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    FDA Issues Drug Compounding Small Entity Compliance Guide

    The US Food and Drug Administration (FDA) on Thursday issued a new questions and answers guidance intended to explain how small entities can comply with its recent final rule detailing the bulk drug substances that can be used in compounded drugs.   In February, FDA finalized its list of bulk drug substances that can be used to compound drugs under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The list currently includes six bulk drug substan...
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    Recon: FDA Approves Novartis’ SMA Gene Therapy With $2.1M Price Tag

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US $2.1 million drug to treat rare genetic disease approved by FDA ( NBC ) ( STAT ) ( FDA ) JPMorgan cuts ties with OxyContin maker Purdue Pharma ( Reuters ) ( CBS ) ( NBC ) McKinsey No Longer Consulting for Purdue, Ends Opioid Work ( Bloomberg ) Trump Administration Preparing Executive Order on Health-Cost Disclosure ( WSJ ) Senate bill to cut health costs, tar...
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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 24 May 2019 to include: FDA approved Novartis' Zolgensma to treat childr...
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    FDA Clears New Tests for Chlamydia, Gonorrhea, Zika Virus and Prosthetic Joint Infections

    The US Food and Drug Administration (FDA) on Thursday cleared three new tests that can detect the presence of chlamydia and gonorrhea and authorized the marketing of a diagnostic to detect Zika virus immunoglobulin (IgM) antibodies in human blood.   The agency also authorized the first diagnostic to aid in detecting whether a patient has an injection around a prosthetic joint implant.   Hologic’s Aptima Combo 2 Assay and Cepheid’s Xpert CT/NG are the first devices ...
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    Recon: Gottlieb Returns to Biotech VC Firm; UN Creates New Ebola Chief Role

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Former FDA head Scott Gottlieb rejoins VC firm ( Axios ) ( WSJ ) ( Endpoints ) ( Fierce ) Novartis CEO plans gene therapy price 'far lower' than $4 million to $5 million range ( Reuters ) ( STAT ) Did FDA unfairly treat Catalyst by approving a similar drug from another company? ( STAT ) In a change of plans, Nektar spins out its opioid into a new biotech subsi...
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    FDA Solicits PreCert Software Developer Volunteers

    The US Food and Drug Administration (FDA) on Wednesday put out a call for digital health software developers to participate in the agency’s software precertification (Pre-Cert) program as part of its 2019 Test Plan .   FDA first detailed the Test Plan in January, saying its primary purpose is to determine whether the excellence appraisal and streamlined review components of the Pre-Cert program “produce an equivalent basis for determining reasonable assurance of saf...
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    Recon: Amgen to Buy Scandinavian Biotech Nuevolution for $167M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The real drug pricing debate is upon us ( Axios ) Eli Lilly's half-price insulin goes on sale, but critics say it's still too costly ( CBS ) Latecomer Lilly preps its IL-23 drug for Crohn’s disease ( PMLive ) ( BioPharmaDive ) China’s ban on fentanyl drugs won't likely stem America’s opioid crisis ( LA Times ) US measles outbreak spreads to Maine, 25th state ...
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    FDA Chief of Staff Calls OTC Monograph Reform a Top Priority

    In a speech at the Consumer Healthcare Products Association’s Regulatory, Scientific and Quality Conference on Tuesday, US Food and Drug Administration (FDA) Chief of Staff Lauren Silvis said the agency is committed to boosting access to safe and effective nonprescription drugs.   In the US, nonprescription drugs can be marketed by conforming to an over-the-counter (OTC) monograph or via the new drug application (NDA) pathway.   “On the monograph side, I want to ma...
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    Recon: Merck to Buy Peloton for $1.1B to Boost Cancer Pipeline

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck agrees $1bn deal to buy biopharmaceutical company Peloton ( Financial Times ) ( WSJ ) ( Reuters ) ( Endpoints ) ( Law360 -$) ( Press ) Merck's Keytruda fails as monotherapy in breast cancer study ( Reuters ) ( Endpoints ) ( PMLive ) ( Press ) Generic drug price-fixing suit is akin to earlier case, but ‘on steroids,’ Conn. prosecutor says ( STAT ) ( PBS ) ...
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    Groups Seek More FDA Flexibility in Early Cell Therapy Development

    A new white paper from the Friends of Cancer Research (FOCR) and the Parker Institute for Cancer Immunotherapy calls on the US Food and Drug Administration (FDA) to ease clinical and manufacturing requirements to speed early development of anti-cancer cell therapies.   In recent years cell therapies, including engineered T-cell receptor (TCR) and chimeric antigen receptor (CAR) T-cell therapies have shown promise in treating a wide range of cancers. To date, FDA has ap...
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    Recon: Canadian Fund Buys Keytruda Rights from UK's LifeArc for £1B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gates-backed Schrödinger raises $110m for new drug push ( Financial Times ) ( Fierce ) Exit Of No. 2 At Amazon’s Haven Keeps Walmart Employee Health Strategy In Lead ( Forbes ) ( STAT ) Dana-Farber prevails in immunotherapy dispute over patents behind blockbuster drug ( STAT ) ( Endpoints ) Commentary: We need to make sure new drug cures don’t widen income gap...
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    Recon: NICE Backs Revlimid for First Line Multiple Myeloma Treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US House Passes Legislation Aiming to Shore Up Health Law and Lower Drug Costs ( NYTimes ) ( The Hill ) ( Politico ) Trump administration backs off a proposal to let Medicare plans exclude certain drugs ( STAT ) ( CNBC ) Gilead CEO parries with congressional Democrats over an HIV prevention pill ( STAT ) ( Endpoints ) AbbVie halts enrollment after brain cancer tr...