Cascade trial of Vadastuximab Talirine (SGN-CD33A) for the treatment of frontline acute myeloid leukaemia (AML), due to patient deaths.

Implementing continuous manufacturing a challenge, say industry delegates

21-Jun-2017 - Industry professionals at a continuous manufacturing (CM) summit last month said while the approach offers advantages, implementing the method can be challenging.

EMA, FDA and PMDA aim to give antibiotic firms option of global trial programme

20-Jun-2017 - The EMA says aligning antibiotic trial requirements with the US FDA and Japan’s PMDA should allow drug firms to conduct single global development programmes.

Pfizer recalls injectables made at Rocky Mount over potential contamination risk

19-Jun-2017 - Pfizer has recalled four injectables – including the already scarce heart surgery drug Sodium Bicarbonate - made at Hospira's facility in Rocky Mount, North Carolina after identifying a potential contamination risk.

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Nevada law requires insulin firms to disclose prices and profits

19-Jun-2017 - Drug manufacturers selling insulin in Nevada in the US must disclose what they charge and how much the make from the drug under legislation signed into law last week.

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