• Regulatory NewsRegulatory News

    This Week at FDA: mRNA boosters for most; Blood lancets reclassified

    Welcome to our weekly digest of regulatory news from the US Food and Drug Administration (FDA), legislative updates, and other news updates we think you’ll find useful — and interesting. This week saw COVID-19 vaccine and therapy updates, the unveiling of Cures 2.0 , and lots of device updates. As usual, we welcome feedback at news@raps.org .    Friday morning, the US Food and Drug Administration (FDA) announced an expansion of the emergency use authorizations (EUA...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    More than a year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; Veklury (remdesivir) in the US, UK and Japan and Lagevrio (molnupiravir) in the UK.   Regulators around the world have allowed a handful of additional treatments to be used on an emergency-use basis including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with et...
  • Feature ArticlesFeature Articles

    The RACE is on: Opportunities in pediatric oncology product development

    Pediatric oncology patients continue to have significant unmet medical need. Although the Pediatric Research Equity Act (PREA) mandated evaluation of new drugs for pediatric patients, the rarity and uniquity of pediatric cancers allowed for waivers or exemptions from PREA requirements. The passing of FDA Reauthorization Act amendments in 2017 included the Research Acceleration for Cure and Equity Act, which expands the scope of oncology products subject to PREA. Sponsors d...
  • Regulatory NewsRegulatory News

    GDUFA III fiscal details emerge

    The generics industry can expect the US Food and Drug Administration (FDA) to take a more flexible approach to resource capacity planning and continue a commitment to financial transparency, according to fiscal experts from the agency who spoke at an FDA meeting earlier this week.   Although much of the framework for the third reauthorization of the Generic Drug User Fee Amendments (GDUFA III) program could be gleaned from the commitment letter released by the US Foo...
  • Regulatory NewsRegulatory News

    Industry, clinician groups have different wish lists for AI/ML-enabled device labels

    Medical device industry groups are urging the U.S. Food and Drug Administration (FDA) not to rush to create new regulatory requirements around the labeling of medical devices that incorporate artificial intelligence or machine learning (AI/ML), while clinician groups are seeking greater transparency about device algorithms and training data sets.     In total, 15 groups offered comments following a virtual public workshop held by FDA on the transparency of AI/ML-enable...
  • RoundupsRoundups

    Euro Roundup: EFPIA calls for EU to drive reform of WTO, shares feedback on emergency authority

    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has called on the European Union to take the lead on the reform of the World Trade Organization (WTO). The pharma trade group sees the 12th ministerial WTO conference as a chance to reform the international trading system and boost the world’s ability to respond to health crises.   As EFPIA sees it, trade played a key role in the response to COVID-19 and the development of the vaccines that c...
  • ReconRecon

    Recon: Novo Nordisk to buy Dicerna for $3.3B; US signs deal for $5.3B worth of Pfizer's COVID antiviral drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer ( BioPharmaDive ) ( FDA ) Pfizer signs $5.3 billion U.S. deal to supply COVID-19 antiviral pills ( Reuters ) J&J sees potential for 14 new multibillion-dollar drugs by 2025 ( Reuters ) White House Plans Major Expansion of Covid Vaccine Production ( NYTimes ) Gilead pays up to retain ...
  • Regulatory NewsRegulatory News

    FDA urged to endorse EPCIS to spur manufacturers' uptake of DSCSA

    The pharmaceutical industry and other trading partners told the US Food and Drug Administration (FDA) to endorse the use of Electronic Product Code Information Services (EPCIS) for tracing products through the supply chain by finalizing its guidance on standards for the interoperable exchange of product information.   Doing so would help improve industry’s uptake of exchanging product data well ahead of the November 2023 deadline when these systems go live, say trading...
  • RoundupsRoundups

    FDA Approvals Roundup: Besremi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Besremi okayed for rare blood disease PharmaEssentia’s Besremi (ropeginterferon alfa-2b-njft injection) has been approved for treating adults with polycythemia vera, a blood disease caused by a JAK2V617F mutation that results in overproduction of red blood cells (RBCs).   The monopegylated, long-acting interferon alfa-2b reduces excess RBCs...
  • ReconRecon

    Recon: Biogen's Alzheimer's drug gets negative trend vote from EMA panel; EMA says Novavax authorization could come 'within weeks'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Plans to Authorize Pfizer Boosters for All Adults This Week ( NYTimes ) Watchdog group calls on FDA to disqualify Hennepin Healthcare doctors, review board from clinical research ( StarTribune ) U.S. plans to invest billions in manufacturing COVID-19 vaccine ( Reuters ) ( Politico ) Pfizer CFO D'Amelio to retire after 15 years at company ( Reuters ) U.S. ...
  • Regulatory NewsRegulatory News

    FDA inspection turns up more problems for Philips Respironics

    Hundreds of thousands of complaints from users of Philips Respironics’ breathing assistance devices have been inadequately addressed by the firm, according to recent information released by the US Food and Drug Administration (FDA). The release of an inspection report and FDA’s accompanying statement provides more detail on what Philips knew, and what the firm did – or did not do – to remedy known problems with degradation of foam components in its breathing devices.   ...
  • Regulatory NewsRegulatory News

    CHMP recommends 11 new medicines for authorization, including two COVID-19 monoclonal antibodies

    The European Medicine Agency’s (EMA) Committee for Medicinal Products (CHMP)   last week recommended 11 new medicines for approval in the EU, including Europe’s first two new monoclonal antibodies for treating COVID-19. The agency also recommended the rejection of a treatment for neovascular (wet) age-related macular degeneration.   CHMP recommended authorizing Celltrion Healthcare Hungary’s Regkirona (regdanvimab) and Roche’s Ronapreve (casirivimab/imdevimab) for tre...