Brain-spine interface system may reverse paralysis

Editor's Note: Fierce Biotech will not publish on Monday, May 29, due to the Memorial Day holiday. We'll be back in your inboxes on Tuesday, May 30. Enjoy your long weekend!

Today's Big News

May 26, 2023

ASCO: After lung cancer fails, Roche's faith in TIGIT rewarded as tiragolumab shows signs of life in liver cancer


ASCO: Regeneron's Opdualag rival records double the historical response rate in melanoma


ASCO: Zentalis showcases ovarian cancer data that will take WEE1 to phase 3


'Quite science fiction': Brain-spine interface system helps man with paralysis walk again  


UK government pledges to reverse flagging trials takeup as part of £650M life sciences 'war chest'


Chutes & Ladders—Amit Munshi lands back in the biotech arena leading RNA-focused ReNAgade


Fierce Biotech Fundraising Tracker '23: Carmot counts $150M series E; VarmX tacks on series B2 funds

 

Featured

ASCO: After lung cancer fails, Roche's faith in TIGIT rewarded as tiragolumab shows signs of life in liver cancer

Roche's faith in TIGIT may have finally been rewarded, as tiragolumab shows signs of efficacy in liver cancer.
12-14
Jun
San Diego, CA
 

Top Stories

ASCO: Regeneron's Opdualag rival records double the historical response rate in melanoma

Regeneron believes its LAG-3 inhibitor and PD-1 inhibitor combo for patients with advanced melanoma could serve as a rival to Bristol Myer Squibb’s Opdualag, although a significant portion of patients discontinued treatment in a phase 1 study.

ASCO: Zentalis showcases ovarian cancer data that will take WEE1 to phase 3

A year after getting Pfizer’s backing, Zentalis Pharmaceuticals says new data for a WEE1 candidate justifies putting the asset into a phase 3 study for ovarian cancer next year.

'Quite science fiction': Brain-spine interface system helps man with paralysis walk again

After a motorbike accident left him paralyzed from the waist down, Gert-Jan wished to walk again. Now, with the help of a "digital bridge" that connects his brain to his spinal cord, he can.

UK government pledges to reverse flagging trials takeup as part of £650M life sciences 'war chest'

The U.K. government has pledged that a chunk of the 650 million pound sterling ($803 million) funding package assigned to boost the country’s life sciences industry will go toward reversing the slowdown in clinical trial uptake.

Chutes & Ladders—Amit Munshi lands back in the biotech arena leading RNA-focused ReNAgade

Former Arena CEO Munshi will lead new RNA-focused biotech. Larkspur launches with an all-woman leadership team. CytoDyn finds itself with another executive hole to fill.

Fierce Biotech Fundraising Tracker '23: Carmot counts $150M series E; VarmX tacks on series B2 funds

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

Illumina shareholders vote in one Carl Icahn nominee over current chairman, reject executive pay proposal

Activist investor Carl Icahn’s proxy battle against Illumina reached its conclusion Thursday with wins and losses on both sides.

ASCO: Merck gives final look at Keytruda study in first-line cervical cancer. Will FDA change its mind?

Keytruda’s first-in-class FDA approval as a first-line therapy in metastatic cervical cancer arrived in 2021 with a restriction. Now, researchers say new patient survival data suggest the Merck drug could be used in a broader patient population.

ASCO: BMS pitches Breyanzi as the first CAR-T for CLL. But will a single-arm trial persuade the FDA?

Bristol Myers Squibb's Breyanzi is the first CAR-T drug to deliver a positive readout in chronic lymphocytic leukemia in a pivotal multicenter study. But the study's small size and its single-arm nature might raise uncertainties for drug regulators.

'The Top Line': The 20 most influential people in biopharma, plus this week's headlines

This week on "The Top Line," we discuss the 20 most influential people in biopharma, plus a topical gene therapy, a new opioid overdose medication, and the rest of the week's headlines.

Fierce Pharma Asia—Carvykti's EU filing; Thermo Fisher's Singapore expansion; Celltrion's Humira biosim nod

J&J and Legend Biotech filed to move Carvykti up the treatment line in Europe. Thermo Fisher opened a new facility in Singapore. Celltrion's Humira biosimilar won an FDA approval after a manufacturing problem delayed the review. And more.
 
Fierce podcasts

Don't miss an episode

'Podnosis': The food is medicine movement and the top-paid healthcare and payer execs

This week on "Podnosis," we discuss the history of 'food is medicine' and where the movement has room to grow. We also talk about our special report comparing top-paid health system execs with payer execs.
 

Resources

Whitepaper

ChatGPT in Drug Discovery: Rise of Large Language Models

ChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations.
Whitepaper

Discovering High-Affinity, Functional Anti-GLP-1R Antibodies

Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties.
eBook

Decentralized Clinical Trials: The Complete Guide for 2023

Discover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success.
Research

How Lilly’s Legal and Library Services Empower Teams Across the Drug Development Pipeline

What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how.

Whitepaper

Medical Affairs Metamorphosis VI: The Changing Face of Stakeholder Engagement

This paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing.
Research

Maximizing Clinical Trial Success

Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies
Whitepaper

Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
Whitepaper

Key Clinical Supply Issues Sponsors Should Consider with their CRO

As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs.

Whitepaper

Specialized Expertise for Management of Clinical Supply Budgets

For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management.
Whitepaper

Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
Whitepaper

Designing an Optimal APAC Clinical Supply Chain

Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific.
Whitepaper

Roles and Responsibilities of Specialized Clinical Supply Experts

How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis.
Whitepaper

Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
Whitepaper

Questions You Need to Ask Your CRO About Clinical Supply

Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
 

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