How much? Pfiz­er leads top phar­ma com­pa­nies' ramped up lob­by spend­ing on Con­gress

K Street saw an­oth­er record year in 2021 for lob­by­ing ex­pen­di­tures, and some of the biggest bio­phar­ma com­pa­nies in the world shelled out mil­lions to sway Con­gress, re­veal­ing some of their key pri­or­i­ties along the way.

Pfiz­er topped the list of the largest phar­ma com­pa­nies in the lat­est quar­ter, spend­ing near­ly $3 mil­lion on lob­by­ing in Q4, which is about half a mil­lion more than they spent in the same quar­ter a year ear­li­er, but not quite as high as its Q1 2020 lev­el of more than $4 mil­lion. In 2021, Pfiz­er spent more than $10.3 mil­lion, about half a mil­lion less than in 2020.

Pfiz­er’s Covid-19 vac­cine com­peti­tor As­traZeneca and phar­ma heavy­weight No­var­tis spent about $1.5 mil­lion each in the lat­est quar­ter on lob­by­ing, which was al­so al­most dou­ble the amount each spent dur­ing the same pe­ri­od the pre­vi­ous year.

No­var­tis list­ed the pro­posed new NIH agency, to be known as the Ad­vanced Re­search Pro­jects Agency for Health (ARPA-H) as a fo­cal point, as well as biosim­i­lars, PDU­FA VII pri­or­i­ties and Cures 2.0.

Ab­b­Vie spent near­ly $1.3 mil­lion in the fourth quar­ter, end­ing the year spend­ing about $1 mil­lion more in 2021 com­pared to 2020. It list­ed sev­er­al in­di­vid­ual bills as “spe­cif­ic lob­by­ing is­sues,” in­clud­ing the Pre­serv­ing Ac­cess to Af­ford­able Gener­ics and Biosim­i­lars Act, which would lim­it “pay-for-de­lay” deals that pre­vent or de­lay gener­ics, and an­oth­er bill that went af­ter prod­uct hop­ping.

GSK al­so spent more than $1 mil­lion more on lob­by­ing in 2021 ver­sus 2020.

Nan­cy Pelosi

Along with the in­di­vid­ual com­pa­nies, in­dus­try groups PhRMA and BIO al­so lob­bied more heav­i­ly to cap­ture Capi­tol Hill at­ten­tion. PhRMA shelled out $7.2 mil­lion in the quar­ter, which was con­sid­er­ably more than the $5.1 mil­lion spent in Q4 2020, and BIO spent an­oth­er $3.4 mil­lion, which was on par with past months.

Joe Manchin

As ex­pect­ed, House Speak­er Nan­cy Pelosi’s HR 3 was fea­tured atop the list of lob­by­ing is­sues cit­ed among the com­pa­nies, as the bill would have in­tro­duced price ne­go­ti­a­tions in ways that could have cost in­dus­try hun­dreds of bil­lions of dol­lars over sev­er­al decades. The more wa­tered-down ver­sion of those ne­go­ti­a­tions, which was in­clud­ed in the re­cent­ly nixed (by Sen. Joe Manchin of West Vir­ginia, who has said he does back ne­go­ti­a­tions) Build Back Bet­ter Act, which was al­so list­ed as a pri­or­i­ty by just about every com­pa­ny.

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

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

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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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.

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.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Sen. Elizabeth Warren (D-MA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

Sen. Eliz­a­beth War­ren urges FTC to 'scru­ti­nize' two phar­ma buy­outs

Sen. Elizabeth Warren (D-MA) is calling on senior Federal Trade Commission officials to “closely scrutinize” two proposed pharma mergers.

Warren expressed concern over “rampant consolidation in the pharmaceutical industry,” in particular Amgen’s $28 billion plans to take over Horizon Therapeutics, and Indivior’s proposed acquisition of Opiant for $145 million upfront, in a letter to FTC Chair Lina Khan and Commissioners Alvaro Bedoya and Rebecca Kelly Slaughter earlier this week.