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- PMLiVE

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- PMLiVE

Bad news for Portola as CHMP considers Factor Xa drugs

The committee are ‘unlikely’ to adopt a positive opinion for betrixaban

EISAI

NICE reverses its rejection of Eisai’s Lenvima

The cost-effectiveness watchdog has now backed the thyroid cancer treatment

Shire teams up with Microsoft and EURORDIS for rare disease project

Will work to accelerate the time to diagnosis for children

- PMLiVE

Gilead’s triple HIV drug approval prompts GSK lawsuit

ViiV claims bictegravir infringes its patent estate

- PMLiVE

EMA’s Amsterdam home will not be ready in time

Staff will initially move to a temporary building in the city after Brexit

- PMLiVE

CHMP hands Santhera second ‘no’ in Duchenne muscular dystrophy

Swiss biopharma says it will re-file Raxone for the licence extension

- PMLiVE

EMA hands UniQure orphan status first in Huntington’s

The Dutch biotech expects to file the treatment for approval later this year

- PMLiVE

Shire says all its studies will publish in open access journals

The Irish biotech says its focus on rare diseases was a key factor behind the decision

- PMLiVE

Novartis gets speedy reviews for new Kymriah filings

US and EU regulatory agencies will review the drug for DLBCL patients

Shire wins FDA approval for haemophilia dosing software

The web-based myPKFiT supports the pharma firm's Advate treatment

- PMLiVE

Shire claims EU approval for haemophilia A drug Adynovi

The drug will battle Bayer’s Kovaltry and Sobi's Elocta in a bid to capture market share

- PMLiVE

Shire separates out neuroscience as it considers its future

Follows last year's strategic review at the Irish biotechnology firm

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