| 01.03.25 | The sudden shift in 2024's FDA drug approvals, and peeks into what 2025 may bring

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Weekly Digest

This Week

Jan 3, 2025

2024 drug approvals: Small companies loom large with several key FDA nods

Novo Nordisk wins hard-fought FDA approval for once-daily hemophilia med Alhemo

Ikena, after tough year of layoffs, merges with Inmagene to focus on phase 2 dermatitis prospect

From AI and layoffs to supply chains and political unknowns, Deloitte outlines key areas for biopharma to watch in 2025

Clinical trials industry to grapple with new tech, additional uncertainty in 2025: Velocity Clinical Research CEO

Editor's Corner: Recapping Fierce Pharma's top stories of the year

Editor's Corner: Fierce Biotech's 10 most-read stories of 2024

Editor’s Corner: Fierce Medtech’s top 10 stories of 2024 chart the industry’s highs and lows

Editor's Corner: The top 10 Fierce Pharma Marketing stories of 2024 recapped

2025 forecast: After Novo, Lilly expansion sprees, 'positive signals' emerge around future supply of GLP-1 drugs

Featured

2024 drug approvals: Small companies loom large with several key FDA nods

By Kevin Dunleavy

Each year, many scientists and other experts working in the biopharma industry see years of their work culminate in FDA approvals. In 2024, the FDA gave a thumbs-up to more than xx new treatments, which was down from 60-plus new drugs in 2023.

Novo Nordisk wins hard-fought FDA approval for once-daily hemophilia med Alhemo

By Fraiser Kansteiner

The FDA approved Novo Nordisk's tissue factor pathway inhibitor (TFPI) antagonist concizumab as a once-a-day treatment to prevent or curb the frequency of bleeding episodes in patients ages 12 and older who have hemophilia A or B with inhibitors. The green light follows a rejection in 2023 and a trial pause over safety concerns several years before that.

Ikena, after tough year of layoffs, merges with Inmagene to focus on phase 2 dermatitis prospect

By James Waldron

After a year that saw Ikena Oncology trim back its workforce and pipeline, the oncology biotech thinks it’s found a sustainable path forward via a merger into privately owned immunology company Inmagene Biopharmaceuticals.

From AI and layoffs to supply chains and political unknowns, Deloitte outlines key areas for biopharma to watch in 2025

By Fraiser Kansteiner

As the life sciences industry prepares for a new administration, cutting edge technology and more, there are plenty of challenges in store for 2025—and much to be optimistic about, too. That’s according to the Deloitte U.S. Center for Health Solutions, which found in a recent survey of 150 C-suite executives across the global life sciences sphere that 75% of respondents are optimistic about the year ahead.

Clinical trials industry to grapple with new tech, additional uncertainty in 2025: Velocity Clinical Research CEO

By Darren Incorvaia

Rising costs and a boom in obesity trials and AI are some of the predicted trends for the clinical trial industry in 2025.

Editor's Corner: Recapping Fierce Pharma's top stories of the year

By Eric Sagonowsky

For many readers, the topics featured in this year’s roundup of top stories won’t come as much of a surprise. Look no further than our top two stories of the year, and you’ll see that the GLP-1 craze and Big Pharma layoffs took center stage in 2024.

Editor's Corner: Fierce Biotech's 10 most-read stories of 2024

By Gabrielle Masson

For the end of this year, Fierce Biotech is taking the opportunity to reflect on trends emerging from 2024’s reporting. And readers have made it easy for us—it’s clear what kind of story drew the most interest.

Editor’s corner: Fierce Medtech’s top 10 stories of 2024 chart the industry’s highs and lows

By Conor Hale

A look back at our top stories of 2024 sees them fall into two major themes: promise, and a realignment of expectations.

Editor's Corner: The top 10 Fierce Pharma Marketing stories of 2024 recapped

By Ben Adams

It’s been a year of big stories about Big Pharmas in the healthcare marketing world. All our top 10 pieces, as read by you in 2024, relate to the biggest players in the industry and the biggest issues of the year, namely: AI, celebrity endorsements, marketing snafus and anti-obesity meds.

2025 forecast: After Novo, Lilly expansion sprees, 'positive signals' emerge around future supply of GLP-1 drugs

By Fraiser Kansteiner

While the recent launches of GLP-1 drugs from Novo Nordisk and Eli Lilly have been nothing short of a staggering financial success, the rollouts of the new class of cardiometabolic medicines have been consistently hamstrung by manufacturing and supply constraints. That said, "positive signals" are emerging around the future of GLP-1 supply, analysts at ZS opined.

Novo Nordisk stock crashes after CagriSema misses phase 3 weight-loss goal

By Nick Paul Taylor

A phase 3 trial of Novo Nordisk’s next-generation obesity prospect CagriSema has failed to achieve the level of weight loss targeted by executives, prompting investors to wipe 19% off the value of the Danish drugmaker.

Viatris says India plant hit with FDA warning letter, import ban on 11 products

By Joseph Keenan

Viatris disclosed that its manufacturing facility in Indore, India, was issued a warning letter from the FDA, which banned 11 products that are produced at the site from being imported into the U.S. for distribution.

Drug candidate restores myelin and leg mobility in multiple sclerosis mouse model

By Darren Incorvaia

An investigational drug for multiple sclerosis from Io Therapeutics has restored leg mobility and myelin nerve coatings in mice, the biotech announced Dec. 23.

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