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Regulatory Data Articles & Analysis
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It is also a mandatory test when submitting registration or approval data to regulatory authorities for diverse chemicals, including pharmaceuticals and biocides. ...
BySTEMart
As the CEO of a feed or pet food company, you face daily challenges involving margin alignment, data accuracy, logistic challenges, and legislative compliance. Simultaneously, you're seeking opportunities for growth, increased profitability, maintaining a robust reputation, streamlining operations, and safeguarding your company's market standing amidst unstable market conditions. Each ...
ByBESTMIX
These achievements indicate a growing inclination among regulatory bodies to accept data on safety, efficacy, and durability for the endorsement of these treatments. ...
The platform prospectively generates Real-time, Regulatory-grade, Clinical data (RRC) for studies and decentralized trials. ...
ByxCures
xCures, a Real-Time Regulatory Grade Clinical Data (RRC) platform, will be joining Aetion, a global real-world evidence software and analytics provider, and a group of leading diverse partners in Aetion’s launch of the Coalition for the Advancement of RWE through Randomized Controlled Trial Emulation (CARE) Initiative. ...
ByxCures
” The xCures platform generates Real-time, Regulatory-grade, Clinical data (RRC). It now includes data on over 1,000 brain cancer patients, permitting real-time insight into which treatments show the most promise across patient cohorts. Emerging data on investigational and off-label interventions will be presented for ...
ByxCures
The power lies in the underlying structuring of data” said Mika Newton, CEO of xCures. “Cancer is personal, and our ...
ByxCures
The full study results were presented during two late-breaking sessions at the 55th Annual Scientific Meeting of the Retina Society, USA. Bayer will submit these data to regulatory authorities outside of the USA. “These data show unprecedented durability of aflibercept 8 mg in patients living with age-related macular degeneration and ...
ByBayer AG
By integrating xCures’ rich real-world longitudinal clinical data with mProbe’s cancer proteomics panels, the two companies are working to expedite the discovery of predictive, diagnostic, and prognostic biomarkers for cancer. ...
ByxCures
The T1DC brings together diverse stakeholders from industry, academia and patient organizations to develop solutions to accelerate drug development for Type 1 Diabetes, including biomarker endpoints and model-informed drug development tools in close collaboration with regulatory agencies to enable easier and faster regulatory approval of new treatments. By ...
“We are delighted to team up with Novocure and see our extensive real-world data from GBM patients applied towards developing a time series analysis of QOL in GBM,” said Mika Newton, CEO of xCures. ...
ByxCures
Its platform allows customers to: Accurately and efficiently assess the probability of success of pipeline drugs, with supporting rationale; Unlock the optimal trial design, with comprehensive benchmarks linked to clinical trial success; Identify and prioritize additional potential indications to explore for each asset; Guide business development decisions by quickly and objectively ...
More recently, Axio has received regulatory clearance by the US FDA for Axiostat and the EU CE Mark to market Maxiocel for use in advanced wound care settings. ...
” The CHMP adopted the positive opinion based on results from the pivotal Phase III CheckMate -9ER trial, which demonstrated significant and clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) compared to sunitinib, with consistent efficacy benefits observed across key subgroups of patients.1 Cabometyx® combined ...
“Today’s announcement is an important milestone in bringing more than just hope to these patients and their loved ones.” Data readout in the study is anticipated in 2022. ABOUT PSP and CBS Progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS) are rare neurodegenerative disorders associated with the accumulation of insoluble deposits of ...
Eliminates unnecessary paper documents currently needed with the current “haul and burn” approach through IoT-enabled software that automatically tracks and stores all required regulatory data in the cloud, where it can be accessed and monitored at any time. ...
Investigational compound LDK378 is a selective inhibitor of ALK[1], a target found in metastatic non-small cell lung cancer (NSCLC) Data show 60% overall response rate in 78 patients with ALK+ NSCLC taking LDK378 at 750 mg; will serve as basis for first filing in early 2014 FDA designated LDK378 as Breakthrough Therapy in March and a robust clinical development plan is ...
/www.w3.org/1999/xhtml">Key vildagliptin data in The Lancet show for the first time individualized HbA1c treatment goals can be reached in elderly type 2 diabetes patients with no major tolerability issues Novartis International AG / Key vildagliptin data in The Lancet show for the first time individualized HbA1c treatment goals can be reached in elderly ...
/www.w3.org/1999/xhtml">New data reinforces strength of Novartis once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations Novartis International AG / New data reinforces strength of Novartis once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations . ...
The list also includes pesticide active ingredients that are being evaluated under EPA’s registration review program to ensure they meet current scientific and regulatory standards. The data generated from the screens will provide robust and systematic scientific information to help EPA identify whether additional testing is necessary, or whether other ...