FDA approves Roche’s assay to assess ovarian reserve
10 January 2017 | By Niamh Marriott, Digital Editor
The blood test produces standardised results for assessing ovarian reserve as compared with the use of vaginal ultrasound...
List view / Grid view
News
Aridis’ human monoclonal antibody pneumonia trial a safe success
9 January 2017 | By Niamh Marriott, Digital Editor
AR-301 (Salvecin) is a fully human monoclonal IgG1 antibody that specifically targets S. aureus alpha-toxin and protects host cells from destruction...
Amorsa to collaborate with J&J on treatment-resistant depression therapy
5 January 2017 | By Niamh Marriott, Digital Editor
Amorsa has announced a research, option and license agreement with Janssen to develop and commercialise a novel small molecule drug candidate for depression...
FDA to review 3 new diabetes drugs that reduce cardiovascular death risk
5 January 2017 | By Niamh Marriott, Digital Editor
In the trial, empagliflozin significantly reduced the relative risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack by 14%...
Enterome starts Phase I Crohn’s disease trial
5 January 2017 | By Niamh Marriott (Digital Editor)
Enterome has launched a Phase I clinical study with its lead drug candidate EB8018, a small molecule designed to block FimH, to treat Crohn’s disease...
Vtesse appoints Jason Meyenburg as Chief Commercial Officer
4 January 2017 | By Niamh Louise Marriott, Digital Editor
Meyenburg joins the company from Alexion Pharmaceuticals, where he most recently served as Senior Vice President of Commercial Operations.
Sanofi’s insulin injection Soliqua 100/33 now available in US
4 January 2017 | By Niamh Louise Marriott, Digital Editor
It is indicated for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide...
FDA grants priority review for Bayer’s liver cancer treatment
4 January 2017 | By Niamh Louise Marriott, Digital Editor
The application is based on data from the placebo-controlled Phase III trial which investigated the drug as a second line treatment...
FDA clears Glenmark’s HER2+ cancer drug for Phase I trial
3 January 2017 | By Niamh Louise Marriott, Digital Editor
Preclinical studies suggest GBR 1302 may have activity against a range of HER2-expressing tumour types, including breast, gastric and other cancers...
Sanofi Pasteur and MSD end joint vaccines business in Europe
3 January 2017 | By Niamh Louise Marriott, Digital Editor
Sanofi and its vaccines business unit Sanofi Pasteur will end their vaccine joint-venture with MSD (known as Merck in the US and Canada) - SPMSD...
NHS England to fund bionic eye surgery
3 January 2017 | By Niamh Louise Marriott, Digital Editor
Surgeons at Manchester and Moorfields Eye Hospital made history by delivering the world’s first trial of the Argus II Bionic Eye implants in RP...
NICE says Roche’s trastuzumab emtansine too expensive for routine NHS use
29 December 2016 | By Niamh Louise Marriott, Digital Editor
Trastuzumab emtansine is currently being funded through the Cancer Drugs Fund (CDF). NICE is looking again at its 2015 guidance to see whether it should...
Orion seeks EU market authorisation for asthma/COPD product
22 December 2016 | By Niamh Louise Marriott, Digital Editor
Based on the results Orion is planning to apply for a marketing authorisation for the product in Europe. Orion currently estimates that the marketing...
Takeda makes €10 million equity investment in TiGenix
22 December 2016 | By Niamh Louise Marriott, Digital Editor
TiGenix, has exercised the option granted by Takeda under the licensing agreement to make a €10 million equity investment in TiGenix...
NICE and FDA team up for technology collaboration
20 December 2016 | By Niamh Louise Marriott, Digital Editor
The National Institute of Health and Care Excellence (NICE) and the United States’ Food and Drug Administration (FDA) will team up, using technology to...
