Positive data for Amylyx’s AMX0035 strengthen its position to enter ALS market
On October 16, Amylyx announced that AMX0035, its amyotrophic lateral sclerosis (ALS) pipeline drug, showed potential to prolong patient survival…
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Trials disrupted due to Covid-19 continue to resume
Since early March, more than 500 companies have publicly announced clinical trial disruptions, both planned and ongoing, due to the…
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Eli Lilly’s and Regeneron’s EUA talk trigger prudence on available Covid-19 data
by Manasi Vaidya in New York and Reynald Castaneda in London. Eli Lilly’s and Regeneron Pharmaceuticals’ bids to secure an FDA Emergency Use Authorization (EUA) for their respective…
Kala’s dry eye syndrome steroid likely to be FDA approved; mixed potential on uptake
by William Newton in Texas. Kala Biopharmaceuticals’ ocular steroid Eysuvis (loteprednol etabonate) has a high probability of attaining the US Food and Drug Administration (FDA)…
Overall clinical trial disruption due to Covid-19 declines, but the number of trials with slow recruitment continues to grow
Since early March, around 1,000 organizations supporting clinical trials as a sponsor, collaborator, or contract research organization (CRO) have publically…
New frontiers in the treatment of metastatic urothelial carcinoma raises hopes for patients and their families
Urothelial carcinoma, the most common histological subtype of bladder cancer in the US and Europe, is also the most common…
vTv’s azeliragon study for Alzheimer’s disease and type 2 diabetes has support but some scepticism remains
by William Newton in Texas. Despite failing a Phase III trial for Alzheimer’s disease (AD), vTv Therapeutics’ azeliragon could have…
EASD 2020: New Results from the EMPEROR-Reduced Trial Demonstrate the Efficacy of Empagliflozin in the Treatment of Heart Failure With or Without Type 2 Diabetes
At the 56th annual European Association for the Study of Diabetes (EASD) 2020 meeting, new results have been presented from…
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EASD 2020: Results from the TIMES 3 trial – efficacy and safety of imeglimin in combination with insulin in Japanese patients with type 2 diabetes
At the 56th annual European Association for the Study of Diabetes (EASD) 2020 meeting, positive results have been discussed for…
Trials disrupted due to Covid-19 steadily resuming
Since early March, more than 500 companies have publicly announced disruptions to their planned and ongoing clinical trials due to…
Real Time Cargo Intelligence to Increase Distribution Quality and Security
Smooth visibility from the place of production to the ultimate destination must be the new standard for vaccine delivery. The…
SIMPONI ARIA (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis (pJIA)
SIMPONI ARIA® (golimumab) is a fully human anti-tumour necrosis factor (TNF) alpha monoclonal antibody. It is indicated for the treatment…
SOM Biotech Announces Poster Presentation on the Repurposing of Eravacycline for the Treatment of SARS-CoV-2
SOM Biotech, a biopharmaceutical company specialising in the repositioning of existing drugs for the treatment of diseases with a high…
How the Formedix Visual Define.xml Editor Gives You Faster Define
Define.xml is the metadata that describes the content and formatting of submission datasets and the case report tabulation data. It’s…