FDA re­view­ers head back to White Oak in 2023, with lead­er­ship look­ing to ap­pease a new Con­gress

Re­pub­li­cans have tak­en a stand against the pan­dem­ic era habit of lax work-from-home sched­ules. Now that they’ve wres­tled con­trol of the House ma­jor­i­ty, the FDA’s lead­er­ship is play­ing ball, send­ing many of the agency’s more than 18,000 em­ploy­ees back to their desks ear­ly next year.

Whether this ex­o­dus back to White Oak in Sil­ver Spring, MD (many staff will still be al­lowed to work from home for mul­ti­ple days per week) will mean more de­fec­tions to in­dus­try and else­where re­mains to be seen.

The FDA told End­points News in a state­ment:

Our re­cent an­nounce­ment about the im­ple­men­ta­tion of our hy­brid work­place mod­el has been pred­i­cat­ed on the fact that our re­view and pol­i­cy work is de­pen­dent on ef­fec­tive in­ter­ac­tions with­in large mul­ti-dis­ci­pli­nary teams and di­rect en­gage­ment with our many ex­ter­nal stake­hold­ers. With­in CDER, col­lab­o­ra­tion across mul­ti-dis­ci­pli­nary teams, func­tions, and or­ga­ni­za­tions is a crit­i­cal com­po­nent of our suc­cess and an im­por­tant el­e­ment of the sci­ence-based de­ci­sion mak­ing that has led to our hard-won rep­u­ta­tion as the gold stan­dard in drug re­view and pub­lic health. Ad­di­tion­al­ly, our en­gage­ment with reg­u­lat­ed in­dus­try, ad­vo­ca­cy groups, and oth­er ex­ter­nal stake­hold­ers re­mains a foun­da­tion­al as­pect of our pub­lic health mis­sion.

The FDA has not said when it might re­turn to in-per­son in­dus­try-FDA meet­ings yet, but this hy­brid ap­proach comes as the FDA’s top can­cer chief Richard Paz­dur re­cent­ly re­ferred to White Oak as “de­sert­ed,” not­ing that “there are more se­cu­ri­ty guards than em­ploy­ees.” But he al­so made clear that it doesn’t make sense to re­quire every­one to re­turn to an in-per­son of­fice.

Paz­dur’s com­ments fol­lowed FDA com­mis­sion­er Rob Califf’s ques­tions on the emp­ty space as rou­tine staff mi­grat­ed away from White Oak and haven’t been re­quired to re­turn since the pan­dem­ic be­gan. But that’s end­ing in Jan­u­ary 2023.

Prin­ci­pal deputy com­mis­sion­er Janet Wood­cock told End­points via email:

We ran a de­fined-time pi­lot that was spec­i­fied ahead of time, and col­lect­ed da­ta and sur­veys dur­ing that time about what worked and staff ex­pe­ri­ence. We al­so heard from stake­hold­ers. At the end of the pi­lot, we made an as­sess­ment of the da­ta and ex­pe­ri­ence and agreed on a way for­ward. We will as­sess how the hy­brid en­vi­ron­ment is work­ing on an on­go­ing ba­sis, us­ing a va­ri­ety of view­points and pa­ra­me­ters.

So will every­one who pre­vi­ous­ly worked at White Oak have to re­turn to White Oak in some ca­pac­i­ty? Prob­a­bly, one in­sid­er told End­points, “de­pend­ing what cen­ter you work for.”

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

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.