News and Press Releases

CARVYKTI▼ (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the EC for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy

Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse Approval is based on results from...

Category: Biotechnology, Clinical Trials
Posted: April 22, 2024

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Kite to Present Comparison of Outcomes of Tecartus (brexucabtagene autoleucel) from the Pivotal ZUMA-2 Trial Versus the EBMT Registry of alloSCT Patients in Mantle Cell Lymphoma (MCL) at 50th EBMT 2024

Additional analysis demonstrates cost-effectiveness of axicabtagene ciloleucel versus standard of care as second-line therapy In patients With large B-cell lymphoma In Italy 9 April 2024 -- Stockley Park, UK --...

Category: Biotechnology, Clinical Trials
Posted: April 12, 2024

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Veklury (remdesivir) recommended by NICE for treatment of COVID-19 in vulnerable adults and children

Remdesivir is the first antiviral treatment recommended by NICE to treat eligible children, including those with a high risk of serious illness from COVID-19 This decision secures long-term access to...

Category: Pharmaceutical
Posted: April 9, 2024

Gilead extends partnership with NHS England to eliminate hepatitis C by 2025

Since the commencement of the Strategic Procurement agreement in 2019, Gilead has worked in partnership with NHS England, non-profit organisations, and industry to help treat and cure over 84,000 people...

Category: Other, Pharmaceutical
Posted: April 8, 2024

Janssen Receives Positive CHMP Opinion for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma

Results from the phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment Most...

Category: Clinical Trials
Posted: February 23, 2024

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Kite Presents New Data for Yescarta (axicabtagene ciloleucel) CAR T-cell Therapy Highlighting Manufacturing Excellence and Cost-Effectiveness in the US

Data Highlights Industry-leading Manufacturing Success Rates for US Axicabtagene Ciloleucel Patients from Launch to Present Data Also Supports Cost-effectiveness of Axicabtagene Ciloleucel Versus Bispecific Antibodies 16 February 2024 – Stockley...

Category: BioManufacturing
Posted: February 21, 2024

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Real-World Evidence Demonstrates Feasibility and Safety of Outpatient Administration of Yescarta (axicabtagene ciloleucel)

Findings show comparable safety for patients administered axicabtagene ciloleucel in the outpatient setting in the US to inpatient infusion  Real-world evidence supports further exploration of use of outpatient administration of...

Category: Clinical Trials
Posted: February 15, 2024

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Gilead Sciences Strengthens Commitment to Inflammatory Disease with New Research Centre

14 February 2024 -- Oxford, UK -- On 14 February, Gilead Sciences held a ribbon-cutting event to celebrate the opening of its new research site at the Business Park in...

Category: BioManufacturing
Posted: February 14, 2024

Janssen Submits Type II Extension of Indication Application to the European Medicines Agency Seeking Approval of RYBREVANT (amivantamab), in combination with Lazertinib, for the First-Line Treatment of Patients with EGFR Mutated Non-Small Cell Lung Cancer

The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with...

Category: Drug Discovery
Posted: February 8, 2024

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AiCuris Received €15m Milestone Payment from Licensing Partner MSD Following EMA Approval of PREVYMIS for Prevention of CMV Infection in High-Risk Adult Kidney Transplant Recipients

PREVYMIS now approved in the US and Europe for prophylaxis of Cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-]) EMA approval...

Category: Pharmaceutical
Posted: January 9, 2024

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Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination with RYBREVANT (amivantamab), for the First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer

The submission is supported by data from the Phase 3 MARIPOSA study, which featured in a Late-Breaking Presidential Symposium session at the 2023 ESMO CongressLazertinib is a highly selective, central...

Category: Clinical Trials
Posted: December 21, 2023

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ViroCell signs manufacturing services agreement with UCL to accelerate research into prevention of relapse in childhood blood cancer

Agreement will leverage ViroCell’s expertise in lentiviral vector manufacturing for an innovative CAR T-cell therapy for the treatment of paediatric acute lymphoblastic leukaemia 12 December 2023 -- London, UK and...

Category: BioManufacturing
Posted: December 12, 2023

New Analyses Presented at ASH 2023 Support the Potential Long-Term Response and Safety of Kite’s TECARTUS (brexucabtagene autoleucel) in patients with aggressive blood cancers

At Almost Four Years of Follow-up in the Pivotal ZUMA-2 Study, Median Overall Survival was 46.4 Months, Supporting Long-term Response in Adult Patients with Relapsed/Refractory(R/R) Mantle Cell Lymphoma (MCL) Real-world...

Category: Clinical Trials
Posted: December 12, 2023

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Kite’s CAR T-Cell Therapy YESCARTA (Axicabtagene Ciloleucel) Compared with Bispecifics in R/R DLBCL in Two Analyses at ESMO 2023

23 October 2023 -- Stockley Park, UK -- Kite, a Gilead Company, today announced results from two indirect comparative analyses of its CAR T-cell therapy Yescarta (axicabtagene ciloleucel) versus bispecific...

Category: Clinical Trials
Posted: October 23, 2023

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Mundipharma and Cidara Therapeutics receive positive CHMP opinion forrezafungin for the treatment of Invasive Candidiasis in adults

The opinion was based on positive results from the pivotal ReSTORE phase 3 clinicaltrial and supported by the STRIVE phase 2 clinical trials and extensive nonclinicaldevelopment programme If approved by...

Category: Biotechnology
Posted: October 17, 2023

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