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  • ReconRecon

    Recon: Drugmakers launch $1B antibiotic development fund; Moderna taps Rovi to supply coronavirus vaccine outside US

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US In race to bring vaccine to market, big pharma struggles to protect its intellectual property rights ( CNBC ) Who Gets a Vaccine First? US Considers Race in Coronavirus Plans ( NYTimes ) Grave Shortages of Protective Gear Flare Again as Covid Cases Surge ( NYTimes ) Merck, Eisai's Keytruda-Lenvima combo stonewalled in liver cancer after Roche's first-in-class ...
  • Regulatory NewsRegulatory News

    NIH kicks off COVID-19 vaccine, monoclonal antibody research network

    The National Institutes of Health (NIH) today announced the kickoff of a national clinical trials network to test vaccines and other treatments that could prevent infection with SARS-CoV2, the virus that causes infection with the novel coronavirus COVID-19.   The network has been established by the National Institute of Allergy and Infectious Diseases (NIAID) through the merger of four previously existing clinical trials networks that focused on HIV/AIDS.   “Star...
  • Regulatory NewsRegulatory News

    More metformin recalled for NDMA; 6 firms now affected

    Two manufacturers have announced voluntary recalls of metformin formulations containing elevated levels of a potential carcinogen.   Granules Pharmaceuticals, based in Virginia, has issued a recall for its extended-release metformin, although just one of 12 batches tested exceeded acceptable levels of N-nitrosodimethylamine (NDMA) in the firm’s testing. The recall includes 100- and 500-count bottles of 750 mg metformin tablets.   Separately, India-based Lupin Pha...
  • RoundupsRoundups

    FDA Approvals Roundup: Rukobia, Byfavo, Inqovi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rukobia gets the green light for hard-to-treat HIV ViiV Healthcare’s Rukobia (fostemsavir) has been approved for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant infection whose current antiretroviral regimen is ineffective because of resistance, intolerance, or safety concerns.   The drug, a ...
  • ReconRecon

    Recon: EU reportedly strikes deals for Roche, Merck KGaA COVID drugs; Biogen submits aducanumab BLA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump administration submits formal notice of withdrawal from WHO ( STAT ) ( WSJ ) Pence, Azar reassure governors Trump won't end virus emergency declaration ( Politico ) Drug prices steadily rise amid pandemic, data shows ( Politico ) In a test for Hahn's FDA, Biogen submits controversial Alzheimer's drug aducanumab ( Fierce ) ( Endpoints ) ( BioPharmaDive ) ...
  • Regulatory NewsRegulatory News

    Unified agenda: FDA publishes lengthy to-do list

    Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.   The importation of prescription drugs continues to be among deregulatory priorities for the Tr...
  • Regulatory NewsRegulatory News

    Device manufacturers warned by FDA for consumer complaint handling

    The US Food and Drug Administration (FDA) today released warning letters to two medical device manufacturers who, according to the agency, failed to address serious consumer complaints adequately. The agency also warned an India-based manufacturer of active pharmaceutical ingredients (API).     Luminex Corporation   Texas-based Luminex Corporation manufactures microsphere-based and PCR-based multiplexing systems; the firm was warned after a February 2020 inspec...
  • Regulatory NewsRegulatory News

    House proposes $3.2 billion for FDA in FY 2021

    On Monday, the US House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies held a markup session for fiscal year 2021 appropriations.   Of the total budget of $23.98 billion – a 2.3% increase from the prior fiscal year -- the bill allocates $3.212 billion for the Food and Drug Administration (FDA). This amount is an increase of $40.8 million over the prior fiscal year’s approximate $3.2 bill...
  • Regulatory NewsRegulatory News

    FDA clarifies informed consent provisions in COVID-19 clinical guidance

    The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to clarify how sponsors can obtain informed consent from patients in isolation or who can receive electronic copies of informed consent documents but due to time constraints cannot print or electronically sign the documents.   The guidance , which has been updated frequently as more questions arise from sponsors during...
  • ReconRecon

    Recon: Novavax, Regeneron get nearly $2B in Operation Warp Speed funding; FDA puts Cellectis CAR-T trial on hold after death

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna spars with US scientists over COVID-19 vaccine trials ( Reuters ) FDA warns of false positives with BD coronavirus diagnostic ( MedtechDive ) ( FDA ) US coronavirus response still crippled by lack of testing, Dr. Scott Gottlieb says ( CNBC ) Death in Cellectis off-the-shelf CAR-T trial triggers FDA hold ( Fierce ) ( STAT ) ( Endpoints ) US Will Pay $1...
  • Regulatory NewsRegulatory News

    FDA asks stakeholders to join PDUFA talks by 17 August

    The US Food and Drug Administration (FDA) on Monday called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Prescription Drug User Fee Act program by 17 August 2020.   The monthly periodic consultation meetings take place alongside FDA’s negotiations with regulated industry and are expected to begin the following month.   The call...
  • ReconRecon

    Recon: GSK, Sanofi in talks for £500M UK coronavirus vaccine deal; Regeneron begins Phase 2/3 trial for COVID-19 antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House teases executive orders on China, immigration and prescription drugs ( Politico ) Regeneron starts COVID-19 antibody cocktail late-stage trials, shares rise ( Reuters ) ( Press ) 2021 Health Plans Granted Leeway To Limit Consumers’ Benefit From Drug Coupons ( KHN ) FDA Commissioner Stephen Hahn won’t confirm Trump’s promises on vaccine timing ( ABC...