Bio­gen pays $900M to set­tle wide-rang­ing physi­cian kick­back claims

Look­ing to clear the deck ahead of its long-await­ed lecanemab da­ta re­lease, Bio­gen agreed to pay the US gov­ern­ment and states a whop­ping $900 mil­lion to set­tle sev­en-year-old al­le­ga­tions that it sub­mit­ted false claims to Medicare and Med­ic­aid by pay­ing kick­backs to physi­cians to in­duce them to pre­scribe Bio­gen drugs.

Michael Baw­duni­ak

The set­tle­ment, which is on the high­er end of these DOJ-re­lat­ed res­o­lu­tions that have be­come com­mon in the phar­ma in­dus­try, re­solves a law­suit filed by for­mer Bio­gen em­ploy­ee (now a di­rec­tor at Gen­zyme) Michael Baw­duni­ak, who will take home al­most $250 mil­lion as part of the deal.

Baw­duni­ak al­leged that for more than five years from 2009 through March 2014, Bio­gen paid speak­er hon­o­raria, train­ing fees, con­sult­ing fees and meals, to health care pro­fes­sion­als at­tend­ing Bio­gen’s speak­er pro­grams, speak­er train­ing meet­ings or con­sul­tant pro­grams to in­duce them to pre­scribe Avonex, Tysabri and Tec­fidera, which ac­cord­ing to the DOJ is in vi­o­la­tion of the An­ti-Kick­back Statute.

The set­tle­ment comes at a cru­cial cross­roads for a com­pa­ny ready to re­lease da­ta on its next top Alzheimer’s prospect, lecanemab, while look­ing to make nice with a fed­er­al gov­ern­ment that has sev­er­al open in­ves­ti­ga­tions (SEC, FTC, OIG, etc.) in­to its con­duct around the ap­proval of its first Alzheimer’s drug, Aduhelm. Adding to the pres­sure for these types of kick­back cam­paigns is Aduhelm’s com­mer­cial flop and grow­ing gener­ic com­pe­ti­tion for its MS drug fran­chise.

Al­most ex­act­ly one year ago, Bio­gen al­so paid an­oth­er $22 mil­lion to set­tle al­le­ga­tions that it con­coct­ed a scheme to lure pa­tients in­to tak­ing these MS drugs by spon­sor­ing their Medicare co­pays.

And to the ques­tion of whether or not these kick­back schemes and the sub­se­quent set­tle­ments are just part of the cost of do­ing busi­ness at this point, Bio­gen’s $900 mil­lion set­tle­ment with DOJ com­pares with a $678 mil­lion set­tle­ment with No­var­tis in 2020, $122 mil­lion for Jazz Phar­ma, Lund­beck and Alex­ion in 2019, $40 mil­lion set­tle­ment for Bay­er this year, and Pur­due Phar­ma’s $2.8 bil­lion set­tle­ment in 2021.

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

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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.