Does J&J's CAR-T have a competitor?
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Today's Rundown

Featured Story

ASCO: Return to in-person 'zoo that it always was,' with added COVID challenges—and bad shoes

While reveling in the human interaction of being back in person, attendees of the 2022 ASCO annual meeting—which wraps its fifth and final day today—were also faced with the somewhat daunting realization that maybe we don’t quite remember how to be back on-site.

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Top Stories

Seres Therapeutics, armed with new safety data, eyes first FDA approval for a microbiome drug

Seres Therapeutics has wrapped up an open-label safety trial of its Clostridioides difficile med, clearing its final hurdle before heading to regulators. If approved, it would be the first microbiome-based therapy to hit the market.

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ASCO: ‘Any way you slice’ it, Arcellx's CAR-T is matching J&J-Legend’s Carvykti, analyst says

Arcellx took a risk by including more patients with a tougher, more aggressive form of multiple myeloma in an early-stage trial for its CAR-T med. But it doesn’t matter, because “any way you slice” the data, the small biotech seems to have come out on top of the market-leading therapy by Johnson & Johnson and Legend Biotech.

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Sponsored: Tech-Enabled Trials Don't Have to Mean Loss of Human Connection

DCTs hold the promise of reducing site and patient burdens but at what cost to human connection? Vault says it doesn't have to be a compromise.

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Annexon is back with final Huntington's data confirming hypothesis—and no new safety issues to declare

Investors were troubled by the dropout rate for patients in a phase 2 trial for Annexon’s Huntington’s disease med earlier this year. But now, the biotech is back with the finalized data from that study, with no new discontinuations to report and a solution to mitigate risk.

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Racing Sanofi, ImmunOs bags $74M for myeloid checkpoint trials in cancer patients

VCs are funneling money into myeloid checkpoint targets. ImmunOs Therapeutics is the beneficiary of interest in the approach, reeling in $74 million to take its lead immuno-oncology candidate through phase 2.

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Code Bio launches with $75M to reinvent genetic medicine for rare and not-so-rare diseases

Duchenne muscular dystrophy and Type 1 diabetes couldn’t be more different: One is fairly rare, and we hear about the other all the time. A new biotech venture is launching with $75 million to try to improve on treatment for both, and it’s taking a few Big Pharmas along for the ride.

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Report finds thousands of uncounted rare diseases in challenge to current estimates

Have we been undercounting rare diseases? That is the question posed by nonprofit RARE-X, which has calculated that the low end of the oft-cited estimated range may miss half of all orphan indications.

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ASCO: Black breast cancer patients want to participate in trials but adequate information is hard to come by

A new study from a breast cancer patient advocacy organization details how poorly disseminated information hinders Black patients from participating in clinical trials. While more than 80% of Black respondents expressed interest in participating in a trial, just more than a third received sought-after details from their care team.

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Lipid may open door to new liver drugs that sidestep serious side effects

An enzyme called SCD1 has tantalized biotechs with the possibility of treating everything from liver disease to cancer. But new research may finally offer a way to confer the benefits of this potential therapy avenue without the associated serious side effects.

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The top 10 nonprofit health systems by 2021 operating revenue

Following a year of pandemic disruptions, the nation's largest nonprofit providers all saw their revenues increase anywhere from 5% to 18% in 2021.

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Eli Lilly whistleblower says she was fired after reporting manufacturing problems at massive NJ plant

A whistleblower who was fired by Eli Lilly three years ago has filed suit, alleging that her dismissal came in response to her reporting manufacturing problems at the company’s massive plant in Branchburg, New Jersey. Amrit Mula, the top human resources officer at the plant for eight years, seeks unspecified damages for Lilly’s alleged violation of New Jersey’s employee protection laws.

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ADA: Dexcom CEO Kevin Sayer on putting M&A on the back burner: 'We've been the organic growth story of the decade'

"No medical device company goes from $40 million to almost $3 billion organically—we’ve done that,” Dexcom CEO Kevin Sayer told Fierce Medtech.

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Plaque to basics: New research hints Alzheimer's treatments may be looking in the wrong place

New research from NYU Langone suggests the first signs of amyloid beta appear inside of the cell as a result of cellular waste management issues. The results could have direct implications on how Alzheimer's is treated, within many current treatment mechanisms targeting amyloid beta deposits outside of the cell.

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Resources

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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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