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Today's Rundown

AstraZeneca dumps late-phase, next-gen COVID-19 vaccine, calling time on a beta player in an omicron world
FDA denies Ardelyx’s appeal against kidney drug rejection, hammering another nail in tenapanor’s coffin
Last call for nominations: The Most Influential People in Biopharma
Lilly, Pfizer-backed Arkuda bags $64M to test drug in frontotemporal dementia in 2023
Silence drug reduces cardiovascular disease risk factor as plans to 'scale up' drug development get underway
Indapta snags $50M financing and signs on former Juno exec as CEO
Engineered TCR-T cells by Fred Hutch, San Raffaele-Intellia fend off evasive leukemia, solid tumors
Republicans push CMS to nix proposal to narrowly cover Alzheimer's drug Aduhelm
Hologic goes big with Mary J. Blige at the Super Bowl
Pfizer re-ups CytoReason collab applying AI disease models to drug development
AstraZeneca's COVID vaccine sales reached $4B last year, but don't expect that much in 2022

Featured Story

AstraZeneca dumps late-phase, next-gen COVID-19 vaccine, calling time on a beta player in an omicron world

By Nick Paul Taylor

AstraZeneca has scrapped its beta-specific COVID-19 vaccine. The removal of AZD2816 from the pipeline follows the conclusion of a phase 2/3 clinical trial that persuaded AstraZeneca to stick with Vaxzevria, its first-generation vaccine, rather than push ahead with plans to seek authorization for its beta-specific sibling.

FDA denies Ardelyx’s appeal against kidney drug rejection, hammering another nail in tenapanor’s coffin

By Nick Paul Taylor

The FDA has deflated Ardelyx's attempt to recover quickly from a complete response letter. With Ardelyx looking to sidestep a request for another trial, the FDA held its ground and denied the appeal—leaving the biotech looking to a Hail Mary pass to overturn the decision.

Last call for nominations: The Most Influential People in Biopharma

By Eric Sagonowsky

For an upcoming special report, Fierce will profile the 20 most influential people in the industry—both in the fight against the pandemic and those who are setting the stage for the industry’s advances for years to come.

Lilly, Pfizer-backed Arkuda bags $64M to test drug in frontotemporal dementia in 2023

By Kyle LaHucik

Arkuda Therapeutics will use a $64 million series B to bankroll studies that tee up the biotech's lead program for a late-2023 clinical entry. The biotech is going after a protein crucial to the function of lysosomes, the cell's recycling center, which is seen as playing a role in neurodegenerative diseases.

Silence drug reduces cardiovascular disease risk factor as plans to 'scale up' drug development get underway

By Kyle LaHucik

Silence Therapeutics is mum no more on its short interfering RNA therapy, which has been found to significantly reduce levels of an independent risk factor for cardiovascular disease.

Indapta snags $50M financing and signs on former Juno exec as CEO

By Max Bayer

Indapta Therapeutics has raised more than $50 million in series A financing and has tapped former Juno Therapeutics executive Mark Frohlich, M.D., as its new CEO in a sprint towards the clinic.

Engineered TCR-T cells by Fred Hutch, San Raffaele-Intellia fend off evasive leukemia, solid tumors

By Angus Liu

Aiming to overcome the obstacles that have stalled the utilization of T-cell immunotherapies in acute myeloid leukemia, two research teams have concurrently found a promising solution in one protein target—along with the potential to expand into solid tumors.

Republicans push CMS to nix proposal to narrowly cover Alzheimer's drug Aduhelm

By Robert King

More than 70 House Republicans want CMS to pull its proposal to only cover the Alzheimer's Disease treatment Aduhelm for Medicare patients in clinical trials.

Hologic goes big with Mary J. Blige at the Super Bowl

By Sharon Klahr Coey

For Hologic’s first DTC commercial spot, the medical tech company which is primarily focused on women’s health, decided to go big—big star, big game, big message—Mary J. Blige, during the Super Bowl, encouraging women to get their screenings.

Pfizer re-ups CytoReason collab applying AI disease models to drug development

By Andrea Park

Since announcing the original collaboration in January 2019, Pfizer has been using CytoReason’s machine learning technology to guide its drug development efforts, with a focus on improving the Big Pharma’s understanding of the immune system.

AstraZeneca's COVID vaccine sales reached $4B last year, but don't expect that much in 2022

By Kevin Dunleavy

AstraZeneca's COVID-19 vaccine sales reached $4 billion in 2021. But the company said not to expect a similar performance this year, projecting a revenue percentage drop in the low-to-mid 20s. In all, AZ reported $37.4 billion in revenue in 2021, a 38% increase from last year.