| 03.31.23 | Sanofi, Regeneron could see $20B peak sales with Dupixent; Bayer deprioritizes women's health R&D

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Weekly Digest

Does motivation to enroll in a study vary by race and ethnicity?

IQVIA conducted a survey and the findings can be quantified to apply to future protocols. Download: How Clinical Trial Design Impacts Enrollment of Diverse Populations.

This Week

Mar 31, 2023

SPECIAL REPORT—Top 10 pharma R&D budgets in 2022

Sanofi, Regeneron's Dupixent could hit $20B in peak sales with COPD expansion: analyst

Bayer, with new leadership stepping in, deprioritizes women's health R&D

GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial

Novartis to ride with Bicycle in radiopharmaceuticals deal that could cruise to $1.7B

FDA floats oncology authorization shake-up, pitching 'one-trial' model for accelerated and full approval

Lilly wants people with Type 2 diabetes to treat their diabetes differently with new Mounjaro campaign

J&J adds medtech head Ashley McEvoy to list of highest-paid execs with $7.4M payout in 2022

In new PD-1 showdown, GSK's Jemperli loses initial edge on Merck's Keytruda

Bluebird bio lays gene therapy launch groundwork as sickle cell application nears

Functional thymus organoids successfully grown from human stem cells

Webinar: 5 Ways to Reduce Costs and Support Life Science Innovation with AWS

Tuesday, April 4, 2023 | 10am ET / 7am PT

Life sciences leaders are reporting that investments in cloud technology are opening new doors for enhanced productivity, improved time-to-insights, and more. Join this one-hour deep dive into the latest solutions and strategies for successfully accelerating innovation while optimizing costs. Register now.

Featured

Top 10 pharma R&D budgets in 2022

By Max Bayer

The latest R&D budget rankings looks a lot like the 2021 list, but Sanofi cracked the list this year and shifts in positions occurred, like Merck reaching the podium after jumping Pfizer for third place.

Sanofi, Regeneron's Dupixent could hit $20B in peak sales with COPD expansion: analyst

By Kevin Dunleavy

Analysts at Evercore ISI believe a label expansion for Sanofi and Regeneron’s Dupixent in COPD would add $3.5 billion in sales, expanding the drug’s peak sales potential to more than $20 billion.

Bayer, with new leadership stepping in, deprioritizes women's health R&D

By Max Bayer

Bayer has elected to move away from early R&D work focused on women's health. The pharmaceutical company behind the birth control brand Yasmin says it will continue to work on clinical-stage assets in the field.

GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial

By Fraiser Kansteiner

After a California judge said a plaintiff's expert witnesses can testify in an upcoming trial over cancer risks on heartburn med Zantac, GSK has hit back. The British drugmaker stressed that litigation is still at an “early stage."

Webinar: Interoperability in Healthcare: Views from Across the Industry

Tuesday, April 11, 2023 | 1pm ET / 10am PT

Achieving interoperability in healthcare can be a daunting task, but sharing and collaborating with data has the potential to generate better clinical outcomes, enable new care models, and enhance patient experience. Join healthcare industry experts for this important roundtable discussion to learn more. Register now.

Novartis to ride with Bicycle in radiopharmaceuticals deal that could cruise to $1.7B

By Annalee Armstrong

Novartis has hopped on Bicycle Therapeutics’ radio-conjugates ride with a $50 million upfront payment and a further $1.7 billion possible down the road.

FDA floats oncology authorization shake-up, pitching 'one-trial' model for accelerated and full approval

By Nick Paul Taylor

The FDA is planning to shake up its approach to the accelerated approval of oncology drugs—and wants to know what you think of its proposals. In draft guidance, the agency outlined plans to move away from single-arm studies and instead favor randomized controlled trials that can potentially serve as the basis for both accelerated and full approval.

Lilly wants people with Type 2 diabetes to treat their diabetes differently with new Mounjaro campaign

By Sharon Klahr Coey

Eli Lilly has officially launched its consumer campaign for Type 2 diabetes drug Mounjaro. The first TV spot “'Diabetes Differently’ premiered on February 12 on Fox.

