News and Press Releases
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
Santhera Announces Approval from China’s NMPA for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
China’s National Medical Products Administration (NMPA) approved AGAMREE® for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only...
Category: Other, Pharmaceutical
Posted: December 11, 2024
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ASH: Sarclisa combinations demonstrated significant benefits in newly diagnosed multiple myeloma patients
New analysis from the IMROZ phase 3 study of Sarclisa-VRd demonstrated higher and sustained MRD negativity rates in transplant-ineligible NDMM patients versus VRd alone New detailed results from the GMMG-HD7...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 9, 2024
ASH: rilzabrutinib demonstrated significant patient benefit in the first positive phase 3 study of a BTK inhibitor in ITP
Pivotal phase 3 data show rapid and durable platelet response, reduced bleeding and need for rescue response, and improved physical fatigue and quality of life measures in patients with persistent...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: December 7, 2024
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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Sanofi launches high-dose egg-based quadrivalent influenza vaccine (QIV-HD) in the UK
Developed with a higher antigen content to increase protection in older adults, a population at greater risk of severe complications from infection. Now available and can be pre-ordered for the...
Category: Pharmaceutical
Posted: October 17, 2024
Sanofi and Orano join forces to develop next-generation radioligand medicines
17 October 2024 -- Paris, France -- Sanofi and Orano Med, a subsidiary of the Orano Group and a pioneer in the development of targeted alphatherapies in oncology, have entered...
Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: October 17, 2024
Scotland first in the UK to recommend a new treatment option for lung cancer, which could help lower the risk of cancer returning
7 October 2024 -- Scotland, UK -- the Scottish Medicines Consortium has recommended MSD's KEYTRUDA® (pembrolizumab) as monotherapy for the adjuvant treatment of adults with non-small cell lung carcinoma (NSCLC)...
Category: Other, Pharmaceutical
Posted: October 7, 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
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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
ERS: Dupixent data reinforce clinically meaningful benefit from pooled analysis of two COPD phase 3 studies
Pooled results from the BOREAS and NOTUS studies show meaningful clinical benefit with 31% reduction in exacerbations along with lung function improvement Data from these two phase 3 studies supported...
Category: Clinical Trials, Drug Delivery, Pharmaceutical
Posted: September 10, 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
