• ReconRecon

    Recon: Sage Depression Drug Fails in Phase III; China’s NMPA Approves Lynparza for Ovarian Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sage depression therapy fails much-awaited trial, stunning investors ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Eli Lilly to put Loxo executives in charge of new cancer research unit ( Reuters ) ( STAT ) ( Press ) Biogen to make case to skeptics for its controversial Alzheimer's drug ( Reuters ) Acadia Pharma's psychosis drug proven better than placebo in de...
  • Feature ArticlesFeature Articles

    Clarity in Chaos: Best Practice Tips for Engaging Influencers for Pharmaceutical Promotion

    Engaging social media influencers for prescription drug promotion can present a challenge for most pharmaceutical companies; however, by working with the right social media influencer and operating within standing regulations, companies can reach appropriate patients via social media. This article demonstrates how one pharmaceutical company used social media to offer guidance to pharmaceutical companies considering using “media influencers” to promote their products. The a...
  • Regulatory NewsRegulatory News

    FDA Sends Untitled Letter to Company Marketing Stem Cell Treatment for Autism

    The US Food and Drug Administration (FDA) late last month sent an untitled letter, its third of the year, to California-based Chara Biologics for marketing an unapproved stem cell product as a possible treatment for autism and other conditions with few treatment options. FDA says the product appears to be a human cell, tissue, or cellular or tissue-based product (HCT/P) and the company’s website notes a few stories that suggest the stem cell treatment may help children ...
  • Regulatory NewsRegulatory News

    FDA to Heartburn Drug Manufacturers: Do Not Release Lots if NDMA is Above Acceptable Levels

    As manufacturers of popular heartburn drugs, like Zantac, continue to pull their products from shelves, the US Food and Drug Administration is now telling the companies to test their drugs for an impurity, known as N-nitrosodimethylamine (NDMA), before making them available. The new requirement comes as earlier last month FDA noted that although many of these NDMA levels observed via FDA testing are much lower than the levels some third-party scientists first claimed,...
  • Regulatory NewsRegulatory News

    House Likely to Pass Pelosi’s Drug Pricing Bill Next Week

    House Speaker Nancy Pelosi (D-CA) and Democrat colleagues said they will pass a wide-ranging drug pricing bill that many in the pharmaceutical industry have warned would be catastrophic. However, the bill is unlikely to make headway in the Republican-controlled Senate and President Donald Trump has already said he opposes the bill. “We have now received enough guidance from CBO to bring the Lower Drug Costs Now Act to the Floor and to reinvest its savings in one of the ...
  • RoundupsRoundups

    EU Regulatory Roundup: HPRA Reduces Fee Increase After Pushback from Industry

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   HPRA Reduces Fee Increase After Pushback from Industry   Ireland’s Health Products Regulatory Authority (HPRA) has reduced its 2020 fee increase in the face of pushback from industry groups. HPRA will now enact a general fee increase of 2%, rather than the previously planned 3%.   In October, HPRA proposed increasing all human medicine, compliance, blood, tissu...
  • Regulatory NewsRegulatory News

    EC Offers Technical Guidance on UDIs

    The European Commission on Wednesday released eight documents related to the technical specifications for unique device identifiers (UDIs). Four of the documents are related to Basic UDI-DI, which manufacturers can use to connect and identify devices with the same purpose, risk class, design and manufacturing characteristics, and which are required elements for the incoming device database, known as Eudamed. The four Basic UDI-DI documents are from GS1, HIBCC, ICCBBA an...
  • Regulatory NewsRegulatory News

    Lawmakers Reiterate Call to Integrate UDIs With Insurance Claim Forms

    Senate Finance Committee Chairman Chuck Grassley (R-IA) joined Sen. Elizabeth Warren (D-MA) and three representatives to support the integration of the device identifier portion of unique device identifiers (UDIs) with electronic health insurance claims forms.  The integration is necessary as currently, when a device fails or is recalled, it can be difficult to identify which patients are affected. And whereas FDA can monitor drugs and vaccines on the market, the agency...
  • Regulatory NewsRegulatory News

    FDA Drafts Recommendations for IC/BSP Drug Development

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations for the clinical development of new drugs to treat patients with interstitial cystitis/bladder pain syndrome (IC/BPS).   According to FDA, “IC/BPS is a complex, poorly understood syndrome of unknown etiology,” that is diagnosed based on symptoms including chronic bladder pain or discomfort and frequent urination or nocturia and the exclusion of other conditions with s...
  • Regulatory NewsRegulatory News

    FDA Debates Creating Pilot to Evaluate Novel Excipients

    The US Food and Drug Administration (FDA) on Wednesday sought comments on whether it should run a voluntary pilot program to evaluate the toxicology and quality of novel excipients. While the agency does currently review new excipients as part of an investigational new drug application (IND) or a marketing application (NDA or BLA), FDA explains how certain novel excipients may provide public health benefits, such as improved drug delivery or utility in abuse-deterrent o...
  • Feature ArticlesFeature Articles

    Drug Pricing Transparency: The Conversation is Far From Over

    This article discusses the US government’s attempts to require drug pricing transparency in advertising. The authors explain the events following the Centers for Medicare and Medicaid Services (CMS) publication of a proposed rule for regulation to require drug pricing transparency. They outline recent initiatives by a number of other federal agencies to develop ways to inform the public about drug costs, efforts by the Pharmaceutical Research and Manufacturers of America (...
  • ReconRecon

    Recon: Novartis Pairs With Amazon for AI in Manufacturing; Rising Pleads Guilty in Generic Price Fixing Case

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A second generic drug maker admits to price fixing as part of a far-reaching probe into generics ( STAT ) ( Law360 -$) ( The Inquirer ) ( DoJ ) Roche wins FDA approval for immunotherapy cocktail against lung cancer ( Reuters ) ( Endpoints ) ( Press ) White House claims Speaker Nancy Pelosi’s drug-pricing bill would result in 100 fewer drugs over a decade ( CNBC...