MSD has launched in the UK Europe’s first biosimilar to Roche/Genentech’s Herceptin, providing an alternative option for treating early breast cancer, metastatic breast cancer and metastatic gastric cancer.
News
US green lights novel HIV treatment
US regulators have approved a new option for treating HIV, marking the first therapy with a new mode of action in a decade.
EMA recommends suspension, recall of Zinbryta
The European Medicines Agency is now recommending the immediate suspension and recall of Biogen’s multiple sclerosis therapy Zinbryta, just days after announcing a safety review.
BI, Lilly expand Jardiance programme in heart failure
Boehringer Ingelheim and Eli Lilly are expanding their clinical trial programme for Jardiance in chronic heart failure (CHF) with two new Phase III studies.
BMS’ Opdivo cleared for monthly use
US regulators have approved a label update to Bristol-Myers Squibb’s Opdivo, waving through a new dosing option for the immunotherapy of every four weeks.
Gedeon’s re-filed Neulasta biosimilar under EU review
European regulators have accepted a resubmission of Gedeon Richter’s biosimilar to Amgen’s Neulasta.
PHE campaign calls on the UK to diet
Public health officials in the UK are calling on people in the UK to reduce their calorie intake in a bid to cut back on levels of obesity and related conditions, which are putting a huge strain on healthcare resources.
Novartis’ Xolair backed in global urticaria guidelines
Novartis’ Xolair has been recommended in global guidelines for treating chronic spontaneous urticaria in patients unresponsive to antihistamines.
Santhera’s Raxone fails in MS trial
Santhera has been hit with more bad news regarding its flagship mitochondrial disease therapy idebenone, after it failed to hit targets in a trial assessing its potential in multiple sclerosis.
Artios in-licenses experimental cancer drug
Cambridge, UK-based Artios Pharma has exercised an option to in-license the first nuclease drug development programme from its research alliance with Masaryk University in the Czech Republic.
GSK’s Nucala improves control of severe asthma
GlaxoSmithKline has presented data showing that its biologic Nucala improved asthma control in patients with severe disease not adequately managed with Novartis’ Xolair.
Shire’s constipation drug under US review
Shire’s prucalopride is being assessed by regulators in the US as a treatment for chronic idiopathic constipation (CIC).
AZ’ Forxiga to be reviewed for diabetes type I
The European Medicines Agency has accepted AstraZeneca’s filing for Forxiga as a treatment for diabetes type I.
Hospitals trialling faster approach to prostate cancer diagnosis
Three hospitals in England are trialling a “world-leading” approach to diagnosing prostate cancer that could significantly cut the time it takes to detect the disease.
UK PM signals intent to remain with EMA
Prime Minister Theresa May has unveiled the government’s desire for the UK to remain part of the European Medicines Agency following its departure from the European Union.
