article thumbnail

To approve Amgen's lung cancer med Imdelltra, FDA saw past 'large number' of missing adverse events

Fierce Pharma

When the FDA approved Amgen’s Imdelltra in May, the T-cell engager was hailed as a breakthrough for the treatment of small cell lung cancer (SCLC) and as the first DLL3-targeting therapy of potenti | In granting an accelerated approval to Amgen's first-in-class DLL3 bispecific Imdelltra, the FDA had to work through a “large number” of missing (..)

FDA 328
article thumbnail

As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

Fierce Pharma

A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions. But these immunotherapies also come with various potentially dangerous side effects. |

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Fierce Pharma Asia—Merck-Curon bispecific deal; Legend's path forward; Missing adverse events in Amgen FDA filing

Fierce Pharma

A large number of missing adverse events in South Korea triggered a full-scale check-up during the FDA's review of Amgen's Imdelltra. . | Merck licensed a bispecific from a Chinese biotech with plans to target oncology and autoimmune diseases. Legend Biotech is taking a close at its business as M&A has emerged as an option.

FDA 264
article thumbnail

Episode 97 – Trade Shows and Events, What’s changed and what you should do. Part 1

Medical Device Success

I am honored to have two event planning experts, Lauren Dustman, Senior Manager, Global Events at Hyperfine and Kimberly Stanséll, Meeting, Trade Show and Event Strategy Consultant to guide us today in this conversation. Combined, these ladies manage about 100 shows and events annually. Reading time: 2 – 4 minutes.

Medical 246
article thumbnail

How Machine Learning Drives Clinical Trial Efficiency

We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety.

article thumbnail

'The Top Line': Panelists at Fierce's JPM Week event talk drug pricing policy, and Bayer's oncology head discusses cancer strategy

Fierce Pharma

The Top Line': Panelists at Fierce's JPM Week event talk drug pricing policy, and Bayer's oncology head discusses cancer strategy qanderson Thu, 01/19/2023 - 11:05

243
243
article thumbnail

*EVENT* The Silent Edge: October 9 in NYC

Authentic Influence Group

The Silent Edge: How Body Language and Communication Skills Shape Leadership Success October 9, 2024 | 8:00 AM | NYC Free Event | Limited to 30 Seats Enjoy a Breakfast Bagel | Take in the NYC Skyline | Master Leadership Through Body Language Harness the power of what’s not being said. Seats Are Limited to 30!

article thumbnail

Cold Calling Tips and Tricks

However, there is also strong evidence which points to the contrary - 78% of decision-makers have taken an appointment or attended an event as a result of a cold call. In fact, less than 2% of today’s cold calls actually result in meetings, and 63% of sales professionals say it’s what they dislike most about their jobs. What’s the verdict?