US regulators are now reviewing Teva Pharmaceutical’s experimental anti-CGRP therapy fremanezumab for the preventive treatment of migraine, and have also granted the drug a fast track designation for the prevention of cluster headache.
News
US priority review for AZ’ Tagrisso
US regulators are undertaking a speedy review of AstraZeneca’s application to market Tagrisso as first-line treatment for lung cancer.
New CNS partnership between Boehringer and Autifony
Germany’s Boehringer Ingelheim and Cambridge, UK-based Autifony Therapeutics have announced a new collaboration focused on a novel therapeutic approach to a range of CNS disorders.
Horizon expands agreement with Roche Diagnostics
Cambridge, UK-based Horizon Discovery has expanded its relationship with Roche Diagnostics with a new agreement to assist in the development of immunohistochemistry (IHC) assays.
Pfizer’s Xeljanz wins US nod for psoriatic arthritis
Pfizer Xeljanz and Xeljanz XR have received US marketing clearance for the treatment of adults with active psoriatic arthritis who have failed to respond or are intolerant to methotrexate or other disease-modifying antirheumatic drugs.
Seven therapies backed for EU approval
Seven therapies have been put forward for approval in the European Union, bringing closer new options for a range of conditions including Crohn’s disease, diabetes and cancer.
Clinical Researcher of the Year – The Americas: Make your mark in 2018
The 2018 competition is well underway. Hundreds of competitors have completed Stage 1, a multiple-choice questionnaire testing knowledge of Good Clinical Practice.
International Clinical Researcher of the Year: Are you allowing yourself enough time?
The deadline for entry to the prestigious PharmaTimes International Clinical Researcher of the Year 2018 is 31 January, so don’t delay, head over to the website today to register your details and get started on the Multiple-Choice Questionnaire.
NICE recommends Imbruvica for some MCL patients
It is looking likely that a subgroup of patients with mantle cell lymphoma (MCL) will get routine access to Janssen’s Imbruvica on the NHS.
Shire and partners launch Irish haemophilia study
Shire, the Royal College of Surgeons Ireland (RCSI) and Science Foundation Ireland (SFI), in collaboration with the Irish Haemophilia Society, have initiated a new study that aims to better personalise the care of haemophilia patients.
Cancer Research Technology links with Celgene
Cancer Research UK’s subsidiary Cancer Research Technology (CRT) has signed a five-year drug-discovery deal with Celgene to develop and commercialise new anti-cancer treatments.
US regulators approve Pfizer’s Remicade biosimilar
The US Food and Drug Administration has issued a green light for Pfizer’s biosimilar of Janssen’s mega blockbuster Remicade.
GW regains US rights to Sativex
GW Pharmaceuticals has reacquired full ownership of US rights to its cannabinoid medicine Sativex following the termination of a previous license agreement with Otsuka.
New initiative to raise awareness of HPV in men
A new initiative aiming to boost awareness of diseases in men caused by the human papillomavirus (HPV) has been launched in the UK.
Freeze-dried Oncaspar gets EU green light
European regulators have approved a new, freeze-dried formulation of Shire’s leukaemia therapy Oncaspar.
