As reg­u­la­tors con­tin­ue to re­ly more on re­al world ev­i­dence, New York-based RWE leader Ae­tion said Tues­day that it has closed a $110 mil­lion Se­ries C fund­ing round, led by War­burg Pin­cus.

The com­pa­ny said it will use the new funds to ex­tend the ca­pa­bil­i­ties of its RWE plat­form, used by many top bio­phar­ma com­pa­nies, ex­pand its Eu­ro­pean and Asian-Pa­cif­ic foot­print, and grow its com­mer­cial team to serve new clients. Ae­tion has now raised a to­tal of $212 mil­lion to date.

“In some in­stances it makes sense for us to have a plat­form bet­ter suit­ed for these re­gion­al needs, es­pe­cial­ly as it re­lates to Asia,” Ae­tion CEO Car­olyn Mag­ill told End­points News in an in­ter­view. “We’ll be build­ing out our team in both places.”

The last year has proven to be a suc­cess­ful one for the com­pa­ny as it near­ly dou­bled its rev­enue and se­cured 100% of cus­tomer re­newals.

Ae­tion ini­tial­ly made its name by es­tab­lish­ing a part­ner­ship with the FDA and more re­cent­ly be­came the first RWE com­pa­ny to es­tab­lish an Covid-19 re­search col­lab­o­ra­tion with the agency. With for­mer FDA com­mis­sion­er Scott Got­tlieb serv­ing on the com­pa­ny’s board, Ae­tion al­so re­cent­ly poached the FDA’s top pol­i­cy of­fi­cial, Low­ell Schiller. Mean­while, the In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view al­so se­lect­ed Ae­tion to help pro­vide RWE for the in­sti­tute’s val­ue as­sess­ments of drugs.

In ad­di­tion to War­burg Pin­cus, B Cap­i­tal and Fore­site Cap­i­tal al­so joined in on the fund­ing in this round, as did Ae­tion’s ex­ist­ing back­ers New En­ter­prise As­so­ci­ates (an­oth­er Got­tlieb em­ploy­er) and Flare Cap­i­tal Part­ners.

So is an IPO in the cards for Ae­tion?

“We are fo­cused on sup­port­ing our cus­tomers, build­ing our busi­ness, build­ing glob­al stan­dards for trans­form­ing da­ta in­to ev­i­dence and do­ing this on such a scale that bio­phar­ma man­u­fac­tur­ers, pay­ers, providers, da­ta providers and reg­u­la­tors can all look to use RWE more rou­tine­ly in how they make these high-stakes de­ci­sions,” Mag­ill added. She al­so ex­plained how RWE is in­creas­ing­ly used by reg­u­la­tors.

In 2019, 48% of FDA drug ap­provals in­clud­ed RWE in sub­mis­sions, and in 2020, it was 75%, ac­cord­ing to Ae­tion analy­ses. “That’s an in­di­ca­tor of the in­creas­ing re­cep­tiv­i­ty and im­por­tance of re­al world ev­i­dence in reg­u­la­to­ry de­ci­sion mak­ing,” she said.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

The government of the United Kingdom is giving out grants to several manufacturers that have a presence in England, Wales and Northern Ireland.

The government announced that four companies, including Ipsen, contract manufacturer Pharmaron, DNA manufacturer Touchlight and diagnostic test producer Randox, will receive a total of £277 million ($341.1 million). According to a release from the UK government, this represents the first portion of grants from the Life Sciences Innovative Manufacturing Fund.