Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pfizer beats profit estimates, raises 2017 earnings forecast ( Reuters ) ( AP ) US states to expand generic drug price-fixing suit – sources ( Reuters ) Is $45B the White House's opioid funding ask? ( Politico ) Trump opioid panel will recommend nationwide drug courts, tightened requirements for prescribers ( STAT ) Gottlieb: FDA Looking at Packaging, Storage ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US CVS-Aetna Deal Could Mean End of Era in How Drugs Are Paid For ( Bloomberg ) Hearing Amazon's Footsteps, the Health Care Industry Shudders ( NYTimes ) Eagle Pharma gets tentative FDA approval for Lilly's Alimta version ( Reuters ) ( Press ) AbbVie surprises with solid earnings, priority review for endometriosis med ( Fierce ) Trump fumes at drug makers for man...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA hires top Mylan executive: report ( The Hill ) CVS makes more than $66 billion bid for Aetna: sources ( Reuters ) ( WSJ ) ( Financial Times ) Endo International units sue FDA over drug compounding policy ( Reuters ) Trump declares opioids a US public health emergency ( Reuters ) ( NPR ) ( FDA ) Words, Not Action, From Mr. Trump on Opioids ( NYTimes ) What...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Purdue Is Under Investigation for Opioid Painkiller OxyContin ( WSJ ) ( Bloomberg ) ( Reuters ) US Committee Recommends GSK Shingles Vaccine Over Merck Rival ( Reuters ) Trump to declare opioids a public health crisis: officials ( Reuters ) ( USA Today ) ( STAT ) Rhode Island doctor pleads guilty to opioid kickback scheme related to Insys ( Reuters ) Pharmacis...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Sanofi files patent infringement suit against Mylan over insulin pen ( MassDevice ) ( Pharmafile ) Incyte grabs a new PD-1 checkpoint drug in $900M deal with MacroGenics ( Endpoints ) AstraZeneca 'all in' on severe asthma launch for late-to-the-party benralizumab ( Fierce ) Trump readies opioid plan, but some worry it won't be enough ( AP ) PTC Therapeutics St...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump confounds Senate on whether he wants health care deal ( politico ) Going all in: Biogen commits an extra $500M to Alzheimer's blockbuster hopeful aducanumab ( Endpoints ) ( Bloomberg ) AbbVie antes up $225M in cash to buy into the Alzheimer's platform at Alector ( Endpoints ) ( Financial Times ) ( Reuters ) ( Fierce ) Alexion wins approval for expanded us...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US   FDA approves a new vaccine for shingles that provides broad protection ( Stat ) ( Reuters ) Will FDA Add Suffixes to Approved Biologics' Names? ( Focus ) Gilead Science’s executive chairman talks about the new era of biomedicine and why drugs cost so much ( Wall Street Journal -$) Drug Makers Find ‘Branded Generics’ Are...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Celgene just lost a crucial drug for its revenue stream after a clinical trial blowup ( Stat ) ( Endpoints ) ( PharmaTimes ) ( Reuters ) ( Press ) Merck plans to lay off 1,800 sales staffers in U.S. commercial shakeup ( Fierce ) Hacking Is a Risk for Pacemakers. So Is the Fix ( Wall Street Journal -$) Statement by FDA Commissioner Scott Gottlieb, ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma ( FDA ) ( Stat ) ( Forbes ) ( Endpoints ) ( WSJ -$) ( NY Times -$) ( Reuters ) FDA Panel Urges Approval of Semaglutide for Type 2 Diabetes ( MedPage Today ) ( Reuters ) ‘Drug Dealers in Lab Coats’ ( New York Times -$) Cybersecurity Concerns and Medical Devic...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA selects Box to help it modernize IT infrastructure ( ZDNet ) With $500M-plus, a buyout and two new billion-dollar pacts, upstart Vir is ready to roll on infectious diseases ( Endpoints ) ( Reuters ) ( Fierce ) ( Press ) Trump leaning toward former Eli Lilly exec for health secretary ( Politico ) ( Endpoints ) US veterans sue drug companies over Iraq bribes...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Allergan Brings the Roof Down On Its Head ( In the Pipeline ) ( NY Times ) ( Focus ) ( Patent Docs ) Senator introduces repeal of 2016 law after "60 Minutes" opioid epidemic report ( CBS News ) The secretive family making billions from the opioid crisis ( Esquire ) Trump tweets that Marino is out of consideration for drug czar ( CNN ) ( Bloomberg ) ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US The Drug Industry's Triumph Over The DEA ( Washington Post / 60 Minutes ) DEA responds to explosive "60 Minutes" report about opioid crisis ( CBS ) Rep. Tom Marino: Drug czar nominee and the opioid industry's advocate in Congress ( Washington Post ) Novo Nordisk diabetes drug effective, no heart risk -FDA review ( Reuters ) ( Endpoints ) ( FDA ) FDA experts gi...