• RoundupsRoundups

    FDA Approvals Roundup: Vabysmo, Cabenuva, Vonvendi

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Vabysmo approved for treating two types of macular disease Genentech’s Vabysmo ( faricimab-svoa; injection ) has been approved for treating wet age-related macular degeneration (AMD) and diabetic macular edema (DME) in adults. The bispecific antibody targets and inhibits the disease pathways in the respective conditions.   Approval of Vabysmo...
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    Orphan drug experts discuss new book on developing rare disease treatments

    Developing therapies for rare diseases involves complex incentives, unique requirements, and often extensive patient engagement. The authors of RAPS’ Orphan Drug Development for Rare Diseases , Sundar Ramanan, PhD, MBA, and Sunny Kamlesh Dave, MPharm, recently took time to discuss with RAPS Senior Editor Gloria Hall the importance of orphan drugs, the peculiarities and challenges of obtaining an orphan drug designation (ODD), and what is covered in the book. During a “m...
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    FDA Approvals Roundup: Ryaltris, Cibinqo, Rinvoq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Ryaltris okayed for seasonal allergic rhinitis Glenmark’s Ryaltris ( olopatadine and mometasone furoate; nasal spray ) has been approved for seasonal allergic rhinitis in adults and pediatric patients aged 12 years or older.   The approval of Ryaltris was based on findings from two multicenter, randomized, double-blind, placebo-and active-co...
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    FDA Approvals Roundup: Quviviq, Recorlev, Rexulti

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Quviviq nabs go-ahead for insomnia in adults Idorsia’s Quviviq ( daridorexant; tablets ) has been approved for treating adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance, pending controlled substance scheduling.   The approval was based on efficacy findings in two studies ( Study 1 and Study 2 )...
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    FDA approved more first-in-class drugs, gave more accelerated approvals in 2021

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure is a slight decrease from 2020 , more drugs were designated as first-in-class and used the accelerated approval pathway than in previous years.   The approvals reported by CDER do not include biologics license applications (BLAs) approved by FDA’s Center for Biologics Evaluation and Research (CBER). In 2021, CBER approved...
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    FDA Approvals Roundup: Tarpeyo, Dartisla ODT, Yusimry

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Tarpeyo approved for reducing proteinuria in IgA nephropathy Calliditas Therapeutics’ Tarpeyo (budesonide) delayed release capsules were granted accelerated approval to reduce proteinuria in adults with primary immunoglobulin A (IgA) nephropathy, also known as Berger’s disease, who are at risk of rapid disease progression. Approval of Tarpeyo wa...
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    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...
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    Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US More than 1 million Americans were diagnosed with COVID over the long holiday weekend ( NPR ) ( Reuters ) Elizabeth Holmes is found guilty of four counts of fraud ( NYT ) ( POLITICO ) The Epic Rise and Fall of Elizabeth Holmes ( NYT ) Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US ( Fierce ) CDER, CBER Approve Total...
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    FDA Approvals Roundup: Apretude, Vyvgart, Tezspire

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals  Apretude cleared for HIV pre-exposure prevention  Viiv’s Apretude (cabotegravir extended-release injectable suspension) has been  approved  for use in at-risk adults and adolescents for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV.  Approval of Apretude was based on safety and efficacy findings from two randomized, dou...
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    Regulatory review of advertising on streaming media

    This article discusses advertising on streaming media and what regulatory reviewers need to take into consideration when reviewing online videos.   Introduction Television. One word, many meanings – it could be the wide-screen home TV, the latest Hulu-exclusive series we binge-watch on an iPad, or the 5-minute Snapchat original series that releases a new episode every week. There is no shortage of places for consumers to view video content outside of a traditional ...
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    This week at FDA: Medtronic MiniMed problems; Device classification flurry

    Welcome to 2021’s last issue of This Week at FDA. This week saw a year-end flurry of device classifications; we are also sharing news of three noteworthy device warning letters and a citizen petition response that closes with FDA’s referring a firm to the Federal Trade Commission (FTC) for anticompetitive practices.    RAPS offices are closed 23 December – 2 January. Regulatory Focus will resume publication on 3 January. From our team to you, our valued readers, best...
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    FDA removes in-person dispensing requirement for abortion medication

    The US Food and Drug Administration (FDA) is modifying the shared Risk Evaluation and Mitigation Strategy (REMS) for mifepristone products to allow women to continue to access the abortion medication through the mail via a certified prescriber.   The move, highlighted on FDA’s mifepristone information webpage and in updates to an associated question-and-answer (Q&A) page on 16 December, makes permanent the eased restrictions permitted during the COVID-19 pandemic. At...