| 02.09.22 | Celltrion races inhaled COVID-19 drug into phase 3; Grape-flavored MS drug approved by FDA

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Today's Rundown

Celltrion races inhaled COVID-19 antibody therapy into phase 3 to counter omicron Azurity bags FDA nod for grape-flavored multiple sclerosis drug Tiziana rethinks oral antibody trial amid feasibility problems Moffitt Dyves back into tumor pH modulation, turning to transdermal delivery to bypass oral barriers Top 10 most anticipated drug launches of 2022

Featured Story

Celltrion races inhaled COVID-19 antibody therapy into phase 3 to counter omicron

By Nick Paul Taylor

Celltrion’s inhaled COVID-19 antibody cocktail therapy is moving into phase 3. Ten weeks after outlining plans to accelerate the program in response to omicron, Celltrion has filed an IND to study the therapy in a trial of 2,200 patients with mild to moderate symptoms of COVID-19.

This week's sponsor is CPC.

Azurity bags FDA nod for grape-flavored multiple sclerosis drug

By Nick Paul Taylor

The market for novel formulations of baclofen is heating up. Weeks after Saol Therapeutics won approval for its strawberry-flavored oral granules, Azurity Pharmaceuticals has received FDA authorization for an oral suspension aimed at the same piece of the market.

Tiziana rethinks oral antibody trial amid feasibility problems

By Nick Paul Taylor

Tiziana Life Sciences has filed an amendment to get its oral antibody program back on track. After hitting a roadblock with its initial design, Tiziana has expanded the patient population and shortened the dosing period in a bid to wrap up the phase 1b by the end of the year.

Moffitt Dyves back into tumor pH modulation, turning to transdermal delivery to bypass oral barriers

By Nick Paul Taylor

Dyve Biosciences is offering Moffitt Cancer Center a way around a long-standing drug delivery problem. After seeing patients repeatedly reject their oral cancer therapy, researchers at Moffitt have teamed up with Dyve to collaborate on the development of a transdermal formulation.

Top 10 most anticipated drug launches of 2022

By Ben Adams

After 55 new drug approvals at the FDA last year, biopharma and the U.S. agency are still going all guns blazing in getting new therapies out to patients. But what are the most hotly tipped—and potentially most lucrative—approvals on the horizon for 2022?

Webinar: Optimizing Lipid-Based Formulation for Commercial Success

Watch this webinar for insights from experts to illustrate how lipid-based drug delivery technologies have been used to overcome challenges like absorption, food effects, and scale-up.