Daiichi ready to compete with new AML data
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Today's Rundown

Featured Story

Another biotech SPAC bites the dust as Blade Therapeutics’ planned merger is cancelled

Blade Therapeutics set out plans for a blank-check deal in November 2021 that would have given Blade about $255 million to bankroll trials in fibrosis and neurodegenerative conditions. But the move to join the NASDAQ by merging with SPRIM Global Investments' special purpose acquisition company have hit a dead end.

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Top Stories

After $750M bet, AbbVie lays down marker in fiercely competitive bispecific niche

AbbVie and Genmab have posted more clinical data on their potential blockbuster rival to Roche’s newly approved Lunsumio, linking the CD20xCD3 bispecific epcoritamab to a 39% complete response rate that fell away somewhat in patients previously treated with CAR-T.

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Daiichi Sankyo’s survival data means it may finally be ready to compete with Novartis’, Astellas’ marketed AML meds

Daiichi Sankyo’s challenger to Novartis’ Rydapt looks like it may get another shot at FDA approval, with quizartinib posting positive survival data from a phase 3 trial.

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Sponsored: An Integrated Approach to Developing Next-Generation Genomic Medicines

The life sciences companies at Danaher enable gene editing, gene therapy and mRNA medicines with integrated solutions that improve research, development and manufacturing.

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A new day for pediatric cancer patients: Day One's share price doubles on initial data for brain tumor drug

Day One Biopharmaceuticals appears to be living up to its namesake, unveiling positive initial data for its oral drug tovorafenib, which aims to treat a brain tumor in children that currently has no approved treatment.

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With stacked to-do list, ImCheck checks off next funding round, refueling with about $101M

A phase 2 trial ready to expand? Check. Plans for combination studies? Check. More pipeline assets to move into the clinic? Check. With all that on the to-do list, ImCheck Therapeutics has refueled with a €96 million ($101 million) funding round that featured existing investors Pfizer, Gimv and more.

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Beta vaccine, alpha player? Sanofi, GSK post next-gen COVID-19 jab data to unlock booster market

Sanofi and GSK have shared a glimpse at the data they plan to use to bring a next-generation COVID-19 booster vaccine to market this year. The data drop covers two clinical trials that suggest the beta-specific vaccine can induce a stronger response against omicron than first-generation products.

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Amid FDA delay, Amylyx scores conditional ALS drug nod in Canada

After some skepticism from the U.S. FDA and its expert advisers, Amylyx Pharmaceuticals has scored the first worldwide approval for its ALS drug, AMX0035. The conditional nod requires the company to deliver phase 3 data from its PHOENIX trial, which is underway.

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Regeneron's Eylea could lose 30% of its patients to Roche's Vabysmo over the next year: analyst survey

A survey of 20 retina specialists conducted by Evercore ISI indicates that Vabysmo could soon become the first choice of macular degeneration patients, eventually supplanting Regeneron and Bayer’s powerhouse Eylea. As a result, Evercore is projecting more sales erosion for Eylea than the Wall Street consensus.

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FDA rebukes small biotech Althera for promotional claims on its cholesterol combo drug

Althera Pharmaceuticals, a maker of cardiovascular medications, is in the FDA crosshairs for its flagship cholesterol oral delivery drug Roszet.

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Bluebird scores 2nd straight win at high-stakes FDA gene therapy meeting

Going into a two-day FDA advisory committee meeting this week, bluebird bio faced uncertainty over the viability of its gene therapy prospects. But the drugmaker has impressed an FDA panel and come away with a pair of expert endorsements for its lead drugs.

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Resources

eBook: Streamline HCP interactions management

Don’t miss these critical considerations when evaluating your HCP interactions management program.

White Paper: Jump Start for Biotech: New Lab Startup Guide

Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals.

eBook: Download the Cell Therapy Handbook

Explore the new cell therapy handbook from Thermo Fisher Scientific.

Whitepaper: Gain Operational Speed and Velocity by Sharing Quality Incident Data

Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders.

Whitepaper: Medical Affairs Metamorphosis: Trends Driving Change & What They Mean

Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve.

Whitepaper: Catalent Pulmonary & Nasal Delivery Capabilities Sheet

Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays?

eBook: Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Whitepaper: Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?

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