Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pfizer breast cancer drug superior to chemotherapy in late stage study ( Reuters ) ( Endpoints ) ( Press ) AHA Calls Regulatory Burden on Hospitals 'Unsustainable' ( AHA ) Activists press Alexion for stepped-up guidance, boardroom edits: report ( Fierce ) ( Endpoints ) M&A slows to a trickle in 2017, but Big Pharma could be on deck for mega deals ( Endpoints ) ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Sage's new depression drug hits mark in clinical trial, though effects fade over time ( STAT ) ( Endpoints ) ( Reuters ) ( Xconomy ) ( Press ) Spark, Pfizer pass another milestone with impressive results treating hemophilia B ( STAT ) ( Endpoints ) Edwards Buys Harpoon for up to $250 Million ( MDDI ) ( MassDevice ) ( Press ) US Health Spending Rose at a Slower ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Cities, counties and schools sidestep FDA foreign drug crackdown, saving millions ( Washington Post ) FDA approves Novo Nordisk diabetes drug Ozempic ( Reuters ) ( Endpoints ) ( Press ) Jury orders Bayer, J&J to pay $28 million in Xarelto lawsuit ( Reuters ) FDA's program to speed up drug approval shaved nearly a year off the process ( Los Angeles Times ) ( FDA...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Biopharma's top 10 overseas cash hoards. And what kind of M&A spree would $171B buy? ( Endpoints ) Galectin Therapeutics stock drops nearly 50% after negative trial results ( Market Watch ) ( Reuters ) ( Press ) Some drug makers are doing a better job of disclosing clinical trial data ( STAT ) Rare disease companies see US take with one hand as it gives with an...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US A Whirlwind Year For The Drug Industry ( C&EN ) Senate Republicans Pass Sweeping Tax Bill ( NYTimes ) ( The Economist ) ( Washington Post ) Tax bill: What comes next for health care ( Politico ) This Company Is About to Flood the US With Cheap HIV Drugs ( Bloomberg ) CVS to Buy Aetna for $69 Billion, Combining Major Health-Care Players ( WSJ ) ( Reuters ) ( NY...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA to Allow Quicker Approval of Some Promising Cancer Drugs ( WSJ ) ( STAT ) ( Reuters ) To Cut Drug Prices, Academy of Sciences Tells the Government to Negotiate With Manufacturers ( NYTimes ) ( Bloomberg ) ( STAT ) Alnylam Chief Makes Pricing Pledges Before Drug Is Even Approved ( Forbes ) CMS Head Verma eyes new methods for drug pricing ( Reuters ) More St...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Senate GOP clears key hurdle on taxes ( Politico ) FDA's Pazdur Named to Bloomberg 50 ( Bloomberg ) US troops get freeze-dried plasma for battlefield bloodshed ( AP ) Center for Responsible Science Sues FDA Over Clinical Trial Protections ( CRS ) ( Complaint ) Health Nominee Grilled on Commitment to Lower Drug Prices ( NYTimes ) ( Reuters ) ( Bloomberg ) FDA ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Alex Azar faces the Senate: What to expect at his hearing today ( Politico ) ( STAT ) ( Hearing ) Warren Asks Trump's HHS Pick About ACA, Drug Prices ( Law360 -$) Large pharmaceutical companies need to support the growth of startups ( STAT ) Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage ( NYTimes ) A Virus Shortage? BlueBird Bio Buys A Factory To Ma...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Where the tax battle stands ( Politico ) Drugmakers Hold Key to Puerto Rico's Future in Tax Overhaul ( Bloomberg ) 7 questions for Alex Azar, Trump's health secretary nominee ( STAT ) Express Scripts To Sell Drug Support Unit As PBM Industry Shifts Focus ( Forbes ) Pfizer, Merck KGaA hit setback as Bavencio fails in PhIII gastric cancer study ( Endpoints ) ( R...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Tangled Incentives Push Drugmakers Away From an Opioid Solution ( Bloomberg ) He Raised Drug Prices at Eli Lilly. Can He Lower Them for the US? ( NYTimes ) The Trump administration is taking on drug prices — but not drug companies ( Washington Post ) As Health Care Changes, Insurers, Hospitals and Drugstores Team Up ( NYTimes ) FDA Cautions Against DIY Gene Th...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Roche gets $12B stock boost from positive cancer, hemophilia results ( Reuters ) ( Endpoints ) ( Forbes ) ( Xconomy ) ( Press )  ( Press ) Purdue Approaches States in Bid to Settle Opioid Claims ( Bloomberg ) White House: True cost of opioid epidemic tops $500 billion ( CNBC ) ( Report ) Acorda Therapeutics scraps Parkinson's drug after deaths ( Reuters ) ( End...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA Committee Votes No On Bayer's Inhaled Cipro ( BioCentury ) ( Medpage ) ( Pink Sheet -$) Painful Truth: Successful Failure Of A Biotech Startup ( LifeSciVC ) FDA backs Roche's Gazyva in first-line follicular lymphoma ( Reuters ) ( Press ) Roche to buy US-based Viewics amid diagnostic data push ( Reuters ) ( Press ) Booming Regeneron gets the green light for...