Clinical trials: Are data managers ready for AI in EDC?
AI in clinical trials has the potential to offer faster insights, greater efficiency, and improved data quality. Nowhere is this …
Post
-
-
Earendil Labs lands $787m to fund biologics development push
Earendil Labs has secured $787m to drive the expansion of its artificial intelligence (AI)-powered drug discovery platform, which has already …
-
ImmunityBio receives Macau approval for Anktiva combo therapy
ImmunityBio has received approval from the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region, China, for Anktiva (nogapendekin …
-
BMS secures FDA and EC approvals for Opdivo in Hodgkin Lymphoma
Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has received approvals for two new indications in classical Hodgkin Lymphoma (cHL) from the …
-
Novo Nordisk’s Wegovy HD secures FDA greenlight amid patent expiries
Novo Nordisk has landed an approval from the US Food and Drug Administration (FDA) for a high dose version of …
-
Novartis to acquire SNV4818 from Synnovation
Novartis has signed an agreement to acquire SNV4818, a pan-mutant selective Phosphoinositide 3-kinase alpha (PI3Kα) inhibitor, from Synnovation Therapeutics. Under the …
-
Congruence secures $39.5m to advance small molecule correctors pipeline
Congruence Therapeutics has announced the completion of a $39.5m financing round to advance its portfolio of small molecule correctors into …
-
J&J wins FDA approval for Icotyde to enter psoriasis pill market
The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s (J&J) Icotyde (icotrokinra) for the treatment of plaque …
-
MHRA and NICE launch aligned pathway for faster medicine regulation
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) will make …
-
Quintessence debuts first ‘living’ artificial cell for CGT bio-separation
Quintessence Biotech has launched a bio-separation tool to reduce the manufacturing bottleneck suffered by cell and gene therapies (CGTs), creating …
-
Huntington’s gene therapy research has reached a turning point, expert says
Despite unanticipated regulatory hurdles following promising clinical results with a novel investigational treatment for Huntington’s Disease, the significance of the …
-
Calls for change as access to cell and gene therapies in the Netherlands falls short
The Netherlands is falling behind other European countries in providing access to advanced therapy medicinal products (ATMPs) according to Peter …
-
Excalipoint debuts with $68.7m to progress TCE pipeline
Chinese biotech Excalipoint Therapeutics is looking to progress its pipeline of T-cell engager (TCE) therapies in immunology and oncology as …
-
GSK prepared for potential expansion of meningitis vaccine schedule amid UK outbreak
Amid an ongoing outbreak of meningococcal disease in Kent, England, GSK has said it is ready to work with UK …
-
Navigating the valley of death: a how-to from an investor’s perspective
In a crowded biotech landscape full of potential, especially in advanced therapeutic medicinal products (ATMPs), companies must differentiate themselves from …
