US re­stricts use of two mon­o­clon­al an­ti­bod­ies that don't work against Omi­cron

Two mon­o­clon­al an­ti­body com­bos from Eli Lil­ly and Re­gen­eron are no longer au­tho­rized in the US, and ship­ments to states have ceased be­cause HHS said they are “high­ly un­like­ly” to work against the sweep­ing new vari­ant Omi­cron.

The move by the FDA comes as states like Flori­da have be­come in­sis­tent that the mAbs need to be in­de­pen­dent­ly eval­u­at­ed, al­though the fed­er­al De­part­ment of Health and Hu­man Ser­vices, which has shipped hun­dreds of thou­sands of these two mAbs to states in re­cent weeks, did not ship any this week.

“Ju­ris­dic­tions, providers and pa­tients should be aware that we have more treat­ments that do work against Omi­cron avail­able than ever be­fore, in­clud­ing oral and IV an­tivi­rals in ad­di­tion to the GSK/Vir mon­o­clon­al an­ti­body,” HHS said.

Still, all of the treat­ments re­main scarce with about 200,000 Covid cas­es per day in the US, ac­cord­ing to the CDC. HHS each week on­ly ships about 50,000 cours­es of GSK’s sotro­vimab, 75,000 of As­traZeneca’s Evusheld, and every two weeks about 100,000 cours­es of Pfiz­er’s pill Paxlovid and an­oth­er 400,000 cours­es of Mer­ck’s pill mol­nupi­ravir.

The de­ci­sion to up­date the Lil­ly and Re­gen­eron EUAs fol­lows the NIH’s de­ci­sion to up­date its clin­i­cal guide­lines to rec­om­mend against both treat­ments at this time. Lab stud­ies have re­peat­ed­ly shown that both an­ti­body com­bos have vir­tu­al­ly no ac­tiv­i­ty against Omi­cron, the vari­ant that now ac­counts for near­ly all coro­n­avirus cas­es in the US.

And un­like with Lil­ly’s for­mer mAb bam­lanivimab, which had its EUA re­voked last April, FDA opt­ed to re­vise, rather than re­voke, these two mAb emer­gency use au­tho­riza­tions, while not­ing that, “In the fu­ture, if pa­tients in cer­tain ge­o­graph­ic re­gions are like­ly to be in­fect­ed or ex­posed to a vari­ant that is sus­cep­ti­ble to these treat­ments, then use of these treat­ments may be au­tho­rized in these re­gions.”

Some re­main un­con­vinced, al­though their opin­ions seem more cen­tered on their po­lit­i­cal stance against Biden’s FDA than any­thing re­lat­ed to the da­ta. Tak­ing a swipe at the FDA, Flori­da’s sur­geon gen­er­al Joseph Ladapo told a lo­cal TV sta­tion that Flori­da will not re­ly on “what oth­er peo­ple, or peo­ple that the me­dia la­bels ‘ex­perts’ say.”

Flori­da’s health de­part­ment al­so re­leased a state­ment call­ing the FDA move “abrupt,” say­ing all of its mAb sites will close, and urg­ing cit­i­zens to call the FDA “on why this de­ci­sion was made.” But Re­gen­eron and Lil­ly both made clear last month the mAbs don’t work against Omi­cron.

Flori­da Gov. Ron De­san­tis re­leased his own state­ment, sim­i­lar­ly mak­ing a fuss about the move by FDA, false­ly call­ing it “abrupt and uni­lat­er­al,” even as there’s broad agree­ment that the mAbs don’t work against Omi­cron.

Ac­cord­ing to Kaiser Health News, Flori­da was among the top two states ad­min­is­ter­ing these two mAbs from Jan. 5 through Jan. 18.

While Flori­da may end up fol­low­ing the da­ta (nei­ther Lil­ly nor Re­gen­eron has raised any is­sues with the de­ci­sion from FDA or HHS), Ladapo high­lights the way in which the FDA and oth­er fed­er­al health agen­cies have been un­der­mined through­out the pan­dem­ic, and have con­tin­ued to lose the trust of the Amer­i­can peo­ple.

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.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

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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In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Robert Califf, FDA commissioner (via AP Images)

User fees in ac­tion: FDA un­veils new short­ened sup­ple­ment re­view, rare dis­ease pi­lots

Thanks to PDUFA VII, signed into law last Friday by President Joe Biden, the FDA this week unveiled two new industry-friendly pilot programs to advance new rare disease endpoints via additional meetings, and to shorten FDA review times for supplemental apps aimed at unmet medical needs.

The agency this week released eagerly-awaited details behind the shortened pilot, known as the Split Real Time Application Review or STAR pilot program, which will speed up certain FDA reviews of efficacy supplements across all therapeutic areas (thanks to earlier submissions of data), but only for those that propose addressing an unmet medical need.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.