FDA accepts Sanofi and Regeneron’s biologics license resubmission
2 May 2017 | By Niamh Marriott, Junior Editor
The FDA has accepted the resubmission of Sanofi and Regeneron Pharmaceuticals’ Biologics License Application for Kevzara (sarilumab)...
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FDA expands approved use of Bayer’s liver cancer treatment
2 May 2017 | By Niamh Marriott, Junior Editor
The FDA has expanded the approved use of Bayer's Stivarga (regorafinib) to include treatment of patients with hepatocellular carcinoma...
NICE recommends Janssen’s Crohn’s Disease biological therapy
2 May 2017 | By Niamh Marriott, Junior Editor
NICE has recommended Stelara (ustekinumab) in its final appraisal determination as a treatment option for adult patients with Crohn’s disease...
Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment
28 April 2017 | By Niamh Marriott, Junior Editor
The European Medicine Agency's CHMP has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ Kevzara...
Novartis real-world data confirms benefit of Gilenya in relapsing MS
28 April 2017 | By Niamh Marriott, Junior Editor
Novartis announced data from the MS-MRIUS study, which confirmed the effectiveness of Gilenya (fingolimod) in the real-world setting...
SIRT is better tolerated than sorafenib, but doesn’t increase overall survival in HCC
28 April 2017 | By Niamh Marriott, Junior Editor
Results of the SARAH trial demonstrate that SIRT resulted in median overall survival (OS) of 8.0 months compared to 9.9 months with sorafenib (p=0.179)...
12 months on: European Commission present updates on GDPR timelines and objectives at 7th annual BioBanking Industry Summit
27 April 2017 | By SMi Group
Legal advisor and policy analyst to provide opening keynote on the Impact of the General Data Protection Regulation (GDPR) on collaborative science in Europe.
AstraZeneca’s lung cancer drug receives full approval in the EU
27 April 2017 | By Niamh Marriott, Junior Editor
The European Commission (EC) has granted full marketing authorisation for AstraZeneca’s Tagrisso (osimertinib) for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Novartis to globally co-commercialise Amgen’s migraine drug
27 April 2017 | By Niamh Marriott, Junior Editor
Novartis has expanded their commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine...
Protein targeting antibiotics bring new hope against multi-drug resistance
27 April 2017 | By Niamh Marriott, Junior Editor
Polyphor presented promising data for their novel class of antibiotics, the Outer Membrane Protein Targeting Antibiotics (OMPTA)...
FDA takes action against 14 companies for selling illegal cancer treatments
26 April 2017 | By Niamh Marriott, Junior Editor
The FDA posted warning letters to 14 US-based companies illegally selling over 65 products that fraudulently claim to prevent, treat or cure cancer...
CPhI expert says quicker approvals for ANDA’s would lower drug costs
26 April 2017 | By Niamh Marriott, Junior Editor
Girish Malhotra argues time reduction for ANDA approvals, arguing that if the current approval time can be reduced, drug costs will decrease...
Gilead’s Phase II study showed 99% HCV cure rates
26 April 2017 | By Niamh Marriott, Junior Editor
Gilead Sciences’ Phase II studies demonstrated HCV cure rates of 99% in children, and 100% in patients co-infected with HCV and hepatitis B virus...
RedHill Biopharma enrols last patient in Phase II irritable bowel syndrome trial
26 April 2017 | By Niamh Marriott, Junior Editor
RedHill Biopharma has enrolled the last patient in the Phase II study with Bekinda for the treatment of diarrhoea-predominant irritable bowel syndrome...
BioMarin receives positive CHMP opinion for fatal brain disorder treatment in children
26 April 2017 | By Niamh Marriott, Junior Editor
CHMP has adopted a positive opinion for the company's MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease...
