Pharmafile Logo

News and Press Releases

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

HUTCHMED
48th Floor, Cheung Kong Center 2 Queen's Road Central, Hong Kong

Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma

Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa and the standard treatment Pd, improved responses and long-term...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 13, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

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

Biofidelity
5151 McCrimmon Parkway, Suite 230 Morrisville, NC 27560

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

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)

Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200...

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

PureTech Health
info@puretechhealth.com
PureTech Health 6 Tide Street Boston, MA 02210

QurAlis Invited to Present at 43rd Annual J.P. Morgan Healthcare Conference

7 January 2025 -- Massaschusetts, US --  QurAlis Corporation, a clinical-stage biotechnology company driving scientific breakthroughs into powerful precision medicines that have the potential to alter the trajectory of amyotrophic...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 7, 2025

QurAlis
info@quralis.com
100 Cambridgepark Dr, Cambridge, MA 02140

IDDI Announces New Leadership to Drive Growth and Innovation

Tim Davis appointed as new Chief Executive Officer and Jeremy Edwards named the new Chief Commercial Officer 7 January 2025 -- Ottignies, Belgium -- International Drug Development Institute (IDDI), a...

Category: Clinical Trials, Other, Pharmaceutical
Posted: January 7, 2025

IDDI
info@iddi.com
Avenue Provinciale, 30 1341 Ottignies-Louvain-la-Neuve Belgium

Neumora Therapeutics Reports Data from KOASTAL-1 Study of Navacaprant in Major Depressive Disorder

Study did not demonstrate statistically significant improvement on primary endpoint of reduction in depressive symptoms as measured by MADRS total score compared to placebo Navacaprant showed an efficacy signal in...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: January 2, 2025

Neumora
investors@neumoratx.com
490 Arsenal Way, Suite 200 Watertown, MA 02472

Bioxodes meets enrollment milestone in Phase 2a intracerebral hemorrhagic stroke trial

Bioxodes has enrolled first 16 patients in trial with BIOX-101 Completing treatment of first cohort of patients will trigger interim analysis BIOX-101 is a first-in-class drug candidate, a peptide developed...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: December 19, 2024

Bioxodes
info@bioxodes.com
Parc d'activités Aéropole Rue Santos-Dumont, 1 6041 Gosselies, Belgique

Tiziana Life Sciences Announces First Patient with Moderate Alzheimer’s Disease Dosed with Intranasal Foralumab

17 December 2024 -- New York, US -- Tiziana Life Sciences, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal...

Category: Biotechnology, Clinical Trials, Pharmaceutical
Posted: December 17, 2024

Tiziana Life Sciences
info@tizianalifesciences.com
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom

Novotech Named a Fierce CRO Award Winner in the Excellence in Clinical Trial Management and Global Operations Categories

11 December 2024 -- Sydney, Australia -- Novotech, the global full-service clinical Contract Research Organization (CRO) that partners with biotech and small to mid-size pharma companies to accelerate the development...

Category: Clinical Trials, Drug Discovery, Logistics, Pharmaceutical
Posted: December 11, 2024

Novotech
mediacontact@novotech-cro.com
Level 19, 66 Goulburn Street, Sydney Australia

Ellipses Pharma Publishes Data from Ongoing Phase 1/2 Clinical Trial of EP0042

9 December 2024 -- London, UK -- Ellipses Pharma Limited, a global drug development company focused on accelerating the development of new oncology treatments, has published the latest data from...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 9, 2024

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

PureTech Presents Data for LYT-200 (anti-galectin-9 monoclonal antibody) for Relapsed/Refractory AML/MDS at the 2024 ASH Annual Meeting

LYT-200 is generally safe and well-tolerated as a single agent as well as in combination with standard-of-care venetoclax and hypomethylating agents LYT-200 demonstrates clinical benefit as a single agent, with...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: December 9, 2024

PureTech Health
info@puretechhealth.com
PureTech Health 6 Tide Street Boston, MA 02210

Longest Follow-Up Data Reported for Kite’s Tecartus CAR T-Cell Therapy at ASH 2024 Reinforce Durable Efficacy and Survival Benefits

Only CAR T to Demonstrate Prolonged Overall Survival After Five Years Follow-Up in Relapsed/Refractory Mantle Cell Lymphoma ZUMA-2 Analysis Shows 91% Overall Response Rate, Including 73% Complete Response Rate, in...

Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: December 9, 2024

Kite Pharma
2400 Broadway Santa Monica, CA 90404

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

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK