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Today's Rundown

Featured Story

Novavax's latest COVID-19 vaccine delay sends shares tumbling nearly 20%

Novavax hit another roadblock in its COVID-19 vaccine journey in the U.S., with the company pushing back an FDA filing from May to July to now the fourth quarter. The company filed in India, Indonesia and the Philippines this week, and expects more submissions later this year with WHO, UK, EU, Australia, Canada and New Zealand.

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Top Stories

Moderna is ready to spend billions in COVID-19 cash, and the famed biotech has sights set on gene editing

Moderna has found a direction to volley its mountain of COVID-19 vaccine cash: gene editing. Executives revealed during a second-quarter earnings call Thursday that Moderna is ready to “expand our horizons” with external technologies or products. Read: They’re ready to start buying.

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Sierra raids the bargain bin again, picking up AstraZeneca cancer drug to pair with Gilead castoff

AstraZeneca has offloaded its BRD4 BET inhibitor AZD5153 to Sierra Oncology. Sierra plans to start a phase 2 trial testing the drug in combination with the JAK inhibitor it picked up from Gilead in 2018.

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Dicerna’s stock sinks after its Alnylam rival shows mixed data, stymieing approval filing

After finding success with one RNAi candidate for a rare metabolic disorder that impacts the kidneys called primary hyperoxaluria 1, Dicerna Pharmaceuticals was hopeful that a second RNAi candidate would be able to tackle other types of PH. However, the company released mixed results from what was meant to be a pivotal study for nedosiran, sending its shares down some 13% when the markets opened today.

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Aprea's myeloid program iced by FDA while tricky adverse event profile is sorted out

The FDA slapped a hold on Aprea Therapeutics’ myeloid malignancy programs for eprenetapopt after serious side effects cropped up in trial patients. The high-risk nature of the patients’ disease and prior treatment means the biotech is not quite sure whether its drug caused the problems. But the FDA decided to pause the entire program while the safety risks are sorted out.

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No discounts here: Biotech EQRx to raise $1.8B in SPAC deal for lofty discount drug goal

After raising $750 million in private financing since January 2020 on its towering mission to rewrite the life sciences pricing model, EQRx has now tapped the public markets for another $1.8 billion in a SPAC deal. 

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Former Merck exec joins Kallyope as president, soon-to-be CEO

Kallyope has been relatively quiet since securing a $112 million raise in March 2020, but now the gut-brain biotech will have a former Merck leader at the helm to ramp up clinical work. Jay Galeota joins the New York City biotech as president and will become CEO by October 1.

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AstraZeneca chief Soriot lends GlaxoSmithKline's Walmsley CEO wisdom, support as activist investors press for change

As GlaxoSmithKline CEO Emma Walmsley faces a high-profile challenge from activist investor Elliott Management, she has won backing from an unexpected source: AstraZeneca chief Pascal Soriot.

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Moderna, citing variants and waning immunity, expects COVID-19 boosters to become a fact of life

For anyone thinking aggressive COVID-19 vaccine rollouts would bring a quick end to the pandemic, Moderna has a word of caution. While U.S. authorities aren’t yet ready to recommend vaccine boosters, the company believes that add-on shots will become a fact of life for some as the virus sticks around and continues to put up a fight.

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Cigna anticipates elevated claims costs for rest of 2021, execs say

Cigna posted $1.5 billion in profit in the second quarter of 2021, echoing its industry peers in seeing its earnings decline from Q2 2020.

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Medtronic boosts ear, nose and throat portfolio with $1.1B bid for sinus implant maker Intersect ENT

Medtronic’s latest acquisition is nothing to sneeze at, with an offer of more than $1 billion for a handful of devices already cleared in the U.S. and Europe.

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Chutes & Ladders—Scholar Rock founding CEO returns to top spot as Kingsley swiftly exits

It's another swift exit for Tony Kingsley as he leaves Scholar Rock's CEO spot to founding CEO Nagesh Mahanthappa, Ph.D. IGM Biosciences snagged Gilead's oncology chief as chief medical officer. And Arch Oncology hired a trio of leaders from AbbVie, Bristol Myers Squibb and Xencor.

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Fierce Pharma Asia—BeiGene's flagship U.S. hub, Brukinsa win; Takeda's tax bill, regulatory delays

BeiGene is building an R&D and manufacturing center in New Jersey as its Brukinsa posted a win in chronic lymphocytic leukemia. Takeda sees delays for two drug candidates in the U.S. and EU and it will have to keep fighting a €398 million Irish tax bill. And more.

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Resources

eBook: Accelerate recruitment with a decentralized clinical trial strategy

Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase.

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.

Content Hub: Post-Marketing Safety Studies

Learn about key post-marketing safety study solutions, including registries and REMS, and how they can most effectively help meet regulatory requirements and maximize patient access.

Content Hub: Process Intensification Resource Center

A one-stop hub for Cytiva resources to support process intesification

Content Hub: Remarque Systems Resource Hub

Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 

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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