Fierce Biotech’s new M&A Tracker launches

Today's Big News

May 17, 2023

After safety signals snare rivals, Roche's MS drug clears lesions without the adverse events


Fierce Biotech M&A Tracker 2023: Gilead nabs PARP1 specialist, Bellus, Satsuma and more


Pfizer's maternal RSV vaccine appears to win over FDA ahead of advisory meeting


Takeda puts $510M on the line to expand KSQ cancer collaboration


A drug once rejected for toxic side effects could see new life in battle against antibiotic resistance


SPAC in business: enGene takes blank-check route to accelerate gene therapy’s path to market


Byondis' breast cancer drug fails to bloom as FDA denies approval


Avidity says partial hold on lead muscle wasting disorder asset has been ‘eased’

 

Featured

After safety signals snare rivals, Roche's MS drug clears lesions without the adverse events

Roche’s BTK inhibitor has hit the mark in a midphase multiple sclerosis trial—and without causing the sort of adverse events that sparked partial holds on Merck KGaA and Sanofi’s rival assets.
 

Top Stories

Fierce Biotech M&A Tracker 2023: Gilead nabs PARP1 specialist, Bellus, Satsuma and more

Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe.

Pfizer's maternal RSV vaccine appears to win over FDA ahead of advisory meeting

The FDA seems to be satisfied that Pfizer's RSV vaccine is safe and effective for administration in pregnant women to protect infants from severe disease.

Understanding Venture Debt Funding for Life Sciences Companies

Venture debt is a type of debt financing obtained by early and growth-stage companies and typically used as a complementary method to equity financing.

Takeda puts $510M on the line to expand KSQ cancer collaboration

Takeda has doubled down on KSQ Therapeutics, handing over “double-digit millions of dollars” on day one and committing up to $510 million on the back end to research and validate novel tumor-intrinsic targets.

Navigating uncertainty in modern clinical development

Developing a new life-saving drug or medical device is fraught with challenges. But while challenges often vary from program to program, one in particular is guaranteed: uncertainty. In this article, Dr Kim, CMO at Cytel, discusses the nature and consequences of the uncertainty challenge, as well as the options available to help pharmaceutical and biotechnology companies navigate it.

A drug once rejected for toxic side effects could see new life in battle against antibiotic resistance

Scientists have a lead in the ever-more-urgent hunt for antibiotics that can combat multidrug-resistant bacteria—and this one is a throwback.

SPAC in business: enGene takes blank-check route to accelerate gene therapy’s path to market

Gene therapy biotech enGene plans to debut on the public market via a SPAC merger with Forbion European Acquisition Corp.

Byondis' breast cancer drug fails to bloom as FDA denies approval

Byondis’ plans to get FDA approval have wilted as the agency hands the Dutch company a complete response letter, denying approval for its antibody-drug conjugate treatment for HER-2 positive metastatic breast cancer.

Avidity says partial hold on lead muscle wasting disorder asset has been ‘eased’

A partial FDA hold on Avidity's lead asset has been "eased," the company announced Wednesday. The hold was first placed in September after a serious adverse event was reported in one treated patient.

Does FTC attempt to block Amgen's Horizon buy spell trouble for Pfizer-Seagen? Not necessarily, analysts say

News of the Federal Trade Commission (FTC) lawsuit challenging Amgen’s $28 billion buyout of Horizon prompted an immediate question: Will the U.S. antitrust enforcer also attempt to derail Pfizer’s plan to acquire Seagen for $43 billion? Analysts at Berenberg Capital Markets say don’t automatically assume that Pfizer-Seagen will face the same hurdle.

Theranos’ Holmes ordered to report to prison amid appeal, fined $452M in restitution alongside Balwani

Elizabeth Holmes’ last-ditch effort to avoid prison time while appealing her fraud convictions was denied this week, paving the way for her 11-year sentence to begin.

Regulatory tracker: Another China-made PD-1 starts FDA journey as Elevar, Hengrui target big cancer type

In this tracker, Fierce Pharma will record the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not make the bar for standalone stories, but we think they are still worth mentioning.

Intuitive Surgical CEO hands off president title to longtime company vet Dave Rosa

Amid a period of rapid growth for Intuitive Surgical, the robotics maker is also expanding its power structure.
 
Fierce podcasts

Don't miss an episode

'Podnosis': How tech can help diagnose neurodevelopmental disabilities and how insurtechs can be profitable

This week on "Podnosis," we discuss how technology can help diagnose neurodevelopmental disabilities in children. We also talk about how insurtechs can be profitable.
 

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

eConsent: Flexible Consent Through Enabling Technologies

How can eConsent provide a more flexible approach to informed consent?

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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