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.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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Elcin Barker Ergun, Menarini Group CEO

Amid Roche and Sanofi's oral SERD set­backs, Menar­i­ni gets speedy re­view at FDA

Menarini and Radius Health are getting a speedy review at the FDA for their oral SERD breast cancer drug months after the field opened up with competitors failing and fleeing.

It was a one-two-three punch in March, April and May as Sanofi flunked its first big test for its oral selective estrogen receptor degrader (SERD), Roche also flamed out in a Phase II and G1 Therapeutics ended its program after scoping out the data and potential partners.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.