EMA has decided on a positive opinion for a new combo of MSD’s cancer blockbuster, Keytruda (pembrolizumab) and Inlyta (axitinib). The organisation’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of the anti-PD-1 therapy and Inlyta combo, a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced
EMA’s CHMP committee has recommended Shire’s Lanadelumab, a new rare disease treatment which has blockbuster potential. Lanadelumab has been endorsed for prevention of recurrent attacks of hereditary angioedema (HAE) a rare, genetic disorder that results in recurring attacks of oedema in parts of the body, including the abdomen, face, feet, genitals, hands and throat. Laryngeal
European Medicines Agency has approved a label extension for UCB’s Cimzia allowing it to be used for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. The approval makes Cimzia, the first Fc-free, PEGylated anti-TNF treatment option for use in moderate-to-severe plaque psoriasis “and marks the entry of UCB into immuno-dermatology, where
An announcement from the EMA has endorsed strengthened regulatory measures for prescribing valproate to women who are pregnant and of child-bearing age. The agency’s Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has endorsed strengthened measures to avoid pregnant women being exposed to the drug. Under the new measures proposed by the
European Medicines Agency has issued marketing authorisation for Orexo and MundiPharma’s Zubsolv for opioid dependence. Zubsolv is a once-daily, sub-lingual formulation of Suboxone (Buprenorphine/Naloxone), which is marketed by Invidior UK in Europe. It will be the first therapy of its kind to be approved in a choice of six different strengths in region, offering the
Jeremy Hunt, Health Secretary, and Greg Clark, Business Secretary, have recently made a bold move to suggest that the UK will consider collaborating closely with the EU in order to navigate drug approvals post-Brexit. The pharmaceutical industry has been insistent since the referendum for clearer indication of the future of drug regulation post Brexit decision
Novartis has filed its migraine drug erenumab with the EMA, putting it in a vital position amongst pharma companies competing to develop a new class of drugs to treat the debilitating condition. The Swiss drug company has stated that erenumab is the first monoclonal antibody inhibiting calcitonin gene-related peptide (CGRP) to be filed with the
Eleven new medicines have been put forward for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use, including new options for a rare eye disease, schizophrenia and cartilage defects. Oxervate won backing as a treatment for moderate or severe neurotrophic keratitis, a rare eye disease that can lead to loss of
Two drug combinations from Gilead and AbbVie that have the potential to improve treatment of chronic hepatitis C have been given accelerated review in the EU. Gilead’s application is for a three-drug combination of NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir and pan-genotypic protease inhibitor voxilaprevir that could achieve a cure for chronic hepatitis C
Merck and Pfizer’s bid to bring PD-1/PD-L1 inhibitor to market is now proceeding, after the EU regulator kicked off a review of avelumab for Merkel cell carcinoma. The drug’s marketing application is based on the results from the JAVELIN Merkel 200 study which were presented at this year’s ADCO meeting, from patients with the rare
