AZ crashes RSV vax race, buying Icosavax

Today’s Big News

Dec 12, 2023

Sanofi scraps Maze deal after FTC throws up antitrust obstacles


BMS pays $800M upfront for antibody-drug conjugate, opening new front in Merck rivalry


Beyfortus-maker AstraZeneca enters RSV vaccine race with $800M Icosavax acquisition


ASH: After landmark FDA approvals, Editas still thinks its gene therapy differentiates itself enough from competition


Bicara nets second nine-digit haul in nine months, raising $165M series C


Merck offers up to $610M for one of C4’s protein degrades


Connect Biopharma plots phase 3 regulatory path after asthma asset hits mid-stage trial goals


Athira’s losing streak continues with phase 2 failure in dementia


Cell engineering platform company Portal Biotechnologies launches with ties to Roche, Bayer 


ISA sees cancer vaccine fail in phase 2, loses Regeneron’s interest but still plans path to market


Fierce Biotech Fundraising Tracker '23: Tome Biosciences raises $213M; Bicara bags $165M series C


New Seattle Hub for Synthetic Biology launches to build a ‘genomic smart watch’ 


New Tune preclinical data suggests HBV therapy is hitting the right notes 

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

Sanofi scraps Maze deal after FTC throws up antitrust obstacles

The Federal Trade Commission has scuttled Sanofi’s licensing deal with Maze Therapeutics. With the FTC moving to block the deal, the Big Pharma is pulling out rather than working through the antitrust maze that has sprung up between it and the asset.
 

Top Stories

BMS pays $800M upfront for antibody-drug conjugate, opening new front in Merck rivalry

Bristol Myers Squibb has filled the antibody-drug conjugate-shaped hole in its pipeline by following the increasingly well-trodden path to China, handing SystImmune $800 million upfront for a phase 1/2 solid tumor candidate as part of a deal worth up to $8.4 billion.

Beyfortus-maker AstraZeneca enters RSV vaccine race with $800M Icosavax acquisition

It looked for a while like AstraZeneca was planning to back out of the vaccines business for good, but the acquisition of respiratory syncytial virus (RSV) shot developer Icosavax suggests the British Big Pharma plans to be a player for a while longer.

Standardizing software: Supporting small pharma with SAP

Aparna Seksaria and Kevin Brophy sit down with Fierce Biotech’s Rebecca Williamson to talk about the importance of levelling the playing field by offering leading-edge software solutions to the smaller businesses in the pharma sphere.

ASH: After landmark FDA approvals, Editas still thinks its gene therapy differentiates itself enough from competition

On the heels of Friday’s FDA approval of not one but two gene therapies to treat sickle cell disease, Editas Medicine is sharing another slice of early data for its gene-edited candidate designed to tackle the same condition.

Bicara nets second nine-digit haul in nine months, raising $165M series C

If you can raise more in a tough financing environment, then why not? Such was the calculus for Bicara Therapeutics, which raised its second nine-digit financing in 2023 after building momentum off new data.

Merck offers up to $610M for one of C4’s protein degraders

Merck & Co. is paying $10 million upfront with $600 million in potential biobucks for a targeted protein degradation med from C4 Therapeutics. The Big Pharma has the option to license three additional targets.

Connect Biopharma plots phase 3 regulatory path after asthma asset hits mid-stage trial goals

A few weeks after selling off certain regional rights to monoclonal antibody (mAb) rademikibart, Connect Biopharma is back to share that an asthma trial assessing the candidate has hit its main goal, demonstrating significantly improved lung function in a mid-stage trial.

Athira’s losing streak continues with phase 2 failure in dementia

Athira had clung to the hope that its drug fosgonimeton could overcome a phase 2 failure in Alzheimer’s to demonstrate success in Parkinson’s and dementia. Unfortunately, a mid-stage trial in those indications has been no kinder.

SQZ founder Armon Sharei opens Portal to to simplify intracellular delivery

As SQZ Biotechnologies slips away, the biotech’s founder and former CEO Armon Sharei, Ph.D., is launching a new cell engineering platform company dubbed Portal Biotechnologies.

ISA sees cancer vaccine fail in phase 2, loses Regeneron’s interest but still plans path to market

ISA Pharmaceuticals' cancer vaccine may have failed to sufficiently improve the overall response rate in a phase 2 trial, but the Netheralands-based biotech is insistent that honing in on a subgroup of patients could reap rewards in phase 3.

Fierce Biotech Fundraising Tracker '23: Tome takes $213M; Bicara bags $165M series C

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

New Seattle Hub for Synthetic Biology launches to build a ‘genomic smart watch’

A collaboration between the Allen Institute, the Chan Zuckerberg Initiative and the University of Washington aims to build new technologies that let scientists measure changes in single cells in real time.

New Tune preclinical data suggests HBV therapy is hitting the right notes

Tune Therapeutics' epigenetic editor represses HBV genes in cell lines in mice almost completely, setting the stage for clinical trials in humans.

Moderna’s commercial lead ousted as mRNA biotech taps leading execs to front all sales, marketing work

Less than two years after snapping up the chief commercial role at Moderna, Arpa Garay is stepping aside amid a shake-up in the Big Biotech’s commercial unit.

Cognito study shows white matter growth, reduced myelin loss in Alzheimer’s patients after neuromod treatment

In the study, patients with Alzheimer’s were tasked with using Cognito’s neuromodulation headset for an hour each day for the entire six-month study period.

Troubled Evofem, marketer of contraceptive gel Phexxi, sells itself to Aditxt in $100M deal

Evofem has struggled to gain commercial traction after a 2020 approval for Phexxi. Now, it's selling itself after shares crashed dramatically over the last few years.

House price transparency legislation passes with bipartisan support

Members on both sides of the aisle are celebrating successful efforts to codify price transparency requirements and establish site-neutral payments in the Lower Costs, More Transparency Act passed by the House of Representatives on Monday.
 
Fierce podcasts

Don’t miss an episode

Turning down the toxicity of nature’s most powerful antifungal

Amphotericin B, an effective antifungal with rare resistance, is associated with significant kidney damage, prompting the search for a potential alternative. This week on "The Top Line," Fierce Biotech Research’s Helen Floersh spoke with Martin Burke, M.D., Ph.D., founder of antifungal startup Sfunga Therapeutics, to discuss the design and path to clinic of a promising new drug that could shape the future of antimicrobials.

 

Resources

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Transitioning from using RUO to cGMP chemicals for clinical trials

By 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially.
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The Potential of Predictive Algorithms for Pharma

Learn about the untapped power of AI-driven insights — where innovation meetings precision, effortlessly unlocking benefits for your organization.
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The Convergence of Consumer Wearables & Medical Devices

Medical devices & consumer wearables are starting to overlap, creating risks & opportunities for traditional medical device companies as well as consumer wearables manufacturers. This paper explores pros and cons from both perspectives.

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Fed-Batch Intensification To Increase Titer In Biologics Manufacturing

Improving efficiency and productivity in biologics manufacturing is a longstanding goal within today’s industry, especially now as new and increasingly complex molecules are fundamentally changing technological and operational approaches to drug development. Process intensification can help accelerate this pace of innovation through advanced process development techniques and high productivity manufacturing platforms.

Whitepaper

Effective Technology Transfers for Mammalian-Derived Biologics

As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. 

eBook

An Introduction to Organ-on-a-Chip Technology

Emulate in vivo biology with next-generation in vitro technology.
 

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