Kodiak shares tank on phase 3 flop
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Today's Rundown

Featured Story

Sanofi, GSK post 58% efficacy in omicron-affected COVID-19 vaccine trial, teeing up race to regulators

Sanofi and GlaxoSmithKline are nearly ready to seek approval for their COVID-19 vaccine. After suffering a delay late in 2020, the partners have linked two doses of the protein vaccine to 58% protection from symptomatic COVID-19 in a variant-affected phase 3 clinical trial.

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Top Stories

Stability woes torpedo Marinus' phase 3 seizure timeline, combining with COVID-19 to cause one-year delay

Marinus Pharmaceuticals has hit pause on its phase 3 seizure clinical trial because of a disruption to the supply of clinical trial material. With the pause adding to the impact of COVID-19 on the study, Marinus has pushed back the targeted completion data of the hospital-based clinical trial by about a year. 

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Kodiak's Eylea rival hits 'major disappointment' with failure in first of 6 phase 3 studies

Kodiak Sciences' attempt to rival Regeneron and Bayer's blockbuster drug Eylea, KSI-301, has flopped the first in a series of six phase 3 studies, casting an ominous cloud over the rest of the program. 

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Sponsored: Recommended Strategies for Your Next Biomarker-Driven Clinical Trial

The use of biomarkers to individualize treatment is a cornerstone of precision medicine. Successful incorporation of biomarkers for effective patient identification and selection requires careful planning. Learn about Precision's recommended strategies for overcoming 4 common challenges in biomarker-driven trials.

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Mnemo lures Bayer oncology business chief as new CEO to lead CAR-T work

Mnemo Therapeutics, a biotech working to refine and improve CAR-T cells, has tapped former Bayer EVP Robert LaCaze as its new CEO, effective May 1.

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Roche's gene therapy unit finds a new Spark as co-founding CEO makes way for new leader

Jeffrey Marrazzo, the co-founding CEO of Spark Therapeutics, will depart April 1 to make way for Chief Operating Officer Ron Philip. Philip will lead the Roche unit as it brings forward programs across hemophilia, Pompe disease, Huntington's and others.

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Plexium nabs $102M for protein degradation work weeks after $500M Amgen tie-up

Just weeks after inking a $500 million biobucks pact with Amgen, protein degradation biotech Plexium has secured $102 million in venture capital funds. 

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Poseida taps former Novartis VP as president of gene therapy

Poseida Therapeutics has hired former Novartis VP Brent Warner as president of gene therapy as the biotech looks to grow its pipeline following a potentially lucrative collaboration inked with Takeda. 

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Moderna taps Thermo Fisher for 15-year mRNA production pact for COVID vaccines and more

Moderna and Thermo Fisher Scientific have forged a manufacturing pact to shore up production of Moderna’s COVID-19 vaccine Spikevax—plus the biotech’s other investigational mRNA products—over the next 15 years, the partners said Wednesday.

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Smith & Nephew taps Siemens diagnostics head to replace outgoing CEO

A little over two years after taking on the top job at Smith & Nephew, CEO Roland Diggelmann is stepping down.

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AbbVie advances major depressive disorder ambitions for Vraylar with hopes for $4B-plus in sales

AbbVie’s Allergan-acquired antipsychotic medicine Vraylar is already going gangbusters in its two approved indications. An expansion into tough-to-treat depression, meanwhile, would only build on the med’s multibillion-dollar trajectory.

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A look at Walmart's COVID-19 vaccination strategy in underserved areas

Walmart has administered tens of millions of COVID-19 vaccines to date, with 80% delivered in medically underserved communities, the retail giant announced Wednesday.

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Somatus clinches $325M-plus series E to expand its value-based kidney care model

Already treating members in 34 states, the Virginia-based company said these funds will help expand its holistic kidney care model and reach more than 150,000 covered lives by the end of the year.

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Discovery of ALS and dementia mechanism points to new treatment strategy

Almost all cases of amyotrophic lateral sclerosis and half of frontotemporal dementia cases are linked to dysfunction in the protein TDP-43. New research from two separate teams have now linked the problem with one of the strongest genetic risk factors for the diseases, revealing a possible biomarker and new therapeutic target.

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Resources

Whitepaper: Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

Whitepaper: Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

Whitepaper: The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Whitepaper: The CNS Market: 2021 Year in Review & Outlook for 2022

What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more.

Webinar: The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Whitepaper: Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

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