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
European Commission Approves Astellas’ PADCEVTM (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer
First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years European Marketing Authorization based on positive overall survival and...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: August 28, 2024
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2
Spikevax 2024-2025 formula expected to be available in pharmacies and care settings across the U.S. in the days immediately following approval 22 August 2024 -- Massachusetts, US -- Moderna, Inc today...
Category: Biotechnology, Clinical Trials, Pharmaceutical
Posted: August 22, 2024
New Real-World Data Published in Journal of Cardiac Failure on Effectiveness of VYNDAQEL (tafamidis) in Patients with Transthyretin Cardiac Amyloidosis
Patients treated with tafamidis were associated with greater rates of survival compared with patients untreated with tafamidis. 6 August 2024 -- Walton Oaks, UK -- Pfizer Ltd today announced publication...
Category: Drug Discovery, Other, Pharmaceutical
Posted: August 8, 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
Evotec and Pfizer collaborate to advance drug discovery in France
Multi-year collaboration will initially focus on early discovery research for metabolic and infectious diseases 11 July 2024, Hamburg, Germany – Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ:...
Category: Drug Discovery
Posted: July 11, 2024
Just – Evotec Biologics, Inc. 401 Terry Avenue North Seattle, WA 98109, US
SYS6002 (CRB-701) A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate Continues to Demonstrate Encouraging Safety and Efficacy Observed in Patients with Nectin-4 Positive Tumours in a Clinical Update Presented at ASCO 2024
An additional 19 patients have been enrolled since January 2024 bringing the total to 37 of whom 25 were evaluable for efficacy SYS6002 (CRB-701) demonstrated 44% ORR and 78% DCR in...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 5, 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
Asymchem Secures Former Pfizer Sandwich, UK, Development and API Pilot Plant Manufacturing Facilities
21 May 2024 -- Teda Tianjin, P R China -- Asymchem Laboratories announced today that it will operate the former Pfizer UK small molecule API pilot plant and part of...
Category: BioManufacturing, Pharmaceutical
Posted: May 21, 2024
Asymchem Laboratories (Tianjin) Co., Ltd No. 6 Dongting 3rd Avenue, TEDA Tianjin, 300457, P.R. China
Headlands Research Announces Fifth Research Site under Partnership with Pfizer to Improve Diversity in Clinical Trials
Headlands Research Orlando satisfies the organisations’ commitment to create multiple research sites aimed at increasing health equity in clinical research 28 March 2024 -- California, US -- Headlands Research, a...
Category: Clinical Trials
Posted: April 2, 2024
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
