• Regulatory NewsRegulatory News

    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...
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    FDA to Launch Expanded Access Pilot ‘Project Facilitate’ by End of May

    Ahead of the launch of a new pilot aimed at improving patient access to unapproved oncology drugs, dubbed Project Facilitate, the US Food and Drug Administration (FDA) held a public workshop on Thursday explaining its goals for the initiative and to discuss ongoing issues related to expanded access.   According to Richard Pazdur, director of FDA’s Oncology Center of Excellence, the pilot will be rolled out towards the end of May.   “Access to clinical trials and ac...
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    Recon: FDA Approves First Blood Thinner for Pediatric Use

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots ( FDA ) Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia ( Reuters ) ( Press ) Gilead CEO to testify before a House committee about pricing for its HIV prevention pill ( STAT ) Novar...
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    FDA Updates on Essure Postmarketing Study

    Months after Bayer ended US sales and distribution of its permanent birth control device Essure, the US Food and Drug Administration (FDA) on Wednesday provided an update on the ongoing postmarketing safety review of the device.   “Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available,” said Center for Devices and Radio...
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    Recon: Japan Clears $306k Pricetag for Novartis’ Kymriah

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vertex to pay startup Kymera $70 million in R&D deal ( STAT ) ( Endpoints ) Gilead struck anti-competitive deals to bolster profits on an HIV drug, lawsuit says ( STAT ) ( CNBC ) To Combat Generic Drugs' High Prices, Civica RX To Make 2 Antibiotics ( NPR ) ( STAT ) ( WSJ ) Alphabet is funding a new way to reduce heart disease, the leading cause of death in the...
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    OPQ Reports on State of Drug Quality in FY2018

    In a report released Monday, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) provides a look at the pharmaceutical quality landscape for drugs and biologics intended for the US market.   The report itself breaks down different metrics related to product quality and manufacturer compliance with current good manufacturing practice (cGMP) to paint a picture of the overall pharmaceutical quality landscape.   While FDA reports an overa...