Applied Clinical Trials Online1d
Enhancing Patient Engagement and Data Accuracy in Decentralized Trials
Andrew Mackinnon, executive GM, Medable, explains how the company ensures high patient participation and data accuracy in ...
PathAI Announces EMA Qualification for AIM-MASH AI Assist, a Groundbreaking AI Tool for MASH Clinical Trials
PathAI, a global leader in AI-powered pathology, today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted full qualification for ...
EU health regulator clears use of AI tool in fatty liver disease trials
A European Medicines Agency committee, on Thursday, accepted the use of an artificial intelligence (AI) tool called AIM-NASH ...
JD Supra3d
Early benefit assessment of medicinal products in Germany – first adaptions to AMNOG implementing the EU HTA Regulation
HTA as described by the HTA Regulation is the multidisciplinary scientific evidence-based process that allows to determine the relative effectiveness of new or existing health technologies. HTA is a ...
Benzinga.com16d
Bristol Myers' Opdivo Plus Yervoy Combo Therapy Secures European Approval For Untreated Liver Cancer Patients
The combination of Opdivo plus Yervoy was granted accelerated approval by the U.S. FDA in 2020 as a second-line treatment for patients with advanced HCC based on Phase 2 CheckMate -040 trial results.
Business Standard17d
Ayush-approved medicines exempt from extra safety trials in research: ICMR
Ayush-approved medicines used in integrative research will not require extra safety trials or preclinical studies but non-codified traditional medicines must undergo the entire regulatory approval ...
dlnews18d
Why XRP investors bet ETF will be approved and spur $8bn bonanza
Trump wants the US to stock XRP, among other major cryptocurrencies. JPMorgan forecasts an inflow of up to $8 billion to XRP ETFs if approved. The buzz about an XRP exchange-traded fund is back.
Pharmabiz18d
EMA committee recommends approval of AstraZeneca’s Imfinzi in combo with chemotherapy to treat resectable non-small cell lung cancer
AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union ... for Medicinal Products for Human Use (CHMP) of the European Medicines ...
Business Wire19d
Medable Achieves Landmark CNIL Approval, Expanding Access for Digital Clinical Trials Across the European Union
--(BUSINESS WIRE)--Medable Inc., a leading provider of clinical development technology, announced that its eConsent and eCOA solutions have been approved ... in more than 300 decentralized and ...
healthandpharma19d
CHMP Recommends Durvalumab Combination for EU Approval in Resectable NSCLC
A durvalumab (Imfinzi)-based perioperative regimen has been recommended by the EMA Committee for the treatment of adults ... in combination with chemotherapy has been recommended for approval in the ...
Pharmabiz19d
EMA committee recommends approval of AbbVie’s upadacitinib to treat adults with giant cell arteritis
AbbVie announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq; 15 mg, once ...