Mark Cuban (Jed Jacobsohn/AP Images)

Mov­ing to the em­ploy­er side of health­care, Mark Cuban's Cost Plus Drugs part­ners with a PBM

From “Shark Tank” to di­rect-to-con­sumer gener­ic drugs, Mark Cuban has made an­oth­er in­road in the on­go­ing bat­tle over pre­scrip­tion drug prices. His cost-plus-15% gener­ic drug com­pa­ny, fre­quent­ly un­der­cut­ting many com­peti­tors, now has its sights set on the em­ploy­er health­care mar­ket.

Cost Plus Drugs, which orig­i­nal­ly pledged to cut out PBMs, has now part­nered with the PBM Em­sa­naRx, ma­jor­i­ty owned by the Pur­chas­er Busi­ness Group on Health, to launch a sup­ple­men­tal drug dis­count pro­gram de­signed specif­i­cal­ly for self-fund­ed em­ploy­ers, the com­pa­ny an­nounced Thurs­day.

The pro­gram will pro­vide drug dis­counts with­out re­quir­ing em­ploy­ees to go out­side of their health­care plans, and it will co­or­di­nate with providers on be­half of em­ploy­ees to trans­fer their med­ica­tions to the low­er-cost op­tion.

“In part­ner­ing with Cost Plus Drugs, we will help em­ploy­ers un­der­stand where high-cost drugs are a prob­lem in their cur­rent ben­e­fit de­sign and give them and their em­ploy­ees ac­cess to low­er-cost al­ter­na­tives,” Es­ma­n­aRx CEO Greg Bak­er said in a state­ment.

The part­ner­ship marks Cost Plus Drugs’ tran­si­tion from op­er­at­ing on­ly in the di­rect-to-con­sumer mar­ket. The shift to the em­ploy­er health­care mar­ket, which pro­vides health ben­e­fits for near­ly half of all Amer­i­cans, could be a key new rev­enue stream.

“At launch, we are plan­ning as func­tion­ing pri­mar­i­ly as a 503(b) com­pound­ing phar­ma­cy specif­i­cal­ly tar­get­ing drugs on the FDA short­age list,” CEO Alex Osh­myan­sky pre­vi­ous­ly told End­points News via email. “That will al­low us to be more ag­ile and ad­dress drug short­ages as they arise.”

It’s a shift for the bil­lion­aire in­vestor’s com­pa­ny, which be­gan in 2021 as a way to of­fer cheap drugs di­rect­ly to con­sumers.

In ad­di­tion to the Cuban-backed Dal­las man­u­fac­tur­ing plant, which Osh­myan­sky said in Jan­u­ary was “about half-way fin­ished with con­struc­tion,” Cuban is al­so plan­ning to run his own PBM, as well as a cash-on­ly phar­ma­cy, where con­sumers can buy more of these cost-plus-15% drugs li­censed via the on­line phar­ma­cy Truepill.

Cuban said his com­pa­ny is com­mit­ted to trans­paren­cy by of­fer­ing gener­ic drugs with a fixed 15% prof­it af­ter dis­clos­ing all costs from the man­u­fac­tur­ing, whole­sale dis­tri­b­u­tion and on­line phar­ma­cy ser­vices for the prod­ucts.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.