FDA OKs RefleXion’s biology-guided radiotherapy tech

Today's Big News

Feb 7, 2023

As J&J overhauls R&D, Arrowhead waits for news on RNAi hepatitis B therapy


ICER chief's agenda: Gene therapy differentiation, post-IRA model updates and more


RefleXion overcomes 'unprecedented hurdles' to land FDA nod for biology-guided radiotherapy tech


With Humira under pressure, AbbVie puts bigger M&A deals back on the table: WSJ 


Stroke maven Imperative Care launches digital health company for patients navigating recovery

 

Featured

As J&J quietly overhauls R&D, Arrowhead waits for news on RNAi hepatitis B therapy

Johnson & Johnson has yet to publicly detail the R&D overhaul reported last week by Fierce Pharma, and apparently at least one company with work that may be deprioritized or reorganized is waiting in the lurch.
 

Top Stories

ICER chief's agenda: Gene therapy differentiation, post-IRA model updates and more

ICER President Steve Pearson, M.D., has put differentiating between gene therapy values on the group's to-do list. He also wants to update the cost watchdog's models after the passage of the Inflation Reduction Act.

RefleXion overcomes 'unprecedented hurdles' to land FDA nod for biology-guided radiotherapy tech

Just over a year after being recognized by the FDA for the potential “breakthrough” nature of its radiation therapy, RefleXion has gotten the go-ahead from the agency to begin rolling out the system across the U.S.

With Humira under pressure, AbbVie puts bigger M&A deals back on the table: WSJ

As biosimilars come for Humira, AbbVie is ready to pull out all the stops. The pharma giant will no longer be limiting itself to $2 billion a year on M&A, according to a Wall Street Journal interview with CEO Richard Gonzalez.

Stroke maven Imperative Care launches digital health company for patients navigating recovery

As an independent spinout, Kandu Health will focus on assisting patients through recovery, with remote clinical navigators and support groups in addition to app-based education.

FDA's Oncology Center of Excellence slowed launch of new projects in 2022 to focus on trial modernization

Five years after the formation of the FDA’s Oncology Center of Excellence, the federal center slowed the launch of new projects to focus on existing programs, with particular focus on ramping up four programs to help modernize clinical cancer trials.

Vertex pricing under fire—again—as activists press 4 governments for Trikafta generics

A coalition of cystic fibrosis patients and their families petitioned governments in South Africa, Brazil, India and Ukraine to either revoke or suspend Vertex patents surrounding the company’s tripartite drug Trikafta.

Investor Syncona blames bear market's ravaging of British biotechs for ‘disappointing’ returns

Life sciences investment firm Syncona has blamed a “disappointing” drop in returns on plummeting share prices for British biotechs across its portfolio in December.

3M rolls out skin-sticking adhesive allowing wearable monitors to last up to 4 weeks

3M has developed a new medical product with major staying power.
 
Fierce podcasts

Don't miss an episode

'The Top Line': 2023's obesity market and 2022's drug approvals

This week on "The Top Line," we discuss what we can expect from the obesity market in 2023. We also recap the drugs approved last year.

 

Resources

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Commercializing Gene Therapies, Part 3 – Cost Drivers

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Quality attributes that are important for GMP-grade NTPs

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Writing the Future of Antibody Discovery Solutions

See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

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Linear Compression vs. Parallel Processing: Speeding Biologics Through Development and Into Clinical Trials

Download this paper to learn considerations on how to move a biologic through clinical trials faster, advantages of Parallel Processing, and more.

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Intranasal Drug Product Development: Formulation to Manufacturing

What are key considerations for intranasal delivery in the treatment of acute and chronic conditions?
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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.

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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.
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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.
 

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