News and Press Releases
Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe
FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025
Venus Remedies gets Marketing Authorization for anticoagulant ‘Enoxaparin’ from Indonesia
Latest approvals from Indonesia, Southeast Asia’s largest pharma market, to help strengthen company’s regional and global aspirations 10 February 2025 -- Panchkula, India -- Venus Remedies Limited, a leading Indian exporter...
Category: Drug Delivery, Other, Pharmaceutical
Posted: February 10, 2025
51-52, Industrial Area Phase-1, Panchkula, Haryana, 134113
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 3, 2025
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Fondazione Telethon Submits EU Marketing Authorisation Application for Etuvetidigene Autotemcel Gene Therapy for the Treatment of Wiskott-Aldrich Syndrome
3 February 2025 -- Milan, Italy -- Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, announced that it has submitted the Marketing Authorization Application (MAA) for the...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other
Posted: February 3, 2025
European Commission approves LAZCLUZE®▼ (lazertinib) in combination with RYBREVANT®▼ (amivantamab) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
Latest topline data from the Phase 3 MARIPOSA study shows amivantamab plus lazertinib is the first regimen to demonstrate superior overall survival benefit compared to the current standard of care...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 21, 2025
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with LAZCLUZE®▼ (lazertinib) for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer
The amivantamab plus lazertinib combination regimen offers potential to provide new standard of care as first-line option for adult patients with advanced NSCLC with EGFR ex19del or L858R substitution mutations...
Category: Clinical Trials
Posted: November 20, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
CHMP recommends RYBREVANT®▼ (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) after failure of prior therapy
Patients with EGFR ex19del or EGFR L858R mutations, the most common EGFR mutations in NSCLC, currently face a poor prognosis and limited treatment options after disease progression on osimertinib1,2,3,4 ...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: July 26, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Johnson & Johnson Receives Positive CHMP Opinion for Yuvanci® (Single Tablet Combination Therapy [STCT] of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
If approved, Yuvanci® would become the only single tablet combination for treatment for patients with PAH Johnson & Johnson’s comprehensive PAH portfolio has the potential to cover all guideline-recommended treatment...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: July 26, 2024
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
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
