Ascendis’ dwarfism drug poses problem for BioMarin

Today’s Big News

Sep 17, 2024

Merck, Daiichi rack up phase 3 ADC lung cancer win but report 2 deaths, immature OS data


Kairos goes public with $6M IPO to fund trials of lead cancer drug


Ascendis’ dwarfism drug accelerates growth in phase 3, teeing up challenge to BioMarin


Alkeus’ oral eye disease asset fails to significantly reduce lesion growth in phase 3


Fierce Biotech Fundraising Tracker '24: Nura nudges up series A by $68M; Candid cashes in $370M debut


Rakovina deepens AI focus with cancer collab to select DNA-damage response kinase targets


Amgen and Merck become first industry partners of academic clinical trial diversity initiative 

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

 

Featured

Merck, Daiichi rack up phase 3 ADC lung cancer win but report 2 deaths, immature OS data

A phase 3 trial of Daiichi Sankyo and Merck & Co.’s HER3-directed antibody-drug conjugate has hit its primary endpoint, boosting plans to take a second shot at FDA approval. But two more people died after developing interstitial lung disease, and the overall survival data are immature.
 

Top Stories

Kairos goes public with $6M IPO to fund trials of lead cancer drug

With a trio of biotechs hitting the Nasdaq on Friday, it was easy to miss a smaller-scale public debut from another clinical-stage drug developer on the other side of the ESMO weekend.

Ascendis' dwarfism drug accelerates growth in phase 3, teeing up challenge to BioMarin

Ascendis Pharma has emerged as a potential threat to BioMarin’s Voxzogo, reporting phase 3 growth disorder data that exceeded analyst expectations and positions the biotech to file for approval next year.

Beyond data: Humanizing clinical research with Avacare

With intricate protocols and shifting regulatory demands, it’s more difficult than ever to find and keep participants, as well as gather reliable data.

Alkeus’ oral eye disease asset fails to significantly reduce lesion growth in phase 3

Though Alkeus Pharmaceuticals’ oral eye disease asset failed to significantly reduce geographic atrophy (GA) lesion growth, the biotech is citing "clinically meaningful" results and a secondary endpoint win as reasons to pursue further development.

Fierce Biotech Fundraising Tracker '24: Nura nudges up series A by $68M; Candid cashes in $370M debut

Welcome to Fierce Biotech's Fundraising Tracker, 2024's version.

Rakovina deepens AI focus with cancer collab to select DNA-damage response kinase targets

Five months after Rakovina Therapeutics pivoted toward artificial intelligence, the cancer-focused biotech has joined forces with Variational AI to identify new therapies against DNA-damage response targets.

Amgen and Merck become first industry partners of academic clinical trial diversity initiative

An academic partnership to improve diversity in clinical trials has drafted its first industry team members. Amgen and Merck will help Equitable Breakthroughs in Medicine Development enroll patients in local clinical trials as part of the partnership’s pilot program.

J&J talc appeal upends $260M award to Oregon woman with mesothelioma

Three months after a jury awarded $260 million to an Oregon woman who claimed that her use of Johnson’s Baby Powder caused her to develop mesothelioma, a state judge has overturned the verdict and granted the company a new trial.

Lupus landscape 'poised for evolution' as US doctors eagerly await new entrants

New biologics such as GSK's Benlysta and AstraZeneca's Saphnelo, along with off-label drugs, have been the mainstay for systemic lupus erythematosus treatment for many years. However, the landscape may be about to change with the introduction of new medicines and indications from other approved treatments.

CDMO Serán snags $200M Bain-led investment to build its first commercial facility

With a hefty investment led by Bain Capital and a new commercial facility on the horizon, growing CDMO Serán Bioscience is looking to bridge the gap between clinic and market for its customers.
 
Fierce podcasts

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A closer look at the Fierce 50

In this week's episode of "The Top Line," we will dive into the annual Fierce 50 special report.
 

Resources

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Unique Solutions for Drug Discovery and Development

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Why Biotech Sponsors Need Outside Support: IRB, IBC, DMCs, and EACs

When the fate of your company hangs in the balance, you need expert guidance to navigate the complexities of biotechnology development and to make informed decisions.
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HPV-based cervical cancer screening: Gaining insights in sample preference and cost-effectiveness.

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Overcoming drug development hurdles with phase-appropriate technology transfers

Facing roadblocks in drug development? Uncover how phase-appropriate technology transfers can help you navigate challenges and speed up your journey to market.

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Building a “Best Practice” Commercial Organization in Biopharma

We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.
 

Industry Events

On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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