Newsletter Tool

Today’s Big News

Nov 2, 2023

Bancel suggests Moderna could be open to out-licensing if sales struggle

Lilly's obesity portfolio in 'all-of-the-above mode'

Rani and Sangamo jettison staff, offices and assets to keep businesses afloat next year

Kymera cuts lymphoma med that performed as expected in phase 1

Prelude thinks SMARCA with AbCellera deal while chopping pair of phase 1 candidates

‘Potential game changer’: Gonorrhea antibiotic compares to standard of care in phase 3

FDA places Nurix's cancer drug on partial hold while manufacturing process upgraded

Medeor cell therapy helps kidney transplant patients taper off immunosuppressant meds

Featured

Bancel suggests Moderna could be open to out-licensing if sales struggle

By Max Bayer

Moderna CEO Stéphane Bancel suggested that partnerships could be on the horizon depending on future sales figures. The company has built a largely wholly-owned pipeline thanks to revenue from the initial launch of its COVID vaccine.

Lilly's obesity portfolio in 'all-of-the-above mode'

By Annalee Armstrong

Eli Lilly is in an “all of the above mode” in obesity, with the research teams moving as fast as possible to advance an oral candidate and build a portfolio of complimentary treatments.

Rani and Sangamo jettison staff, offices and assets to keep businesses afloat next year

By James Waldron

Rani Therapeutics and Sangamo Therapeutics have become the latest biotechs to significantly shrink their workforces in order to eke out cash for another year.

Debunking 7 Common Myths About Data Quality in Clinical Trials

Kymera cuts lymphoma med that performed as expected in phase 1

By Annalee Armstrong

The targeted IRAK4 protein degrader KT-413 did exactly what it was supposed to in an early-stage clinical trial, but Kymera Therapeutics is jettisoning the program.

Prelude thinks SMARCA with AbCellera deal while chopping pair of phase 1 candidates

By James Waldron

Increasingly confident in the potential of its SMARCA2 degrader and a CDK9 inhibitor to treat cancers, Prelude Therapeutics is scrapping the other half of its clinical pipeline.

‘Potential game changer’: Gonorrhea antibiotic compares to standard of care in phase 3

By Gabrielle Masson

An antibiotic from the non-profit Global Antibiotic Research & Development Partnership (GARDP) and Innoviva Specialty Therapeutics has met the current standard-of-care for gonorrhea, hitting the main goal of a pivotal phase 3 trial.

FDA places Nurix's cancer drug on partial hold while manufacturing process upgraded

By James Waldron

Nurix Therapeutics has had a phase 1 trial of its B-cell malignancy drug put on partial hold by the FDA while the biotech revamps its manufacturing process.

Medeor cell therapy helps kidney transplant patients taper off immunosuppressant meds

By Annalee Armstrong

Medeor Therapeutics’ kidney transplant cell therapy, which combines a living donor’s cells with the recipient's, allowed more than half of study participants in a phase 3 pivotal trial to stay off immunosuppressants for two years.

Fierce Biotech Fundraising Tracker '23: Gate unveils with $60M; Aiolos launches with $250M

By Gabrielle Masson,Max Bayer,Annalee Armstrong

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

Resolian, the CRO formerly known as Alliance, makes move into China with Denali acquisition

By Joseph Keenan

Resolian, which rebranded from Alliance Pharma earlier this year, expanded its services with the acquisition of China-based bioanalytical CRO Denali Medpharma for an undisclosed price.

Eli Lilly 'aggressively planning' manufacturing expansions, CEO says, as Mounjaro soars

By Angus Liu

As strong demand continues to push Mounjaro sales to new highs, Eli Lilly CEO David Ricks said the company is "not done with" manufacturing expansions.

3D spatial omics profiler Stellaromics scores $25M series A

By Conor Hale

The startup aims to provide a view into the workings of tissue and chart out cellular maps for a better understanding of organ function and disease.

Moderna takes hefty $1.3B COVID write-off, scales back manufacturing as sales shrink

By Zoey Becker

The company is focusing on scaling back its manufacturing efforts to cope with the lack of COVID-19 vaccine demand.

Sempre Health partners with Organon on pricing program that ties patient copays to adherence

By Heather Landi

Sempre Health has added two of Organon's asthma therapies to its platform that gives patients a financial incentive to refill medications on time.

Fierce podcasts

Don’t miss an episode

'Podnosis': A look at Blue Shield of California's new pharmacy benefits model

In this week's episode of “Podnosis,” we explore Blue Shield of California's plan to transform its pharmacy model. This includes a shift away from the traditional PBM relationship in favor of forming partnerships with five companies: Amazon Pharmacy, Abarca, Mark Cuban Cost Plus Drugs Company, CVS Caremark, and Prime Therapeutics.

'The Top Line': A look at the FDA's Aduhelm approval and the potential for regulatory bias

'The Top Line': Leqembi's full approval and the future of Alzheimer's treatment

Resources

Whitepaper

Artificial Intelligence in Healthcare & Medical Affairs

This paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders.

Presented by Blue Matter, strategic consultants in the life sciences

eBook

Industry Events

Drug Development Boot Camp® Spring 2024 VIRTUAL

April ‌10-11, ‌2024

Genesis 2023

December ‌7, ‌2023

Upcoming Fierce Events

14-15

Nov

Diversity, Equity & Inclusion Forum

Free Virtual Event

14-16

Nov

European Trial Master File Summit

London, UK

Dec

Fierce 50 Awards Gala Dinner

Edison Ballroom, New York City

9-10

Jan

Fierce JPM Week

San Francisco, CA

16-18

Jan

Fierce JPM Week - Virtual Event

Virtual Event

View all events

This email was sent to newsletter@newslettercollector.com as part of the Fierce Biotech email list.

Today’s Big News

Featured

Bancel suggests Moderna could be open to out-licensing if sales struggle

Top Stories

Lilly's obesity portfolio in 'all-of-the-above mode'

Rani and Sangamo jettison staff, offices and assets to keep businesses afloat next year

Debunking 7 Common Myths About Data Quality in Clinical Trials

Kymera cuts lymphoma med that performed as expected in phase 1

Prelude thinks SMARCA with AbCellera deal while chopping pair of phase 1 candidates

‘Potential game changer’: Gonorrhea antibiotic compares to standard of care in phase 3

FDA places Nurix's cancer drug on partial hold while manufacturing process upgraded

Medeor cell therapy helps kidney transplant patients taper off immunosuppressant meds

Fierce Biotech Fundraising Tracker '23: Gate unveils with $60M; Aiolos launches with $250M

Resolian, the CRO formerly known as Alliance, makes move into China with Denali acquisition

Eli Lilly 'aggressively planning' manufacturing expansions, CEO says, as Mounjaro soars

3D spatial omics profiler Stellaromics scores $25M series A

Moderna takes hefty $1.3B COVID write-off, scales back manufacturing as sales shrink

Sempre Health partners with Organon on pricing program that ties patient copays to adherence

Don’t miss an episode

'Podnosis': A look at Blue Shield of California's new pharmacy benefits model

'The Top Line': A look at the FDA's Aduhelm approval and the potential for regulatory bias

'The Top Line': Leqembi's full approval and the future of Alzheimer's treatment

Resources

Artificial Intelligence in Healthcare & Medical Affairs

An Introduction to Organ-on-a-Chip Technology

What Are the Benefits of Generative AI for Pharma?

Improving yield and reproducibility with advanced sample prep

Accelerate drug discovery with high-performance computing powered by the cloud

Discover Strategies for Combatting Disruptions in Gene Therapy Development

Understanding the hidden value of quality

Industry Events

Upcoming Fierce Events