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Today's Big News

Dec 5, 2022

With Neogene buy and a CAR-T in the clinic, AstraZeneca builds up cell therapy 'library'

Amgen, seeking to crash Novo's party, links bispecific to weight loss months after end of dosing

We're looking for the fiercest companies for Fierce Medtech's 2022 Fierce 15

Do Verve's gene edits pass down to patients' children? The FDA wants to know

Dermata's mid-stage rosacea study sees far-from-rosy results, piling pressure on acne ambitions

Hunt for new non-hormonal birth control sends scientists under the sea

 

Featured

With Neogene buy and a CAR-T in the clinic, AstraZeneca builds up cell therapy 'library'

With the acquisition of Neogene Therapeutics this week and with a CAR-T now in phase 1 courtesy of a Chinese partnership, AstraZeneca hopes to add the first volumes to a planned “library” of off-the-shelf cell therapies.
 

Top Stories

Amgen, seeking to crash Novo's party, links bispecific to weight loss months after end of dosing

Amgen’s late run for the obesity market is gathering pace. In phase 1, recipients of the highest dose of the company’s would-be challenger to Novo Nordisk’s Wegovy maintained double-digit percentage weight loss 150 days after receiving the last of three shots. 

We're looking for the fiercest companies for Fierce Medtech's 2022 Fierce 15

Each year, we ask for your help in bringing to our attention the companies you believe are the fiercest in medtech.

Do Verve's gene edits pass down to patients' children? The FDA wants to know

The FDA has set out its reasons for putting Verve Therapeutics’ high cholesterol gene editing therapy on hold. Officials want additional data to allay concerns that patients could pass on the edited genes to their children before they lift the clinical hold.

Dermata's mid-stage rosacea study sees far-from-rosy results, piling pressure on acne ambitions

Dermata Therapeutics' rosacea ambitions are in the red after the company’s lead asset failed a phase 2 trial, placing additional pressure on the med as an acne treatment. 

Hunt for new non-hormonal birth control sends scientists under the sea

Scientists used a common biomedical material to create a non-hormonal birth control that stops sperm in its tracks, with promising findings in sheep.

In free fall, Clovis defaults on loan and agrees to further restrict Rubraca use

With bankruptcy looming for Clovis Oncology, the company has reported in a securities filing that it has defaulted on a loan by failing to make an interest payment. Clovis also revealed that it has decided—at the request of the FDA—to restrict the use of its cancer drug Rubraca to those whose tumors have BRCA mutations.

Pfizer bolsters blockbuster investment spree with $750M outlay at one of its biggest manufacturing plants

Pfizer is throwing down $750 million to upgrade sterile injectables production at its facility in Kalamazoo, Michigan, where the company cranked out some of the earliest COVID-19 vaccines in the U.S. The project is expected to generate 300 new jobs.

Medtronic's HeartWare pump racks up another safety alert, this time for jammed driveline covers

Medtronic’s HeartWare Ventricular Assist Device may be off the market, but it’s still very much on the company’s mind.

Havas Health & You teams up with Evermed for its own Netflix moment

New York healthcare marketing agency Havas Health & You is partnering with software company Evermed to deliver tailored video content for doctors.

Digital health VCs eye healthcare workforce, cancer care as ripe for startups in 2023

Despite the market downturn and economic pressures, the majority of investors expect digital health dollars in 2023 to be roughly on par with 2020, bringing in an estimated $15 billion to $25 billion.
 
Fierce podcasts

Don't miss an episode

'The Top Line': The initial reactions to Biogen's new CEO, plus this week's headlines

This week on “The Top Line,” we discuss the current state of Biogen and recent investor reactions to the new hire. Plus we cover the week's news including: What Albert Bourla said that has him in hot water, a $3.5 million drug, and we tease a possible major acquisition. 
 

Resources

Video

Discover the future of mAb manufacturing

Revolutionize your monoclonal antibody (mAb) manufacturing with expert insights.
Whitepaper

Enhance the cost-effectiveness of your chemical supply chain

Learn how to develop a high-performing supply chain for GMP-manufactured chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific.
Whitepaper

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.
Webinar

Webinar: Writing the Future of Antibody Discovery Solutions

Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

Executive Summary

Scale-Up Strategies for Late-Stage Cell Therapies

Readers will learn manufacturing by Design Builds on Quality by Design, De-risking the Tech Transfer Process, and more.

Whitepaper

Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?
Whitepaper

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.

Whitepaper

Intranasal Drug Product Development: Formulation to Manufacturing

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

Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.
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.
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.
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.

 

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