• ReconRecon

    Recon: Moderna touts bivalent booster’s response against Omicron subvariants; EU to raise investment in Latin American drug manufacturing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna booster candidate shows strong response against Omicron subvariants ( Reuters ) Moderna CEO: COVID variant vaccine to be ready for shipping in August ( Reuters ) Omicron-specific COVID vaccines on the horizon, Pfizer chief says ( Reuters ) More vulnerable people receiving fewer COVID pills - U.S. study ( Reuters ) FDA to Order Juul E-Cigarettes Off U....
  • Regulatory NewsRegulatory News

    EU reference labs: Commission adopts implementing acts

    A new set of implementing acts adopted by the European Commission outlines what EU reference laboratories need to consider in order to serve their customers. The regulations address issues such as how to ensure the labs have proper training and resources to handle workloads as well as how to ensure pricing transparency.   On 17 June, the Commission published two regulations on EU reference labs that may be used by notified bodies and member states to give technical ass...
  • ReconRecon

    Recon: Novartis loses patent appeal for MS drug Gilenya; European Commission investigates Vifor for anticompetitive practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 'Put up or shut up': Biden, Dems have one last chance to resurrect drug pricing reforms ahead of elections ( Endpoints ) Medicare could have saved billions on drugs if it paid what Mark Cuban charges at his new pharmacy ( STAT ) ( Endpoints ) Merck touts new data for breakthrough pneumococcal vaccine as it heads to PhIII trials ( Endpoints ) U.S. Supreme Court...
  • RoundupsRoundups

    Asia-Pacific Roundup: India proposes QR codes on key medicines within the year

    India’s Ministry of Health has revived a proposal to add bar codes or quick response (QR) codes to the packaging of 300 top medicines to facilitate product authentication. The requirement is set to come into force at the start of May 2023.   Proposals to include a barcode on drug packaging date back to 2015 when the Indian government released a draft proposal for consultation. The proposal was never finalized because many “pharmaceutical companies showed their inabilit...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely. Among those treatments are dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocilizumab), Paxlovid (ni...
  • Regulatory NewsRegulatory News

    FDA caught up on domestic preapproval inspections, foreign inspections still a challenge

    The US Food and Drug Administration (FDA) eliminated its backlog of overdue domestic preapproval inspections, yet such progress has been stunted at the international level as getting to sites in China has remained a challenge amid the country’s COVID-19 pandemic restrictions. So asserted Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research (CDER), who provided an update on the center’s activities and priorities for 2022 at the Food and Drug ...
  • ReconRecon

    Recon: Pfizer to buy 8.1% stake in Valneva, Merck explores Seagen buyout

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID vaccine rollout for US children close after CDC panel vote ( Reuters ) Lawmakers ask GAO to probe pharmacy benefit managers over their role in drug pricing ( STAT ) Comparing the Pfizer and Moderna Covid vaccines for young children ( STAT ) Merck Explores Purchase of Biotech Seagen ( WSJ ) FDA advisors mostly agree that Acadia’s Nuplazid isn't effective...
  • Regulatory NewsRegulatory News

    This Week at FDA: FDA authorizes COVID vaccines for youngest children; Congress holds budget, pandemic hearings

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. It was budget week on the Hill and with that, we saw a number of hearings related to the FY2023 budget and pandemic funding. The biggest news of the week is FDA's  authorization of two mRNA COVID-19 vaccines for children as young as 6 months of age. The authorizations comes after months...
  • Regulatory NewsRegulatory News

    FDA authorizes Pfizer, Moderna vaccines for youngest children

    The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months of age, asserting that the benefits of the vaccines outweigh the risks.   This action comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to support expanding the emergency use authorizations (EUAs). (RELATED: VRPAC recommends Pfizer, Mode...
  • Regulatory NewsRegulatory News

    CBER outlines recognition process for regenerative medicine therapy standards

    The US Food and Drug Administration (FDA) outlined its process for recognizing voluntary consensus standards (VCS) related to regenerative medicine therapies in a new draft guidance document. The draft guidance , issued 15 June 2022 by the Center for Biologics Evaluation and Research (CBER), outlines how VCS bodies and standards will be evaluated by agency staff, where these standards can be accessed, and how individuals can request recognition of a specific VCS. The g...
  • Regulatory NewsRegulatory News

    Senate HELP committee tussles over additional COVID funding

    Partisan disagreement set the tone at a 16 June hearing of the Senate Health, Education, Labor and Pensions (HELP) Committee, where Democrats on the committee warned lack of additional COVID-19 funding would set back the progress made in managing the crisis while Republicans questioned whether the administration had spent the funding it already received wisely.   At the hearing , commmitte members heard testimony from federal officials including Rochelle Walensky, dir...
  • Regulatory NewsRegulatory News

    FDA takes a step forward for machine learning with quantitative imaging guidance

    The US Food and Drug Administration finalized guidance on what to consider when using quantitative imaging algorithms in radiological device submissions. While most imaging diagnostics rely on qualitative readings by trained physicians, imaging devices increasingly rely on quantitative imaging results using machine learning.   On 15 June, FDA finalized its Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions guidance ...