Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amgen and Allergan Launch Mvasi and Kanjinti, the First Anticancer Biosimilars, in the United States ( Center for Biosimilars ) ( Endpoints ) ( Fierce ) ( Press ) Canada warns US against drug import plans, citing shortage concerns ( Reuters ) Biotech enters an era of ‘platform’ dominance ( STAT ) Second opioid distributor charged over role in US drug epidemic ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis Sets Aside $700 Million to Settle Bribery Allegations ( WSJ ) ( STAT ) ( Reuters ) Fraud conviction of ‘pharma bro’ Martin Shkreli upheld by federal appeals court ( CNBC ) Kronos, a startup led by Gilead alumni, raises $105 million in latest mega-round ( STAT ) Elizabeth Holmes Wins Judge’s Backing in Getting FDA Documents Faster ( Bloomberg ) ( Law36...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck's treatment for urinary, abdominal infections gets FDA approval ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) Merck urges caution on use of its newly approved antibacterial ( BioPharmaDive ) Pharma deploys its top guns to Capitol Hill as senators mull drug pricing package ( STAT ) States Are Making Progress on Opioids. Now the Money That’s Helping Them May...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How pharma, under attack from all sides, keeps winning in Washington ( STAT ) 2020 candidates throw punches at drug industry ( Politico ) ( BioPharmaDive ) Democrat Harris unveils plan to lower drug costs, put 'people over profit' ( Reuters ) ( The Hill ) ( Washington Examiner ) ( Harris ) Democratic chair: Medicare negotiating drug prices not moving before Au...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead to raise stake in Belgian biotech in $5.1bn deal ( Financial Times ) ( STAT ) ( Endpoints ) ( PMLive ) ( Press ) Lawmakers urge Trump administration to alter trade deal or Americans will pay more for drugs ( STAT ) ( Center for Biosimilars ) AstraZeneca's Farxiga fails to get US approval for Type-1 diabetes ( Reuters ) ( Endpoints ) Eton's conjunctiviti...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amgen, Novartis abandon two Alzheimer’s drug studies ( Financial Times ) ( Endpoints ) ( Pharmafile ) ( Press ) Nexus to build $250M manufacturing facility in Wisconsin ( BioPharmaDive ) Indivior says Reckitt settlement in U.S. unrelated to its cases ( Reuters ) ‘There’s a lot of screaming into the void’: Toddler’s parents battle for coverage of $2.1 million g...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US President Trump Withdraws Plan to Eliminate Drug Price Rebates ( NYTimes ) ( STAT ) ( Reuters ) ( WSJ ) ( Politico ) Reckitt will pay $1.4B to settle federal probes into marketing of opioid-addiction treatment ( STAT ) ( The Guardian ) ( Financial Times ) ( WSJ ) Winning the Obamacare Suit Would Be a Disaster for Republicans ( Bloomberg ) ( NYTimes ) Faced wit...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The FDA's Janet Woodcock talks about some big changes she's pushing for in drug development, and agency reviews ( Endpoints ) ( Fierce ) 23andMe’s chief scientific officer, a star in drug development, is leaving role ( STAT ) ( Endpoints ) DNA-Testing Service Exposed Thousands of Customer Records Online ( Bloomberg ) CDC made a synthetic Ebola virus to test tr...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Judge Blocks Pharma Prices in TV Ad Rule From Taking Effect ( Focus ) ( NYTimes ) ( Reuters ) ( Endpoints ) Pharma defendants invoke SCOTUS in bid to keep prescription data secret ( Reuters ) GOP senators raise concerns over potential deal to lower drug prices ( The Hill ) Judge dismisses J&J’s request to toss out lawsuit over opioids crisis ( The Guardian ) ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Experimental gene therapy for hemophilia, developed by Pfizer and Sangamo, shows early promise ( STAT ) ( Endpoints ) ( Press ) As Sangamo Touts Data, BioMarin Preps Hemophilia Gene Therapy For FDA ( Xconomy ) Intra-Cellular drug fails bipolar depression study; shares fall 14% ( Reuters ) ( Endpoints ) FDA resists livestock lobby’s push on GE animals ( Politic...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Says ‘Favored Nations’ Drug Plan Would Lower US Prices ( Bloomberg ) ( STAT ) ( CNBC ) Cancer deaths cost the U.S. $94 billion in lost earnings in a single year ( STAT ) Okla. Opioid Case 'Should End Here And Now,' J&J Says ( Law360 -$) Reflux Drugs Tied to Bone Fractures in Children ( NYTimes ) New Markers For Alzheimer's Disease Could Aid Diagnosis An...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves new multiple myeloma drug despite toxicity concerns ( STAT ) ( FDA ) ( Press ) Stem-cell biotech seeing strong growth ( STAT ) Oklahoma portrays J&J as opioid crisis 'kingpin' in court battle ( Politico ) Opioid drug defendants ask Oklahoma judge to end case ( CNBC ) HHS gets a new HIV prevention patent, but will the agency demand royalties from ...