Otsuka details antibody’s ph. 3 kidney disease win

Today’s Big News

Jun 6, 2025

'Not a horse and pony show': At FDA cell and gene roundtable, officials look for ways to cut red tape 


As the investor pendulum swings away from cell therapy, Immatics CEO focuses on raising the bar 


Otsuka’s kidney disease drug halves UPCR levels in phase 3 study 


TegMine, with ex-Stemcentrx scientists at the helm, bags tech from OBI to help fuel ADC ambitions


Chutes & Ladders—Protara gears up for next steps with commercial pro 


Introducing Fierce Medtech's Fierce 15

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

 

Featured

'Not a horse and pony show': At FDA cell and gene roundtable, officials look for ways to cut red tape

At a June 5 cell and gene therapy roundtable hosted by the FDA, Department of Health and Human Services Secretary Robert F. Kennedy Jr. asked the assembled scientists and advocates to provide a list of regulations they’d like to see gone.
 

Top Stories

As the investor pendulum swings away from cell therapy, Immatics CEO focuses on raising the bar

As favor in the general market swings away from cell therapy, Immatics’ CEO is choosing to focus on what he can control: raising the bar for his biotech’s investigational treatment.

Otsuka's kidney disease drug halves UPCR levels in phase 3 study

Otsuka Pharmaceutical has shared data behind its kidney disease drug’s phase 3 win, showing the monoclonal antibody halved patients’ urine protein-to-creatinine ratio levels.

Precision medicine’s next frontier: unlocking the power of biospecimens

Austin Read of Thermo Fisher Scientific discusses how combining biospecimens with real-world data is advancing diagnostics, treatment and the future of patient care.

TegMine, with ex-Stemcentrx scientists at the helm, bags tech from OBI to help fuel ADC ambitions

TegMine Therapeutics has secured certain rights to OBI Pharma’s antibody-drug conjugate technology, advancing the efforts of former Stemcentrx scientists to treat cancer by targeting carbohydrates.

Forging the future of cell therapy: Bayer and BlueRock’s unique journey

Discover how Bayer and BlueRock are redefining biotech partnerships. From breakthrough Parkinson’s therapies to a unique “arm’s-length” model, this episode of The Top Line dives into what makes their collaboration a blueprint for the future.

Chutes & Ladders—Protara gears up for next steps with commercial pro

Protara, hoping to ultimately transition to a commercial stage company, snagged a chief commercial officer in Bill Conkling, who brings to the table two decades of industry experience. Before his most recent position as Rafael Holdings’ CEO, Conkling spent over 10 years at Novartis including as commercial lead for the launch of the first ever approved CAR-T therapy, Kymriah, in 2017.

Delivering the Future of Radiopharmaceuticals with Precision

Radiopharma is revolutionizing modern medicine. Discover how precision logistics empowers faster, safer delivery of life-impacting therapies when every second counts.

Introducing Fierce Medtech's Fierce 15

The companies that make up this class of the Fierce 15 exemplify the idea of moving the field forward by using innovation to build upon what’s come before.

Orca hires ex-Legend exec Gavel to hammer open cell therapy market as CCO

Orca Bio is preparing to make a splash in the cell therapy market. The biotech has hired Steve Gavel as chief commercial officer, securing itself a leader with cell therapy expertise accrued at Legend Biotech and Celgene.

Fierce Pharma Asia—Bispecific field's roller coaster week; Enhertu's first-line win; Regeneron-Hansoh obesity deal

The PD-(L)1xVEGF field had a roller coaster week marked by an imperfect readout and a potentially $11 billion deal. AstraZeneca and Daiichi Sankyo trotted out Enhertu's detailed data in first-line breast cancer. Regeneron signed on a GLP-1/GIP candidate from Hansoh Pharma. And more.

GOP Senators mull Medicare cuts in bid to get megabill over the finish line: media report

As senators seek a path forward for President Trump's "big beautiful bill," Medicare cuts are reportedly on the table, according to media reports. The version of the bill that passed the House in May includes work requirements imposed sooner and changes to state-directed payments, cost-sharing reductions, eligibility checks and gender-affirming care.
 
Fierce podcasts

Don’t miss an episode

What’s next for tech-enabled home care? A look at the policy road ahead

This week on "Podnosis," we’re examining the future of tech-enabled home care and the policy decisions that could determine whether these models become permanent fixtures in the U.S. healthcare system.
 

Resources

Whitepaper

Building Peak Performance Go-to-Market Operations

We analyzed ~300 launches to identify the factors most correlated with commercial success & built a framework for peak go-to-market performance.
 

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