No AdComm for Madrigal’s NASH drug

Today’s Big News

Sep 13, 2023

After initial stumbles, Moderna finally gains clean phase 3 win for mRNA flu shot 


Calidi goes public via SPAC with $70M lined up to push allogeneic cancer therapies into clinic


Smooth sailing for Madrigal as NASH candidate gets FDA priority review, no AdComm 


Eiger ends hepatitis med's journey after liver damage reported, hunts for cash


With Roctavian as a launching pad, BioMarin looks to up pace of new drug filings 


Rocket boosted as FDA alignment on pivotal gene therapy trial design sends stock skyward


Fierce Biotech Fundraising Tracker '23: Actio closes $55M series A; Grit gets $60M

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

 

Featured

After initial stumbles, Moderna finally gains clean phase 3 win for mRNA flu shot

After tweaking the formula behind an mRNA flu vaccine, Moderna has finally met all the goals needed for a successful shot in a phase 3 trial. Now, CEO Stéphane Bancel is eyeing a launch as early as 2024. 
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Top Stories

Calidi goes public via SPAC with $70M lined up to push allogeneic cancer therapies into clinic

Calidi Biotherapeutics has become the latest biotech to take the SPAC route to the public market, loading up with around $70 million in funding agreements to develop its allogeneic stem cells through to 2025.

Smooth sailing for Madrigal as NASH candidate gets FDA priority review, no AdComm

Just days after a CEO shake-up, Madrigal Pharmaceuticals has shared that the FDA has given its NASH drug priority review and that the agency doesn’t plan on holding an advisory committee meeting.

IQVIA supports sites and participants through patient-centric trial experiences

With IQVIA’s clinical trial solutions and flexible site support strategies, decentralized trial elementss are being leveraged to enhance patient- centered care as well as support sites through hands- on enablement and implementation of DCT platforms these services.

Eiger ends hepatitis med's journey after liver damage reported, hunts for cash

Eiger BioPharmaceuticals is finally putting a pin in efforts to find a home for peginterferon lambda, a drug once tried in COVID-19 that has now failed in a study for chronic hepatitis delta.

With Roctavian as a launching pad, BioMarin looks to up pace of new drug filings

To build the "best pipeline in BioMarin history," the California biotech is looking to its already approved meds as a jumping-off point. 

Rocket boosted as FDA alignment on pivotal gene therapy trial design sends stock skyward

Rocket Pharmaceuticals has reached alignment with the FDA on the design of a pivotal phase 2 rare disease trial, positioning it to run a 12-patient study that could support accelerated approval of a gene therapy.

Fierce Biotech Fundraising Tracker '23: Actio closes $55M series A; Grit gets $60M

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

The companies included in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.

Orthofix board gives CEO, other C-suite members the boot for 'offensive conduct'

The spine and orthopedics company said that President and CEO Keith Valentine, Chief Financial Officer John Bostjancic and Chief Legal Officer Patrick Keran will be replaced, effective immediately.

Phesi in pact with Krystelis to improve trial diversity efforts

Clinical development and analytics provider Phesi in partnership with Krystelis has launched a new service to recruit more diverse patients in clinical trials.

Moderna looks to scale back manufacturing for COVID booster to cope with falling demand: Reuters

Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine to adapt to the endemic phase of the disease, Moderna’s president and R&D head, Stephen Hoge, said, Reuters reports.

Icon to conduct U.S. government trial of next-gen COVID-19 vaccines

CRO giant Icon has been tapped by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority to conduct a clinical trial to evaluate next-generation vaccines for COVID-19.

Provider groups warn proposed Medicare payment cuts will pinch docs, hamper access to care

Provider groups are urging the Biden administration to reconsider proposed cuts to physician payments in its annual fee schedule rule, arguing that the cuts could force service and staffing reductions as practices feel the financial pinch.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': Trends at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage

This week on "The Top Line," we discuss the trends seen at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage
 

Resources

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Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives.

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What Are the Benefits of Generative AI for Pharma?

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Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties.

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Transitioning from using RUO to cGMP chemicals for clinical trials

By 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially.

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Biotech in the UK: Mapping the Runway to Success

15 biotech executives from the Cambridge area discuss the current biotech landscape, as well as challenges, opportunities, and best practices for emerging biotech companies seeking success in the UK and beyond.
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Plan for success with your process liquid and buffer preparation

Learn how process liquids and buffers impact your total cost of ownership (TCO) and how outsourcing can revolutionize your approach, ensuring quality standards and improving productivity.
 

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