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    Industry Comments on ICH Product Lifecycle Management Guideline

    The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's (ICH) draft guideline on pharmaceutical product lifecycle management.   The 31-page draft guideline , ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management , was adopted by ICH and released for public consultation last year.   Most of the comments EMA received express...
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    Recon: Chinese Scientist May Face Criminal Charges After Editing Babies' Genes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The Warren bill could promote beneficial public-private partnerships in the life sciences ( STAT ) Tufts to review ties to Purdue Pharma after ‘deeply troubling’ disclosures ( STAT ) AbbVie's Imbruvica fails to meet main goal in pancreatic cancer study ( Reuters ) ( Evaluate ) ( Press ) Study Links Drug Maker Gifts for Doctors to More Overdose Deaths ( NYTimes...
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    Recon: FDA Panel Split on Sanofi-Lexicon Diabetes Drug; Lilly's Latruvo Fails Confirmatory Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists ( CNBC ) Immunomedics' cancer treatment fails to win accelerated approval from the FDA ( Reuters ) ( STAT ) ( Endpoints ) Lilly’s approved cancer drug Lartruvo fails confirmatory study, setting the stage for withdrawal of regulatory endorsement ( Endpoints )...
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    FDA Modifies REMS Program for Clozapine

    The US Food and Drug Administration (FDA) announced changes to its risk evaluation and mitigation strategy (REMS) for the antipsychotic drug clozapine, set to take effect on 28 February 2019.   Background   Clozapine, which is marketed as Clozaril, Fazaclo ODT and Versacloz, is an antipsychotic drug first developed in the late 1950s and was first approved by FDA in 1989. Clozapine is indicated for the treatment of schizophrenia in patients whose symptoms are not ad...
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    Recon: NICE Recommends Lilly's Verzenios for Advanced Breast Cancer; J&J to Use Apple Watch for Heart Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Key House Dem: I don't want to 'punish' drug companies ( The Hill ) Rep. DeGette, newly atop an oversight subcommittee, promises to grill drug industry CEOs and investigate insulin makers ( STAT ) HHS secretary, Senate Finance Republicans talk drug pricing ( The Hill ) PhRMA CEO 'hopeful' Trump officials will back down on drug pricing move ( The Hill ) Johnso...
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    EU Advances SPC Waiver Proposal

    The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) took a step forward on Wednesday after EU ambassadors backed the EU Council's position on the proposed regulation during a meeting of the Committee of the Permanent Representatives (Coreper).   "The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established o...
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    Recon: Massachusetts AG Says Sackler Family Pushed Opioid Sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sacklers Directed Efforts to Mislead Public About OxyContin, New Documents Indicate ( NYTimes ) ( Reuters ) ( WSJ ) ( NBC ) FDA nervous about PDUFA ( Politico ) ( CNN ) Senators Ask FDA to Update Rules on Certain Pot Products ( NYTimes ) ABC documentary on Theranos features ex-CEO deposition tapes ( Reuters ) Can Trump claim credit for $26 billion in savings ...
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    Gottlieb, Marks Detail Plans to Advance Development of Cell and Gene Therapies

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks on Tuesday detailed plans for the agency to keep pace with an expected influx of applications for cell and gene therapies over the coming years.   "The FDA is witnessing a surge of cell and gene therapy products entering early development, evidenced by a large upswing in the number of investigational new drug (IND) applications,...
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    Recon: Edwards Pays Boston Scientific $180M to End Patent Dispute

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lawmakers want feds to look at how a Bristol-Celgene deal affects prices and competition ( STAT ) ( Letter ) Edward Lifesciences pays Boston Scientific $180 million to end patent row ( Reuters ) Biopharma Dealmaking in 2018 ( Nature ) 2018 FDA approvals hit all-time high — but average value slips again ( Nature ) Vermont Report Finds that the Costs of Prescri...
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    EMA Consults on Harmonized Antibacterial Drug Development Guideline

    The European Medicines Agency (EMA) on Monday released a draft version of its guideline on developing antibacterial medicines for consultation.   The 30-page guideline, which is now on its third revision, has been updated to reflect a harmonized approach to antibacterial drug development based on the tripartite discussions between EMA, the US Food and Drug Administration and Japan's Pharmaceuticals and Medical Devices Agency.   "Antimicrobial resistance is a glob...
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    Recon: FDA Staff Unfazed by CV Signal in Amgen's Osteoporosis Trials; China Opens Probe Into Expired Polio Vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca Departures Continue as Medical Chief Bohen Exits ( Bloomberg ) ( Endpoints ) FDA staff largely unfazed by CV signal in Amgen osteoporosis drug trials ( Endpoints ) Trump falsely claims ‘drug prices declined in 2018’ ( STAT ) Booker tries to shake doubts about pharmaceutical ties ahead of 2020 ( The Hill ) Sanofi-Genzyme inappropriately sought conf...
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    Democrats, Republicans Unveil Drug Pricing Bills

    As a new Congressional term kicks off, Democrats and Republicans in Congress, as well as the Trump administration, are pushing policies to lower prescription drug prices.   On Wednesday, Sens. Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) introduced a bill, dubbed the Safe and Affordable Drugs from Canada Act of 2019, that would allow for Americans to import drugs from Canada. The bill mirrors the bill by the same name championed by the late Sen. John McCain (R-AZ...