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Emerging Therapies eBook September 2024 www.biopharminternational.com
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F
rom cancer to COVID-19, the middle third of 2024
saw a slew of approvals and expanded indica-
tions for new and emerging therapies worldwide.
Drugs were steadily updated or introduced, and
moves were also being made in outsourcing, manufac-
turing, acquisitions, and new partnerships. The follow-
ing is a survey of the most impactful developments.
Next-generation products and strategies
With the fifth anniversary of the COVID-19 pandemic
approaching, and as a summer surge increased pres-
sure to respond, FDA on Aug. 22 announced it granted
an Emergency Use Authorization for updated versions of
messenger RNA (mRNA) SARS-CoV-2 vaccines made by
Moderna and Pfizer (1). The vaccines are designed to pri-
marily target the KP.2 strain of the dominant Omicron
variant; however, it is likely that the major vaccine devel-
opers are already working on a formula for 2025–2026.
The COVID vaccines elevated mRNA into the main-
stream lexicon, and while not foreshadowing this new
round of shots, when Pharmaceutical Technology® spoke
with Christian Cobaugh, PhD, CEO and founder of Ver-
nal Biosciences, at BIO 2024 in San Diego, Calif., in June,
Cobaugh addressed the landscape for the outsourcing of
mRNA production in 2025 and beyond (2).
"There [are] those that just generally do GMP [good
manufacturing practice] for multi different types of
drug products, and then there [are] more specialty com-
panies that were set up to make nucleic acids," Cobaugh
said in reference to mRNA service providers, pivoting to
a discussion of next-generation sequencing (NGS). "NGS
offers … an opportunity to go deeper and pick off multi-
ple critical quality attributes from the same test, which,
along with consolidating platforms more broadly, pres-
ents significant cost of goods savings in the long run."
While not an emerging therapy per se, MediWound
said on Aug. 15 that NexoBrid, a topically administered
enzymatic therapeutic for removal of nonviable burn tis-
sue, was granted a pediatric indication by FDA for treat-
ing deep partial and/or full-thickness thermal burns (3).
Update on Trends in
Emerging Therapies
and Manufacturing
Patrick Lavery
The latest developments in emerging therapies, including
new innovations and collaborative efforts in manufacturing.
