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Today's Rundown

Featured Story

Roche-backed AC Immune finds even mixed-bag Alzheimer's data are enough to make shares explode

Semorinemab has shown the first clinical evidence of a tau-targeting monoclonal antibody in patients with mild-to-moderate Alzheimer’s disease in a phase 2 study, Roche’s Genentech and AC Immune said Tuesday. The therapy reduced the rate of cognitive decline, meeting one of the co-primary endpoints of the study.

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Top Stories

The descent of van de Stolpe: Galapagos CEO exits after R&D setbacks wipe out billions in value

Exits are hard to time. Onno van de Stolpe rode high for years after founding Galapagos. Yet, after presiding over a period in which Galapagos’ share price fell 80%, wiping out billions of dollars in value, van de Stolpe is hitting the exit on a low ebb—and leaving with the future of the biotech in doubt. 

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GSK, Korean biotech SK go head-to-head against AstraZeneca's COVID-19 shot with their experimental vaccine

GlaxoSmithKline has been a little late to the COVID vaccine game and stumbled with partner Sanofi on the way, but it’s now hoping to rival and maybe even beat out AstraZeneca’s vaccine as it starts a new test with a new partner.

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Sponsored: Accelerating Outcomes with a Pancreatic Cancer Adaptive Platform through Collaboration and IRT Expertise

When your goal is to identify effective and ineffective treatments more quickly than traditional trials through a Complex Innovative Design, the right IRT system is crucial.

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J&J's HIV vaccine fails phase 2b, extending long wait for an effective jab

The wait for an HIV vaccine goes on. Johnson & Johnson, having seen peers including Merck swing at HIV and miss, has reported the failure of a vaccine based on similar technology to its COVID-19 jab to protect women from infection with the virus. 

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Versanis Bio snags $70M for a ditched Novartis muscle drug, with a little help from its old CEO Joe Jimenez

Versanis Bio emerged with a $70 million series A to test a former failed Novartis drug in a phase 2 study for obesity. Backing the biotech is former Novartis CEO Joe Jimenez, who was in the top spot when bimagrumab flunked a phase 2b/3 study in a rare, muscle-wasting disease.

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A year after a death and accompanying trial hold, Poseida hopes for reprieve with early solid tumor CAR-T data

The death of a patient in its solid tumor trial last August hit Poseida hard, but since then it has seen the hold lifted and is now reporting some early and broadly positive data from that same therapy.

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Key vaccine leaders departing FDA as COVID-19 booster questions linger

Two key vaccine leaders will leave the FDA this fall, just as the agency faces key decisions over COVID-19 booster shots and as variants take a bite out of the shots’ efficacy. The FDA’s Officer of Vaccines Research and Review Director Marion Gruber, Ph.D. and Deputy Director Phillip Krause, M.D. will depart the agency.

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Mayo Clinic, nference AI studies find antibody treatment may reduce hospitalization in high-risk COVID cases

After kicking off the new year by expanding their year-old data analytics-based research collaboration, Mayo Clinic and nference’s union continues to bear fruit.

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Louisiana hospitals mend damaged roofs, coordinate patient transfers following Hurricane Ida

Despite no injuries from the storm within their facilities, executives from Louisiana's largest health system say they and other providers have their hands full with repairs, transfers, workforce accommodations and the looming threat of post-storm admissions.

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Resources

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Whitepaper: How to build a robust packaging strategy for rapid commercialization

Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals.

Whitepaper: Understanding the CMC regulatory landscape for cell and gene therapy products

Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality.

Whitepaper: Navigating the Digital Transformation Journey

Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem.

eBook: Get solutions to market faster

Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization.

eBrief: Drug Product Process Development: Ensuring a Consistent, High-quality Biologic

Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase.

Whitepaper: Achieving a Successful Drug Product Technology Transfer

Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent.

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