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Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars.
Tinostamustine has been granted Orphan Drug Designation by the European Commission to the treatment of T-cell prolymphocytic leukaemia (T-PLL).
The licence extension submission for Invokana and Vokanamet has been accepted by the EMA.
The EMA has granted a Marketing Authorization for Zubsolv, a novel rapidly-disintegrating treatment option for opioid dependence...
23 February 2017 | By Niamh Marriott, Digital Editor
The European Commission has approved Truxima (biosimilar rituximab) for all indications of reference rituximab in the European Union.
4 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Studies showed that Nyxoid is bioequivalent to injectable naloxone as a first line treatment for opioid overdose, with an intranasal 1.8 mg dose...
14 July 2016 | By Victoria White, Digital Content Producer
A first in class, fusion molecule, S101 is currently being developed for the treatment of relapsed-refractory haematological malignances...
30 June 2016 | By Victoria White, Digital Content Producer
Orexo’s Zubsolv (buprenorphine and naloxone sublingual tablet) is a potential new treatment option for patients with opioid dependence...
6 January 2016 | By Victoria White
Newly presented data from the largest real world study to date demonstrate effectiveness of biosimilar infliximab in patients with inflammatory bowel diseases who have been switched from reference infliximab...
3 August 2015 | By Victoria White
The FDA has accepted Mundipharma EDO’s IND for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours...
17 February 2015 | By Mundipharma
Mundipharma to provide supplies for at least two million handwashes in Ebola treatment centres...
7 January 2015 | By Mundipharma
Mundipharma announced that Targin® (Targinact®, Targiniq®), a fixed combination of prolonged-release oxycodone/naloxone, has received a positive European Commission decision for a new indication, as a second line symptomatic treatment for patients with severe to very severe idiopathic restless legs syndrome (RLS), after failure of dopaminergic therapy...
11 November 2014 | By Mundipharma
New research unveiled by Mundipharma highlights inconsistencies in health economic models and measurement methods used in clinical trials for pain therapies...
8 September 2014 | By Mundipharma
New data from a randomised, multicentre, phase III study, being presented at the European Respiratory Society (ERS) annual congress in Munich, Germany, supports the potential of flutiform® for the treatment of paediatric asthma...
Results from the StiL NHL-1 study...
