Shire’s prucalopride is being assessed by regulators in the US as a treatment for chronic idiopathic constipation (CIC).
News
AZ’ Forxiga to be reviewed for diabetes type I
The European Medicines Agency has accepted AstraZeneca’s filing for Forxiga as a treatment for diabetes type I.
Hospitals trialling faster approach to prostate cancer diagnosis
Three hospitals in England are trialling a “world-leading” approach to diagnosing prostate cancer that could significantly cut the time it takes to detect the disease.
UK PM signals intent to remain with EMA
Prime Minister Theresa May has unveiled the government’s desire for the UK to remain part of the European Medicines Agency following its departure from the European Union.
Biogen, AbbVie pull MS drug from the market
European regulators have started an “urgent review” of Biogen and Abbvie’s multiple sclerosis therapy Zinbryta following a stream of cases of serious inflammatory brain disorders in patients taking the drug.
Verona’s RPL554 improves lung function in CF trial
London, UK-based Verona Pharma’s experimental phosphodiesterase therapy has hit targets in a mid-stage trial in patients with cystic fibrosis.
Sanofi files Dupixent for severe asthma
US regulators have accepted for review Sanofi/Regeneron’s biologic Dupixent as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma.
Mylan, Revance link to develop Botox biosimilar
Mylan and Revance Therapeutics have unveiled plans to develop a biosimilar to Allergan’s neuromodulator Botox.
Novartis, Pear to develop digital therapies for schizophrenia, MS
Novartis and Pear Therapeutics have signed a deal to develop digital therapeutics for patients with schizophrenia and multiple sclerosis.
MHRA authorises in vivo genome editing trial
The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted permission for initiation of Europe’s first in vivo genome editing study.
FDA turns away filing for Celgene’s MS drug
US regulators are refusing to file Celgene’s application to market its experimental multiple sclerosis therapy ozanimod.
Cell and Gene Therapy Catapult forges stronger link with Japan
The UK’s Cell and Gene Therapy Catapult (CGT Catapult) is linking with the Japanese Society for Regenerative Medicine (JSRM) to propel progress in regenerative medicine and cell/gene therapies in both countries.
GP satisfaction hits all time low
Satisfaction with GP services has dropped to its lowest point in 35 years, while overall public satisfaction with the NHS has also taken a significant downturn, according to findings of the latest British Social Attitudes (BSA) survey.
NICE nod for Merck/Pfizer’s Bavencio
Patients in England, Wales and Northern Ireland with a rare and aggressive type of skin cancer will get routine access to a new treatment option on the NHS after cost regulators waved through Merck and Pfizer’s Bavencio.
Novo files N8-GP in the US and EU
Novo Nordisk has filed regulatory applications in the US and European Union seeking approval to market N8-GP for the treatment of haemophilia
