COVID-19 dominates our top 10 list
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Editor's Note: This special edition newsletter recaps Fierce Biotech's top 10 most-read stories of the year, counting down from our No. 1 story. We will be returning to your inboxes on Jan. 4. Be sure to check www.fiercebiotech.com for the biggest headlines until then. Happy Holidays, and best wishes for the coming year.

Today's Rundown

Featured Story

Editor's Corner: Fierce Biotech's top 10 most read stories in 2021

You may sense a theme in our top 10 most read stories this year, and it’s not a surprise. Six out of 10 stories had something to do with COVID-19.

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Top Stories

BioNTech CEO applies COVID-19 vaccine's mRNA tech to multiple sclerosis

The new vaccine technology mRNA is making waves these days as COVID-19 shots based on it deliver efficacy that’s unrivaled by other platforms. BioNTech's Pfizer-partnered vaccine Comirnaty is one of those vaccines. Now, the German biotech’s CEO, Ugur Sahin, has led a study showing an mRNA vaccine was effective against multiple sclerosis in mice.

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Novavax targets May approval for COVID-19 vaccine in the U.S.

Novavax is targeting a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the first half of the year.

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Sabatini, biotech founder and mTOR pioneer, ousted after sexual harassment investigation

David Sabatini, the scientific founder of several biotechs, has been ousted from his lab after a sexual harassment investigation. The high-profile cell signaling and cancer metabolism scientist is “no longer associated” with either the Whitehead Institute or the Howard Hughes Medical Institute. 

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Merck has better luck with 2nd COVID-19 drug attempt as it sees a positive in early molnupiravir data

Merck has had a torrid time with COVID-19 vaccines and a major setback with its OncoImmune-partnered pandemic med, but now, finally, it’s seeing some good news on that R&D front.

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He authorized Moderna's vaccine 6 months ago. Now, ex-FDA chief Hahn joins biotech's backer

Ex-FDA Commissioner Stephen Hahn, M.D., is joining Moderna incubator Flagship Pioneering six months after granting the company an emergency use authorization for its COVID-19 vaccine.

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AHA: AstraZeneca, Moderna shine early light on mRNA potential in heart failure

Although AstraZeneca and Moderna are archrivals in the COVID-19 vaccine space, the two have an interesting mRNA pact that has been operating largely under the radar.

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Novavax COVID-19 vaccine 90% efficacious in phase 3, but protection plummets against one variant

Novavax’s COVID-19 vaccine has achieved 89.3% efficacy in a phase 3 clinical trial that enrolled subjects exposed to the B.1.1.7 variant found in the U.K. However, the vaccine performed far worse in a smaller phase 2b that pitted it against another variant first identified in South Africa, intensifying concerns that updated prophylactics will be needed to protect against the evolving virus.

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Johnson & Johnson's closely watched single-shot COVID-19 vaccine readout 'next week' as CFO sees 'robust data'

While the world struggles with two-shot vaccine production as a handful of pharma companies try to make enough for almost the entire global population, a single-dose option from Johnson & Johnson has become a major hope in the fight against COVID-19.

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Eli Lilly's Alzheimer's moment has arrived after Biogen plows through the FDA gates

Eli Lilly's neuroscience team has moved quickly since Aduhelm's June approval to get their own therapy, donanemab, to an accelerated approval filing with the FDA by the end of the year. And the Big Pharma is hoping to beat their competitor to the punch with proof their drug actually slows progression of the disease.

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Moderna's RSV vaccine catches the fast track on heels of Pfizer's leapfrog into the queue

Moderna has its next act lined up: an mRNA respiratory syncytial virus vaccine, which the FDA has just put on the fast track. The biotech, which made its name in 2020 with its COVID-19 vaccine, has been granted a fast track designation for mRNA-1345, which is under investigation as a single-dose vaccine.

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Resources

Research: How Buffer Prep Services Alleviate Sudden Spikes in Campaign Volume

Learn how a CDMO partnered with Thermo Fisher Scientific to manage high-volume process liquid and buffer preparation scale-up. Download the free case study from Thermo Fisher Scientific

Whitepaper: Tailored, Dedicated Support Expedites COVID-19 Vaccine Trial

Sites receiving augmentation support enroll more than 30,000 patients in just over three months. See how additional site resources can make a difference.

Whitepaper: Patients Want Choice Offered through Hybrid Clinical Trials

New survey results and insights help clinical trial sponsors improve diversity and inclusion, enroll faster, and keep participants engaged longer.

Whitepaper: Healthcare Technical Due Diligence: Assessing a New Cancer Treatment

A major Korean biopharmaceutical company wanted to gather unbiased opinions on a new cancer treatment product. Fill out our form to learn more.

Whitepaper: Demand Planning for New Drug/Device Combination

Download now to learn how GLG helped a biotech company plan for the demand of a new drug/device combination by commissioning a forecasting study.

Whitepaper: QC for ex vivo manipulated cell lines and tissues

A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants.

Whitepaper: Modernizing Key Clinical Trial Processes with Artificial Intelligence

This whitepaper addresses where AI can make the biggest impact in clinical trials. The stakes are too high for patients to leave decision-making to machines, but AI can lend administrative support that empowers staff and medical experts alike to carry out their jobs more effectively.

Whitepaper: Medable was able to cut costs in multiple clinical trials by over US$25,000,000

Find out how to improve clinical protocol adherence, and thus patient outcomes, by 15%+ with Medable’s latest White Paper.

Webinar: Using Next Best to Elevate your Omnichannel Marketing Strategy

Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making.

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.

Whitepaper: Enhance the cost-effectiveness of your cGMP chemical supply chain

Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific

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.

Events