Pharmafile Logo

News and Press Releases

Ellipses’ next generation selective RET inhibitor EP0031/A400 granted Fast Track designation by US Food and Drug Administration

Compound is currently undergoing clinical trials as a potential treatment option for patients with RET altered tumours 5 March 2024 -- London, UK -- Ellipses Pharma, a global drug development...

Category: Drug Discovery
Posted: March 5, 2024

Ellipses Pharma
enquiries@ellipses.life
10 STRATTON STREET W1J 8LG LONDON

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

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

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

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

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

AiCuris Anti-Infective Cures
info@aicuris.com
Friedrich-Ebert-Str. 475 / Building 302 42117 Wuppertal Germany

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

Johnson & Johnson Innovative Medicine
mediaenquiries@its.jnj.com
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG

CN Bio wins ‘Most Impactful Industry Collaboration of the Year’ at the OBN Awards 2023 for ongoing research with the FDA

Six-year collaboration recognised at prestigious awards ceremony for its continued success in advancing OOC research to support widespread adoption across the pharmaceutical industry 23 November 2023 -- Cambridge, UK --...

Category: Clinical Trials
Posted: November 23, 2023

CN-Bio
enquiries@cn-bio.com
30 Upper High Street, Thame, Oxfordshire, OX9 3EZ

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

Cidara Therapeutics
info@cidara.com
6310 Nancy Ridge Drive Suite 101 San Diego, CA 92121

Signum Surgical Completes Clinical Trial for BioHealx

Galway based company compiling data for submission of a De Novo classification request to US FDA Novel surgical option for the treatment of anal fistula, a painful and debilitating colorectal...

Category: Clinical Trials
Posted: September 12, 2023

Signum Surgical
INFO@SIGNUMSURGICAL.COM
NEW DOCKS, THE DOCKS, GALWAY