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%.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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One work­er at a Lat­vian man­u­fac­tur­er is dead af­ter a fire breaks out at fa­cil­i­ty

A press release referred to it as simply, “the incident.” But a fire at an Olainfarm site in Latvia last week has left one person dead, and injured another, the company announced Monday.

Just before midnight Nov. 26, a fire broke out in the production building of JSC Olainfarm,  as the result of an “accident,” a company spokesperson said in an email to Endpoints News. The two victims were both company employees, and the causes of the accident are still being determined.

Fu­ji­film Diosynth dumps an­oth­er $454M in­to its sup­ply chain, this time at a fa­cil­i­ty in the UK

Fujifilm Diosynth Biotechnologies is in the middle of a monumental point in the company’s 10-year history, and the CDMO is about to grow even more, as it sets out to be the “beating heart” of the UK’s North East Life Sciences ecosystem.

A site in Billingham, Teeside, UK will receive a $453.72 million investment package from the manufacturer to double the existing footprint and create the largest multi-modal biopharmaceutical manufacturing site in the UK, bringing another 350 jobs to the region by late 2023.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.