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- PMLiVE

buprenorphine

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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

- PMLiVE

Shire claims US okay for HAE blockbuster-in-waiting

FDA approves Takhzyro as a preventative measure for HAE attacks

- PMLiVE

FDA clears Kyowa Kirin’s skin lymphoma therapy Poteligeo

Becomes the first drug approved to treat Sézary syndrome

- PMLiVE

Pfizer CEO reckons rebates will disappear, and that’s a positive

The move also has the support of FDA Commissioner Scott Gottlieb

- PMLiVE

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

Speech coincides with Biosimilars Action Plan

- PMLiVE

Novartis follows Pfizer and freezes US prices this year

And still expects revenues to come in at the high end of expectations for 2018

- PMLiVE

Novartis rejects claims it misled Senate over Cohen links

Report says Novartis discussed drug-pricing with the President’s former ‘fixer’

- PMLiVE

Pfizer builds gap between pharma and consumer health units

Its consumer health division will become a standalone unit after lack of buyer interest

- 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

- PMLiVE

AbbVie, Roche get FDA OK for broader use of Venclexta

The drug is tipped to become a $2.5bn product by 2024

- PMLiVE

Pfizer drug gets speedy FDA review for rare heart failure complication

Tafamidis chalked up a comprehensive win in its phase III trials programme

- PMLiVE

bluebird bags breakthrough status for CALD gene therapy

News comes after impressive data from a phase II/III trial

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