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Breakthrough Therapy Designation

Payer focus in the personalised world of oncology and orphan diseases

Personalised medicine is transforming disease understanding and many traditional diagnoses may be fundamentally revised based on the new scientific understanding

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FDA clears Bayer/ Algeta’s prostate cancer radiotherapy

Approval for Xofigo comes three months ahead of schedule

- PMLiVE

FDA expands use of Roche/ Astellas’ Tarceva in lung cancer patients

New indication approved alongside companion diagnostic to detect gene mutation

- PMLiVE

MSD updates Univadis, adds apps

New UK version of its HCP website will allow users to personalise the portal

- PMLiVE

FDA to review Merck & Co’s allergy immunotherapy

Accepts application for oral tablet to protect against ragweed-based allergies

- PMLiVE

Endocyte appoints Parexel’s Scot Harper to oversee clinical trials

He also previously served at Novartis and Lilly

- PMLiVE

Merck & Co wins green light in US for Zetia-Lipitor combo

Vytorin extension wins FDA approval

- PMLiVE

Roche survey says Scottish cancer patients moving house to get treatment

But NHS Scotland hits back at report's "extremely dubious" findings

- PMLiVE

FDA committee turns down Aveo/Astellas’ cancer drug

Tivozanib unable to prove superiority to Bayer's Nexavar

- PMLiVE

FDA says Janssen’s myeloma drug is a ‘breakthrough therapy’

Should speed up regulatory process for daratumumab

- PMLiVE

Merck & Co enters $430m diabetes deal with Abide

Will target group of enzymes known as serine hydrolases

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