| 12.23.24 | The year's top stories in life sciences; Vertex, Novo, Lilly secure year-end FDA nods

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Editor's Note: This is the last issue of the Fierce PM Tracker in 2024. Starting tomorrow, the Fierce team will be taking a break for the holidays. We'll be back in your inbox on Jan. 2, but be sure to visit the website for the latest news until then. We hope you have a great holiday season and a happy New Year.

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Today’s Big News

Dec 23, 2024

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

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

Fierce Biotech's top 10 editor's picks for 2024

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

Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off

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

Lilly's Zepbound scores 2nd approval with landmark FDA nod in obstructive sleep apnea

Whitepaper: Strategic Pathways to European Market Access: A Guide to Leveraging Early Access Programs for Rare Disease Therapies

The European orphan drug market presents a significant opportunity, with forecasts predicting substantial growth in the coming years. Early access programs (EAPs) have emerged as a critical strategy for successfully launching rare disease therapies in this complex and diverse market. Access this whitepaper to learn more.

Featured

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.

Fierce Biotech's top 10 editor's picks for 2024

By James Waldron

From the conference circuit to the Nasdaq trading floor, we run down some of the highlights from Fierce Biotech's coverage this year.

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.

Whitepaper: The benefits of 5,000L single-use bioreactors for biologics manufacturing

As the market for complex biologics continues to grow, effective capacity planning becomes more challenging. The entry of the 5,000L single-use bioreactor (SUB) is providing an important bridge between small-scale and large-scale production, offering more flexibility than ever before to respond to fluctuations in demand quickly and efficiently. Access this report to learn more.

Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off

By Angus Liu

The FDA has approved Vertex’s Alyftrek, a once-daily triple combination for the treatment of cystic fibrosis. But analysts have different views on how the switch from Vertex's twice-daily Trikafta will play out.

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.

Lilly's Zepbound scores 2nd approval with landmark FDA nod in obstructive sleep apnea

By Fraiser Kansteiner

Thanks to a new FDA green light, Lilly’s dual GIP/GLP-1 blockbuster Zepbound has become the first prescription medicine cleared to treat adults with moderate-to-severe obstructive sleep apnea and obesity. The nod marks the second indication for Zepbound behind the inaugural obesity approval it scored in November 2023.

FDA approves Humacyte’s off-the-shelf artery implant for vascular trauma repair

By Conor Hale

Humacyte’s tissue-based Symvess is designed to be universally implantable, to help rapidly reconnect the vascular system when a patient is facing the loss of a limb.

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.

Rapt re-rolls after flameout, paying $35M for challenger to Novartis, Roche drug

By Nick Paul Taylor

Rapt Therapeutics has charted a new course following the implosion of its lead program, agreeing to pay $35 million for a long-acting challenger to Novartis and Roche’s Xolair.

Phase 2 data will drive biopharma VC investments next year: PitchBook

By James Waldron

Phase 2 trial data will continue to be the name of the game when it comes to VC investments into biopharma in 2025, according to PitchBook.

Fierce podcasts

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A conversation with Fierce 50 of 2024 honorees

This week on "The Top Line," we bring you a special conversation from earlier this month at our New York City gala, where we celebrated this year’s Fierce 50 honorees.

Novo’s chief scientific officer looks to the future of GLP-1s

Integrating social-emotional learning in child education

Whitepaper: Setting the Standard in CGT: Perspectives on Performance, Scalability and Regulatory Compliance

With unique perspectives from key opinion leaders, this whitepaper examines the challenges associated with process development and manufacturing of cell and gene therapies. Download now to take your cell and gene therapy techniques to new heights.

Resources

Whitepaper

Building a “Best Practice” R&D Organization in Biopharma

We interviewed 14 R&D biopharma leaders on the critical success factors for building a Best Practice R&D organization. This report shares what we learned.

Presented by Blue Matter, strategic consultants in the life sciences