News and Press Releases

TREMFYA (guselkumab) receives positive CHMP opinion for treatment of patients with moderately to severely active Crohn’s Disease

Recommendation based on the findings from the Phase 3 studies (GALAXI programme and GRAVITI) in Crohn’s disease 28 March 2025 -- Beerse, Belgium -- Johnson & Johnson today announced that...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 28, 2025

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RYBREVANT (amivantamab) plus LAZCLUZE (lazertinib) demonstrates significant overall survival benefit in patients with EGFR-mutated advanced non-small cell lung cancer versus osimertinib

Median overall survival not yet reached with a projected improvement of more than one year versus osimertinib 26 March 2025 -- Beerse, Belgium -- Janssen-Cilag International NV, a Johnson &...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: March 26, 2025

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Icotrokinra results show potential to set a new standard of treatment in plaque psoriasis

Combination of complete skin clearance data and favourable safety profile in a once daily pill could shift treatment paradigm Nearly half of patients with moderate-to-severe plaque psoriasis (Pso) treated with...

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

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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

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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

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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

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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

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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

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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

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Biofidelity and CellCarta partner to deploy Aspyre Lung in global clinical trials

9 January 2025 -- Cambridge, UK and Montreal, Canada -- Biofidelity, a leader in innovative genomic solutions, and CellCarta, the global contract research organization (CRO) partner of choice for biopharmaceutical...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: January 9, 2025

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New Sarclisa subcutaneous formulation met co-primary endpoints in the IRAKLIA phase 3 study in multiple myeloma

Sarclisa SC formulation added to Pd for the treatment of R/R MM met the co-primary endpoints in the IRAKLIA phase 3 study, demonstrating non-inferiority compared to Sarclisa IV IRAKLIA is...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025

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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

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Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO®/DARZALEX® (daratumumab) as subcutaneous monotherapy for high-risk smouldering multiple myeloma

If approved, daratumumab will become the first treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: November 8, 2024

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DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible

Phase 3 PERSEUS study of daratumumab subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone induction and consolidation, followed by daratumumab SC and lenalidomide maintenance showed a 58 percent...

Category: Drug Discovery
Posted: October 23, 2024

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HUTCHMED Announces that TAGRISSO plus ORPATHYS demonstrated high,clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial

New data demonstrate efficacy for the oral treatment combination to address MET-driven resistance in EGFR-mutated lung cancer MET is a common biomarker in this setting for patients who develop resistance...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 16, 2024