In Focus: US BioMarin scores long-sought FDA nod for Palynziq, but its $192K launch could be tough ( Fierce ) ( BioPharma Dive ) ( PMLiVE ) ( Endpoints ) ( Reuters ) ( PharmaTimes ) Imagen Tech wins de novo clearance for OsteoDetect wrist fracture software ( MassDevice ) ( MIT Technology Review ) ( MD Magazine ) ( FDA ) Prothena axes half its staff after phase 3 catastrophe ( pharmaphorum ) ( Fierce ) ( Scrip- $) AstraZeneca caps its big win in lung cancer with posit...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US J&J Loses Second Talc-Asbestos Trial and Damages May Grow ( Bloomberg ) ( Fierce ) ( Reuters ) Recro Pharma shares plummet after FDA rejects non-opioid pain shot ( Reuters ) ( BioPharma Dive ) ( Endpoints ) Medtronic tops estimates with fiscal Q4, 2018 results ( MassDevice ) ( Star Tribune ) ( Reuters ) Solicitor General Urges High Court To Take Up Merck's Fosama...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Congress OKs letting terminal patients try unapproved drugs ( AP ) ( Washington Post -$) ( NYT -$) ( Focus ) ( LA Times ) A Preferable Path For Thwarting Pharmaceutical Product Hopping ( Health Affairs ) Patient and Prescriber Outreach Materials for Biosimilars ( FDA ) FDA warns teething medicines unsafe, wants them off shelves ( AP ) Gene Therapies That Could T...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Accent Therapeutics Launches with $40 Million: Focus on RNA-Modifying Proteins ( BioSpace ) ( Fierce ) ( Endpoints ) ( Boston Business Journal -$) ( C&EN ) Johnson & Johnson scraps Alzheimer's trials on safety concerns ( Reuters ) ( Endpoints ) ( The Pharma Letter ) ( PharmaTimes ) ( Scrip -$) ( Fierce ) AstraZeneca sales hit by generic competitors to Crestor stat...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Study Finds More Isn't Better for Roche Breast Cancer Drug ( Bloomberg ) ( WSJ ) ( Reuters ) ( AP News ) ( NPR ) ( NYT ) The first drug for opioid withdrawal has gotten the green light — and it targets risky symptoms that others ignore ( Business Insider ) ( Focus ) ( Reuters ) ( Endpoints ) ( WSJ ) ( Pharmacy Times ) FDA faults IQVIA for errors in opioid sales da...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Novartis’s Top Lawyer is Out After Payments to Michael Cohen ( NYT ) ( CNN ) ( Bloomberg ) ( Endpoints ) ( Reuters ) ( Fortune ) ( Axios ) ( Politico ) ( Financial Times ) ( STAT ) Pfizer collects its third US FDA biosimilar approval with Retacrit ( BioPharma-Reporter ) ( The Center for Biosimilars ) ( Fierce ) ( Lexology- $) ( Focus ) ( Reuters ) ( Endpoints ) Ev...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Broad Institute Spinout Aims To Bring Precision Medicine To Autoimmune Disease ( Forbes ) ( Fierce ) ( C&EN ) ( Endpoints ) Roche pens death notice for NewLink IDO/TDO cancer collaboration ( Fierce ) ( GEN ) Insys sees no change in estimated litigation costs ( Reuters ) ( Fierce ) Indivior in settlement with Par Pharma over Suboxone ( The Pharma Letter ) ( PBR ) ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Azar, striking an aggressive tone, suggests Trump will call out drug companies behind major price hikes ( STAT ) ( Reuters ) ( MedCity News ) Bluebird adds targets, $500M in milestones to Medigene TCR pact ( Fierce ) ( GEN ) ( Endpoints ) A startup that wants to make treatments that edit single letters in our DNA just raised $87 million ( Business Insider -$) ( C&...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Akcea, Ionis win over most FDA experts to their rare disease drug volanesorsen, vastly improving odds of success ( Endpoints ) ( Fierce ) ( PharmaTimes ) ( PMLiVE ) AstraZeneca's Fasenra Fails in Trial of Severe Lung Disease ( Bloomberg ) ( Reuters ) ( BioCentury ) Akari CEO Horn Solomon ousted after allegedly abusing the company credit card ( Endpoints ) ( BioSpa...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Eli Lilly Buys Immunotherapy Cancer Treatment Company for $1.6 Billion ( WSJ ) ( Bloomberg ) ( Endpoints ) ( STAT -$) ( Fierce ) ( Reuters ) Proposal to Curb Drug Prices Would Hand More Competition to Insurers ( WSJ ) ( Fierce ) ( The Hill ) Setback to Roche hopes for Tecentriq as fails key cancer trial ( Reuters ) ( PMLiVE ) ( Fierce ) Eight years after Eli Lill...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Valeant, Distancing Itself From Its Past, Will Change Its Name to Bausch Health ( NYT ) ( Fortune ) ( Reuters ) ( WSJ ) ( BioPharma Dive ) ( Fierce ) Trump calls on Congress to pull back $15 billion in spending, including on Children’s Health Insurance Program ( The Washington Post ) ( The Hill ) ( Politico ) ( Reuters ) Merck and OncoSec expand Keytruda/IL-12 col...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Johnson & Johnson preps for esketamine filing in resistant depression, despite a missed trial ( Fierce ) ( BioPharma Dive ) ( Pharmabiz ) ( Drug Deliver Business News ) ( Business Insider ) FDA promises Roche a snap decision on Tecentriq triple for frontline lung cancer as it falls even further behind Merck, Bristol-Myers ( Endpoints ) ( Reuters ) Portola's Andexx...