| 06.18.24 | Roche makes RNA play with $1.8B biobucks; Zentalis plummets on FDA hold

Laden...

5 maanden geleden

Html
Tekst

Editor’s Note: Fierce Biotech will not publish on Wednesday June 19 in observance of Juneteenth. We will be back in your inbox from Thursday June 20.

A 7-Step Roadmap for Operationalizing Large‑Scale Clinical Validation Studies

Liquid biopsy tests offer a promising alternative to existing screening methods and the potential to develop cancer detection tests for previously unscreened indications. Due to the risks of false positives and negatives, these tests face stringent regulatory scrutiny, typically following the pre-market approval (PMA) pathway and requiring costly, large-scale validation studies. Download our guideto learn more.

Today’s Big News

Jun 18, 2024

Roche wades deeper into RNA waters, paying Ascidian $42M to develop exon editing drugs

Zentalis' shares plunge 30% after FDA places WEE1 drug on partial hold over sepsis deaths

Third Rock’s Marea ropes in $190M to pioneer ‘the next frontier’ of cardiometabolic medicines

Day One inks $1.2B biobucks pact for MabCare’s solid tumor ADC

Sanofi heads out to surf Belharra in $700M biobucks immunology deal

Malaria drug shows early potential as polycystic ovary syndrome treatment in rodents and people

Fierce Biotech Fundraising Tracker '24: Iambic adds on $50M; Marea emerges with $190M


A message from Montgomery County Economic Development Corporation

Featured

Roche wades deeper into RNA waters, paying Ascidian $42M to develop exon editing drugs

By Nick Paul Taylor

Roche has added to its flotilla of RNA alliances, handing Ascidian Therapeutics $42 million upfront to use an alternative to gene editing to treat neurological diseases. The agreement includes up to $1.8 billion in milestones.

Zentalis' shares plunge 30% after FDA places WEE1 drug on partial hold over sepsis deaths

By James Waldron

The FDA has placed three trials of Zentalis’ WEE1 candidate on partial hold in the wake of two deaths that are presumed to be from sepsis.

Third Rock’s Marea ropes in $190M to pioneer ‘the next frontier’ of cardiometabolic medicines

By Gabrielle Masson

Marea Therapeutics has emerged with $190 million, a mid-stage clinical program and a plan to harness genetics and pioneer “the next frontier” of cardiometabolic medicines.

Revolutionizing cancer treatment: the potential of immune-modulating cancer vaccines

New Product Planning Summit

September 30- October 1, 2024| Boston, MA

The Fierce New Product Planning Summit is the only conference focused on how life science professionals make informed, value-based, data-driven decisions about pipeline products. Experts gather annually to discuss resource utilization and key questions for commercial success. Stay Updated!

Day One inks $1.2B biobucks pact for MabCare’s solid tumor ADC

By Gabrielle Masson

Day One Biopharmaceuticals is offering MabCare Therapeutics up to $1.2 billion for exclusive licensing rights to an antibody drug conjugate (ADC) taking aim at solid tumors in both adults and kids.

Sanofi heads out to surf Belharra in $700M biobucks immunology deal

By Annalee Armstrong

Sanofi is offering Belharra Therapeutics up to $700 million in biobucks for a tow out to surf the waves of small molecule drug discovery in immunology.

Malaria drug shows early potential as polycystic ovary syndrome treatment in rodents and people

By Helen Floersh

Ancient plant compounds called artemisinins were the original anti-malaria heroes, but new research suggests drugs based on them may have the potential to treat a different condition entirely: polycystic ovary syndrome (PCOS).

Fierce Biotech Fundraising Tracker '24: Iambic adds on $50M; Marea emerges with $190M

By Gabrielle Masson,Annalee Armstrong,Max Bayer

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

Merck's Keytruda snags 40th US indication, leaps ahead of GSK with broad endometrial cancer approval

By Angus Liu

The world’s best-selling medicine is still adding new uses, and its latest FDA approval marks a first in the cancer immunotherapy class.

J&J’s DePuy Synthes orthopedics robot cleared for partial knee replacements

By Conor Hale

DePuy Synthes said partial replacements, also known as unicompartmental knee arthroplasty, have been underutilized due to the procedure's complexity.

Amazon Pharmacy expands RxPass subscription service to Medicare patients

By Heather Landi

The RxPass program, launched in January 2023, provides unlimited access to 60 eligible generic medications and will ship the medications to customers' homes for a flat monthly fee of $5.

Merck gets shot in the arm with FDA approval for first pneumococcal vaccine designed for adults

By Kevin Dunleavy

The FDA has approved the world’s first pneumococcal disease vaccine designed for adults, signing off on Merck’s Capvaxive (formerly V116) and positioning it to become the primary shot used by seniors to protect against the bacterial infection.

Boston Scientific snags Silk Road Medical in $1.26B deal

By Conor Hale

Silk Road is known as the developer of TCAR, for transcarotid artery revascularization, which reduces the risk of stroke in carotid artery procedures.

Fierce podcasts

Don’t miss an episode

Inside this year’s ASCO: Biggest data drops, trends and the best exhibit booth

In this week's episode of "The Top Line," journalists from Fierce Biotech and Fierce Pharma discuss the most talked-about data drops at ASCO and share on-the-ground details, including their experience with Gilead’s virtual reality Trodelvy ride.

Cybersecurity lessons from the Change Healthcare hack

A look at the top 10 pharma drug ad spenders


A message from Promab Biotechnologies

Resources

Webinar

Enhance your long-term cell & gene therapy success with pDNA manufacturing solutions

Watch our on-demand webinar video to learn more about the challenges in pDNA manufacturing for gene and cell therapy and how to resolve many of these barriers by partnering with our experts through the adoption of vital manufacturing technologies and strategies.

A Comprehensive and Flexible Approach to CMC for Fab and Fc-Fusion Development Programs

New molecular formats are gaining momentum in today’s market. Characterizing these products and developing robust manufacturing processes can help to usher them to market and provide new treatment options for diseases which are currently challenging to treat. Read this white paper to learn more.

Presented by: Lonza

Whitepaper

Fresenius Medical Care gets 25x faster kidney disease insights

This detailed case study shows how Fresenius Medical Care achieved 25 times faster insights to help kidney disease patients, launching the world’s largest global database of dialysis care with fully anonymized patient data.

Sponsored by: Privacy Analytics, an IQVIA company

Whitepaper