• ReconRecon

    Recon: Boston Scientific to Buy BTG for £3.3B; MHRA Head Hudson to Step Down in 2019

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US PhRMA funnels millions to addiction group with close ties ( Politico ) Sanders unveils aggressive new bill targeting drug prices ( The Hill ) As power shifts hands in Washington, a top analyst predicts an unavoidable war over rising drug prices ( Endpoints ) Consumer group says most US cancer centers use misleading ads ( NBC ) US court allows generic version ...
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    Gottlieb, Woodcock Highlight FDA’s Efforts to Tackle Drug Shortages

    The US Food and Drug Administration (FDA) is working to update its approach to drug shortages in the wake of Hurricane Maria in 2017 and other high profile manufacturing-related shortages that occurred over the last year.   In a blog post Monday, FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock described some of the challenges facing the agency and its plans for addressing those challenges ahead of a public meetin...
  • ReconRecon

    Recon: Genentech to Pay Immunocore $100M to Test MAGE-A4 Drug With Tecentriq

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pharma dreads Chuck Grassley as Senate Finance chair ( Axios ) Company hiked price for opioid overdose treatment 600 percent: Senate report ( The Hill ) ( Politico ) ( CBS ) ( Report ) Novartis' blood disorder drug gets FDA approval for expanded use ( Reuters ) ( Press ) Gottlieb pushes for funding to speed gene therapy reviews ( STAT ) FDA declines to approv...
  • ReconRecon

    Recon: FDA Expands Use of Seattle Genetics’ Adcetris Under Real-Time Review Pilot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A newcomer rises to the defense of pharma — and tries to salvage its bruised reputation ( STAT ) FDA approves Seattle Genetics’ Adcetris for first-line treatment of peripheral T-cell lymphoma under new review pilot ( FDA ) ( Press ) Key AstraZeneca lung cancer treatment misses study goal ( Reuters ) ( Financial Times ) ( Endpoints ) ( Fierce ) ( Press ) AbbVie...
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    Draft Brexit Agreement Moves Forward on Shaky Ground

    EU and UK negotiators on Wednesday advanced a draft agreement setting terms for the UK’s withdrawal from the EU in March 2019 and the two parties’ relationship during a 21-month transition period.   The agreement is being sent to the EU27 member states for consideration and must clear the UK Parliament before the negotiations can move to the next phase and avoid the possibility of a “No-Deal” scenario.   However, the deal appears to be in jeopardy after Brexit secr...
  • ReconRecon

    Recon: United Therapeutics Licenses Arena’s Ph. III PAH Drug for $800M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Alexander: China Can Become the Global Leader in Stopping Synthetic Opioids ( Sen. Alexander ) United Therapeutics pays $800M-plus to grab Arena’s PhIII PAH drug ( Endpoints ) ( STAT ) ( Press ) FDA official hints at a tough road ahead for ‘right to try’ ( STAT ) Biotech is looking woozy: ferocious selling and a sense of foreboding ( STAT ) Lower Drug Prices ...
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    FDA Warns Against Using Implanted Pumps With Unapproved Drugs

    The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid with drugs they were not approved for use with.   Using drugs that have not been approved for compatibility with the pumps could lead to dosing errors, pump failure, opioid withdrawal, infection, fever, vomiting, muscle spasms, cognitive changes and cardiac or respiratory distress, FDA says.   “The...
  • ReconRecon

    Recon: UK Supreme Court Rules Against Pfizer in Lyrica Patent Case

    In Focus: US Pfizer Launches Epoetin Alfa Biosimilar, Retacrit, at 33.5% Discount to Reference Epogen ( Center for Biosimilars ) Celgene Doubles Down on Dragonfly, Pays $50M to Expand Cancer Pact ( Xconomy ) ( Endpoints ) Allergan Loses Appeal Over Validity of Restasis Patents ( Bloomberg ) The new Google Health unit is absorbing health business from DeepMind, Alphabet's AI research group ( CNBC ) ( Fierce ) HHS will bring in fetal tissue experts for ‘listening sess...
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    FDA Proposes Changes to Informed Consent Rules

    The US Food and Drug Administration (FDA) on Tuesday proposed changes that would allow institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.   Under current FDA regulations, exceptions for obtaining informed consent can only be made in life-threatening situations or when conditions for emergency research are met. Outside those situations, FDA regulations requi...
  • ReconRecon

    Recon: Sobi Buys US Rights to AstraZeneca’s Infant Lung Infection Drug Synagis for $1.5B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sobi buys rights to AstraZeneca infant drug for $1.5 billion upfront ( Reuters ) ( Endpoints ) Roche's Tecentriq wins fast FDA review in tough-to-treat breast cancer ( Reuters ) ( Press ) Some pharmacies fail to offer easy access to naloxone, or to stock it, despite anti-opioid initiatives ( STAT ) New ads push lawmakers to keep the drug pricing promises they ...
  • Regulatory NewsRegulatory News

    WHO Finds Wide Disparities in Antibiotic Use Between Countries

    A new report from the World Health Organization (WHO) published Monday reveals major differences in the amount of antibiotics consumed by countries around the world and calls for changes in how countries monitor and use antimicrobial drugs.   “Overuse and misuse of antibiotics are the leading causes of antimicrobial resistance. Without effective antibiotics and other antimicrobials, we will lose our ability to treat common infections like pneumonia,” said Suzanne Hill,...
  • ReconRecon

    Recon: Moderna Seeks $500M IPO; China Proposes New Laws for Vaccine Management

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drug prices and IP rights to come up at review of NAFTA ( Politico ) Gottlieb: New drug approval criteria limited to opioids ( Axios ) ( Pharmafile ) Pharma's grip on the health care economy ( Axios ) Something Happened to US Drug Costs in the 1990s ( NYTimes ) Amarin's Fish-Oil-Derived Drug Shows Great Promise—With Big Caveats ( Forbes ) ( STAT ) ( Endpoints...