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  • ReconRecon

    Recon: FDA rejects AbbVie eye drug BLA; Novartis, Alcon to pay $347M to settle bribery investigations

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis, Alcon Pay $347 Million to Settle Bribery Probes ( WSJ ) ( STAT ) ( DOJ ) FDA Approves Zogenix's Drug for Rare Childhood Epilepsy ( Reuters ) ( STAT ) ( FDA ) AbbVie's Allergan, Molecular Partners hit by FDA eye drug rejection ( Fierce ) ( Endpoints ) ( Press ) DBV lays off employees, scales down programs after receiving no word from FDA ( Endpoints )...
  • Regulatory NewsRegulatory News

    EMA nominates executive director to replace Rasi

    The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director.   Rasi, whose second term as EMA executive director ends on 15 November, served as Executive Director from 2011-2014 before being forced to step down after the European Union Civil Service Tribunal annulled his appointment. (RELATED: Rasi returns to head EMA for five-year term , Regula...
  • Regulatory NewsRegulatory News

    EMA recommends remdesivir to treat COVID-19, authorization expected next week

    Following a rolling review that kicked off in late April, the European Medicines Agency (EMA) on Thursday recommended conditionally authorizing Gilead Sciences’ (Veklury) remdesivir to treat patients ages 12 and older with severe coronavirus disease (COVID-19) requiring supplemental oxygen.   EMA says it expects the European Commission to sign off on the conditional marketing authorization for remdesivir next week using a fast-track process, which will allow the drug t...
  • ReconRecon

    Recon: NIH may own IP for Moderna COVID-19 vaccine; UniQure sells gene therapy rights to CSL for $450M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump’s Drug Push Still Keeps Door Open for Banned Indian Firm ( Bloomberg ) Bolton casts light on Trump’s deference to China on coronavirus ( Politico ) Trump administration ending support for drive-thru testing sites ( Politico ) Breakthrough Drug for Covid-19 May Be Risky for Mild Cases ( NYTimes ) The NIH claims joint ownership of Moderna's coronavirus va...
  • Regulatory NewsRegulatory News

    FDA finalizes bacterial pneumonia drug development guidances

    The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia.   Both guidances offer recommendations to sponsors on the development of drugs to treat bacterial pneumonia acquired in different settings and feature input on nonclinical development, trial population, efficacy trial considerations and other issues including pharmacokinetic/ph...
  • ReconRecon

    Recon: Merck strikes deal with Yumanity for neurodegenerative disease drugs; Feds allege Regeneron used charity to pay kickbacks

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Federal prosecutors allege Regeneron used a charity to pay kickbacks to Medicare patients ( STAT ) Yumanity Therapeutics, Merck strike deal aimed at developing new medicines for neurodegenerative disease ( STAT ) ( Endpoints ) FDA urged to heighten safety warnings on common type 2 diabetes drugs ( STAT ) ( Public Citizen ) By $4M, La Jolla outbids Melinta for ...
  • Regulatory NewsRegulatory News

    Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals

    US Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, on Tuesday testified before the House Energy and Commerce Committee on his agency’s response to the coronavirus disease (COVID-19) pandemic.   User fee goals, policy review   Despite an “incredible surge in volume” of applications and constraints on the agency’s ability to conduct inspections, Hahn said that FDA, “Has maintained the same pace of meeting its goals on applications for medical produc...
  • ReconRecon

    Recon: Sanofi accelerates COVID-19 vaccine plans; Gilead inks $1.5B buyout deal for Pionyr

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The new Janet: The FDA turns to a quiet problem-solver who brings expertise — and a little controversy ( STAT ) Lawmakers push Covid-19 bills to prevent price gouging, track federal funds used to discover drugs ( STAT ) As approval decision nears, fate of Intercept’s NASH drug clouded by murky FDA review delays ( STAT ) Gilead pens $1.5B buyout option deal for...
  • Regulatory NewsRegulatory News

    FDA explains COVID-19 impact on MDUFA goals, meetings

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective questions and answers guidance explaining the impact of the coronavirus disease (COVID-19) public health emergency on formal meetings and applications for medical devices.   FDA released a similar guidance pertaining to formal meetings and applications for drugs and biologics amid the pandemic in late May. (RELATED: FDA explains impact of COVID-19 on applications, formal meetings , ...
  • ReconRecon

    Recon: Gilead to begin trials of inhaled version of remdesivir; FDA rejects Nabriva’s antibiotic for the second time

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead to Begin Human Testing of Inhaled Version of Covid-19 Drug Remdesivir ( WSJ ) FDA rejects Nabriva a second time; Nabriva pins it on travel restrictions ( Endpoints ) Rules for Clinical Trials in a Pandemic ( WSJ ) CDC coronavirus test kits were likely contaminated, federal review confirms ( Washington Post ) Efforts for Coronavirus Vaccine Focus on Vul...
  • ReconRecon

    Recon: FDA nods for Ultragenyx, Epizyme; Roche posts mixed results in late-stage prostate cancer trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Ultragenyx's Crysvita scores FDA nod in 2nd ultra-rare bone disorder ( Fierce ) ( FDA ) Epizyme wins second OK for Tazverik, in follicular lymphoma ( Endpoints ) ( FDA ) US biotech group to trial Covid-19 pill for use at home ( Financial Times ) Rush for Generic Go-Ahead on Novel Drugs Roils Pharma Industry ( Bloomberg ) Coronavirus Attacks the Lungs. A Feder...
  • Regulatory NewsRegulatory News

    FDA officials update on orphan drugs, gene therapies at DIA

    Officials from the US Food and Drug Administration (FDA) discussed the agency’s recent efforts to support the development of products to treat rare diseases during a session at DIA’s Global Annual Meeting on Wednesday.   Orphan and rare pediatric disease designations   While the number of products approved to treat rare diseases has increased over the last decade, the vast majority of rare diseases lack approved treatment options.   Janet Maynard, director of F...