Bayer exits Atara cell therapy pact after patient death
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WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST

Sanofi and Regeneron’s Dupixent has scored once again with an FDA approval for eosinophilic esophagitis, becoming the first drug approved for that disease. Meanwhile, after a patient death in an early-stage trial, Bayer is exiting a CAR-T pact with Arena that the German drugmaker once touted as a “fundamental element” of its cell and gene therapy strategy. And as the monkeypox outbreak continues to capture headlines, experts aren’t worried it will become the next global pandemic. Those headlines and more are featured in this week’s Fierce Life Sciences weekly roundup. 

Featured Story

Sanofi's Dupixent scores big as the first FDA-approved treatment for eosinophilic esophagitis

Patients with eosinophilic esophagitis have been suffering with no hope for relief as there are no FDA-approved treatments for the disease. That's now changed with an FDA nod for Sanofi's Dupixent.

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Top Stories Of The Week

Bayer pulls plug on $670M CAR-T cell therapy pact with Atara in wake of patient death

Bayer is pulling the plug on its $670 million CAR-T pact with Atara Biotherapeutics. Three months after a death paused a study of the lead candidate, the German drugmaker has decided to cut its ties to Atara’s two mesothelin-directed CAR-T cell therapies.

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A vibrating pill for constipation heads to the FDA after completing phase 3 study

Vibrant Gastro is putting forward its novel approach as a completely drug-free alternative to treatments for infrequent or difficult bowel movements.

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'The Top Line' podcast: How biopharma is tackling the monkeypox outbreak, insight on nominations for our Fierce 15 list, plus this week's headlines

This week on "The Top Line," we discuss the new monkeypox outbreak, what the treatment options are and why health officials don’t seem concerned. We also talk about Dexcom's potential megamerger with Insulet, the upcoming ASCO meeting and the week's other big headlines. Plus, we have a special announcement about the prestigious Fierce 15 competition.

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Monkeypox outbreak won't be the next global pandemic thanks to vaccines, drugs: analysts

An unusual wave of monkeypox cases in non-endemic regions has raised the possibility of another global health crisis. But two groups of biopharma experts argue monkeypox likely won’t escalate into another pandemic that humans struggle to contain.

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100% overall survival data for gene therapy fuel Rocket for flight to regulators

One hundred percent overall survival in just seven patients has provided the jet fuel needed by Rocket Pharmaceuticals to head to regulators for a rare childhood immunodeficiency disorder gene therapy. The company unveiled the phase 2 pivotal results from patients with severe leukocyte adhesion deficiency-I at the 25th Annual Meeting of the American Society of Gene and Cell Therapy Thursday.

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Insurer plans $4B investment blitz to add lab space outside of U.S. biotech hot spots

Legal & General is getting into the U.S. life science property game. By putting up $500 million and allying with Ancora, the U.K. insurer is aiming to spark a five-year, $4 billion property blitz outside of the biotech hot spots.

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Kadmon consultant charged with insider trading ahead of biotech's $1.9B sale to Sanofi: SEC

The Securities and Exchange Commission has charged California-based executive compensation consultant Frank Glassner with insider trading, according to a complaint filed in a federal Manhattan court Tuesday. Glassner was a long-time consultant to Kadmon who was enlisted to provide acquisition-related services to the biotech, the SEC said in a release. Sanofi closed its $1.9 billion deal for the biotech in November.

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CSL Behring gene therapy makes comeback after hold for FDA priority review

The FDA has accepted CSL Behring’s priority review application for a hemophilia B gene therapy, potentially fast-tracking the drug after a bumpy ride that included a clinical hold—and later, a lift.

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Seagen's potential breast cancer blockbuster Tukysa shows promise in colorectal cancer

Two years after its approval in breast cancer, Seagen’s potential blockbuster Tukysa delivered data that could lead to a label expansion in colorectal cancer.

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When will biotech markets get better? BridgeBio fears they may stay 'pretty bad' until 2024

BridgeBio Pharma is digging in for a prolonged bear market. Since suffering a phase 3 flop late last year, the biotech has taken a series of steps to extend its cash runway, reflecting its CEO’s belief that markets could “stay pretty bad up until the end of next year”.

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Eli Lilly plots $2.1B manufacturing expansion at America's crossroads, with 500 new hires

After socking $1 billion into a new injectables factory in North Carolina in January, Lilly is dipping back into its pocketbook for another blockbuster manufacturing expansion stateside. And this time, it’s reinvesting in its roots.

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Precision BioSciences makes case for 2 gene editing programs over CRISPR with preclinical data

Precision BioSciences boasted two sets of early preclinical data of its gene editing platform at ASGCT, making its case over CRISPR. Notably, the company said it was able to make an insertion in the genome in non-human primates using its treatment for ornithine transcarbamylase deficiency.

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Pharma bucks trend, shunning digital and sticking with TV when it comes to ads

Pharma is bucking the trend that is seeing most other sectors rush to digital advertising, instead deciding to stick with TV ads. That’s according to a new report out by MediaRadar that found not only does TV remain king and “digital spending lagged considerably" but also that we can expect that focus on TV advertising to continue.

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Resources

Executive Summary: PBPK Modelling for Optimizing Controlled Release Dosage Form Development

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

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

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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.

eBook: Streamline HCP interactions management

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