News

BMS immunotherapy accepted for UK early access scheme

Patients in the UK with certain forms of lung cancer will be able to access Bristol-Myers Squibb’s immunotherapy Opdivo after the drug was approved by the Medicines and Healthcare products Regulatory Agency for the country’s Early Access to Medicines Scheme.

Intercept files rare liver disease drug in US, EU

Intercept Pharmaceuticals has filed obeticholic acid on both sides of the Atlantic as a treatment for primary biliary cirrhosis, a rare liver disease that primarily results from autoimmune destruction of the bile ducts.

Roche’s MS therapy to be filed Q1 2016

Roche’s investigational multiple sclerosis therapy ocrelizumab has smashed targets in two Phase III trials putting it on track for regulatory filing in the first quarter of next year.

Widespread use of point-of-care CRP test could save UK £56m

Experts are calling for wide-spread use across the UK of a simple blood test to distinguish between the presence of viral and bacterial respiratory infections to help reduce prescriptions for antibiotics while saving millions of pounds.

First therapy for hidradenitis closes in on EU market

AbbVie’s Humira could soon become the first approved therapy for a chronic skin condition called hidradenitis suppurativa after European regulatory advisors backed its use in patients failing to respond to systemic treatment.

UK researchers develop breath test for infection

UK scientists have developed a test able to detect bacterial infection from the breath of critically ill patients, and thus accelerate the identification of those at highest risk of developing pneumonia.

Japan OKs new indication for Bayer’s Eylea

Japanese regulators have expanded the scope of Bayer’s eye jab Elyea to include treatment of a common retinal vascular disease that affects around 2% of people aged over 40 in the country.

Ten new therapies are backed for approval in Europe

Regulatory advisors in Europe have backed the approval of 10 new treatments, including two enzyme replacement therapies for rare diseases, cancer drugs, generics and ‘hybrid’ medicines.