US regulators are refusing to file Celgene’s application to market its experimental multiple sclerosis therapy ozanimod.
News
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.
Record number benefitting from NHS talking therapies
A record number of people are recovering from mental ill health after accessing talking therapies on the NHS, new figures show.
Twenty percent of antibiotics prescribed inappropriately
At least 20 percent of all antibiotic prescriptions written in primary care in England are inappropriate, estimates research published by Public Health England (PHE) in the Journal of Antimicrobial Chemotherapy.
Prokarium raises $10m for thermostable vaccines
UK-based synthetic biology firm Prokarium has secured $10 million from Saudi, Swedish and Korean investors to help drive clinical development of thermostable vaccines.
Prescription charge in England to rise
The government is aiming to increase the prescription charge by 20 pence per item to help it deliver its promise of streaming £10 billion into frontline NHS services by 2020/21, but campaigners say the system is “unfair”.
Lilly’s Verzenio bags third breast cancer nod
Eli Lilly’s Verzenio has been given another green light in the US for breast cancer, significantly expanding the drug’s treatment scope.
EU clears rare musculoskeletal disorder drug
Doctors can now treat children living in the EU with the rare, chronic progressive musculoskeletal disorder X–Linked Hypophosphataemia with Kyowa Kirin/Ultragenyx’ Crysvita following its conditional approval in the region.
