• Regulatory NewsRegulatory News

    Court Finds Sanofi Improperly Listed Insulin Device Patent in FDA’s Orange Book

    The US Court of Appeals for the First Circuit last week ruled that Sanofi improperly submitted a patent for its insulin device in the US Food and Drug Administration’s (FDA) Orange Book and could potentially be held liable for extending its monopoly. The case concerns Sanofi’s insulin glargine product Lantus, which first won FDA approval in 2000, and pulled in almost $8 billion in US sales in 2014. With its original application, Sanofi submitted a patent for listing ...
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    CBER Plots New Draft Guidance in 2020 on Genome Editing, CAR-T Therapies

    The FDA’s Center for Biologics Evaluation and Research (CBER) unveiled its 2020 guidance list on Friday, with new drafts coming on several increasingly crowded areas for drug development. Three new drafts this year will likely draw lots of comments from industry and other stakeholders. They deal with considerations for the development of Chimeric Antigen Receptor (CAR) T-cell therapies, considerations for the development of human gene therapies incorporating genome edit...
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    EMA Begins Publishing All Health Professional Communications

    The European Medicines Agency (EMA) said Friday it’s now publishing all safety communications sent directly to health professionals by marketing authorization holders (MAHs) and competent authorities on its website.   In the EU and European Economic Area, direct health care professional communications (DHPCs) are used to convey important safety information about medicines either by MAHs or competent authorities, such as the suspension or withdrawal of a medicine for sa...
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    RWE: Cost and Time Savings Entice Sponsors as Pitfalls Linger

    The New England Journal of Medicine published an article earlier this week raising questions about the use of observational real world evidence (RWE), and how part of this drive toward using nonrandomized studies to assess the effects of treatments is due to the expensive and complex way that randomized clinical trials are being conducted. The timing of the article coincides with the US Food and Drug Administration (FDA) Commissioner Stephen Hahn recently pointing t...
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    RAPS' LatestRAPS' Latest

    With EU Medical Device Regulation Deadline Looming, Regulatory Pros to Gather in Brussels for RAPS Euro Convergence

    RAPS will host its annual European conference, newly dubbed Euro Convergence 2020 , in Brussels, 11–13 May, at the Radisson Blu. The event will draw a broad range of professionals and regulators concerned with the regulation of medical devices, medicines and other healthcare products, and take place just two weeks before the planned implementation of the EU’s extensive overhaul of its rules governing devices, the Medical Device Regulation (EU MDR).   While much attent...
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    CBER Raises Concerns With Cell Product Promoter RejuvaYou

    The US FDA’s Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research (CBER) earlier this week raised alarms with South Pasadena, CA-based RejuvaYou Medical Corporation, which claims to treat people with serious illnesses with umbilical cord blood and other cellular products. RejuvaYou markets the products to treat various diseases or conditions, including some that are serious or life-threatening, FDA’s untitled letter notes, and t...
  • ReconRecon

    Recon: 21 States Reject Drug Wholesalers’ $18B Opioid Settlement; China NMPA Approves Roche’s Tecentriq for Lung Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 21 States Reject $18 Billion Offer From Drug Wholesalers to Settle Opioid Litigation ( WSJ ) ( Reuters ) Americans with employer coverage saw growth in drug spending outpace other medical costs ( STAT ) As opioid crisis intensified, many family doctors found promotional pitches were very good ( STAT ) The list of the 11 blockbusters-to-be in line for a 2020 la...
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    UK Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul

    Just two weeks after Brexit, the UK government has introduced a bill to update its regulatory framework for human and veterinary medicines, clinical trials and medical devices, while ensuring the UK remains an attractive market for the life sciences industry.   The bill was read for the first time in the House of Commons on Thursday and is scheduled for a second reading on 2 March.   The UK is currently in the midst of an 11-month transition period ending 31 Decemb...
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    Eisai Voluntarily Withdraws Belviq at FDA’s Request

    The US Food and Drug Administration (FDA) on Thursday announced it has requested the withdrawal of Eisai’s weight-loss drug Belviq (lorcaserin) and the extended release version Belviq XR after a large postmarketing study found increased rates of pancreatic, colorectal and lung cancer among patients taking the drug.   The announcement comes one month after the agency issued a safety communication warning about a possible increased risk of cancer with the drug.   B...
  • ReconRecon

    Recon: Coronavirus Cases Surge After Change in Diagnostic Criteria; Teva Reports Higher Margins After Restructuring

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Coronavirus Test Kits Sent to States Are Flawed, CDC Says ( NYTimes ) ( Reuters ) Amgen Sues Pfizer Over Proposed Neulasta Biosimilar ( Big Molecule Watch ) ( Law360 -$) The RAS rush: Revolution Medicines bags remarkable $238M IPO raise, more than doubling original goal ( Endpoints ) LabCorp weathers rising personnel costs to beat expectations in Q4 ( MedtechD...
  • Feature ArticlesFeature Articles

    Estimating the Probability of Regulatory Registration Success

    This article discusses how to estimate the probability of regulatory/registration success for pharmaceutical products in development. The authors define the factors and methods used to assess regulatory/registration success and offer objective and data-driven methods to define probabilities for the purposes of documenting specific factors and/or risks relative to a likelihood of success. They provide a case study demonstrating how to use data and make estimate adjustments ...
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    Ireland’s NSAI Designated as 11th Notified Body Under MDR

    The National Standards Authority of Ireland (NSAI) was added to the European Commission’s NANDO database as the 11th notified body and first from Ireland to be designated under the EU’s Medical Devices Regulation (MDR), which takes effect on 26 May. The designation for the Dublin-based authority is for active implantable devices, active non-implantable devices, non-active implants and long term surgically invasive devices and non-active non-implantable devices, among ot...