US regulatory advisors are not recommending approval of Johnson & Johnson’s Plivensia for rheumatoid arthritis, having concluded – based on the data available – that the benefits of the drug do not outweigh the potential risks.
News
Wide range of companies set to be represented at Marketer & Comms Team of the Year 2017
This year’s competition has attracted entries from a wide range of companies, including Celgene, Shire, Bayer, AbbVie, Eisai Europe, Novartis, MSD, Lundbeck, Novo Nordisk, Internis, Sanofi, HFA Healthcare Products, Sandoz and Bristol-Myers Squibb Pharmaceuticals among others. “Don’t miss out on this crucial opportunity to identify and benchmark talent within your organisation and against others in the industry,” says PharmaTimes business manager and competition lead, Luci Chalk.
FDA green lights first treatment for chronic GvHD
The US Food and Drug Administration has expanded the scope of Johnson & Johnson/AbbVie’s Imbruvica to include the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments, marking the first therapy specifically approved for the condition in the US.
Diabetes prescriptions rocket 80 percent in a decade
Growth in prescriptions for diabetes medicines is exceeding the rise in overall prescribing, according to new figures from NHS Digital.
Green light for Celgene’s targeted AML drug
US regulators have issued a green light for Celgene and Agios’ Idhifa, the first and only targeted treatment for adult patients with relapsed/refractory acute myeloid leukaemia and an isocitrate dehydrogenase-2 mutation.
Fast-track pancreatic cancer surgery boosts success, saves money
Accelerating access to pancreatic surgery has been shown to boost success rates by more than a fifth with a cost saving to the NHS of around £3,200 per patient.
Priority review and breakthrough status for AZ’ acalabrutinib
AstraZeneca and group member Acerta Pharma say acalabrutinib is being given a priority review by the US Food and Drug Administration for mantle cell lymphoma (MCL), hot on the heels of it having been assigned a breakthrough designation by the regulator.
Grantham Hospital extends overnight closure of A&E
Grantham and District Hospital’s emergency department will shut its doors overnight for at least another three months because of staff shortages, United Lincolnshire Hospitals NHS Trust has announced.
Kite first to submit CAR-T therapy in Europe
Kite Pharma has submitted the first CAR-T cell therapy in Europe, seeking permission to market its axicabtagene ciloleucel (axi-cel) to treat patients with three subtypes of aggressive non-Hodgkin lymphoma (NHL).
Amgen, Allergan’s Herceptin biosimilar filed in the US
US biotech giant Amgen and Dublin, Ireland-based Allergan have now filed ABP 980 – a biosimilar version of Roche’s blockbuster biologic trastuzumab – with the US Food and Drug Administration.
Patients at risk in Brexit negotiations, warns Alliance
The Brexit Health Alliance is warning that patients could be at risk if their interests are not protected in negotiations over the UK’s departure from the European Union.
Gov’t unveils plans to create 21,000 new mental health posts
Health Secretary Jeremy Hunt has unveiled new plans to expand the mental health workforce and address the “historic imbalance” in capacity in order to “fulfil ambitions” to improve mental health services.
NICE bars obesity pill from routine NHS use
Cost regulators for NHS treatments in England and Wales are standing by their position that Orexigen’s weight loss pill Mysimba can not be recommended as a cost-effective treatment option.
New hepatitis C therapies approved in Europe
Patients with hepatitis C in Europe could soon gain access to two new pan-genotypic treatment options after the European Commission issued approval for AbbVie’s Maviret and Gilead’s Vosevi following an accelerated review.
GP leaders warn of ‘break-point’ for the profession
GP leaders are warning that the profession will reach break point unless progress on certain elements of the GP Forward View is accelerated.
