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pre-exposure prophylaxis (PrEP)

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FDA gives Loxo breakthrough tag for second cancer drug

US regulatory body to expect a NDA for LOXO-292 in late 2019

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Daily Brief: setback for Akcea/Ionis, Urovant adds gene therapy, Metrion gains funding

FDA rejects Waylivra, Roivant group continues gene therapy drive, UK biotech gains £637k

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Novartis and Gilead rival CAR-Ts approved in Europe, but supply capacity in question

Gilead looks to have edge in crucial manufacturing capability

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Shire claims US okay for HAE blockbuster-in-waiting

FDA approves Takhzyro as a preventative measure for HAE attacks

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Daily Brief: another departure at Gilead, veteran researcher to head up Karuna

Exodus continues from Gilead

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FDA clears Kyowa Kirin’s skin lymphoma therapy Poteligeo

Becomes the first drug approved to treat Sézary syndrome

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Daily Brief: Theresa May and the diabetes sensor, Biosimilars hit Roche in Europe, Gilead CEO to step down

News from pharma, biotech and healthcare

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GSK two-drug trial in untreated HIV raises Gilead rivalry

Intends to file the combination later this year to challenge Gilead’s Biktarvy

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FDA’s Gottlieb lambasts industry’s biosimilar-blocking tactics

Speech coincides with Biosimilars Action Plan

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CAR-Ts Kymriah and Yescarta step closer to approval in Europe

Final European approval around the corner - but reimbursement and specialist centres among outstanding issues

Gilead Sciences

Gilead’s Biktarvy gets European approval, setting up battle with GSK

The drug could offset Gilead's disappointing hep C franchise

- PMLiVE

Sage surges after depression drug gets rapid path to approval

Will be able to file a marketing application based on its phase II trial

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