Focus:
Comment
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17 January 2020
New Wuhan coronavirus spreads to Thailand and Japan
On December 31 2019, China alerted the World Health Organization (WHO) about a mysterious outbreak of pneumonia in Wuhan, the capital of the Hubei province in Central-Eastern China. Wuhan is...
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17 January 2020
Intercept’s Ocaliva access in NASH likely to be hit by payers’ biopsy requirements
Intercept Pharmaceuticals should brace for payers requiring liver biopsies before clinicians are able to access Ocaliva (obeticholic acid) for nonalcoholic steatohepatitis (NASH) after its expected FDA approval, most experts agreed....
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17 January 2020
How significant is a novel route of administration for dry eye syndrome?
Although treatments for dry eye syndrome (DES) have been well-established, lack of efficacy in their modes of action (MOAs) and often unfavorable tolerability profiles have spurred companies to develop therapies...
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17 January 2020
Chronic diseases to keep an eye on in 2020 and beyond
Epidemiological trends in the last decade have shown a significant increase in the burden of chronic illnesses globally, such as the growing epidemics of obesity and type 2 diabetes. In...
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16 January 2020
Alexion bets on ALS with pivotal phase III study for its future blockbuster ultomiris
This quarter, Alexion Pharmaceuticals is set to launch a pivotal Phase III study of Ultomiris (ravulizumab) in amyotrophic lateral sclerosis (ALS), a rare and fatal neurodegenerative disease that is characterised...
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16 January 2020
Assessing recent approvals in bladder cancer
On December 18 2019, the FDA granted accelerated approval for Seattle Genetic/Astellas Pharmaceutical’s Padcev (enfortumab vedotin-ejfv). Merck and Co’s Keytruda (pembrolizumab) was granted approval for Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle...
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14 January 2020
Regulatory review of the first ever gene therapy for haemophilia to start in January 2020
In November 2019, BioMarin, a biotechnology company specialising in developing therapies for rare diseases driven by genetic causes, submitted a marketing authorization application (MAA) to the European Medicines Association (EMA)...
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10 January 2020
Could photobiomodulation be a breakthrough for Alzheimer’s disease?
A Canadian biotechnology company leader in brain photobiomodulation (PBM) technology, Vielight, has developed a new headset device that could be a medical and therapeutic breakthrough for Alzheimer’s disease (AD) patients....
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10 January 2020
Using AI to successfully predict risk of breast cancer
Predicting future health outcomes for patients at an individual level will allow physicians to deliver care more quickly to those who need it most while preventing future harms and improving...
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7 January 2020
Maintenance treatment positioned to become standard of care in acute myeloid leukemia
Following the report of a successful clinical trial in patients with acute myeloid leukemia (AML), Celgene plans to pursue a new drug application (NDA) in Q1 2020 for its formulation...