News

The FDA has approved Celltrion and Pfizer’s biosmiliar of Johnson & Johnson’s Remicade (infliximab) for treating Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine – making it only the second biosimilar approved in the US.

Pfizer and Allergan are reportedly looking to jointly terminate their planned $160 billion merger following new US rules designed to curb so-called ‘tax inversion’ deals.

Increasing workloads for GPs and nurses are unsustainable, and general practice in England could be reaching saturation point, a new study published in The Lancet has suggested.

The US Department of Treasury has unveiled new measures to curb so-called tax inversion deals, which may affect Pfizer’s plans for its $160-billion merger with Allergan.

Amgen and UCB have unveiled Phase III results backing romosozumab’s efficacy in boosting bone mineral density in certain postmenopausal women with osteoporosis. 

NHS Improvement and NHS England have published the first national, integrated whistle-blowing policy to help standardise the way organisations should support staff who raise concerns.

The US Food and Drug Administration has green-lighted Gilead Sciences’ Descovy for the treatment of HIV, marking the first approval of new core therapy for the disease in more than 10 years.

Gilead Sciences is snapping up a subsidiary of Nimbus Therapeutics for access to its experimental therapy for a metabolic disorder causing fat buildup in the liver.

Eisai’s breast cancer drug Halaven could soon be available in Europe to treat liposarcoma, after regulatory advisors backed expanding its use.

Private UK group Oxford BioTherapeutics has signed a deal with Italy-based Nerviano Medical Sciences to secure access to its novel drug-linker technology with a view to expanding its own portfolio of antibody drug conjugates (ADC).

Novartis has released new analysis showing that Entresto cut cardiovascular death or hospitalisation for heart failure, “consistently benefitting” patients with reduced ejection fraction regardless of clinical stability or background therapy.

Seven new medicines – including the first gene therapy for patients with an ultra-rare immune disorder – have been endorsed by regulatory advisors for approval in Europe. 

GlaxoSmithKline is planning to adopt a new intellectual property (IP) framework under which it will not file for patent protection in the world’s poorest nations, to help widen access to its medicines.

European regulators have issued a green light for Bio Products Laboratory’s Coagadex, marking the first-ever treatment for the rare bleeding disorder factor X deficiency.

NHS England will release crucial funding for HIV therapy Rezolsta, its once-daily, fixed-dose combination of darunavir and the ‘pharmacoenhancer’ cobicistat.