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

PureTech Health 6 Tide Street Boston, MA 02210

Tiziana Life Sciences Announces $4 Million Grant Awarded by National Institutes of Health to Study Anti-CD3 in Alzheimer’s Disease

19 September 2024 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3...

Category: Biotechnology, Clinical Trials, Pharmaceutical
Posted: September 19, 2024

Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom

AC Immune Receives Second Milestone Payment Following Progress in Phase 2b ReTain Trial of ACI-35.030 in Preclinical Alzheimer’s Disease

Prescreening rate of Phase 2b ReTain trial triggers clinical development milestone payment in September Potentially registrational trial is targeting enrollment of approximately 500 participants with pre-symptomatic AD FDA Fast Track...

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

EPFL Innovation Park-Building B 1015 Lausanne / Switzerland

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

Asceneuron Secures $100m Series C Financing to Advance Groundbreaking Therapeutics in Neurodegenerative Diseases

Financing led by Novo Holdings, including new investment from EQT Life Sciences – LSP Dementia Fund, OrbiMed and SR One with participation from existing investors M Ventures, Sofinnova Partners, GSK...

Category: Biotechnology, Clinical Trials, Other
Posted: July 16, 2024

Asceneuron SA, EPFL Innovation Park, Bâtiment B, CH-1015 Lausanne, Switzerland

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

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

Eisai Named on TIME100 Most Influential Companies 2024 List

3 June 2024 -- Tokyo, Japan -- Eisai Co announced today that TIME has selected Eisai as one of the TIME100 Most Influential Companies of 2024. TIME reveals the TIME100...

Category: Biotechnology, Other
Posted: June 3, 2024

4-6-10 Koishikawa, Bunkyo-ku, Tokyo 112-8088, Japan

Allyx Therapeutics Announces Positive Phase 1b Multiple Ascending Dose Data and Advances ALX-001 to Patients

Safety of ALX-001 reinforced by new data presented at AD/PD 2024 Conference in Lisbon, Portugal Two oral doses selected for further study in Alzheimer’s and Parkinson’s disease patients. 11 March 2024...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: May 11, 2024

555 Long Wharf Drive Floor 11 New Haven, CT 06511, US

Experimental gene therapy for giant axonal neuropathy shows promise in NIH clinical trial

Treatment for rare childhood disease was well tolerated and slowed loss of motor function 20 March 2024 -- Maryland, US -- An investigational gene therapy for a rare neurodegenerative disease...

Category: Clinical Trials, Drug Discovery
Posted: March 20, 2024

9000 Rockville Pike Bethesda, Maryland 20892

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

10 STRATTON STREET W1J 8LG LONDON

New Data Demonstrate Sunbird Bio’s APEX Diagnostic Test Accurately Differentiates Key Alzheimer’s Disease Biomarker in Blood

Blood-based diagnostic effectively discriminated between patients who were positive versus negative for amyloid beta on PET scans Data will be shared in a poster presentation at AD/PD 2024 on 8-9...

Category: Biotechnology
Posted: March 5, 2024

35 Cambridgepark Drive Suite 100 Cambridge, MA 02140

PharmaKure announces epigenetics collaboration with Sheffield Hallam University to understand mechanisms of Alzheimer’s Diseases

New collaboration will enhance ability to identify those more at risk of developing brain diseases to enable earlier interventions 29 February 2024 -- Manchester, UK -- PharmaKure, a clinical stage...

Category: Other
Posted: February 29, 2024

Alderley Park Congleton Road Nether Alderley Open Access Lab 19S6 Macclesfield SK10 4TG

Galimedix Therapeutics announces new pre-clinical data with GAL-201 in an Alzheimer’s disease transgenic model to be presented at AD/PD 2024 Conference

Galimedix’s novel, orally administered small molecule offers the hope of changing the course of disease by targeting amyloid beta oligomers and protofibrils 28 February 2024 -- Maryland, US -- Galimedix...

Category: Biotechnology
Posted: February 28, 2024

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