Mallinck­rodt be­comes the lat­est vic­tim of the FDA's pan­dem­ic-re­lat­ed de­lays as it push­es off ap­pli­ca­tion for skin graft

With Covid-19 lock­ing down trav­el across the world, not even drug safe­ty reg­u­la­tors have been spared from cost­ly de­lays. For the FDA, whose in­spec­tion sched­ule keeps the trains on time for new mar­ket­ing ap­provals, those de­lays are con­tin­u­ing to prove cost­ly.

The FDA has pushed re­view of Mallinck­rodt’s al­lo­gene­ic skin graft for burns, dubbed Strat­a­Graft, af­ter the agency ad­mit­ted it wasn’t able to con­duct a plant in­spec­tion in the need­ed time­frame for a de­ci­sion, the drug­mak­er said last week.

Steven Ro­mano

Mallinck­rodt tied the de­lay to “Covid-19 trav­el re­stric­tions” and said it had no hang-ups about its graft’s chances at an ap­proval.

“We are con­fi­dent in the ef­fi­ca­cy and safe­ty of Strat­a­Graft for the treat­ment of deep par­tial-thick­ness burns based on our piv­otal Phase 3 clin­i­cal tri­al re­sults,” CSO Steven Ro­mano said in a re­lease. “We plan to work close­ly with the FDA to com­plete the re­view and sched­ule its site in­spec­tion.”

With the pan­dem­ic con­tin­u­ing to rage, the FDA has been forced to pri­or­i­tize planned in­spec­tions for new drug ap­pli­ca­tions. Of­ten, that sys­tem has fa­vored drug­mak­ers with new mol­e­cules with a high clin­i­cal need and shoved to the side low­er-im­por­tance prod­ucts, par­tic­u­lar­ly in aes­thet­ics.

In late No­vem­ber, the FDA de­layed its re­view of Re­vance’s frown-line in­jec­tion dax­i­bot­u­linum­tox­i­nA, say­ing it didn’t have enough time to look over its Newark, Cal­i­for­nia, man­u­fac­tur­ing fa­cil­i­ty on time. In Oc­to­ber, the agency pushed back Spec­trum’s neu­trope­nia can­di­date Rolon­tis af­ter of­fi­cials twice de­layed a plant in­spec­tion of South Ko­rea’s Han­mi, which holds the drug’s li­cense.

Mean­while, in­spec­tion de­lays have al­so nixed time­ly ap­provals for big­ger-name prod­ucts as well. The FDA re­peat­ed­ly de­layed a site in­spec­tion for Bris­tol My­ers Squibb’s liso-cel, even­tu­al­ly con­duct­ing a site vis­it at Lon­za Hous­ton’s con­tract site in De­cem­ber that re­sult­ed in a Form 483. That de­lay pushed liso-cel’s ap­proval past the Dec. 31 cut­off point tied to a $9 CVR in­vestors held from Bris­tol’s ac­qui­si­tion of Cel­gene.

Lon­za af­ter the fact said the FDA’s de­lays didn’t give ei­ther com­pa­ny enough time to ad­dress any par­tic­u­lar man­u­fac­tur­ing is­sues, which are quite com­mon for CAR-Ts on the whole. Liso-cel was even­tu­al­ly ap­proved ear­li­er this month and will be mar­ket­ed as Breyanzi.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, just two weeks after submitting a supplemental BLA. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Anna Protopapas, Mersana CEO

In $1.36B biobuck deal with GSK, Mer­sana touts 'biggest pre­clin­i­cal ADC deal ever'

Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.

Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

David Reese, Amgen R&D chief

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Sen­ate Dems cling to a sim­ple ma­jor­i­ty to pass some of the biggest drug pric­ing re­forms ever

The Pharmaceutical Research and Manufacturers of America — and their fleet of drug industry lobbyists on Capitol Hill — are known for never losing.

Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

But for perhaps the largest drug pricing reforms ever enacted, after more than a decade of Congress trying and failing to allow Medicare to negotiate prescription drug prices, those same lobbyists and their biopharma clients were dealt a stunning blow on Sunday afternoon.

GSK and IQVIA launch plat­form of US vac­ci­na­tion da­ta, show­ing drop in adult rates

Throughout the Covid-19 pandemic, the issue of vaccine uptake has been a point of contention, but a new platform from GSK and IQVIA is hoping to shed more light on vaccine data, via new transparency and general awareness.

The two companies have launched Vaccine Track, a platform intended to be used by public health officials, medical professionals and others to strengthen data transparency and display vaccination trends. According to the companies, the platform is intended to aid in increasing vaccine rates and will provide data on trends to assist public health efforts.

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