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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Sekar Kathiresan, Verve Therapeutics CEO

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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