President Biden delivers a speech on the Cancer Moonshot initiative at the John F. Kennedy Presidential Library and Museum, Monday, Sept. 12 (Evan Vucci/AP Images)

Moon­shot re­fresh: Biden calls to cut can­cer death rate by at least 50% in 25 years

Pres­i­dent Joe Biden has long been an al­ly for the fight against can­cer, hav­ing lost his son Beau to an ag­gres­sive brain can­cer in 2015, af­ter which he launched the first Can­cer Moon­shot pro­gram in 2016 as VP.

On Mon­day, Biden looked to hit the re­set but­ton on the moon­shot pro­gram, an­nounc­ing a new goal to cut can­cer in the same way that for­mer Pres­i­dent John F. Kennedy pur­sued the moon, Biden said at the John F. Kennedy Pres­i­den­tial Li­brary and Mu­se­um in Boston.

Biden’s speech came ex­act­ly 60 years to the day af­ter Kennedy spoke at Rice Uni­ver­si­ty about send­ing the US to the moon, ex­plain­ing that as a na­tion in 1962,

We choose to go to the moon in this decade and do the oth­er things not be­cause they are easy, but be­cause they are hard. Be­cause that goal will serve to or­ga­nize and mea­sure the best of our en­er­gies and skills, be­cause that chal­lenge is one that we’re will­ing to ac­cept. One we are un­will­ing to post­pone.

Biden, mean­while, called for Amer­i­cans to work to­geth­er to cut the can­cer death rate.

“The goal is to cut can­cer death rates by at least 50 per­cent — at least 50 per­cent — in the next 25 years,” Biden said. “I’m call­ing on the pri­vate sec­tor to de­vel­op and test new treat­ments, make drugs more af­ford­able, share more da­ta and knowl­edge that can in­form the pub­lic and ben­e­fit every com­pa­ny’s re­search. And I’m re­spect­ful­ly call­ing on peo­ple liv­ing with can­cer, and care­givers and fam­i­lies, to keep shar­ing their ex­pe­ri­ence and push­ing for progress.”

The speech came amid a busy day of sci­ence and biotech-fo­cused an­nounce­ments for the Biden ad­min­is­tra­tion: from new plans that were hatched to fur­ther grow do­mes­tic bio­man­u­fac­tur­ing with new train­ing and ed­u­ca­tion­al pro­grams, to an ex­ec­u­tive or­der that will ig­nite a new ge­nom­ic da­ta ini­tia­tive and look in­to reg­u­la­to­ry re­forms, to re­veal­ing his ap­point­ment of Re­nee We­grzyn, VP of busi­ness de­vel­op­ment at Gink­go Bioworks, as the first di­rec­tor of the Ad­vanced Re­search Pro­jects Agency for Health (ARPA-H), which aims to en­gage in riski­er bio­phar­ma R&D.

To­mor­row, the White House will host a sum­mit on its Na­tion­al Biotech­nol­o­gy and Bio­man­u­fac­tur­ing Ini­tia­tive dur­ing which cab­i­net agen­cies will an­nounce a wide range of new in­vest­ments and re­sources that will al­low the Unit­ed States to har­ness the full po­ten­tial of biotech­nol­o­gy and bio­man­u­fac­tur­ing and ad­vance the Pres­i­dent’s Ex­ec­u­tive Or­der.

The EO al­so called on FDA and oth­er fed­er­al agen­cies to de­ter­mine what might be re­formed, call­ing for new “process­es and time­lines to im­ple­ment reg­u­la­to­ry re­form, in­clud­ing iden­ti­fi­ca­tion of the reg­u­la­tions and guid­ance doc­u­ments that can be up­dat­ed, stream­lined, or clar­i­fied; and iden­ti­fi­ca­tion of po­ten­tial new guid­ance or reg­u­la­tions.”

Each year, the FDA com­mis­sion­er will be tasked with iden­ti­fy­ing “any gaps in statu­to­ry au­thor­i­ty that should be ad­dressed to im­prove the clar­i­ty and ef­fi­cien­cy of the reg­u­la­to­ry process for biotech­nol­o­gy prod­ucts, and shall rec­om­mend ad­di­tion­al ex­ec­u­tive ac­tions and leg­isla­tive pro­pos­als to achieve such goals,” the EO text adds.

And this now-re­vi­tal­ized Can­cer Moon­shot was in­fused re­cent­ly with a CDC check to the tune of $215 mil­lion as part of a 5-year, $1.1 bil­lion grant to fund the first year of three na­tion­al pro­grams es­tab­lished in the 1990s to im­prove can­cer pre­ven­tion, de­tec­tion, di­ag­no­sis and con­trol.

“With progress over the last 25 years, the death rate from can­cer has fall­en more than 25 per­cent,” Biden said Mon­day. “But de­spite the progress of lives ex­tend­ed, lives saved, can­cer is still the num­ber two cause of death in Amer­i­ca, sec­ond on­ly to heart dis­ease.”

Biden al­so pre­vi­ous­ly ap­point­ed three doc­tors to serve three-year terms on his Can­cer Cab­i­net: chair Eliz­a­beth Jaf­fee, a deputy di­rec­tor at Johns Hop­kins’ can­cer cen­ter and a pre­vi­ous AACR pres­i­dent; Mitchel Berg­er, di­rec­tor of UCSF’s Brain Tu­mor Cen­ter; and Car­ol Brown, an on­col­o­gist, SVP and chief health eq­ui­ty of­fi­cer at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter.

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.