| 02.23.22 | Sanofi, GSK prep COVID-19 shot for regulators on omicron data; Marinus phase 3 warped by stability woes

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Today's Rundown

Sanofi, GSK post 58% efficacy in omicron-affected COVID-19 vaccine trial, teeing up race to regulators Stability woes torpedo Marinus' phase 3 seizure timeline, combining with COVID-19 to cause one-year delay Kodiak's Eylea rival hits 'major disappointment' with failure in first of 6 phase 3 studies Sponsored: Recommended Strategies for Your Next Biomarker-Driven Clinical Trial Mnemo lures Bayer oncology business chief as new CEO to lead CAR-T work Roche's gene therapy unit finds a new Spark as co-founding CEO makes way for new leader Plexium nabs $102M for protein degradation work weeks after $500M Amgen tie-up Poseida taps former Novartis VP as president of gene therapy Moderna taps Thermo Fisher for 15-year mRNA production pact for COVID vaccines and more Smith & Nephew taps Siemens diagnostics head to replace outgoing CEO AbbVie advances major depressive disorder ambitions for Vraylar with hopes for $4B-plus in sales A look at Walmart's COVID-19 vaccination strategy in underserved areas Somatus clinches $325M-plus series E to expand its value-based kidney care model Discovery of ALS and dementia mechanism points to new treatment strategy

Featured Story

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

By Nick Paul Taylor

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.

This week's sponsor is Farrar-Trane Scientific.

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

By Nick Paul Taylor

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.

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

By Kyle LaHucik

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.

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.

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

By Kyle LaHucik

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.

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

By Kyle LaHucik

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

Poseida taps former Novartis VP as president of gene therapy

By Max Bayer

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.

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

By Fraiser Kansteiner

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.

Smith & Nephew taps Siemens diagnostics head to replace outgoing CEO

By Andrea Park

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

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

By Fraiser Kansteiner

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.

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

By Paige Minemyer

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

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

By Dave Muoio

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.

Discovery of ALS and dementia mechanism points to new treatment strategy

By Angus Liu

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.