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%.
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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.
Joan Perelló, Sanifit CEO
Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.
Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.
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In an effort to up its development of microbial-derived proteins, Swiss CDMO Lonza will invest in its manufacturing capacities in its home country.
The extension will be good to go by the end of this year, the company said. The expanded development will strengthen the upstream, downstream and process analytics support for new projects. The microbial footprint at its Visp site will be consolidated, and new high-throughput equipment and automation processes will be added to increase efficiency and project delivery. That will include three liquid handling workstations, and the upgrades will help improve data generation.
Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)
As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.
GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.
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Michael Engsig, Nykode CEO
Vaccibody who? A little over a year after securing a $700 million-plus deal with Roche for its neoantigen cancer vaccine, the Norwegian biotech has attracted yet another Big Pharma partner with deep pockets — and with it, a new name and facelift.
Regeneron is betting nearly $1 billion on five new vaccine programs from Vaccibody, now called Nykode Therapeutics. The deal will double Nykode’s current pipeline, adding three programs in cancer and two in infectious disease.
AstraZeneca’s Cambridge R&D center
One of the biggest projects that Pascal Soriot initiated, all the way back in 2013, after he first took over as AstraZeneca’s CEO is finally complete.
AstraZeneca is formally unveiling its $1.34 billion (£1 billion) R&D campus in Cambridge, UK, a shiny new facility spanning 19,000 square meters in the southern part of the city. On top of 2,200 research scientists, it will also host a suite of robotics, high-throughput screening and AI-driven technology.
Stephen Hahn and Donald Trump, AP Images
The House Select Subcommittee on the Coronavirus Crisis on Monday questioned former FDA commissioner Stephen Hahn on whether he acquiesced to political pressure in authorizing the use of hydroxychloroquine and convalescent plasma early in the pandemic, despite limited evidence of their effectiveness.
Hahn publicly disavowed any political interference in any of his agency’s EUA decisions, but behind the scenes, the pressure clearly caught up with him.
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Most people know if they’re ‘Team Pfizer’ or ‘Team Moderna,’ but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.
And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novovax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as ‘Covid-19 Vaccine Janssen.’
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Ronald Lorijn, NeuExcell CEO
Pennsylvania’s already well-established biotech scene got word of a boost last week with several announcements, including the building of a massive life sciences manufacturing center in Pittsburgh thanks to some funding from an area nonprofit and a local university. But those jawns in Philadelphia aren’t letting go of its stranglehold on the state easily.
NeuExcell Therapeutics, a preclinical gene therapy biotech that focuses on neurodegenerative diseases, announced that it signed a deal with The Discovery Labs in King of Prussia, about 25 miles northwest of downtown Philly.
https://endpts.com/new-drug-applications-pile-up-with-delays-as-theres-no-easy-fix-for-the-inspection-backlog/
