News and Press Releases
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
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
Recommendation based on a phase 3 study showing a significantly greater proportion of children on Dupixent achieved histological remission, compared to placebo, consistent with improvements seen in adults and adolescents...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
The Charter Building, Vine Street, Uxbridge, Middlesex, United Kingdom, UB8 1JG
ERS: Dupixent data reinforce clinically meaningful benefit from pooled analysis of two COPD phase 3 studies
Pooled results from the BOREAS and NOTUS studies show meaningful clinical benefit with 31% reduction in exacerbations along with lung function improvement Data from these two phase 3 studies supported...
Category: Clinical Trials, Drug Delivery, Pharmaceutical
Posted: September 10, 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
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 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
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
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
