Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Showdown Looms as Senate Democrats Prepare to Reject Spending Bill ( WSJ -$) ( Politico ) House passes stopgap bill that would delay medical device tax; Senate Dems vow filibuster ( MassDevice ) ( MedPage Today ) ( Stat ) No One’s Interests Would Be Served by a Shutdown ( Alliance for a Stronger FDA ) The FDA Budget FY 18: Where Does the Money Come From?...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US US Doctors Plan to Treat Cancer Patients Using CRISPR ( MIT Technology Review ) Gilead's Kite Teams up With Pfizer on a Lymphoma Combo ( Endpoints ) ( Press ) Fed Up With Drug Companies, Hospitals Decide to Start Their Own ( NYTimes ) ( STAT ) How a government shutdown could affect drug safety, flu response, and more ( STAT ) Senate committee advances Azar nom...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Celgene in discussions to buy Juno Therapeutics ( Financial Times ) ( CNBC ) FDA and Pentagon Forge Breakthrough Designation Agreement ( Focus ) ( Reuters ) ( FDA ) FDA expects IV fluid shortage to improve in coming weeks, months ( Reuters ) ( FDA ) Is Juno worth a $10B-$12B buyout price? Analysts see megabucks deal in the making on reported Celgene talks ( End...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Room for another: Sandoz files Humira biosimilar in US ( BioPharmaReporter ) ( PMLive ) ( Press ) Eiger to abandon blood pressure drug after trial failure ( Reuters ) ( Endpoints ) ( Press ) Big Pharma efforts on Alzheimer's tested by Pfizer exit ( Financial Times ) Transparency: FDA to Release Portions of Redacted Clinical Study Reports ( Focus ) ( STAT ) Op ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Gene Therapy Could Make Cancer Care More Unequal, and This Map Shows Why ( MIT Technology Review ) States require doctors to use prescription drug monitoring systems for patients ( Washington Post ) FDA Delays Implementing Parts of 'Intended Use' Rule ( Focus ) ( STAT ) ( Pink Sheet -$) ( Law360 -$) Billionaire-owned Hearing Aid Manufacturer's Former Executives...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US In a pioneering first, AstraZeneca scores FDA OK to use its PARP against breast cancer ( Endpoints ) ( Reuters ) ( GenomeWeb ) ( FDA ) Trump expects medical exam to go well Friday ( Reuters ) Drugmakers see a pricing blueprint in an $850,000 gene therapy ( Reuters ) Wait, It Costs How Much? Biotech Balances Optimism, Uncertainty For 2018 ( Forbes ) Gene therap...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US The FDA still hates low T drugs — experts bat back a pair of contenders ( Endpoints ) ( Medpage ) ( Fierce ) ( Lipocine ) Endo subpoenaed for information on opioid painkillers ( Reuters ) ( WSJ ) An 'unsustainable' model: Drug makers signal interest in exiting vaccine development during crises ( STAT ) JPM18 Day 3: Valeant and Acorda make plans, promises of M&A...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Bayer, J&J win reversal of $28 million verdict in Xarelto lawsuit ( Reuters ) HHS Secretary Nominee: 'No Silver Bullet' to Bring Down Drug Prices ( Focus ) ( NYTimes ) ( STAT ) ( Fierce ) ( Axios ) Bluebird to seek approvals for three treatments by end of 2019 ( Reuters ) ( Endpoints ) Trial Transparency: NIH Says Final Rule From 2017 has Helped ( Focus ) Face...

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...

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 ...

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...

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...