Carolyn Magill, Aetion CEO

RWE up­start maps a new glob­al plan as in­vestors pour in the lat­est mega-round

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.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

Viswa Colluru, Enveda Biosciences

A Re­cur­sion vet­er­an is map­ping plant life to chart a course to new ther­a­pies — and in­vestors like what they see

One of the earliest employees at AI biotech Recursion Pharmaceuticals is leading a new company, and he’s just closed a hefty Series A to get things moving.

Enveda Biosciences pulled in $51 million in the raise, the company announced Tuesday morning, with the goal of pushing some of its preclinical programs further along. Led by CEO Viswa Colluru, Enveda aims to research how machine learning can utilize natural biology to create new therapies for Wilson’s Disease, NASH and Parkinson’s disease, among others.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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