European regulators have agreed to review Bristol-Myers Squibb’s application to extend the current indications for cancer immunotherapy Opdivo to include the treatment classical Hodgkin lymphoma (cHL).
News
Sanofi, Regeneron to file eczema drug this year on strong data
Sanofi and Regeneron’s atopic dermatitis candidate dupilumab has turned in a strong performance in late stage clinical trials, showing high levels of efficacy and a solid safety profile in patients with this severe form of eczema.
UK trialling genetic test for children with cancer
A pilot study aiming to sequence 81 cancer genes in children’s tumours has begun in the UK, in the hope of driving dramatic improvements in treating the disease through a more personalised approach.
US nod for first rare liver disease drug
US regulators today approved the first treatment for a rare and life-threatening condition called hepatic veno-occlusive disease.
US officials request more info on Allergan/Pfizer merger
The US Federal Trade Commission is asking for more information on the proposed merger of Pfizer and Allergan.
NICE proposes new guidance for treating multimorbidities
Cost regulators for the National Health Service in England and Wales have published new draft guidelines designed to help streamline the treatment of multimorbidities.
SBRI streams £1.4m into new solutions for A&E
SBRI Healthcare, an NHS England funded scheme to develop innovative products that address unmet health needs, is awarding £1.4 million to companies developing innovative new technologies that reduce pressures on A&E.
Sun Pharma buys Japan rights to Novartis brands
Indian speciality generic druggmaker Sun Pharma has delved into Japan’s prescription medicines market with a line of Novartis drugs in tow.
NHS outreach scheme equips 200,000 people with online skills
NHS England has revealed that 200,000 homeless, older and vulnerable people have had ‘lessons’ to help them get online and contact their doctor, to reduce GPs visits and thus save money and resources.
Medical leaders urge renewed talks on junior docs contract
The Academy of Medical Royal Colleges is asking junior doctors to end strike action and the government to suspend its imposition of the new working contract to protect patient welfare.
FDA rejects Brintellix label expansion for cognitive symptoms
The US Food and Drug Administration has turned down an application to include new clinical data in the label of Lundbeck/Takeda’s Brintellix supporting its use to treat the cognitive symptoms of major depressive disorder (MDD).
FDA panel backs Acadia’s Parkinson’s psychosis drug
Shares in Acadia were on the rise after US regulatory advisors endorsed a drug with the potential to bring a step change in the way Parkinson’s disease is treated.
Japanese approval for GSK, AZ drugs
GlaxoSmithKline’s novel biologic Nucala has picked up an approval in Japan for the treatment of bronchial asthma.
Sanofi poaches MedImmune research chief Yong-Jun Liu
Sanofi has named Yong-Jun Liu, chief of research at AstraZeneca’s MedImmune unit, as its new head of research, global R&D.
NICE drops acupuncture from back pain guidelines
Cost regulators for the NHS in England and Wales are planning to significantly reduce the treatment options for patients with lower back pain and sciatica, dropping acupuncture from the list and pushing back paracetamol to the second-line setting.
