• Regulatory NewsRegulatory News

    FDA tallies pandemic inspection toll, issues new 'resiliency roadmap'

    A new report from the US Food and Drug Administration details its performance on inspections during the public health emergency of the COVID-19 pandemic and details the agency’s roadmap going forward.   “The numbers reveal the state of our inspectional oversight and how we plan to address postponed inspectional work using a risk-based approach,” wrote acting FDA director Janet Woodcock, MD, in a forward to the Resiliency Roadmap for FDA Inspectional Oversight .   ...
  • Regulatory NewsRegulatory News

    What’s behind drug price spikes – and what can be done?

    Two newly published studies have highlighted the rising cost of brand-name and generic drugs, looking at why generic price spikes happen and how drug price hikes affect insured patients.   In an analysis published in Health Affairs , Aayan N. Patel, a researcher with the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital in Boston, and colleagues said that although there have been fewer spikes in drug prices be...
  • RoundupsRoundups

    FDA Approvals Roundup: Kloxxado, Farxiga, Ferriprox

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Higher-dose Kloxxado nasal spray cleared for countering opioid overdose Hikma’s Kloxxado (naloxone hydrochloride nasal spray) has been approved for treating opioid overdose. Its indicated dose of 8 mg is notably higher than the previously approved doses of 2 and 4 mg for other naloxone nasal spray products.   Kloxxado was approved thro...
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    FDA welcomes alternative approaches to generic drug development

    Issuance of a product specific guidance should not “diminish innovation or creativity” in generic drug development, Robert Lionberger, director for the office of research and standards in the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of Generic Drugs, said at a 5 May webinar on the development of product specific guidance.   FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of G...
  • ReconRecon

    Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters ) Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms ( STAT ) Rising wholesale drug prices really do matter to half of all commercially insured Americans ( STAT ) Facing fresh pricing threats in D.C., pharma spent a record $92...
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    EMA begins rolling review of Sinovac's COVID vaccine

    The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review.   The inactivated, adjuvanted Vero cell vaccine, known as Coronavac, joins three others that are in EMA’s rolling review process, which allows sponsors to add to the candidate vaccine’s portfolio as data accrues.   EMA’s human medicines committee (CHMP) then meets periodically to assess reports in support of the submission, notifying the spons...
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    Panelists: Sluggish pace of DSCSA testing is worrisome

    In a recent traceability forum, the pharmaceutical industry and other trading partners were told to start testing their data systems now to ensure that any glitches are ironed out before prescription drug products must be electronically tracked through the supply chain to ward off counterfeiting. The Drug Supply Chain Security Act (DSCSA) mandates that these systems go live in November 2023.   To ensure readiness, panelists participating in the 29 April Healthcare Dist...
  • Regulatory NewsRegulatory News

    BsUFA talks continue on technology, regulatory science and reviews

    The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March.   During the two meetings, FDA and industry discussed issues related to application reviews, information technology, finance and staffing, regulatory science, review timelines and product safety updates. (RELATED: FDA, Industry set priorities for BsUFA III , R...
  • RoundupsRoundups

    Asia-Pacific Roundup: New Zealand bans unapproved COVID vaccines

    The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has banned the trade in unapproved COVID-19 vaccines for a year to prevent the use of vaccines that may not be safe or effective.   Only Comirnaty (Pfizer/BioNTech) is approved for use in New Zealand; vaccines from AstraZeneca and Johnson & Johnson currently are under rolling review. The ban on the importation, manufacture, packing, sale, supply, possession, administration or use of unapproved C...
  • ReconRecon

    Recon: Pfizer plans COVID vaccine BLA submission this month; Gilead sues Russia over remdesivir compulsory license

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ) The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. ( NYTimes ) Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine ( NYTimes ) ( WSJ ) ( Endpoints ) ( Reuters ) White House to shift COVID-19 vaccine to sta...
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    Pfizer COVID vaccine under EMA review for younger teens

    The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years.   Pfizer reported that it submitted its application for extension of authorization last week, and EMA announced today that it has undertaken the evaluation of the messenger RNA (mRNA) vaccine. The vaccine has been authorized by the EU for use in people 16 years and up since December 2020.   Trials of ...
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    CDER regulatory science division touts 2020 accomplishments

    In its 2020 annual report, the division of the US Food and Drug Administration (FDA) tasked with addressing emerging regulatory issues and developing new tools and approaches for regulatory reviews said it was able to expand its efforts despite the COVID-19 pandemic impacting most of the year.   “2020 was a challenging year. In addition to adjusting to new work environments related to the COVID-19 pandemic that involved 100% teleworking for some staff and laboratory wo...