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    FDA Warns Joint Replacement Maker, Australian Drugmaker

    The US Food and Drug Administration (FDA) recently warned Massachusetts-based device maker Conformis Inc. and Australian over-the-counter (OTC) drugmaker Wild Child WA Pty Ltd. for good manufacturing practice (GMP) issues uncovered during inspections earlier this year.   Conformis Inc.   FDA’s warning letter to Conformis comes after a seven-day inspection in September and November of this year for failing to establish and maintain an adequate corrective and prevent...
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    Recon: FDA Warns of Breathing Problems With Gabapentinoids; Merck’s Ebola Vaccine Wins FDA Approval

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck receives FDA approval for Ebola vaccine ( Reuters ) ( STAT ) ( FDA ) ( Press ) Gilead submits an NDA for its big blockbuster hopeful ( Endpoints ) ( Fierce ) ( Press ) Novartis wins Medicaid approval for new sickle cell drug in key US states ( Reuters ) Behind the Biotech Stock Rally: New Deals and Easing Political Worries ( WSJ ) House Passes North Ame...
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    Regulatory NewsRegulatory News

    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 20 December 2019 to include: Merck won a PRV for the approval of its Ebo...
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    WHO Prequalifies its First Biosimilar

    The World Health Organization (WHO) on Wednesday announced it has prequalified its first biosimilar, a year and a half after it invited manufacturers to submit applications for prequalifying biosimilars to two biologics on its Essential Medicines List , Roche’s Rituxan (rituximab) and Herceptin (trastuzumab).   The newly prequalified medicine is Samsung Bioepis’ Ontruzant, a biosimilar version of trastuzumab. WHO says it assessed the medicine and found it “comparabl...
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    FDA Drafts Guidance on Demonstrating Substantial Evidence of Effectiveness

    The US Food and Drug Administration (FDA) on Thursday issued draft guidance on demonstrating “substantial evidence” of effectiveness for drugs and biologics, expanding on decades old guidance issued to address statutory changes brought on by the Food and Drug Administration Modernization Act of 1997 (FDAMA).   Specifically, the 18-page draft guidance builds on FDA’s 1998 guidance Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products ,...
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    Recon: Novartis Plans Lottery for Free Zolgensma Treatments; FDA Approves Astellas, Seattle Genetics' Padcev for Advanced Urothelial Cancer

    Editor's note: this edition of Regulatory Recon has been updated to correctly attribute the approval of Padcev to Astellas and Seattle Genetics and to correctly identify Urogen's submission and acceptance for priority review of UGN-101  for low-grade upper tract urothelial carcinoma. Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA grants accelerated approval to Astellas, Seattle Genetics' Padcev ( Re...
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    FDA Drafts Guidance on Bridging Data for Combination Product Applications

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance explaining how drug-device and biologic-device combination product sponsors can bridge data from earlier stages or development or other development programs to support an application.   In the 14-page draft guidance, FDA describes how sponsors can develop an analytical framework for identifying information gaps that could be addressed with bridging. The draft provides three examples of bridgin...
  • ReconRecon

    Recon: FDA Panel Backs New Indications for Keytruda, Lynparza; FTC Moves to Block Illumina’s PacBio Acquisition

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drug Importation Plans: Lots of Exclusions, Unclear Timeline ( Focus ) The FTC moves to block DNA sequencer Illumina’s acquisition of PacBio, calling company a ‘monopolist’ ( STAT ) ( Endpoints ) ( Law360 -$) ( FTC ) US sues CVS for fraudulently billing Medicare, Medicaid for invalid prescriptions ( Reuters ) ( STAT ) FDA Supports Budget Bill’s Changes to Chem...
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    Regulators Launch International Sterile Medicines Inspection Pilot

    The European Medicines Agency (EMA) on Tuesday announced the launch of a two-year pilot that will allow regulators across the EU, US, UK, Australia and Canada to share information from good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.   Specifically, the pilot will enable information sharing from GMP inspections of manufacturers located in countries that are not participating in the pilot and allow participants to organize joint in...
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    Recon: Roche Completes Spark Acquisition; FDA Approves Expanded Indication for Pfizer’s Xtandi

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves expanded label for Pfizer’s prostate cancer drug Xtandi ( CNBC ) ( Endpoints ) ( Press ) Alnylam gene-silencing therapy succeeds in late-stage study ( STAT ) ( Reuters ) ( Endpoints ) ( Press ) FDA’s staff review offers bleak assessment of Epizyme’s tazemetostat ( Endpoints ) ( Fierce ) Adamas drug to help MS patients walk does not show expected c...
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    FDA Wants to End Quarterly Reporting of Device Decisions

    The US Food and Drug Administration (FDA) on Monday proposed revisions to its medical device regulations to end its practice of publishing quarterly lists of its approval or denial decisions for premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register .   FDA says the rule will improve efficiency and eliminate duplication in publishing PMA and HDE decisions, as the agency publishes the same information, along with summar...
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    Recon: Novartis Drops Asthma Drug After More Trial Misses; Gilead NASH Combo Fails in Mid-Stage Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bristol-Myers wins $752 million in US patent case against Gilead ( Reuters ) ( Law360 -$) ( Endpoints ) Axsome’s depression drug succeeds in late-stage trial ( STAT ) ( Reuters ) Gilead's NASH combination treatment fails mid-stage study ( Reuters ) ( Endpoints ) A controversial dwarfism drug, after clearing pivotal study, heads to the FDA ( STAT ) ( Endpoints ...