FDA paus­es do­mes­tic drug in­spec­tions again, this time to pro­tect against Omi­cron

The FDA qui­et­ly an­nounced on Tues­day that just be­fore New Year’s eve, the agency again paused all of its non-mis­sion-crit­i­cal in­spec­tions in the US, like­ly lead­ing to an even larg­er back­log of in­spec­tions world­wide.

The pause, which will last at least two weeks, is meant to en­sure the safe­ty of FDA em­ploy­ees and the com­pa­nies it reg­u­lates as the agency fur­ther adapts to the spread of Omi­cron.

“Through Jan.19, the agency in­tends to con­tin­ue mis­sion-crit­i­cal work but has tem­porar­i­ly post­poned cer­tain in­spec­tion­al ac­tiv­i­ties with the hopes of restart­ing these ac­tiv­i­ties as soon as pos­si­ble,” the FDA said in a state­ment.

The agency had on­ly just re­turned to rel­a­tive­ly nor­mal do­mes­tic in­spec­tions last Ju­ly, af­ter a long pre­vi­ous pause that be­gan as the pan­dem­ic hit in ear­ly 2020. In a re­port from last No­vem­ber, the agency not­ed that 52 new drug ap­pli­ca­tions were de­layed as a re­sult of the in­spec­tion back­log cre­at­ed by that long pause.

On the for­eign in­spec­tion side, where ac­tiv­i­ties have still been most­ly on pause since ear­ly 2020, FDA said it’s post­pon­ing the plan­ning of pri­or­i­tized sur­veil­lance for­eign in­spec­tion as­sign­ments that were sched­uled to be­gin in Feb­ru­ary 2022.

But the FDA said it will con­tin­ue con­duct­ing mis­sion-crit­i­cal for­eign and do­mes­tic in­spec­tions.

Be­tween April and Sep­tem­ber 2021, the FDA said it com­plet­ed just 37 for­eign drug in­spec­tions, which com­pares with more than 1,200 in 2019.

And the FDA’s to­tal tal­ly for drug and bi­o­log­ic in­spec­tions in 2020 shows how the agency con­duct­ed 1,500 few­er in­spec­tions in 2020, when com­pared to 2019 (and over 2,600 few­er when com­pared to 2011). On­ly 74 in­spec­tions end­ed with an Of­fi­cial Ac­tion In­di­cat­ed in 2020, which com­pared with 202 OAIs in 2019.

The agency has sought to shift to more re­mote as­sess­ments of fa­cil­i­ties, but that hasn’t proven to be a ma­jor help as the back­log is filled most­ly with sur­veil­lance in­spec­tions, and the le­gal de­f­i­n­i­tion of an in­spec­tion is one that is con­duct­ed on site.

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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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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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.

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.

Post-hoc analy­sis: EMA's CHMP re­jects Ipsen's po­ten­tial drug for rare ge­net­ic dis­ease

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday rejected Ipsen Pharma’s potential treatment for a rare genetic disease known as fibrodysplasia ossificans progressiva (FOP), which causes extra bone to form outside the skeleton.

The EMA said on its website that it could not draw any firm conclusions on the benefits of the French biopharma’s Sohonos (palovarotene), which selectively targets the retinoic-acid receptor gamma (RARγ), “as the applicant’s conclusion was based on a post-hoc analysis which was neither scientifically nor clinically justified and pre-specified study objectives were not met.”

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.