New drug ap­pli­ca­tions pile up with de­lays as there's no easy fix for the in­spec­tion back­log

The FDA’s back­log of drug man­u­fac­tur­ing fa­cil­i­ty in­spec­tions con­tin­ues to be a sore spot for the agency, as FDA said Mon­day that a to­tal of 52 new drug (but no bi­o­log­ics) ap­pli­ca­tions still re­main de­layed due to the back­log from the pan­dem­ic.

And while the agency has main­tained that it won’t is­sue a CRL for a de­layed in­spec­tion, the num­ber of de­layed ap­pli­ca­tions is ris­ing as FDA said in May that 48 new drug ap­pli­ca­tions have been de­layed due to FDA’s in­abil­i­ty to con­duct pre-ap­proval, pre-mar­ket, or pre-li­cense in­spec­tions as of last March.

The agency’s in­abil­i­ty to work over­seas has al­so hurt its out­put well in­to 2021, with just 37 for­eign drug in­spec­tions be­tween April and Sep­tem­ber 2021. Pri­or to the pan­dem­ic, the FDA typ­i­cal­ly con­duct­ed about 1,000 for­eign drug in­spec­tions per year.

“FDA be­gan the new fis­cal year with on­go­ing trav­el re­stric­tions and oth­er un­cer­tain­ties con­tin­u­ing to im­pact over­sight op­er­a­tions. FDA is con­tin­u­ing to com­plete mis­sion-crit­i­cal work, pri­or­i­tize oth­er high­er-tiered in­spec­tion­al needs (e.g., for-cause in­spec­tions), and car­ry out sur­veil­lance in­spec­tions us­ing risk-based ap­proach­es for eval­u­at­ing pub­lic health im­pact,” FDA said in its new re­port.

The agency has sought to shift to more re­mote as­sess­ments of fa­cil­i­ties, but the le­gal de­f­i­n­i­tion of an in­spec­tion is one that is con­duct­ed on site.

“As we have done through­out the pan­dem­ic, FDA will use every op­tion avail­able to meet our reg­u­la­to­ry re­spon­si­bil­i­ties and pro­tect the pub­lic health, in­clud­ing con­tin­ued col­lab­o­ra­tion with state, lo­cal, trib­al, ter­ri­to­r­i­al, and for­eign reg­u­la­to­ry part­ners,” the agency added.

De­spite the back­log, there were a few bright spots in the re­port too.

In ear­ly 2021, the FDA es­ti­mat­ed that more than 15,000 sur­veil­lance in­spec­tions through­out the US had been post­poned thanks to the Covid-19 pan­dem­ic. The agency pre­dict­ed that it would com­plete 14% of those in­spec­tions, in­clud­ing 26% of the re­main­ing hu­man and an­i­mal med­ical do­mes­tic sur­veil­lance in­spec­tions. The agency ex­ceed­ed that num­ber two-fold, it re­port­ed, a com­ple­tion rat­ing of 134%.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Up­dat­ed: US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Paul Chaplin, Bavarian Nordic CEO

Bavar­i­an Nordic nets ma­jor vac­cine con­tract to re­spond to mon­key­pox out­break

The current monkeypox outbreak is now at a phase where some governments are approaching a point of concern, at least enough to start stockpiling vaccines.

In response, at least one government is placing its order with vaccine manufacturer Bavarian Nordic to secure sufficient supply for vaccinating individuals. According to the company, it has inked a supply contract with an undisclosed country for the company’s smallpox vaccine, called Jynneos. The aim is to ensure there will be enough supply to meet the undisclosed country’s requirements for vaccinating individuals at risk for monkeypox in the short to medium term. The vaccine is approved for use against monkeypox by the FDA and Health Canada.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.