Pfiz­er wants to help the FDA with its new, court-man­dat­ed $4-5M FOIA re­lease on the com­pa­ny's Covid-19 vac­cine da­ta

An FDA court loss ear­li­er this month has put the agency’s Free­dom of In­for­ma­tion Act of­fice on its heels, as it now has to dump $4 mil­lion to $5 mil­lion in­to hir­ing 15 con­trac­tors to com­plete a his­tor­i­cal­ly swift an­ti-vac­cine FOIA re­quest that won a court-man­dat­ed re­lease of 55,000 pages of da­ta per month on Pfiz­er’s Covid-19 vac­cine.

What’s more, Pfiz­er told the court this week that it’s ready to in­ter­vene to help the agency redact those pages.

While stress­ing that it sup­ports the pub­lic dis­clo­sure of “the vast ma­jor­i­ty of this in­for­ma­tion to pro­mote trans­paren­cy and the pub­lic’s con­fi­dence in the vac­cine,” Pfiz­er told the Texas dis­trict court that it on­ly seeks to in­ter­vene in the case to en­sure “in­for­ma­tion that is ex­empt from dis­clo­sure un­der FOIA is not dis­closed in­ap­pro­pri­ate­ly.”

This comes as the FDA, mean­while, re­al­ized it doesn’t have the staff to meet the needs of this mas­sive FOIA re­quest, and has had to pull over staffers from CBER while call­ing on the court to amend its time­line so it can bring on about two dozen em­ploy­ees and con­trac­tors to deal with this sit­u­a­tion.

While trans­paren­cy is sup­pos­ed­ly at the heart of this law­suit, a clos­er look re­veals it’s an­oth­er ploy to drum up in­ac­cu­rate an­ti-vac­cine re­sent­ment. Pfiz­er notes in its brief the ex­tent of the da­ta that has al­ready been made pub­lic around the safe­ty and ef­fi­ca­cy of its vac­cine by the CDC, FDA and pub­lished in jour­nals.

An­ti-vax lawyer Aaron Siri, who rep­re­sents the plain­tiffs in the case, called on the court to re­ject the FDA’s ask to slow the sched­ule for re­leas­ing the doc­u­ments, claim­ing that FDA’s staffers could read more than five pages per hour and call­ing the $4-$5 mil­lion fig­ure “an ab­surd over­es­ti­mate.”

The Jan. 6 court or­der re­quired that FDA dis­close more than 12,000 pages of in­for­ma­tion by the end of this month, and then 55,000 pages every 30 days, in­clud­ing the pro­duc­tion of redact­ed ver­sions of any doc­u­ments for which FDA claims a priv­i­lege, ex­emp­tion or ex­clu­sion.

“FDA re­spect­ful­ly re­quests that the Jan­u­ary 6 Or­der be mod­i­fied to pro­vide that — for on­ly the first two 30-day pe­ri­ods fol­low­ing FDA’s sched­uled Jan­u­ary 31, 2022 pro­duc­tion — FDA’s month­ly quo­ta be ad­just­ed to 10,000 pages per month,” the agency wrote on Jan. 18. “FDA would use this pe­ri­od to ‘stand up’ the ex­tra­or­di­nary re­sources that will be re­quired to bring full com­pli­ance with the Or­der with­in the realm of pos­si­bil­i­ty — while still pro­cess­ing records at a rate on par with the most ex­treme pro­cess­ing rates that Plain­tiff cit­ed in its brief­ing.”

FDA al­so said that it shares Pfiz­er’s view that “in the un­usu­al and in­deed ex­tra­or­di­nary cir­cum­stances here pre­sent­ed, Pfiz­er’s in­ter­ven­tion would fa­cil­i­tate an or­der­ly res­o­lu­tion of this mat­ter, and con­sents to Pfiz­er’s in­ter­ven­tion.”

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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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.

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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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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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.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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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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