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    Regulatory Recon: Pfizer Signs $830M Discovery Pact with Arvinas Philippines Fines Sanofi, Pulls Dengvaxia Registration (4 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pfizer lines up an $830M alliance with Arvinas on protein degradation ( Endpoints ) ( Fierce ) ( Pharmafile ) ( Press ) Drug Policy: The Year In Review, And The Year Ahead ( Health Affairs ) Momenta, Mylan plan trial of biosimilar to Regeneron eye drug ( Reuters ) FDA Denies 3rd Allergan Citizen Petition to Block Restasis Generics ( Focus ) Allergan to cut mo...
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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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    Asia Regulatory Roundup: TGA Adopts Guidance on Device Priority Review Pathway (2 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Adopts Guidance on Medical Device Priority Review Pathway Australia’s Therapeutic Goods Administration (TGA) has adopted guidance on its priority review pathway for medical devices. The adoption of the guidance allows developers of highly promising devices aimed at serious unmet needs to jump to the front of the queue when they file for approval. Devices must mee...
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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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    European Regulatory Roundup: Roche Escapes Penalty for Breaching EU Pharmacovigilance Rules (21 December 2018)

    Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe. Roche Escapes Penalty for Breaching European Pharmacovigilance Rules Roche has escaped punishment over its failure to comply with pharmacovigilance requirements. The European Commission showed leniency after concluding Roche's response to its shortcomings made the imposition of a financial penalty unnecessary. The genesis of the case dates back to 2012, when the Commission...
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    Perspective: Regulatory Bill Could be Dangerous for FDA, Public Health

    A bill making its way through Congress could end up having "potentially disastrous consequences" for the US Food and Drug Administration (FDA) and public health, professors from the Program on Regulation, Therapeutics, and Law at Harvard Medical School and the Georgia State University College of Law, wrote in the New England Journal of Medicine this week. The bill, known as the Regulatory Accountability Act , has been promoted as a way to decrease burdensome regul...
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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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    Asia Regulatory Roundup: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines (19 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines Australia’s Therapeutic Goods Administration (TGA) has finalized its timelines for reporting adverse events involving biologicals. The timelines are unchanged from draft guidance published last year that was criticized by companies including Pfizer for giving sponsors too little time to act. Un...
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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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    Use of Standards at CBER: New Draft Guidance

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Monday released draft guidance offering recommendations on the use of standards in product development and the use of such standards in CBER’s managed review process. The draft describes how standards are developed, the benefits of using standards and CBER’s policy on accepting standards used in regulatory submissions. Questions and answers contained within the draf...