Martin Shkreli (Dennis Van Tine/MediaPunch/IPX via AP Images)

In up­hold­ing Mar­tin Shkre­li's life­time ban, judge rules any state­ment he makes about phar­ma could be a vi­o­la­tion

A fed­er­al judge in New York has up­held the life­time in­dus­try ban placed on Mar­tin Shkre­li last month af­ter the ex-Phar­ma Bro ap­pealed the de­ci­sion.

Shkre­li and his lawyers large­ly ob­ject­ed to the scope of the ban, ar­gu­ing it was too vague and bur­den­some. The lat­est opin­ion Fri­day, how­ev­er, es­sen­tial­ly pre­vents Shkre­li from mak­ing any pub­lic state­ments about the phar­ma in­dus­try at all.

In his ap­peal, Shkre­li said the life­time ban vi­o­lat­ed his First Amend­ment right to free speech and his Fifth Amend­ment rights in forc­ing him to sell his shares in Phoenixus AG, the par­ent com­pa­ny of Vy­era Phar­ma­ceu­ti­cals. He went fur­ther, say­ing the ban as pre­vi­ous­ly writ­ten did not say whether or not he could take a job at an aca­d­e­m­ic in­sti­tu­tion work­ing with bio­phar­mas.

Judge Denise Cote of New York’s South­ern Dis­trict re­ject­ed those claims, writ­ing in no un­cer­tain terms that any state­ment Shkre­li makes about the phar­ma in­dus­try can be con­sid­ered an at­tempt to im­prop­er­ly in­flu­ence it, should a “rea­son­able per­son” deem it has that ef­fect.

“While First Amend­ment rights de­serve of great pro­tec­tion, Shkre­li’s vi­o­la­tions of the an­titrust laws have lost for him the right to speak pub­licly about the phar­ma­ceu­ti­cal in­dus­try when such speech is ut­tered to in­flu­ence the man­age­ment or busi­ness of a Phar­ma­ceu­ti­cal Com­pa­ny,” Cote wrote in her 10-page opin­ion.

Among the pro­vi­sions that were clar­i­fied: Shkre­li can­not speak with friends who work at a phar­ma com­pa­ny and can­not write blog posts com­ment­ing on the phar­ma in­dus­try.

Such re­stric­tions are no­table be­cause Shkre­li en­gaged in an­ti­com­pet­i­tive ac­tiv­i­ty while in prison, dis­cussing busi­ness de­ci­sions over a con­tra­band cell phone and the jail’s com­mu­ni­ca­tions sys­tems. He al­so ran a blog from prison.

Shkre­li must al­so still pay back the $64.6 mil­lion as or­dered in last month’s rul­ing.

Shkre­li first gained no­to­ri­ety in late 2015, when as CEO of then-Tur­ing Phar­ma­ceu­ti­cals, he raised the price of the an­tipar­a­sitic drug Dara­prim by more than 4,000% overnight. Af­ter lat­er be­ing con­vict­ed of de­fraud­ing Tur­ing in­vestors, sev­en state at­tor­neys gen­er­al brought a new case against him in 2020, al­leg­ing he worked from jail to keep Dara­prim gener­ics off the mar­ket.

Cote found Shkre­li’s ac­tions vi­o­lat­ed fed­er­al and state laws that pro­hib­it an­ti­com­pet­i­tive con­duct, say­ing Dara­prim com­pe­ti­tion was de­layed by at least 18 months. The $64.6 mil­lion Vy­era and Shkre­li must re­turn rep­re­sent the il­lic­it prof­its from this scheme.

Ad­di­tion­al­ly, in De­cem­ber, Vy­era and Phoenixus AG were or­dered to pay more than $40 mil­lion for block­ing gener­ic Dara­prim ac­cess. Vy­era was re­quired to make Dara­prim avail­able to any po­ten­tial gener­ic com­peti­tor at list price and to pro­vide pri­or no­ti­fi­ca­tion of any planned phar­ma­ceu­ti­cal trans­ac­tion val­ued at $25 mil­lion or more.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfizer CEO Albert Bourla told the BBC last December that he had “no doubt in my mind that the benefits, completely, are in favor” of vaccinating 5- to 11-year-olds for Covid-19. Almost a year later, those comments have reportedly landed him in trouble with a UK pharma watchdog.

Children’s advocacy group UsForThem filed a complaint with the UK’s Prescription Medicines Code of Practice Authority (PMCPA) last year accusing Bourla of making “disgracefully misleading” statements during the BBC interview, including one that “Covid in schools is thriving.” At the time, UK regulators had not yet cleared the vaccine for the 5 to 11 age group, though the vaccine did have a positive opinion from the EMA’s human medicines committee.