• ReconRecon

    Recon: CMS Finalizes CAR-T Coverage Decision; Bayer Buys Remaining Stake in Cell Therapy Co. BlueRock

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bayer to buy rest of US biotech company in rare offensive move ( Financial Times ) ( Endpoints ) ( Press ) CMS finalizes long-sought rules for Medicare CAR-T coverage ( STAT ) ( WSJ ) ( Reuters ) ( CMS ) Better Birth Control Could Exist, But It Wouldn’t Pay for Big Pharma ( Bloomberg ) Bausch Health CEO: Big Pharma will survive US drug regulations ( CNBC ) FD...
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    Fabry Disease: FDA Drafts Drug Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations to drugmakers on clinical trial design and eligibility criteria for products to treat Fabry disease. Fabry disease is a rare inherited disorder caused by a deficiency of the lysosomal enzyme alpha-galactosidase A (α-Gal A). According to FDA, patients with Fabry disease experience chronic gastrointestinal and neuropathic symptoms and progressive organ damage that eventu...
  • ReconRecon

    Recon: AZ Claims Phase III Success for Lynparza in Prostate Cancer; NICE Backs Nerlynx in Adjuvant HER2+ Breast Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amag's female libido injectable therapy to sell at $899 ( Reuters ) Patient groups push back against Gilead's pricey HIV prevention treatment ( Reuters ) Opioid Distributors Propose $10 Billion to End State Claims ( Bloomberg ) ( CNBC ) US Judge Expresses Support for Novel Opioid Settlement Talks Framework ( Reuters ) Boom in overdose-reversing drug is tied t...
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    FDA Reports on Status of Postmarketing Requirements and Commitments

    The US Food and Drug Administration (FDA) on Tuesday released a report on drugmakers’ performance in conducting postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in FY2018 that finds most of the studies are progressing on schedule.   A PMR is a study or clinical trial that an applicant is required by statute or regulation to conduct following approval, while a PMC is a study or clinical trial that an applicant agrees in writing to conduct postappro...
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    Updated: FDA Reviewing Data Manipulation in Application for Novartis Gene Therapy Zolgensma

    In a statement issued Tuesday, Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), said the agency is investigating data manipulation submitted in the biologics license application (BLA) for Novartis’ gene therapy Zolgensma (onasemnogene abeparvovec-xioi).   Zolgensma was developed by AveXis, Inc., which was acquired by Novartis in an $8.7 billion deal in April 2018 and was approved last May to t...
  • ReconRecon

    Recon: GSK Ends Ebola Vaccine Development, Transfers Vaccine Candidates to Sabin Institute

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 2020 election creates ‘perfect storm’ for drug price reform by year-end ( CNBC ) Deadly Germ Research Is Shut Down at Army Lab Over Safety Concerns ( NYTimes ) Diabetes drug maker Novo Nordisk buys pill factory in North Carolina ( Reuters ) Amid rising concern, pay-to-play clinical trials are drawing federal scrutiny ( STAT ) Help how? Patient charities favor...
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    International Regulators Call for Action on Antimicrobial Resistance

    The International Coalition of Medicines Regulatory Authorities (ICMRA) on Thursday issued a statement calling on industry, healthcare practitioners, researchers and other global health leaders to address the growing threat of antimicrobial resistance (AMR).   ICMRA says it supports the World Health Organization’s (WHO) efforts on the matter, and notes that WHO has called AMR “one of the top ten threats to global public health [and] threatens our ability to treat even ...
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    EMA Clarifies Requirements for Peptones Used in Active Substance Manufacturing

    The European Medicines Agency (EMA) on Monday clarified the documentation and declaration requirements for peptones used in the manufacture of active substances in an update to its quality of medicines questions and answers (Q&A) guide.   The Q&A covers issues brought to EMA’s Joint Committee for Medicinal Products for Human Use/Committee for Medicinal Products for Veterinary Use Quality Working Party and express the harmonized position of European Economic Area compet...
  • ReconRecon

    Recon: Roche Reports Positive Phase III Results for Tecentriq Combo in Bladder Cancer; Colombia Fines Pfizer for Exceeding Price Caps

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Daiichi Sankyo's treatment for rare joint tumor ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) White House Weighs September Rollout of Health Plan ( WSJ ) ( Reuters ) Drug industry urges Canada to act early on U.S. import plan ( Reuters ) Eli Lilly confirms probe by New York’s Attorney General over insulin prices ( CNBC ) States Clash with Cities Ov...
  • ReconRecon

    Recon: Philippines Considers Reviving Use of Sanofi Dengue Vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US PhRMA’s top lobbyist will leave at the end of August ( STAT ) A Blood Test for Alzheimer’s? It’s Coming, Scientists Report ( NYTimes ) Federal judge allows pharma to proceed with lawsuit against California transparency law ( STAT ) BioMarin drops lower dose of its hemophilia gene therapy as it eyes submissions by year-end ( Fierce ) ( Endpoints ) Clovis dives...
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    Radiopharmaceuticals: FDA Finalizes Guidance on Nonclinical Studies, Labeling

    The US Food and Drug Administration (FDA) on Thursday finalized guidance on designing nonclinical studies and product labeling for radiopharmaceuticals used in oncology.   FDA says the guidance is meant to provide a “more consistent approach in nonclinical studies and product labeling” for a “unique and challenging area of product development.”   In the guidance, FDA defines therapeutic radiopharmaceuticals for oncology as products that contain a radionuclide that ...
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    FDA FY2020 User Fee Table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2020 from the manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities that produce compounded drugs. The table below lists the fees for each program:   Program: FY2020 FY2019 Prescription Drug User Fee Act (PDUFA VI)     Applications:          Requiring clinical data $2,942,965 $2,588,478      Not...