Europe’s innovative and generics drugmakers have come together to urge the continent’s lawmakers to adopt an integrated life sciences strategy.
News
FDA OKs Ipsen’s gastroenteropancreatic tumours drug
Patients with a rare type of cancer called gastroenteropancreatic neuroendocrine tumours (GEP-NETs) have gained access to a new treatment option following US approval of Ipsen’s Somatuline Depot (lanreotide) injection.
Auspex drug on target in Ph III Huntington’s trial
Auspex Pharmaceutical’s experimental medicine designed to reduce abnormal movements associated with Huntington’s disease is on track for a US filing next year after hitting targets in a Phase III trial.
EMA says much more info needed on Ebola meds
The European Medicines Agency says that “at this point in time there is not enough evidence for any” of the experimental therapies for Ebola to draw conclusions on their safety or efficacy.
FDA gives green light to Novartis acromegaly drug
Regulators in the USA has approved a long-acting release of Novartis’ Signifor as a treatment for acromegaly.
Janssen launches HIV combo Rezolsta in UK
Johnson & Johnson unit Janssen has launched its once-daily, fixed-dose HIV combination therapy Rezolsta in the UK.
NHS cost watchdog in favour of Bayer’s Xofigo
It is looking likely that patients with prostate cancer will, in certain circumstances, get ‘routine’ access to treatment with Bayer’s Xofigo (radium 223) on the National Health Service in England and Wales.
Pfizer’s Inlyta close to approval for NHS use
The National Institute for Health and Care Excellence has published final draft guidelines endorsing the use of Pfizer’s Inlyta (axitinib) by the National Health Service to treat advanced kidney cancer in some patients.
80% of bowel cancer surgery patients alive after two years
Eighty percent of bowel cancer patients in England and Wales who have had major surgery are still alive two years after diagnosis versus 43% of patients who haven’t, data published this morning shows.
Cancer Drugs Fund ‘costly mistake’ as re-evaluation begins
An important week for the future of the Cancer Drugs Fund has begun as NHS England starts its re-evaluation of 25 treatments currently on the list and reviews the merits of another ten.
Novartis backs $34M funding for Annexon Huntington’s drug
Novartis has led a $34 million financing in Annexon Bioscience, which is developing ANX005 for the treatment of neurodegenerative and autoimmune disorders, principally Huntington’s disease.
Pfizer buys Opko’s growth hormone for $570m
In move to further fatten its R&D pipeline and strengthen its commitment to rare diseases, Pfizer is buying access to Opko Health’s investigational long-acting human growth hormone for up to $570 million.
Roche files melanoma combo in USA
Roche’s Genentech unit has filed cobimetinib in combination with already-marketed Zelboraf with regulators in the USA for the treatment of the deadliest form of skin cancer.
US breakthrough status for Genentech’s Lucentis
US regulators have assigned Genentech’s VEGF inhibitor Lucentis (ranibizumab) breakthrough therapy status as a treatment for diabetic retinopathy.
NICE U-turn backs biologics for ulcerative colitis
The National Institute for Health and Care Excellence has reversed a previous guidance and recommended use on the NHS of three big-selling biologics – Merck & Co’s Remicade and Simponi and AbbVie’s Humira – for treating moderately to severely active ulcerative colitis.
