European regulators have backed expanding approval of MSD’s immunotherapy Keytruda to include the treatment of locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
News
ViiV’s long-acting two-drug HIV regimen hits targets
A long-acting, two-drug HIV regimen being co-developed by ViiV Healthcare and Janssen Sciences Ireland UC has shown comparable viral suppression rates to a three-drug regimen in a Phase II trial, indicating its potential to reduce the dosing burden for patients and thus improve treatment adherence.
GSK files for extended use of Relvar Ellipta in asthma
GlaxoSmithKline and Innoviva have applied to market Relvar Ellipta for extended use in patients with asthma who are already adequately controlled on inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy.
NHS England consults on blocking ‘wasteful’ prescriptions
NHS England has unveiled detailed proposals of how prescriptions for “ineffective, over-priced and low value treatments” will be cut in order to shave millions off of the NHS’ drugs bill.
Merck, Pfizer’s avelumab clears first hurdle in early access scheme
Patients with Merkel Cell Carcinoma living in the UK are a step closer to getting early access to Merck and Pfizer’s avelumab after regulators assigned the drug Promising Innovative Medicines (PIM) status.
Eleven medicines leap closer to EU approval
Eleven therapies, including five targeting rare diseases, have taken a giant leap towards being approved in Europe after winning backing from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
NICE u-turn backs use of Teva’s asthma biologic
The National Institute for Health and Care Excellence (NICE) is now backing routine NHS commissioning of Teva’s Cinqaero to treat a severe form of asthma after having initially been minded to block the drug’s use.
EU nod for Vifor’s Veltassa
European regulators have approved Vifor Pharma’s new potassium binder Veltassa to treat hyperkalaemia in adult patients.
Tentative US approval for Merck’s diabetes therapy
The US Food and Drug Administration has given a tentative green light to Merck & Co’s follow-on biologic basal insulin Lusduna Nexvue.
Sanofi, Ablynx sign $2.7bn research, licensing pact
Sanofi has signed a research pact and licensing deal with Ablynx that could bring as much as $2.7 billion euros to the Belgian biotech’s coffers if all targets are met.
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EU approves LEO Pharma’s psoriasis biologic
A new treatment option has been approved in the European Union for patients with psoriasis, paving the way for access to a novel approach for those with moderate-to-severe forms of the disease who are candidates for systemic therapy.
Final NHS green light for Amgen’s Kyprolis
Patients living with multiple myeloma across England and Wales should now get ‘routine’ access to Amgen’s Kyprolis on the NHS within three months following a final green light from the National Institute for Health and Care Excellence.
‘Compelling’ mid-stage data for Vertex’ CF drugs
Vertex Pharmaceuticals has unveiled “compelling data” from Phase I and Phase II studies assessing three experimental triple combination regimens for patients with certain forms of cystic fibrosis (CF).
GSK to cut 320 jobs amid manufacturing revamp
GlaxoSmithKline is trimming its UK workforce by around 320 under a shake-up of its manufacturing network in the country, in a move designed to boost efficacy and competitiveness.
