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    Regulatory Recon: Spark Prices Gene Therapy at $850,000 WHO Prequalifies Typhoid Vaccine (3 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Spark to charge $850,000 per patient for blindness gene therapy ( Reuters ) ( Endpoints ) ( STAT ) ( CNBC ) ( Washington Post ) ( Forbes ) ( WSJ ) Drugmakers raise 2018 US prices, stick to self-imposed limits ( Reuters ) ( STAT ) ( Fierce ) 2017 Was the Year of Gene-Therapy Breakthroughs ( MIT Technology Review ) Scott Gottlieb issues a lot of statements. Quite...
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    Regulatory Recon: Biopharma and Legislative Questions for 2018 (2 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US After Hurricane Maria, IV bags are still in short supply ( Newsweek ) FDA chief: I'm surprised it took big tech this long to get into health care ( CNBC ) Trump FDA Chief Scott Gottlieb Isn't Pharma's BFF After All ( Bloomberg ) Toward Better-Quality Compounded Drugs — An Update from the FDA ( NEJM ) In 2018, we will CRISPR humans ( Gizmodo ) Mallinckro...
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    Regulatory Recon: Roche Buys Cancer Specialist Ignyta for $1.7B FDA Approves La Jolla's Low Blood Pressure Drug (22 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves La Jolla's low blood pressure drug ( Reuters ) ( FDA ) Roche snaps up Ignyta and its experimental lung cancer drug for $1.7 billion ( STAT ) ( Reuters ) ( Endpoints ) ( Financial Times ) ( Press ) New Drug Approvals for FDA: 2017 Hits 21-Year High ( Focus ) ( STAT ) FDA Chief Says He's Open To Rethinking Incentives On Orphan Drugs ( NPR ) 2.3% Tax...
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    Regulatory Recon: United Therapeutics Settles US Kickback Probe for $210M Roche Wins US, EU Cancer Approvals (21 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US United Therapeutics to pay $210 million to resolve US kickback probe ( Reuters ) ( STAT ) ( DoJ ) Fearful of a Shutdown, Congress Inches Toward Stopgap Spending Bill ( NYTimes ) Will Trump Listen to AdvaMed's 11th Hour Tax Plea? ( MDDI ) ( AdvaMed ) CHIP gets some funding, but will Democrats go along? ( Politico ) Those high-priced CAR-T therapies are actually...
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    Regulatory Recon: Legal Experts Question Alternative 510(k) Pathway France Fines J&J Over Painkiller Patch (20 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Best of 2017: What Readers Clicked on This Year ( Focus ) GOP Finally Notches 2017 Victory While Bracing for 2018 Verdict ( NYTimes 1, 2 ) ( Washington Post ) ( Senate Finance ) House to vote again on tax bill; Trump on verge of win ( Reuters ) FDA Medical Device Proposal May Skirt the Law: Legal Experts ( Reuters ) NY AG Announces $13.5M Multi-State Settleme...
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    Regulatory Recon: FDA Approves Aerie's Glaucoma Drug US Lifts Funding Ban on High Risk Virus Research (19 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Aerie's glaucoma treatment gets early FDA approval ( Reuters ) ( Endpoints ) ( Press ) Dr. Reddy's resolves US probe over child safety of drug packaging ( Reuters ) ( Economic Times ) US lifts moratorium on funding controversial, high-risk virus research ( STAT ) Senate, House Agree to Cut Orphan Drug Research Credit in Half in Tax Bill ( Focus ) FDA Plots New...
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    Regulatory Recon: Whistleblowers Say DEA Went Easy on McKesson Ultragenyx Sells PRV to Novartis for $130M (18 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US The Winners and Losers in the Tax Bill ( NYTimes ) Whistleblowers: DEA attorneys went easy on McKesson, the country's largest drug distributor( 60 Minutes ) ( Washington Post ) ( STAT ) Ultragenyx Sells Priority Review Voucher to Novartis for $130 million ( Press ) ( Endpoints ) In Opioid Battle, Cherokee Want Their Day in Tribal Court ( NYTimes ) CRISPR in ...
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    Regulatory Recon: FDA Lifts Hold on Alnylam Hemophilia Trials EMA Recommends 7 New Medicines for EU Approval (15 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Aclaris's drug to treat common skin growth gets FDA nod ( Reuters ) FDA allows Alnylam to restart hemophilia treatment trials ( Reuters ) ( Endpoints ) ( Press ) Pfizer's Xeljanz gets FDA nod as joint disease treatment ( Reuters ) ( Press ) To Be (a Device) Or Not to Be? That Is the Question ( Fortune ) CAR T cells — what have we learnt? ( Nature ) What's Com...
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    Regulatory Recon: Months After Approval, Gilead's Yescarta Has Treated Just Five Patients Teva to Cut 14,000 Jobs (14 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Months After Approval, Breakthrough Cancer Drug Given to Just Five Patients ( Bloomberg ) Pfizer's second biosimilar of J&J's Remicade wins FDA approval ( Reuters ) ( Pharmafile ) ( Press ) FDA Panel Gives Thumbs Down to Spine Device ( Medpage ) ( EP Vantage ) Drug Companies' Liability for the Opioid Epidemic ( NEJM ) Pharma industry's return on R&D investment...
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    Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Why a drug for aging would challenge Washington ( Politico ) FDA statement on The Uncertain Hour's OxyContin episode ( Marketplace ) How Alex Azar could try to shake up drug prices through Medicare Part B ( STAT ) Some drug makers are considered good corporate citizens ( STAT               ) What pharma's watching as Congress tries to hammer out a tax bill ( S...
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    Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis Allergan Acquires Ailing Repros (12 December 2017)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA warns companies for promoting alternatives to street drugs ( FDA ) FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis ( FDA ) Allergan buys an ailing Repros, bagging a women's health drug for the pipeline ( Endpoints ) FDA Plans New Medical-Device Approval Processes ( WSJ ) ( Reuters ) ( FDAVoice ) Three more drug makers allegedly us...
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    Regulatory Recon: News From ASH 2017 Drugmakers Sue to Block Calif. Price Law (11 December 2017)

    • 11 December 2017
    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Drug companies sue to block California drug price law ( AP ) ( LA Times ) ( Reuters ) ( Bloomberg ) ( Law360 -$) Tax bill may target pharma's DTC deduction, but ad industry's ready to defend it ( Fierce ) Sympathetic Congress has not acted to derail medical device tax ( Star Tribune ) When Buying Prescription Drugs, Some Pay More With Insurance Than Without It ...