| 12.01.21 | Omicron spurs work on nebulized COVID-19 drug; China approves subcutaneous checkpoint inhibitor

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Webinar: Protocol Diagnostic 101: How to assess your protocol for implementation risks

Thursday, December 2 | 11:00am ET / 8:00am PT

Protocols are like babies...no one wants to tell someone their baby is ugly. This webinar will review tactics and approaches dissecting protocols for clarity, consistency, and true operational feasibility so that sites are able to execute the study - reducing risk, deviations, and amendments. Register Now.

Today's Rundown

Omicron spurs Celltrion to accelerate development of nebulized COVID-19 antibody cocktail Chinese firms win subcutaneous checkpoint inhibitor approval, beating global heavyweights to new opportunity Seelos eyes chronic ketamine dosing after bagging rights to sublingual candidate EpiPen rival Kaléo snapped up in $310M deal by investor group 'What it takes': Beyond the headlines, women are pushing groundbreaking new Alzheimer's treatments forward

Featured Story

Omicron spurs Celltrion to accelerate development of nebulized COVID-19 antibody cocktail

By Nick Paul Taylor

With the mix of mutations in omicron raising fears the new COVID-19 virus will evade our existing defenses, Celltrion is stepping up work on a nebulized cocktail it thinks may remain effective against the pathogen.

Webinar: Advances in Precision Medicine in Lupus and Rheumatoid Arthritis

Thursday, December 2 | 11:00am ET / 8:00am PT

Precision medicine aspires to revolutionize healthcare by using novel biomarkers to individualize patient treatments and ensure that patients receive the most effective drugs the first time. We will review recent precision medicine studies in lupus and rheumatoid arthritis and discuss new advances in biomarker research for patient stratification. Register Now.

Chinese firms win subcutaneous checkpoint inhibitor approval, beating global heavyweights to new opportunity

By Nick Paul Taylor

A trio of Chinese biopharma companies has won the first approval for a subcutaneous checkpoint inhibitor, beating rivals including Merck and Pfizer by securing authorization in its home market.

Seelos eyes chronic ketamine dosing after bagging rights to sublingual candidate

By Nick Paul Taylor

Seelos Therapeutics has secured near-global rights to a sublingual ketamine wafer, agreeing to pay iX Biopharma $9 million upfront to take control of a candidate it envisages unlocking chronic use of the drug.

EpiPen rival Kaléo snapped up in $310M deal by investor group

By Joseph Keenan

Kaléo, a small drugmaker and EpiPen rival, has been acquired by Marathon Asset Management in a deal valued at $310 million. The funding is expected to fuel the company’s growth in the allergy treatment arena and beyond.

'What it takes': Beyond the headlines, women are pushing groundbreaking new Alzheimer's treatments forward

By Annalee Armstrong

As Fierce Biotech reported out the aftermath of the controversial approval of Biogen’s Aduhelm, we discovered a common thread at many of the top pharma companies who are working on the most advanced treatments in development: women. We wanted to know—how have they kept going?

Webinar: Next Supply Chain Challenge: Syringes

Wednesday, December 8 | 11am ET / 2pm PT | Presented by: Apiject

What’s behind the growing global shortage of syringes for COVID and other vaccinations? How is the industry meeting the demand? Hear from experts in pharma and global health discuss potential solutions. Register now.