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News and Press Releases

CARBOGEN AMCIS Announces Two Successful FDA Inspections at its Manufacturing Sites in Neuland and Aarau, Switzerland

23 July 2024 -- Bubendorf, Switzerland -- Switzerland-based CARBOGEN AMCIS, a leading pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, is pleased to announce the successful completion of...

Category: BioManufacturing, Other, Pharmaceutical
Posted: July 23, 2024

CARBOGEN AMCIS
info@carbogen-amcis.com
Hauptstrasse 171 CH-4416 Bubendorf Switzerland

Certa Therapeutics Receives EU Orphan Designation for FT011, a GPR68 Inhibitor Being Developed as an Anti-Fibrotic Treatment for Systemic Sclerosis

22 July 2024 -- Melbourne, Australia -- Certa Therapeutics, a biotechnology company developing innovative precision therapies for patients with inflammatory and fibrotic diseases, today announces that the European Medicines Agency...

Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: July 22, 2024

Certa Therapeutics
info@certatherapeutics.com
Level 9, 31 Queen Street Melbourne VIC 3000 Australia

FDA and CluePoints Sign New 3 Year Cooperative Research and Development Agreement to Assess Data Quality using Statistical Modelling and Machine Learning

FDA extends its use of CluePoints to include AI/ML within an automated system to assess data quality in multicenter clinical trials 5 June 2024 -- Pennsylvania, US -- CluePoints, providers...

Category: Biotechnology, Pharmaceutical
Posted: June 5, 2024

CluePoints
contact@cluepoints.com
1000 Continental Drive, Suite 240, King of Prussia, PA 19406

Sartorius Collaborates with Sanofi to Commercialise End-To-End Platform for Downstream Process Intensification

Sartorius selected as preferred partner for development and commercialisation of integrated and continuous biomanufacturing (ICB) platform Modular platform will combine highest flexibility with standardisation ICB supports lower resource consumption and...

Category: BioManufacturing, Pharmaceutical
Posted: May 13, 2024

Sartorius Group
info@sartorius.com
Sartorius Corporation, Otto-Brenner-Straße 20, 37079 Goettingen, Germany

Ellipses’ next generation selective RET inhibitor EP0031/A400 granted Fast Track designation by US Food and Drug Administration

Compound is currently undergoing clinical trials as a potential treatment option for patients with RET altered tumours 5 March 2024 -- London, UK -- Ellipses Pharma, a global drug development...

Category: Drug Discovery
Posted: March 5, 2024

Ellipses Pharma
enquiries@ellipses.life
10 STRATTON STREET W1J 8LG LONDON

Medidata and Sanofi Vaccines Extend Collaboration to Improve Patient Centricity and Trial Efficiency

Collaboration will harness Medidata Electronic Clinical Outcome Assessment (eCOA) for remote patient engagement and real-time data capture 6 February 2024 -- New York, US -- Medidata, a Dassault Systèmes company...

Category: Clinical Trials
Posted: February 7, 2024

Medidata
helpdesk@mdsol.com
350 Hudson Street New York, NY 10014 USA

CN Bio wins ‘Most Impactful Industry Collaboration of the Year’ at the OBN Awards 2023 for ongoing research with the FDA

Six-year collaboration recognised at prestigious awards ceremony for its continued success in advancing OOC research to support widespread adoption across the pharmaceutical industry 23 November 2023 -- Cambridge, UK --...

Category: Clinical Trials
Posted: November 23, 2023

CN-Bio
enquiries@cn-bio.com
30 Upper High Street, Thame, Oxfordshire, OX9 3EZ

Signum Surgical Completes Clinical Trial for BioHealx

Galway based company compiling data for submission of a De Novo classification request to US FDA Novel surgical option for the treatment of anal fistula, a painful and debilitating colorectal...

Category: Clinical Trials
Posted: September 12, 2023

Signum Surgical
INFO@SIGNUMSURGICAL.COM
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