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BLA Accepted: Novartis Inches Ahead In CAR-T Race With Kite

 
• By Mandy Jackson

Novartis may very well have the first CAR-T therapy approved in the US, beating its rival Kite Pharma to the finish line, since the FDA has accepted the Swiss big pharma's BLA for priority review. Kite says it will complete its rolling BLA submission in a different indication by the end of March.

T-cells attacking cancer_1200x675

Novartis AG shot ahead of Kite Pharma Inc. in the race to get the first chimeric antigen receptor T cell (CAR-T) therapy approved in the US for hematological malignancies, announcing on March 29 that its biologic license application (BLA) for CTL019 (tisagenlecleucel-T) has been accepted by the FDA for priority review.

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Stock Watch: Disappointing ACC Share Price Reactions For AstraZeneca And Lilly

 
• By Andy Smith

The end of the American College of Cardiology conference was a prelude to a volatile trading week for most stocks. Even before Liberation Day, reactions to the conference announcements were not encouraging.

Korean Biotech Roundup: GNT Set For First Direct Korean Biopharma IPO On Nasdaq

 
• By Jung Won Shin

GNT Pharma prepares for the first listing of a Korean biotech on Nasdaq, while others sign major global out-licensing deals with large multinational partners.

Ironwood To Consider All Options With Apraglutide Setback In SBS

 
• By Joseph Haas

With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.

Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 
• By Jessica Merrill

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

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Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 
• By Jessica Merrill

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

Amgen’s Imdelltra Sets The Pace In Small-Cell Lung Cancer

 
• By Andrew McConaghie

The bispecific is the first in its class to record a Phase III survival win in small-cell lung cancer, although antibody-drug conjugates and other rivals could challenge in the coming years.

Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.