Vertex, Editas score wins for CRISPR meds

Today's Big News

Jun 9, 2023

Eisai, Biogen's Alzheimer's disease drug Leqembi passes muster at FDA adcomm


BIO: Can GLP-1s help you quit smoking or drinking? Lilly is looking into it—cautiously


Landmark approval for Vertex's CRISPR drug 2 steps closer after trial wins, PDUFA date granted


SunMed soaks up Avanos' respiratory health business for $110M


Editas' sickle cell CRISPR therapy shows early promise, but can it stand out against Vertex?

 

Featured

Eisai, Biogen's Alzheimer's disease drug Leqembi passes muster at FDA adcomm

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen's Leqembi is heading into the final stretch of its regulatory review on strong footing.
12-14
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Top Stories

BIO: Can GLP-1s help you quit smoking or drinking? Lilly is looking into it—cautiously

Lilly is aware of and “closely looking into” anecdotes that patients taking GLP-1 drugs seem to have an easier time quitting alcohol or cigarettes—but proving a genuine impact is easier said than done. 

Landmark approval for Vertex's CRISPR drug 2 steps closer after trial wins, PDUFA date granted

Vertex and CRISPR Therapeutics’ dream of getting the first-ever CRISPR gene editing therapy approved now seems within reach as the candidate aced primary endpoints in a pair of phase 3 trials mere hours after the FDA penciled in a decision date for December.

SunMed soaks up Avanos' respiratory health business for $110M

Just a few months after expanding its respiratory and anesthesia device portfolio by purchasing some of Vyaire Medical’s hardware, medtech manufacturer SunMed is shining its light on yet another acquisition target.

Editas' sickle cell CRISPR therapy shows early promise, but can it stand out against Vertex?

Editas Medicine has shared early clinical data on the cell therapy it is developing to challenge Vertex and CRISPR Therapeutics for the sickle cell market. The CRISPR-edited therapy showed clear signs of efficacy, but, with its rivals awaiting FDA approval, differentiating a late-to-market challenger could be tough.

Bristol Myers' cell therapy manufacturing site in Massachusetts is good to go, FDA says

Bristol Myers Squibb took a positive step toward beefing up its cell therapy manufacturing capabilities as the FDA gave the go-ahead for the company to begin commercial production at its sprawling facility in Devens, Mass.

'The Top Line': News from ASCO's annual meeting, plus this week's headlines

This week on "The Top Line," we discuss the the top news from this year's annual ASCO meeting, plus contesting the Inflation Reduction Act, an ADHD video game, and the rest of the week's headlines.

Activist shareholders blast Merck's IRA lawsuit, urge company to reconsider

After Merck's bombshell lawsuit contesting the Inflation Reduction Act, shareholders at the Interfaith Center on Corporate Responsibility are asking the company to reconsider. They're citing Merck's stated commitments to access and affordability as the rationale behind their plea.

Foundation Medicine’s latest companion diagnostic nod pairs its blood test with Pfizer’s Braftovi combo

The FoundationOne Liquid CDx test's 10th approval allows it to be used to pair patients with a combination of Pfizer’s encorafenib, marketed under the name Braftovi, and the cancer drug cetuximab, sold as Erbitux by Eli Lilly in the U.S.

Sanofi, AstraZeneca's RSV antibody for infants easily clears FDA adcomm, likely setting up approval

Seeking to launch their RSV prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.
 
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'The Top Line': Democratizing access to women's meds , plus this week's headlines

This week on "The Top Line," we discuss the need to democratize access to medications like emergency contraception, plus Elizabeth Holmes, the state of Alzheimer's research, and the rest of the week's headlines.
 

Resources

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Autoantibodies: Powerful Biomarkers in Cancer Precision Medicine

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Running Decentralized Trials at Scale

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Strategies to Optimize Clinical Trial Enrollment Timelines

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Commercializing Gene Therapies, Part 4 – Market Entry

This paper outlines various market archetypes and key considerations leaders must address when prioritizing new potential markets for gene therapies.
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ChatGPT in Drug Discovery: Rise of Large Language Models

ChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations.
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Discovering High-Affinity, Functional Anti-GLP-1R Antibodies

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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How Lilly’s Legal and Library Services Empower Teams Across the Drug Development Pipeline

What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how.
 

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