News and Press Releases

Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER-ILD, in progressive pulmonary fibrosis

Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2025

Binger Strasse 173 55216 Ingelheim am Rhein

Opella reaches study milestone for Cialis

21 January 2025 -- Paris, France -- Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual...

Category: Clinical Trials, Other, Pharmaceutical
Posted: January 21, 2025

One Onslow Street, Guildford, Surrey, GU1 4YS, UK

GILEAD AND LEO PHARMA ENTER INTO STRATEGIC PARTNERSHIP TO ACCELERATE DEVELOPMENT OF ORAL STAT6 PROGRAM WITHPOTENTIAL IN MULTIPLE INFLAMMATORY DISEASES

11 January 2025 – Foster City, California, US and Ballerup, Denmark – Gilead Sciences, Inc. (Nasdaq: GILD) andLEO Pharmatoday announced a strategic partnership to accelerate the development and commercialization of...

Category: Pharmaceutical
Posted: January 13, 2025

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

PureTech Health 6 Tide Street Boston, MA 02210

VALANX Biotech and Fina Biosolutions Introduce ClickCRM for Rapid Conjugate Vaccine Development

Joint licensing agreement to commercialize ready-to-conjugate vaccine carrier protein CRM197 will enable rapid development of conjugate vaccines 29 October 2024 -- Klosterneuburg, Austria, and Maryland, US -- VALANX Biotech, a...

Category: BioManufacturing, Biotechnology, Drug Delivery, Pharmaceutical
Posted: October 29, 2024

VALANX Biotech Gmbh, Plöcking 1, IST Park Building, 3400 Klosterneuburg, Austria

CluePoints Appoints Richard Young as Chief Strategy Officer

28 October 2024 -- Pennsylvania, US -- RBQM innovator CluePoints has today announced that Richard Young has been appointed as its new Chief Strategy Officer. With 30 years of experience...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 28, 2024

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Publication Demonstrates Potential for Multi-Marker CTC Profiling in Early Prostate Cancer

Parsortix enriched CTCs detected at high rates in localised disease Multi-marker profiling of CTCs could support development of targeted therapies and help stratify patients in clinical trials 17 October 2024...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 17, 2024

2 Occam Court, Occam Road, Surrey Research Park, Guilford, GU2 7QB

Mosaic Therapeutics appoints Dr Barry Davies as CSO

Former AstraZeneca Senior Director, Global Project Leader adds significant experience and expertise to leadership team Appointment will drive further development of Mosaic’s targeted oncology combination therapies pipeline and platform. 7...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 7, 2024

Mosaic Therapeutics Wellcome Genome Campus Cambridge CB10 1DR

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

PureTech Health 6 Tide Street Boston, MA 02210

CluePoints Launches Medical & Safety Review (MSR) Software to Revolutionize Clinical Data Review

CluePoints furthers its commitment to delivering innovative solutions that enhance clinical trial efficiency with this latest addition to its enterprise software platform 27 September 2024 -- Pennsylvania, US -- CluePoints...

Category: Biotechnology, Clinical Trials, Drug Discovery
Posted: September 27, 2024

1000 Continental Drive, Suite 240, King of Prussia, PA 19406

Expert Speaker Line-Up Revealed for Industry-Leading RBQM Event

CluePoints Supports Launch of RBQMLive 2024 as Premier Event Sponsor 4 September 2024 -- Pennsylvania, US -- CluePoints, the premier sponsor of RBQMLive and provider of Risk-Based Quality Management (RBQM) and...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 4, 2024

1000 Continental Drive, Suite 240, King of Prussia, PA 19406

Plexium Selects Xavo as their Sample Management Lab Operations Platform

24 July 2024 -- Massachusetts, US -- Xavo, a leading provider of innovative software solutions for life sciences R&D, proudly announces Plexium as its latest esteemed client. “We are thrilled...

Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: July 24, 2024

One Boston Place, Suite 2600 Boston, MA 02108, USA

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

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

Level 9, 31 Queen Street Melbourne VIC 3000 Australia