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- PMLiVE

MNK-795

Biogen Idec building

Eisai and Biogen plan phase III trials for Alzheimer’s drug

BACE inhibitor E2609 may offer new treatment option

- PMLiVE

Novo Nordisk’s Tresiba gaining ground in basal insulin market

Delivers $216m this year despite ICER's report of insufficient data to favour the drug over Sanofi's Lantus

Novartis Gehry Building

FDA deems ribociclib a breast cancer breakthrough

Novartis looks to catch-up with Pfizer’s Ibrance with early approval in the US

- PMLiVE

EMA suspends generic drugs on data integrity concerns

Reports by FDA and WHO find evidence of data manipulation by Semler Research Centre

- PMLiVE

Santhera facing long delay for muscular dystrophy drug in US

FDA rejects accelerated marketing application for Raxone to await phase II trial results

- PMLiVE

Juno cleared to restart CAR-T trial after deaths

Study attributes fatalities to pre-conditioning therapy, not the cancer immunotherapy

- PMLiVE

Novartis gets FDA panel backing for biosimilar Enbrel

However Amgen claims patent protection for the psoriatic arthritis therapy is valid until 2029

- PMLiVE

Amgen’s Humira biosimilar moves closer to US approval

FDA committee backs company's version of AbbVie's blockbuster

Shire Basingstoke

FDA finally approves Shire’s potential blockbuster Xiidra

Dry eye disease treatment wins US licence

- PMLiVE

Amgen’s Kyprolis wins new indication in Europe

Regulators have handed the treatment a less restrictive licence in multiple myeloma 

- PMLiVE

FDA approves Gilead’s ‘universal’ hep C combination Epclusa

Adds a third Sovaldi-based treatment to the firm’s portfolio

Roche Basel Switzerland

Roche’s MS drug Ocrevus awarded priority review by FDA

Comes as Swiss company files the therapy with the FDA and EMA

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