In stun­ning about-face, FDA in­vites Eli Lil­ly to quick­ly re­file block­buster hope­ful baric­i­tinib

Just a few weeks ago Eli Lil­ly $LLY made it clear that the FDA was de­mand­ing a new clin­i­cal study to clar­i­fy the safe­ty pro­file of its would-be rheuma­toid arthri­tis block­buster baric­i­tinib, de­lay­ing any re­sub­mis­sion by at least 18 months and per­haps years.

But this morn­ing the phar­ma gi­ant and its biotech part­ners at In­cyte $IN­CY say they’re fil­ing a new mar­ket­ing pitch in just 5 months in an at­tempt to bull their way to an ap­proval by mid-year.

In a state­ment to En­doints News, Lil­ly says the FDA in­vit­ed a new ap­pli­ca­tion with­out the re­quire­ment to com­plete a new study, mark­ing a po­ten­tial­ly dra­mat­ic change in its stance.

The FDA has grant­ed us the op­por­tu­ni­ty to file our re­sub­mis­sion pack­age with­out a new clin­i­cal study.

That’s no guar­an­tee of a quick ap­proval, but it re­flects a ma­jor shift in the FDA’s stance on an im­por­tant new drug, one that comes af­ter Pres­i­dent Don­ald Trump ap­point­ed Scott Got­tlieb to run the FDA.

Lil­ly shares surged 2.4% on the news, with In­cyte spik­ing 4%.

The FDA de­clined to com­ment, a stan­dard prac­tice at the agency, which lets the com­pa­nies do all the talk­ing.

Lil­ly took months to ex­plain the FDA’s rea­son for the stun­ning re­jec­tion, re­cent­ly not­ing that reg­u­la­tors con­cerns about throm­boem­bol­ic events –clot­ting — in two of 7 stud­ies raised an alarm, even though Lil­ly com­plete­ly dis­agreed with the agency’s po­si­tion on safe­ty while in­sist­ing that there was noth­ing aber­rant about the rate of clots. Lil­ly not­ed in a state­ment this morn­ing:

Lil­ly will re­sub­mit the New Drug Ap­pli­ca­tion (NDA) for baric­i­tinib be­fore the end of Jan­u­ary 2018. The re­sub­mis­sion pack­age will in­clude new safe­ty and ef­fi­ca­cy da­ta. The com­pa­nies an­tic­i­pate the FDA will clas­si­fy the ap­pli­ca­tion as a Class II re­sub­mis­sion, which will start a new six-month re­view cy­cle.

Said Christi Shaw, pres­i­dent of Lil­ly Bio-Med­i­cines:

“We are pleased with the op­por­tu­ni­ty to pro­vide our re­sub­mis­sion pack­age for baric­i­tinib soon­er than an­tic­i­pat­ed and look for­ward to con­tin­u­ing to work with the FDA as we seek to bring baric­i­tinib to peo­ple with RA in the U.S.”

Got­tlieb won law­mak­ers’ sup­port for his ap­point­ment a few weeks af­ter Lil­ly was hand­ed a re­jec­tion in April. While he vowed to main­tain the gold stan­dard on safe­ty and ef­fi­ca­cy, Got­tlieb al­so pledged to do every­thing pos­si­ble to ac­cel­er­ate new drug OKs, urg­ing that all of the agency groups fol­low the path pur­sued by its ag­gres­sive on­col­o­gy di­vi­sion.

If the agency fol­lows through with an ap­proval soon, the im­pli­ca­tions would be pro­found for every­one in drug de­vel­op­ment, par­tic­u­lar­ly the larg­er play­ers like Lil­ly.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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Leo Tarkovsky, Fingerpaint Group's new chief commercial officer

Fin­ger­paint Group taps for­mer WPP and Mc­Cann Health ex­ec for new com­mer­cial role

Healthcare agency veteran Leo Tarkovsky has joined Fingerpaint Group as chief commercial officer to oversee its growing portfolio of pharma and healthcare agencies and communications companies.

Tarkovsky came to Fingerpaint from WPP where he was EVP for global healthcare growth over the past year. Before that served at McCann Health for seven years including as president overseeing the New York agencies with pharma clients including AstraZeneca, Bristol Myers Squibb, Eli Lilly and Johnson & Johnson’s Janssen.

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