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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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Simba Gill, CEO of Evelo Biosciences

While down 87% YOY, Evelo gets Flag­ship and oth­ers to in­fuse new cap­i­tal for come­back hope

Just four years after Flagship spinout Evelo Biosciences went public in an IPO worth $85 million, the biotech has seen its share price tank from $13 a share this time last year (ultimately reaching a peak of over $17) to now under $1.50. And today, it looks like Flagship still thinks the fledging biotech, in a down market, is still worth something after initial pre-IPO backing from the likes of Google’s GV, Celgene, Mayo Clinic and Alexandria Venture.

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Peter Thompson, Terremoto Biosciences interim CEO

For­mer Prin­cip­ia team looks to shake up co­va­lent small mol­e­cules again, this time at 'earthquake' scale

Terremoto Biosciences goes back a long ways, in a sense, to about a dozen years ago when Principia Biopharma was founded by UCSF professor Jack Taunton. Peter Thompson initially helmed the biotech.

The company helped expand covalent small molecule inhibitors beyond oncology and into autoimmune disease by targeting cystine. But that amino acid is uncommon in a lot of proteins, offering fewer drug targets than, say, lysine, which is present in most proteins of interest. So, over the years, Taunton went back to the drawing board to check out that second amino acid.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

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