News and Press Releases
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
HUTCHMED Announces NMPA Full Approval for ORPATHYS® (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
Indication expands to include treatment-naïve patients The 2021 conditional approval in previously treated patients converted to full approval. 14 January 2025 -- Hong Kong, Shanghai, and New Jersey, US --...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 14, 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
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
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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
Duke Street Bio Granted Approval by European Medicines Agency to Launch Next-Generation PARP1-Selective Inhibitor Trial
24 September 2024 -- London, UK -- Duke Street Bio Ltd, a precision medicine biotech developing next generation small molecule cancer therapies, is pleased to announce that the European Medicines...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 24, 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
DARZALEX® (daratumumab)-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Recommendation supported by findings from quadruplet therapy PERSEUS study with daratumumab subcutaneous (SC) formulation in the frontline setting Findings showed 60 percent reduction in risk of disease progression or death...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 20, 2024
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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
CHMP adopts positive opinion for BALVERSA (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers The CHMP’s recommendation is based on results...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: June 28, 2024
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Kite Receives European Medicines Agency Approval of Safety Monitoring Variation for CAR T-Cell Therapy Portfolio
In-hospital patient monitoring for adverse events reduced from ten to seven days following CAR T-cell therapy infusion 6 June 2024 -- Stockley Park, UK -- Kite, a Gilead Company, today...
Category: Biotechnology, Other, Pharmaceutical
Posted: June 6, 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
PlaqueTec and the Babraham Institute collaborate on early phase target discovery and development
Campus Innovation Award (CIA)-funded project evaluated lead compounds predicted to bind a pro-inflammatory protein discovered by PlaqueTec 14 May 2024 -- Cambridge, UK -- PlaqueTec, a company identifying endotype-specific biomarkers...
Category: Biotechnology, Drug Discovery
Posted: May 14, 2024
Johnson & Johnson receives positive CHMP opinion for RYBREVANT▼ (amivantamab) in combination with chemotherapy for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC The recommendation is...
Category: Clinical Trials, Pharmaceutical
Posted: April 29, 2024
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