News and Press Releases
PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)
Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025
QurAlis Invited to Present at 43rd Annual J.P. Morgan Healthcare Conference
7 January 2025 -- Massaschusetts, US -- QurAlis Corporation, a clinical-stage biotechnology company driving scientific breakthroughs into powerful precision medicines that have the potential to alter the trajectory of amyotrophic...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 7, 2025
Neumora Therapeutics Reports Data from KOASTAL-1 Study of Navacaprant in Major Depressive Disorder
Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo Navacaprant showed an efficacy signal in...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: January 2, 2025
Medidata and Cogstate Strike Strategic Partnership Transforming Clinical Trials in Neurology with Clinical Outcome Assessment (eCOA) and Clinician Solutions Powered by AI and Advanced Analytics
Science-driven collaboration ameliorates neurological assessments and endpoint data quality, enhances the rater and patient experience, and integrates Medidata App innovations with Cogstate capabilities 29 October 2024 -- New York, US...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other
Posted: October 29, 2024
PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
1 October 2024 -- New Jersey, US -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: October 1, 2024
PTC Therapeutics Inc. 100 Corporate Court South Plainfield, NJ 07080-2449
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
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
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
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
Broken String Biosciences and the Francis Crick Institute collaborate to advance ALS research
Partnership to expand applications of DNA break-mapping technology and advance understanding of genomic instability in development of the neurodegenerative disease amyotrophic lateral sclerosis 07 May 2024 -- Cambridge and London,...
Category: Drug Discovery, Pharmaceutical
Posted: May 7, 2024
Unit AB3-04, Level 3 BioData Innovation Centre Wellcome Genome Campus Hinxton Cambridge, CB10 1DR
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
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
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
