Gilead's long-acting HIV drug approved

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Today's Big News

Dec 22, 2022

Third patient death potentially tied to Eisai's Alzheimer's drug reported


Epidemiology group no longer recommends universal asymptomatic COVID screening at healthcare facilities


After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca


Embecta outperforms its own revenue estimates with $566M in first 6 months of BD spinout


Merck puts eye-popping $9.3B on the line in lopsided ADC deal with Kelun-Biotech


Pfizer, Sanofi settle first California Zantac case slated for trial: report

 

Featured

3rd patient death potentially tied to Eisai's Alzheimer's drug reported

A third patient death potentially tied to Eisai and Biogen’s Alzheimer’s disease drug lecanemab has been reported in a phase 3 extension study, according to a report from Science.
 

Top Stories

Epidemiology group no longer recommends universal asymptomatic COVID screening at healthcare facilities

While exceptions remain, the Society for Healthcare Epidemiology of America said blanket asymptomatic screening has "unclear benefit" when layered upon a healthcare facility’s other infection prevention measures.

After overcoming vial issue, Gilead wins FDA approval for long-acting HIV injectable Sunlenca

It's no question that Gilead is on top of the HIV game, but throughout the HIV epidemic, one patient population has been left out. The FDA approved Gilead's lenacapivir, a long-acting HIV injectable, for patients whose virus is resistant to multiple drugs.

Embecta outperforms its own revenue estimates with $566M in first 6 months of BD spinout

Six months after leaving the BD nest, Embecta seems to be well on its way to carving out its own path within the medtech industry.

Merck puts eye-popping $9.3B on the line in lopsided ADC deal with Kelun-Biotech

In one of the most lopsided biobucks deals this publication has ever seen, Merck & Co. is offering $175 million upfront to Kelun-Biotech for seven antibody-drug conjugates, plus an eye-popping $9.3 billion in potential milestones on the tail end.

Pfizer, Sanofi settle first California Zantac case slated for trial: report

Pfizer and Sanofi reached an out-of-court settlement with the plaintiff in a California case that was slated for trial, Bloomberg reports.

Japan greenlights Sysmex's amyloid blood test for Alzheimer's disease

Sysmex received approval within the country for a two-step test kit that gauges the ratio between two beta amyloid proteins in the bloodstream.

Leaked Whitehead report found Sabatini interfered with abuse investigation, fostered toxic lab culture

A leak of the Whitehead Institute's investigation into David Sabatini has come to light, detailing claims against the former MIT professor. The report concluded that Sabatini fostered a toxic culture in his lab and interfered in the institute's investigation.

Moderna manufacturing site in UK will be able to produce 250M vaccines annually

Moderna’s planned manufacturing site in the United Kingdom will have the ability to churn out 250 million vaccine doses annually, the company said on Thursday. As for the exact location of the facility? Stay tuned.

2023 forecast: 7 immediate and long-term priorities for hospital leaders

With no shortage of hurdles in store for 2023, hospital finance experts offered seven quick wins and big-picture goals they believe executive teams should have in mind going into the new year.

2023 forecast: Employers who self-insure face new responsibilities and opportunities

Provisions of the Consolidated Appropriations Act that go into effect next year will give employers who self-insure more oversight of the health benefits they provide for their employees.

2023 forecast: Biotech plummeted from 'the highest of highs' in 2022. Will the sun shine again next year?

After a brutal year in the markets that saw companies slashing programs, culling staff and reorganizing, the industry is much leaner and preparing to find its voice again. 

Editor's corner: Fierce Medtech's top 10 stories of 2022 finally got back to 'normal'

For 2020 and 2021, our year-end lists of the most-read articles were dominated by COVID-19—and rightly so, with the coronavirus being front-of-mind as it grew to define our daily lives. But this year? Not so much.
 
Fierce podcasts

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'Podnosis': 2022's digital health unicorns and tapping population health for better care delivery

This week on "Podnosis," we talk about this year's class of digital health companies that crossed the $1 billion valuation despite an overall funding slowdown. We also discuss how best to leverage population health management to improve how care is delivered and make it more holistic.
 

Resources

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

Strategies to help scale-up for commercial manufacturing are critical to getting cell and gene therapies to patients as more advanced therapies reach late-stage clinical studies and regulatory decisions.

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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?
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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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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.
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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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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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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