J&J adds medtech head Ashley McEvoy to list of highest-paid execs with $7.4M payout in 2022

By Andrea Park

For the first time in at least a decade, the head of Johnson & Johnson’s medtech division is among the company’s highest-paid executives.

In new PD-1 showdown, GSK's Jemperli loses initial edge on Merck's Keytruda

By Angus Liu

GSK and Merck provided a new opportunity to compare their PD-1 drugs side by side. After a head-to-head win last year, GSK's Jemperli this time appears to have lost its competitive edge against Merck's Keytruda.

Bluebird bio lays gene therapy launch groundwork as sickle cell application nears

By Fraiser Kansteiner

While commercial revenue has yet to materialize in bluebird bio's earnings report, the company is flying high on the U.S. launches of its two new gene therapies Zynteglo and Skysona.

Functional thymus organoids successfully grown from human stem cells

By Helen Floersh

Though the work is only in the proof-of-concept stage, the “mini organs” could help develop patient-specific therapies for treating thymic dysfunction.

Fierce podcasts

Don't miss an episode

'The Top Line': The financial trends biotechs could face in 2023, plus this week's headlines

This week on "The Top Line," we discuss how 2023 is shaping up to be much the same as last year when it comes to financing trends for biotechs. We also cover Emergent's Narcan winning the first over-the-counter approval for an opioid-overdose drug and more of this week's top headlines.

'Podnosis': Insight on the Ohio train derailment class-action lawsuit, and how data analytics can improve social risk factor identification

'The Top Line': Fierce Medtech's annual Fierce 15 honorees, plus this week's headlines

'Podnosis': The importance of nuanced care for neurodivergent adults, and a lawyer's fight in the opioid crisis

Webinar: Shaping your data value chain - from instrument data to insights!

Tuesday, April 11, 2023 | 12pm ET / 9am PT

In this webinar we will guide you along the scientific data journey where you can discover smart ways to get from raw data to insights and how to achieve an automated, interconnected lab with data liquidity across the organization. Register now.

Resources

Research

Three Considerations to Expand Physicians’ Bandwidth and Improve Real-World Safety Reporting

The current real-world safety reporting process is too burdensome for most HCPs – how can technology help?

Plan for scalable process liquid and buffer preparation

Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.

Sponsored by: Thermo Scientific Production Chemicals and Services

Whitepaper

Spotting Influences in the HCP-Patient Conversation

Learn how HCP statements influence patient decisions

Sponsored by: ZoomRx - HCP-Patient Dialogue Research

Whitepaper

US/EU Governance: The Importance of Company Culture and Proven, Real-World Solutions

This paper describes the key elements of good US/EU corporate governance for US-based biopharma companies in operating Europe.

Sponsored by: Blue Matter, strategic consultants in the life sciences

Executive Summary

Optimizing drug discovery in a fast-moving market

Read about the latest survey results from over 200 biopharma executives and the changing approaches to building biologic drug development pipelines.

Answering your specific questions about mRNA/saRNA manufacturing

Have you had your questions about mRNA/saRNA manufacturing unanswered during a webinar; have no fear, we have you covered here.

Proven Pharmaceutical Go-To-Market Model

Download Herspiegel Consulting’s Go-To-Market Model, based on 100+ launches, to learn the critical components, and timelines for commercial success.

Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

Catalent’s Carla Vozone discusses the significant trends in the Orally Inhaled & Nasal Drug Delivery (OINDP) segment including large molecules and novel indications.

Step-wise strategy to address process characterization and late phase development

Learn more on Catalent’s step-wise approach for the definition and execution of Process Characterization for the production of a monoclonal antibody for late phase process characterization and development.

Sponsored by: Catalent

Whitepaper

Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.

Sponsored by: Catalent

Research

A Strategy to Standardize Process Characterization & Late Phase Development

Learn more on an approach for process characterization for the production of a monoclonal antibody, which will improve the efficiency and effectiveness of the process by targeting the right design and number of experiments.

Sponsored by: Catalent

Whitepaper

Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.

Sponsored by: Catalent

Case Study