Newsletter Tool

Editor’s Note: Vote now in #FierceMadness: The Best Biotech Name Tournament. The Final Four is open for voting!

Today’s Big News

Apr 4, 2024

'We're open for business': FDA's Peter Marks says agency ready to review novel cancer vaccines despite unknowns

Merck KGaA signs $1.4B biobuck deal with Caris to expand ADC pipeline

CureVac, chasing Moderna’s mRNA flu vaccine, runs into the same B strain problems

Surrozen's Wnt mimetic antibody improves lung function in mice with pulmonary fibrosis

Amylyx to pull failed ALS drug Relyvrio from market, cut 70% of staffers

Featured

'We're open for business': FDA's Peter Marks says agency ready to review novel cancer vaccines despite unknowns

By Angus Liu

As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks said the agency is ready to review the shots despite AI-related unknowns.

Merck KGaA signs $1.4B biobuck deal with Caris to expand ADC pipeline

By James Waldron

Merck KGaA has become the latest biopharma to swell its oncology pipeline with further antibody-drug conjugate potential this week.

CureVac, chasing Moderna's mRNA flu vaccine, runs into the same B strain problems

By James Waldron

CureVac and GSK have been racing behind Moderna to try and get the first mRNA flu vaccine to market. But now the European partners have come up against the exact same problem as their U.S. competitor when it comes to the "historically challenging" B strains of influenza.

Surrozen's Wnt mimetic antibody improves lung function in mice with pulmonary fibrosis

By Helen Floersh

The results, published in the journal Respiratory Research, are an early signal of a potential new indication for the company’s SWAP technology.

Amylyx to pull failed ALS drug Relyvrio from market, cut 70% of staffers

By Angus Liu

Amylyx is keeping a promise by pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after the drug failed in a confirmatory trial. And 70% of the company's staff will soon lose their jobs.

Lindus launches 'all-in-one' CRO for respiratory clinical trials

By Helen Floersh

Lindus Health has developed another full-service CRO package for a specific therapeutic area, this time geared toward clinical trials for drugs to treat respiratory diseases like COPD, asthma, and pulmonary hypertension.

Basilea completes marathon quest with FDA approval to treat 3 types of infections

By Kevin Dunleavy

Fifteen years after Basilea's antibiotic ceftobiprole sustained a rejection from the FDA, the company has finally won over the U.S. regulator and done so in triplicate. The FDA has approved Basilea’s Zevtera for three different kinds of infections.

Fierce podcasts

Don’t miss an episode

'The Top Line': The top money raisers in biotech

This week on "The Top Line," we explore our annual special report on the top money raisers in the biotech industry. Which company raised the most funding in 2023? What does the biotech financing landscape look like for this year? Fierce Biotech's Annalee Armstrong and Max Bayer answer those questions and many more in today's episode.

'Podnosis': A closer look at social prescribing and the impact of the arts on our health

'The Top Line': A closer look at European biotech investment in 2024

Resources

Whitepaper

Oncology Market Outlook 2024

This paper assesses the current state of the oncology market, reviewing key expectations for 2024. It addresses CAR-T therapies, KRAS, radiopharmaceuticals, & targeted protein degradation.

Presented by Blue Matter, strategic consultants in the life sciences

Whitepaper

Guidance for Biotechs Choosing Next-Gen Contract GMP/CMC Labs

Choosing the right contract lab can help drug developers accelerate their timelines and generate cost-efficiencies. For insights into what to look for when selecting a GMP/CMC lab partner read this white paper which delves into a range of factors that can support your needs in both the short-term and in planning for the future.

PPD®️ Laboratory Services