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EC grants marketing authorisation to necitumumab in NSCLC
24 February 2016 | By Victoria White
This is the first authorisation for necitumumab in Europe and follows US Food and Drug Administration (FDA) approval in November 2015...
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EC approves two new indications for Lilly’s ramucirumab
28 January 2016 | By Victoria White
The European Commission has approved two new indications for Lilly’s Cyramza (ramucirumab): one in patients with NSCLC and the other in patients with mCRC...
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European Pharmaceutical Review’s top 10 stories from 2015
Mega mergers, 3D printed drugs, a call for action on antimicrobial resistance: 2015 certainly was an interesting year for the pharmaceutical industry. Here we pick a selection of the top stories that hit the headlines.
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NICE recommends five new therapies
27 January 2016 | By Victoria White
NICE has published its final recommendations on whether six different drug treatments should be routinely funded by the NHS...
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FDA accepts filing of cardiovascular outcomes for Jardiance
26 January 2016 | By Victoria White
The FDA has accepted a sNDA for Jardiance (empagliflozin) based on cardiovascular risk reduction data from the EMPA-REG OUTCOME trial...
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Lilly and Incyte submit NDA for baricitinib to the FDA
Lilly and Incyte have announced the submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA).
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FDA approves Basaglar, a long-acting insulin treatment
17 December 2015 | By Victoria White
The FDA has approved Basaglar for the treatment of adult and paediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus...
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Lilly and Merck expand their immuno-oncology collaboration
10 December 2015 | By Victoria White
The companies are to evaluate Lilly’s abemaciclib (LY2835219) and Merck’s Keytruda (pembrolizumab) in a Phase I study across multiple tumour types...
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Trulicity effective as add-on treatment to sulfonylurea in study
New data from a completed Phase 3 trial show Lilly’s Trulicity (dulaglutide) 1.5 mg plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering haemoglobin A1c (A1C) from baseline after 24 weeks of treatment.
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FDA approves Portrazza for metastatic squamous NSCLC
25 November 2015 | By Victoria White
The approval is based on the Phase III study where the Portrazza regimen demonstrated a significant improvement in overall survival...
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Phase III study to evaluate pemetrexed and pembrolizumab in NSCLC
19 November 2015 | By Victoria White
Lilly and Merck are to evaluate the safety and efficacy of the combination of pemetrexed and pembrolizumab in a Phase III study in non-squamous NSCLC...
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Lilly’s ixekizumab demonstrates efficacy in psoriatic arthritis
10 November 2015 | By Victoria White
Psoriatic arthritis patients treated with ixekizumab for 24 weeks achieved significant improvements in signs and symptoms of their disease compared to placebo...
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Baricitinib demonstrates superiority to adalimumab in rheumatoid arthritis
Baricitinib demonstrated superiority over adalimumab (Humira) after 12 weeks based on several critical measures of rheumatoid arthritis disease activity...
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AstraZeneca and Lilly expand immuno-oncology collaboration
22 October 2015 | By Victoria White
Under the terms of the expanded agreement, AstraZeneca and Lilly will evaluate the safety and efficacy of a range of additional combinations across the companies’ portfolios...
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Baricitinib demonstrates superiority to adalimumab in rheumatoid arthritis
Lilly and Incyte have announced positive topline results from the fourth successful Phase 3 study (RA-BEAM ) of baricitinib.
