Biotech Archives - Page 18 of 795

2 minute read

Novartis’ Oral Drug For Chronic Skin Disease Candidate Shows Efficacy, Long-term Safety

May 31, 11:02 AM

Novartis reveals Phase 3 data confirming remibrutinib's long-term efficacy and safety for chronic spontaneous urticaria, showing significant symptom improvement and a favorable safety profile up to Week 52.

NVS

2 minute read

Europe Approves Biogen’s Tofersen For Adult Patients With Rare Type Of Neurodegenerative Disorder

By Vandana Singh

May 31, 10:25 AM

The European Commission has granted exceptional marketing authorization for Biogen's Qalsody (tofersen), the first EU-approved treatment targeting the genetic cause of ALS.

BIIB

1 minute read

Summit Therapeutics’ Lung Cancer Therapy Ivonescimab Shows Improved Progression-Free Survival Versus Merck’s Multi-Billion Keytruda In China Study

By Vandana Singh

May 31, 10:21 AM

Summit Therapeutics shares dropped 27.3% to $7.94 in premarket trading Friday after a 272.1% surge on Thursday. The company announced Phase 3 HARMONi-2 trial results, where ivonescimab significantly improved progression-free survival in NSCLC patients compared to Keytruda.

MRK

1 minute read

Takeda Gets Positive CHMP Opinion For Recombinant ADAMTS13 In Congenital Thrombotic Thrombocytopenic Purpura

By Benzinga Newsdesk

May 31, 9:59 AM

cTTP Is an Ultra-rare, Potentially Fatal Blood-Clotting Disorder with Limited Treatment Options; Untreated, Acute TTP Events Have a Mortality Rate of >90%1,2If Approved in the European Union, rADAMTS13 Will Be the

TAK

2 minute read

Gilead’s Trodelvy Fails To Hit Primary Goal In Late-Stage Study With Most Common Type Of Bladder Cancer

By Vandana Singh

May 31, 9:27 AM

Gilead Sciences' announced topline results from the Phase 3 TROPiCS-04 study on Trodelvy for metastatic urothelial cancer. The study did not meet the primary endpoint of overall survival but showed numerical improvements favoring Trodelvy.

GILD

2 minute read

FDA Extends Review Deadline For Regeneron/Sanofi’s Dupixent For ‘Smoker’s Lungs’ Disease

By Vandana Singh

May 31, 9:23 AM

The FDA extends the target action date for reviewing Dupixent as an add-on treatment for uncontrolled COPD to September 27, 2024. This follows the submission of additional efficacy analyses from pivotal trials. European Medicines Agency also supports Dupixent for COPD.

REGN

1 minute read

Mirum Pharmaceuticals Gets Positive CHMP Opinion For LIVMARLI Oral Solution For The Treatment Of PFIC In Patients 3-Months Or Older

By Benzinga Newsdesk

May 31, 8:39 AM

Positive opinion from CHMP based on Phase 3 MARCH study with highly statistically significant (p<0.0001) reduction in pruritus severity between LIVMARLI vs. placebo across all PFIC types studied.CHMP assessment

MIRM

1 minute read

Novartis Scemblix Phase III Data Shows Superior Efficacy With A Favorable Safety And Tolerability Profile Vs. Standard-Of-Care TKIs In Adults With Newly Diagnosed CML

By Benzinga Newsdesk

May 31, 8:20 AM

https://www.novartis.com/news/media-releases/novartis-scemblix-phase-iii-data-first-show-superior-efficacy-favorable-safety-and-tolerability-profile-vs-standard-care-tkis-adults-newly-diagnosed-cml Phase

NVS

1 minute read

Gilead Sciences To Present EVOKE-01 Study Results In Metastatic NSCLC At An Oral Session At ASCO 2024

By Benzinga Newsdesk

May 31, 8:16 AM

– Simultaneously Published by the Journal of Clinical Oncology –Gilead Sciences, Inc. (NASDAQ:GILD) today announced detailed results from the Phase 3 EVOKE-01 study that will be presented during an oral session (Abstract

GILD

1 minute read

Autolus Therapeutics Presents Additional Data Analysis Of Pivotal Phase 2 Felix Study Of obe-cel For Adult r/r B-all In An Oral Presentation At ASCO

By Benzinga Newsdesk

May 31, 8:11 AM

The majority of patients that responded to obe-cel showed durable responses with the potential for a long-term plateau of survival outcomes40% patients are in ongoing remission without subsequent stem cell transplant

AUTL