Janet Woodcock (AP Images)

Janet Wood­cock on if the FDA is get­ting tougher on drug re­views: ‘I don’t think so’

Fol­low­ing a re­cent string of set­backs for some drug de­vel­op­ers, act­ing FDA com­mis­sion­er Janet Wood­cock said Wednes­day that she does not think the FDA is get­ting more strin­gent in its re­views of new drugs even as the agency hosts a 3-day ad­vi­so­ry com­mit­tee next week to take a clos­er look at sev­er­al ac­cel­er­at­ed ap­provals.

“I don’t think so,” Wood­cock said when ques­tioned about the tougher stance at a we­bi­nar for the Al­liance for a Stronger FDA. “I think that what’s hap­pen­ing is that sci­ence is mov­ing in­to fields that typ­i­cal­ly haven’t seen ad­vances that we’re see­ing in oth­er ar­eas, and so I think there is some ad­just­ment that has to be made as peo­ple deal with that.”

She not­ed her ex­pe­ri­ence at the FDA dur­ing the HIV epi­dem­ic in the 1980s when the FDA took some chances ear­ly on with treat­ments.

“That kind of bold­ness is pred­i­cat­ed on the need be­ing so great that you can take those chances,” Wood­cock said. “I think peo­ple ask­ing these ques­tions should have more con­ver­sa­tions with [new­ly mint­ed CDER di­rec­tor] Pa­trizia Cavaz­zoni and [head of the FDA’s Of­fice of New Drugs] Pe­ter Stein.”

She al­so not­ed that CDER was try­ing to fin­ish a ma­jor re­or­ga­ni­za­tion just as the pan­dem­ic took off, and they haven’t been able to fin­ish that work and to ful­ly staff up.

“I wouldn’t read too much in­to the tea leaves over this, but it’s worth hav­ing more con­ver­sa­tions with the cen­ter,” she said.

The com­ments come as SVB Leerink an­a­lyst Ge­of­frey Porges re­cent­ly said in an in­vestor note that the FDA may be hard­en­ing its stance against the in­dus­try, par­tic­u­lar­ly with re­spect to safe­ty is­sues.

Mary Deni­gan-Macauley

“There is a per­cep­tion among in­vestors that the FDA has be­come more ac­tive and de­mand­ing un­der new act­ing com­mis­sion­er Janet Wood­cock,” Porges wrote. “If this is a sea change (rather than a co­in­ci­dence of tim­ing), then it seems sen­si­ble to as­sume that reg­u­la­to­ry ap­pli­ca­tions with any un­cer­tain­ties or ques­tions have a high­er-than-ex­pect­ed risk of be­ing de­layed and will be sub­ject to fur­ther in­for­ma­tion re­quests and ad­vi­so­ry com­mit­tee re­views.”

Wood­cock al­so made clear that the FDA’s in­spec­tion back­log of drug man­u­fac­tur­ing fa­cil­i­ties is a pri­or­i­ty. The pan­dem­ic has forced the FDA to for­go more than 1,000 of its planned fis­cal year 2020 in­spec­tions and the agency will like­ly face a back­log of fu­ture in­spec­tions for years to come, ac­cord­ing to Mary Deni­gan-Macauley, di­rec­tor of health care at the Gov­ern­ment Ac­count­abil­i­ty Of­fice.

“We have our own re­cov­er­ies to make on fa­cil­i­ty sur­veil­lance and in­spec­tions and things that we may not have got­ten to,” she said in ref­er­ence to a ques­tion on what the agency will fo­cus on fol­low­ing the pan­dem­ic.

The FDA on Wednes­day un­veiled new guid­ance on re­mote in­spec­tions, ex­plain­ing how they will be re­quest­ed by the FDA and con­duct­ed for the du­ra­tion of the Covid-19 pub­lic health emer­gency at any fa­cil­i­ty where phar­ma­ceu­ti­cal prod­ucts, in­clud­ing bi­o­log­ics, are man­u­fac­tured, processed, packed or held.

The FDA is al­so prep­ping to de­cide where to spend an ad­di­tion­al $500 mil­lion from Con­gress that came as part of Covid-re­lat­ed stim­u­lus funds.

She said a sig­nif­i­cant amount of those funds will be spent on sur­veil­lance in its pre­mar­ket work and that sur­veil­lance must be stepped up across the agency.

“We are al­so go­ing to in­vest in sup­ply chain. This pan­dem­ic made clear we don’t have enough vis­i­bil­i­ty in­to sup­ply chains, and much of this is IT-dri­ven,” Wood­cock said.

Oth­er ma­jor pro­grams at the agency this year in­clude tech and in­fra­struc­ture mod­ern­iza­tion projects, ini­tial­ly led by Amy Aber­nethy, who’s now de­part­ing the agency lat­er this month.

And as the next it­er­a­tion of PDU­FA ne­go­ti­a­tions has in­di­cat­ed, Wood­cock al­so not­ed, “Cell and gene ther­a­py is the most press­ing re­source need.” The push comes as INDs for new gene ther­a­pies have cat­a­pult­ed from just 32 in 2010 to 161 in 2019, and many more are ex­pect­ed in the com­ing years.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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