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.
News
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
GW’s cannabidiol gets EU orphan status for TS
GW Pharma’s cannabidiol (CBD) has been granted orphan drug designation by European regulators for the treatment of tuberous sclerosis (TS).
Speedy EU review for Shire’s lanadelumab
European regulators will undertake an accelerated assessment of Shire’s hereditary angioedema (HAE) drug lanadelumab.
Roche/Chugai’s Hemlibra wins green light for bleeding disorder
The European Commission has licensed Roche/Chugai’s Hemlibra for the routine prevention of bleeding episodes in patients with haemophilia A with factor VIII inhibitors.
AstraZeneca spins out new firm Viela Bio
AstraZeneca’s biologics research and development arm MedImmune has spun out six molecules from its early-stage inflammation and autoimmunity programmes into new independent biotech Viela Bio.
