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- PMLiVE

soft tissue sarcoma

- PMLiVE

New FDA guidance for advertising

Clarifies circumstances when drug names need to be mentioned

Biogen Idec building

Biogen Idec wins EU battle on Tecfidera exclusivity

Oral MS drug gains New Active Substance status

- PMLiVE

Ariad’s cancer drug to remain on EU market

But EMA restricts use of Iclusig due to blood clot risk

- PMLiVE

CHMP recommends Gilead’s sofosbuvir for hep C

Set to be first interferon-free treatment regime

- PMLiVE

FDA turns down Forest/Gedeon Richter’s antipsychotic

US regulator wants more information for cariprazine

Eli Lilly HQ

Lilly exploring diabetes portfolio for Alzheimer’s potential

Undertakes pre-clinical investigations as it monitors the area

- PMLiVE

AZ drug for opioid constipation starts FDA review

Naloxegol on course to compete with Takeda’s Amitiza

EU flag

EMA drug data to address HTA needs

EU regulator agrees joint work plan with EUnetHTA

- PMLiVE

Teva withdraws US filing for cancer biologic

FDA requests more data for balugrastim

- PMLiVE

EMA warns of excessive caution by regulators

Agency says risk aversion could deny patients new treatments

- PMLiVE

Lilly invests $700m in insulin manufacturing

Expands plants in Puerto Rico, France, China and US

- PMLiVE

FDA clears J&J’s breakthrough lymphoma therapy

Imbruvica approved to treat mantle cell lymphoma

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