• ReconRecon

    Recon: Oklahoma Makes Final Bid in J&J Opioid Trial; Life Sciences VC Vida Ventures Raises $600M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Oklahoma makes final bid to hold J&J responsible for opioid epidemic ( Reuters ) ( Law360 -$) Life sciences VC firm Vida Ventures raises $600 million in second fund ( STAT ) ( Endpoints ) Trump firms up plan to import medicines; pharma companies resist ( Reuters ) Drug costs push some to extreme measures as Trump admin unveils plan to import medicines from Can...
  • Regulatory NewsRegulatory News

    OPDP Issues Untitled Letter Over Birth Control Device TV Ad

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) sent an untitled letter to CooperSurgical last week over misleading claims made in a television advertisement for its hormone-free prescription intrauterine birth control device ParaGard.   OPDP says the letter, its fourth in 2019, was prompted by its review of the Form 2253 submitted by CooperSurgical for the ad and notes that the agency received a complaint about the ad via its ...
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    Recon: FDA Approves Bayer, Orion Prostate Cancer Drug Nubeqa

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas ( Focus ) ( NYTimes ) ( Endpoints ) Trump Administration Moves To Make Health Care Costs More Transparent ( KHN ) Democrats brawl on health care, with more to come tonight ( Politico ) ( NYTimes ) Orion, Bayer prostate cancer drug gets FDA approval ( Reuters ) ( PMLive ) ( Endpoints ) ( Pre...
  • Regulatory NewsRegulatory News

    USP, British Pharmacopoeia Formalize Quality Standards Partnership

    The US Pharmacopeia (USP) and its UK counterpart the British Pharmacopoeia (BP) on Friday signed a memorandum of understanding formalizing a partnership to strengthen quality standards for medicines.   While the two organizations are the officially recognized pharmacopeias in their respective countries, drugmakers often propose specifications in their applications based on quality standards from international pharmacopeias. In 2017, the US Food and Drug Administration ...
  • ReconRecon

    Recon: Merck Beats Q2 Earnings Estimate, Boosted by US MMR Vaccine Sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck smashes Wall Street earnings and revenue estimates ( CNBC ) ( Financial Times ) ( Bloomberg ) Nasty US measles outbreak helps boost Merck’s vaccine sales in second quarter ( CNBC ) Gilead, Novartis cancer therapies losing patients to experimental treatments ( Reuters ) Eli Lilly CEO to 2020 candidates: Capping drug prices would not lead to lower health-c...
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    Industry Groups Support FDA’s Latest Biosimilar Analytic Assessment Guidance

    Industry groups representing pharmaceutical, biologic and biosimilar manufacturers say they support the US Food and Drug Administration’s (FDA) draft guidance on comparative analytical assessment and other quality-related considerations for developing biosimilars, though some sticking points remain.   The 28-page draft guidance revises the agency’s 2015 guidance on quality consideration for demonstrating biosimilarity and replaces a 2017 draft guidance on statistical...
  • ReconRecon

    Recon: Pfizer to Merge Off-Patent Drug Business With Mylan

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer to Merge Its Off-Patent Drug Unit With Mylan ( NYTimes ) ( Financial Times ) ( STAT ) ( WSJ ) ( NBC ) ( Bloomberg ) ( Forbes ) ( Press ) Pfizer posts 30% rise in quarterly profit ( Reuters ) ( Press ) Little-known generic drugmakers played central role in opioid crisis, records show ( Washington Post ) Cummings plans to call pharma executives to testify...
  • ReconRecon

    Recon: CHMP Recommends Five New Medicines; AbbVie’s Humira Expected to Remain Top Selling Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie raises guidance as cancer treatments boost sales ( Financial Times ) Humira set to remain world's best selling drug ( Reuters ) McKinsey Advised Johnson & Johnson on Increasing Opioid Sales ( NYTimes ) 76 Billion Pills, 6 Companies And An Opioid Trial For The Ages ( 1A ) Litigation Over America's Opioid Crisis Is Heating Up ( NPR ) Robotic Surgical To...
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    Senate Committee Advances Bipartisan Drug Pricing Package

    The US Senate Committee on Finance on Thursday advanced a bill aimed at lowering drug prices for Medicare and increasing price transparency within the program in a 19-9 vote, sending it to the full Senate for consideration.   While the bipartisan Prescription Drug Pricing Reduction Act of 2019 was proposed by Committee Chairman Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR), most votes in favor of the bill came from the Democratic minority in the committee...
  • ReconRecon

    Recon: BMS Posts Mixed Results for Opdivo in Lung Cancer Phase III Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pharma gets an audience with Trump ( Politico ) White House preparing order that would cut drug prices for Medicare: sources ( Reuters ) First CRISPR study inside the body to start in US ( STAT ) Eli Lilly's hypoglycemia treatment wins FDA approval ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) Vertex Pharmaceuticals’ Jeffrey Leiden to step aside as CEO ( STAT )...
  • Regulatory NewsRegulatory News

    FDA Seeks Input on Biomarker, Endpoint Glossary

    Two-and-a-half years after its release, the US Food and Drug Administration (FDA) is asking for input from the public on the utility of its Biomarkers, EndpointS, and other Tools (BEST) glossary as it looks to refine the resource going forward.   “Today we are seeking public comment on this resource to help determine its utility, develop future iterations and best identify methods for conveying this information. Ultimately, we hope that this glossary will help in acc...
  • ReconRecon

    Recon: Roche Among Companies Hit by Winnti Cyber Attack; FDA Cancels Advisory Panel for Intra-Cellular’s Schizophrenia Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA cancels panel review of Intra-Cellular’s schizophrenia drug, causing shares to tumble ( STAT ) ( Endpoints ) ( BioPharmaDive ) 6 burning questions about the Senate Finance Committee’s ambitious new drug pricing plan ( STAT ) Sun Pharma sales reps claims he was fired for complaining about off-label marketing ( STAT ) Patients, backed by ‘dark money’ group, ...