Digital therapeutics to get creative in '24

Editor’s note: This is the last edition of Fierce PM Tracker for 2023. The Fierce team is taking a break from the regular newsletter schedule until Jan. 2, but be sure to check our sites for the biggest headlines until then. Enjoy your holiday season, and best wishes for the coming year.  

Today’s Big News

Dec 22, 2023

UPDATE: BMS unwraps $14B deal for Karuna, adding a schizophrenia drug awaiting FDA OK  


With FDA approval, Ionis and AstraZeneca gear up to launch rare disease drug Wainua 


2024 forecast: Digital therapeutics makers will have to get creative to conquer reimbursement issues


Merck KGaA, Mersana abandon ADC licensing pact before the New Year 


2024 forecast: Biden admin efforts show there's no pricing relief on the horizon for pharma  


'The Top Line': The year in biotech 

 

Featured

UPDATE: BMS unwraps $14B deal for Karuna, adding a schizophrenia drug awaiting FDA OK

Christmas has come early for Karuna Therapeutics’ shareholders. Bristol Myers Squibb has unwrapped a $14 billion deal to acquire the biotech, which sits on the cusp of having the first schizophrenia treatment approved in years.
 

Top Stories

With FDA approval, Ionis and AstraZeneca gear up to launch rare disease drug Wainua

The approval in hereditary transthyretin-mediated amyloid polyneuropathy, which affects around 40,000 to 50,000 patients globally, sets the stage for a potential label expansion down the line to treat the broader transthyretin amyloid cardiomyopathy patient population.

2024 forecast: Digital therapeutics makers will have to get creative to conquer reimbursement issues

Commercial green lights have largely failed to translate into profitability for makers of digital therapeutics, many of whom found themselves struggling to stay afloat this year.

Merck KGaA, Mersana abandon ADC licensing pact before the New Year

It’s been a trying 2023 for Mersana Therapeutics and the year doesn’t appear to be ending on a high note. The antibody-drug conjugate (ADC) biotech and Merck KGaA have severed ties for a licensing pact related to one of Mersana’s tech platforms.

2024 forecast: Biden admin efforts show there's no pricing relief on the horizon for pharma

Based on the series of measures centered on U.S. drug prices coming out of Washington, the Biden administration is clearly emboldened on the topic.

'The Top Line': The year in biotech

This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her.

J&J, Legend’s Carvykti slapped with FDA black-box warning over secondary cancer risk

As the FDA investigates a safety signal for approved CAR-T therapies, the agency has elevated a warning about secondary cancers following the use of Johnson & Johnson and Legend Biotech’s Carvykti. 

2024 forecast: Will generative AI find what it needs to deliver for patients?

While AI has already made a deep impact on healthcare, the spotlight on programs such as ChatGPT has led to new debates on AI ethics and safety.

Triple phase 3 disaster sends AlloVir searching for options as shares plunge 64%

AlloVir’s ambitions, like its share price, have shrunk significantly as the biotech abandons three late-stage trials of its lead asset after deciding none were likely to achieve success.

2024 forecast: M&A saw an uptick in 2023. Analysts expect the trend to continue

Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024.
 
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Don’t miss an episode

'The Top Line': The year in biotech

This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her.
 

Resources

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Transitioning from using RUO to cGMP chemicals for clinical trials

By 2030, the global demand for biologics is projected to grow at a CAGR of 8.7% and the challenges, risks, and costs of bringing large molecule products to market are growing exponentially.
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The Potential of Predictive Algorithms for Pharma

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The Convergence of Consumer Wearables & Medical Devices

Medical devices & consumer wearables are starting to overlap, creating risks & opportunities for traditional medical device companies as well as consumer wearables manufacturers. This paper explores pros and cons from both perspectives.

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Fed-Batch Intensification To Increase Titer In Biologics Manufacturing

Improving efficiency and productivity in biologics manufacturing is a longstanding goal within today’s industry, especially now as new and increasingly complex molecules are fundamentally changing technological and operational approaches to drug development. Process intensification can help accelerate this pace of innovation through advanced process development techniques and high productivity manufacturing platforms.

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Effective Technology Transfers for Mammalian-Derived Biologics

As a leader of technology transfer activities in the industry, Lonza understands the challenges associated with this critical step. Download this White Paper today to learn more. 

eBook

An Introduction to Organ-on-a-Chip Technology

Emulate in vivo biology with next-generation in vitro technology.
 

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