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    Regulatory NewsRegulatory News

    Regulatory Recon: Lilly CEO Says Tax Reform May Boost Pharma Deal Making 50 Top Managers Replaced at GSK in Walmsley's 1st Year (9 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Eli Lilly CEO Says Tax Reform May Lead to More Successful Deals ( Bloomberg ) ( CNBC ) Drug Industry Isn't Giving Up on Alzheimer's ( WSJ ) The Winners And Losers Of JP Morgan Monday ( Forbes ) Axovant: That positive p-value we reported yesterday? Um, we screwed that up too ( Endpoints ) Pfizer program seeks closer ties with top universities ( Fierce ) ( Press...
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    Asia Regulatory Roundup: China Posts Guiding Principles on Device Trials (9 January 2018)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Seeks Feedback on Drug Data Management Practices China is seeking feedback on its draft drug data management practices. The China Food and Drug Administration (CFDA) text details how individuals and organizations involved in the development, production, distribution and monitoring of drugs should ensure the accuracy and traceability of the data they generate. C...
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    Regulatory Recon: Celgene to Buy Impact Biomedicines for Up to $7B Ablynx Rejects Novo's $3.1B Bid (8 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US $11 billion biotech binge fuels forecasts of 2018 M&A surge ( Reuters ) ( Boston Globe ) Celgene to Buy Impact Biomedicines ( WSJ ) ( STAT ) ( Endpoints ) ( Fierce ) ( Financial Times ) ( Press ) Good morning from JPM ( Politico ) ( STAT ) JPM is like a biotech dating game, just ask these questions before hooking up ( STAT ) Axovant shares blasted as premier ...
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    Regulatory Recon: FDA Expands Use of Amgen's Fracture Prevention Drug Xgeva Takeda Signs Alzheimer's Pact With Denali, Strikes Deal to Acquire TiGenix (5 January 2018)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Drug Industry Is Ripe for a Wave of Deals ( WSJ ) FDA expands use of Amgen's blockbuster drug ( Reuters ) Look out, Teva: Mylan's Copaxone copy has already captured serious share ( Fierce ) Johnson & Johnson pens Alzheimer's gene therapy pact ( Fierce ) ( Endpoints ) Kala Pharma shares damaged by mixed data from PhIII dry eye program ( Endpoints ) ( Press ) C...
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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...