Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Billionaire founder of Insys to plead not guilty to opioid bribe scheme ( Reuters ) ( Forbes ) Old Habits Die Hard: Newer Diabetes Drugs Slow to be Adopted ( Medscape ) Powerful new cancer drugs are saving lives, but can also ignite diabetes or other autoimmune conditions ( Science ) Astellas faces US probe over patient assistance charity support ( Reuters ) F...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Long-awaited study finds monthly Vivitrol as effective as daily pill for opioid addiction ( STAT ) ( Endpoints ) ( NYTimes ) ( NIH ) ( The Lancet ) AstraZeneca's scores FDA OK for a blockbuster severe asthma drug ( Endpoints ) ( Reuters ) ( PMLive ) ( Press ) FDA Approves AstraZeneca's Faslodex Combo for Advanced Breast Cancer ( Press ) FDA Clears First Device...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves digital pill that tracks when patients take it ( Reuters ) ( NYTimes ) ( WSJ ) ( STAT ) ( Press ) ( FDA ) Health officials lay out progress toward regulatory reform under Trump ( STAT ) Hospitals Sue to Block HHS From Slashing Lucrative Drug Subsidies ( WSJ ) Neurodegeneration upstart Denali outlines $100M IPO for its growing clinical work ( Endpoi...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump: Former Eli Lilly Exec to be Nominated as Next HHS Secretary ( Focus ) ( NYTimes ) ( Washington Post ) ( Politico ) ( The Hill ) ( Twitter ) Price investigation continues to roil HHS ( Politico ) Gates makes $100m personal investment to fight Alzheimer's ( Reuters ) ( Endpoints ) ( Financial Times ) ( Gates ) US Investments in Medical and Health Research ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Dynavax's hepatitis B vaccine gets FDA nod on third try, shares up ( Reuters ) ( Endpoints ) Deal would keep Pentagon out of product approvals ( Axios ) Former FDA Commissioners To Congress: Don't Give Pentagon The Power To Approve Drugs ( Politico ) Grading Gottlieb: How Attys View FDA Chief's First 6 Months ( Law360 -$) Heron takes on Merck's Emend with FDA ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump says he and China's Xi to try to end opioid crisis ( Reuters ) Despite Trump's Pleas, China's Online Opioid Bazaar Is Booming ( NYTimes ) The White House punted to Congress on opioids funding. Congress doesn't have a plan ( STAT ) FDA OKs Merck drug that prevents infection post-stem cell transplant ( Reuters ) ( Press ) ( Endpoints ) Sage Therapeutics sh...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA Commissioner Talks About His Tenure, Recruiting And LDTs ( Medtech Insight -$) Ohio's Drug Pricing Ballot Initiative Fails ( Cleveland ) ( STAT ) ( NYTimes ) Trump wants to cut Pharma's tax bill, but what are drugmakers actually paying? ( STAT ) House punts med device tax until after tax reform is finished ( MassDevice ) ( Washington Examiner ) FDA chief: ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Lawmakers defend 'unprecedented' Pentagon health panel, which could undermine FDA ( Politico ) ( Endpoints ) ( The Hill ) Mylan's EpiPen sales plummet as pricing scandal bites back ( Fierce ) Sen. Harris Investigates How Drugmaker Alkermes Pushed Its Opioid-Addiction Treatment ( Bloomberg ) ( Endpoints ) ( STAT ) ( The Hill ) FDA Approves Roche's Zelboraf to Tr...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Valeant to hand back maker of 'female Viagra' to former owners ( Financial Times ) ( Reuters ) ( Endpoints ) Earnings Preview: What To Expect From Valeant Pharmaceuticals On Tuesday ( Forbes ) Amgen is shaking up R&D (again), chopping 200 as Genentech targets 130 layoffs ( Endpoints ) CVS to offer nationwide next-day delivery in preemptive shot at Amazon ( USA ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Valeant finally wins long-delayed FDA OK for its glaucoma drug, which is more good news for Aerie ( Endpoints ) ( Press ) Senators call for crackdown on pharmaceutical industry 'revolving door' ( Washington Post ) ( STAT ) GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits ( Focus ) 7 ways biopharma would win — and lose — under the new tax bill ( STA...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US CMS Finalizes Policies that Lower Out-of-Pocket Drug Costs and Increase Access to High-Quality Care ( CMS ) Hospitals Vow Fight to Keep Medicare Drug Subsidies ( WSJ -$) ( Modern Healthcare ) ( Politico ) Want Drug Regulators To Consider Real-World Evidence? Then Disrupt Their Outdated Regulatory Infrastructure ( Health Affairs ) FDA Panels Like Long-Ac...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pharma industry faces hypocrisy charge over patents ( Financial Times ) Pfizer expects broad interest for consumer health business ( Reuters ) FDA Panel Backs Indivior Opioid Addiction Drug ( Reuters ) ( Financial Times ) ( Endpoints ) OPDP Enforcement Letters at Record Low ( EyeOnFDA ) Innovating at the speed of the 21st century in pharmaceuticals ( McKinsey ...