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- PMLiVE

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- PMLiVE

First mAb biosimilars set for European approval

Celltrion and Hospira's versions of J&J's blockbuster Remicade recommended by CHMP

- PMLiVE

US FDA nets $41m of illegal medicines in online pharmacy crackdown

Regulator shuts down 1,677 sites in global operation

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EMA commits to disclosure of data from trials

Seeks feedback on clinical trial data access policy

- PMLiVE

US FDA approves Vibativ for lung infection caused by MRSA

Theravance’s drug backed to treat hospital-acquired bacterial pneumonia

Novartis building

US FDA deems Novartis’ heart failure candidate a ‘breakthrough’

Serelaxin demonstrates ability to reduce shortness of breath and lower chance of dying

- PMLiVE

US charity calls for release of diabetes drug data

American Diabetes Association demands review of incretin-based medicines linked to pancreatic cancer

- PMLiVE

FDA clears Amgen’s Xgeva for rare bone condition

US approval provides alternative to surgery for use in giant cell tumour of the bone

Teva and Sun pay dearly for ‘at-risk’ generic Protonix launch

Will pay $2.15bn in landmark patent infringement lawsuit

- PMLiVE

EMA seeks comment on final biosimilar guidance

Outlines thinking on non-clinical and clinical development requirements

- PMLiVE

France investigates Teva after packaging mix-up

Some packages of diuretic furosemide found to contain sleeping pill zopiclone

- PMLiVE

FDA approves Sanofi’s four-in-one flu vaccine

But wants more safety data for hepatitis B vaccine from Dynavax

- PMLiVE

FDA turns down tivozanib for kidney cancer

Agency describes data provided by Aveo Oncology and Astellas as "uninterpretable"

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