• Regulatory NewsRegulatory News

    Senators ‘Disappointed’ by FDA’s Pivot on Progressive Approvals for Devices

    In a letter to top US Food and Drug Administration (FDA) officials on Monday, Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) say they are concerned about the agency’s renewed interest in a progressive approval system for certain medical devices.   The letter, addressed to Acting FDA Commissioner Brett Giroir and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren, questions the agency’s about-face on progressive approvals for devices after ...
  • ReconRecon

    Recon: Takeda Licenses MD Anderson CAR NK Therapies; FDA Offered Divergent Forecasts on Fecal Transplants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Concerns raised about Giroir at FDA ( Politico ) FDA Approves 24th Biosimilar, 3rd for Neulasta  ( Focus ) ( Reuters ) ( Endpoints ) 1 in 2 seriously ill Medicare enrollees struggles with bills ( AP ) ( Axios ) A New Approach to Gene Therapy—Now In Dogs, Maybe Later In Humans ( WSJ ) Obscure Model Puts a Price on Good Health—and Drives Down Drug Costs ( WSJ )...
  • Regulatory NewsRegulatory News

    ICH Updates: What to Expect Through 2020

    At a joint public consultation in Ottawa on Monday, officials from Health Canada and the US Food and Drug Administration (FDA) gave an overview of the progress made on more than two dozen International Council for Harmonisation (ICH) guidelines ahead of the upcoming ICH Assembly meeting in Singapore later this month.   The consultation comes roughly six months after FDA hosted the previous joint consultation with Health Canada in advance of the ICH Assembly’s meeting...
  • ReconRecon

    Recon: Stryker to Buy Wright Medical for $4B; China Conditionally Approves First Domestically Developed Alzheimer’s Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Stryker boosts bone implants with $4 billion Wright Medical buyout ( Reuters ) ( Financial Times ) Halozyme’s lead drug fails; company will cut 55% of workforce in bid for profitability ( STAT ) ( Endpoints ) Trump Nominates Hahn to be FDA Commissioner ( Focus ) FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns ( The Daily Be...
  • ReconRecon

    Recon: Amgen Takes 20.5% Stake in BeiGene; Novartis Cosentyx Fails to Top Humira in Head-to-Head Trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA is modernizing its technology to prepare for a new wave of therapies ( Politico ) Google takes on wearables giants with $2.1 billion Fitbit deal ( Reuters ) ( WSJ ) Realizing the Dream of Molecularly Targeted Therapies for Cystic Fibrosis ( NEJM ) ( NIH ) ( NYTimes ) AbbVie Earnings, Revenue Beat in Q3 ( Yahoo ) ( Press ) AbbVie says multiple parties vyin...
  • Regulatory NewsRegulatory News

    Chronic Hepatitis D: FDA Drafts Drug Development Guidance

    With no drugs currently approved to treat chronic hepatitis D (HDV), the US Food and Drug Administration (FDA) on Thursday issued draft guidance laying out recommendations for developing new treatments.   In an overview of current chronic hepatitis D management, authors Patrizia Farci, chief of the Hepatic Pathogenesis Section of the Laboratory of Infectious Diseases at the National Institute of Allergy and Infectious Diseases and Grazia Niro, staff clinician at IRCCS ...
  • ReconRecon

    Recon: Swiss Competition Authority Names Boehringer, 10 Others in Antitrust Probe; Roche Pays $200M to License Dicerna RNAi Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pelosi Calls Pharma’s Bluff on Drug Prices ( Bloomberg ) Insurance, pharma figures spar over drug price legislation’s innovation impact ( STAT ) Merck loses bid to revive $2.54 billion patent verdict against Gilead ( Reuters ) ( Law360 -$) How Contaminated Stool Left a Fecal Transplant Patient Dead ( NYTimes ) ( STAT ) ( NEJM ) CMS proposes lifting restrictio...
  • Regulatory NewsRegulatory News

    Senators Reiterate Concerns About FDA’s Software Pre-Cert Program

    One year after questioning the US Food and Drug Administration (FDA) over its proposed approach to regulating digital health products through its Software Precertification (Pre-Cert) Pilot Program, Democratic senators say they still have concerns and are asking the agency for more information about the program.   In an October 2018 letter to FDA, Sens. Patty Murray (D-WA), Elizabeth Warren (D-MA) and Tina Smith (D-MI) posed more than two dozen questions about the pro...
  • ReconRecon

    Recon: Novartis’ Zolgensma Study Halted on Safety Concerns; FDA Panel Backs Withdrawing Approval for Amag’s Makena

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis' Zolgensma study halted by FDA amid safety questions ( Reuters ) ( Endpoints ) ( STAT ) FDA panel recommends removing the Makena drug for preventing premature births ( STAT ) ( BioPharmaDive ) ( Endpoints ) ( Evaluate ) Small relief for Biogen in MS drug approval ( Reuters ) ( Endpoints ) ( Press ) Amgen posts higher biosimilar sales, ends neuroscienc...
  • Regulatory NewsRegulatory News

    FDA to Require Certain IND Safety Reports be Submitted to FAERS

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance requiring sponsors to submit investigational new drug (IND) safety reports for serious and unexpected suspected adverse events to the FDA Adverse Event Reporting System (FAERS) starting 24 months after the guidance is finalized.   Currently, such reports are submitted to FDA in electronic common technical document (eCTD) format using PDF files, which FDA says are “inefficient and labor intensive...
  • ReconRecon

    Recon: Pfizer Raises 2019 Guidance on Strong Cancer, Heart Drug Sales; Drugmakers Settle Medicaid Fraud Suit for $248M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer raises 2019 forecast as sales of cancer drug, heart medicine surge ( Reuters ) ( Financial Times ) ( WSJ ) ( Press ) Mirati gives a first look at its KRAS-blocking cancer drug ( STAT ) ( Endpoints ) ( Reuters ) ( Press ) Will an FDA panel recommend a drug for preventing premature births remain available? ( STAT ) Drugmakers Ink $242M Settlement In Ill. ...
  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Type V DMFs for Combination Products

    The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about Center for Drug Evaluation and Research (CDER)-led combination products that include a device constituent that may be used in multiple combination products.   DMFs are a voluntary submission to FDA of confidential information about certain aspects related to a drug or manufacturer. There are five types of DMFs...