Pharmafile Logo

News and Press Releases

PureTech-Invented KarXT Receives U.S. Food and Drug Administration Approval for the Treatment of Schizophrenia in Adults

Milestone triggers payments to PureTech totaling $29 million under agreements with Royalty Pharma and PureTech’s Founded Entity, Karuna Therapeutics, which was acquired by Bristol Myers Squibb in March 2024, and...

Category: Other, Pharmaceutical
Posted: September 27, 2024

PureTech Health
info@puretechhealth.com
PureTech Health 6 Tide Street Boston, MA 02210

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

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

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
NEW DOCKS, THE DOCKS, GALWAY