Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pharma dreads Chuck Grassley as Senate Finance chair ( Axios ) Company hiked price for opioid overdose treatment 600 percent: Senate report ( The Hill ) ( Politico ) ( CBS ) ( Report ) Novartis' blood disorder drug gets FDA approval for expanded use ( Reuters ) ( Press ) Gottlieb pushes for funding to speed gene therapy reviews ( STAT ) FDA declines to approv...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A newcomer rises to the defense of pharma — and tries to salvage its bruised reputation ( STAT ) FDA approves Seattle Genetics’ Adcetris for first-line treatment of peripheral T-cell lymphoma under new review pilot ( FDA ) ( Press ) Key AstraZeneca lung cancer treatment misses study goal ( Reuters ) ( Financial Times ) ( Endpoints ) ( Fierce ) ( Press ) AbbVie...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Alexander: China Can Become the Global Leader in Stopping Synthetic Opioids ( Sen. Alexander ) United Therapeutics pays $800M-plus to grab Arena’s PhIII PAH drug ( Endpoints ) ( STAT ) ( Press ) FDA official hints at a tough road ahead for ‘right to try’ ( STAT ) Biotech is looking woozy: ferocious selling and a sense of foreboding ( STAT ) Lower Drug Prices ...

In Focus: US Pfizer Launches Epoetin Alfa Biosimilar, Retacrit, at 33.5% Discount to Reference Epogen ( Center for Biosimilars ) Celgene Doubles Down on Dragonfly, Pays $50M to Expand Cancer Pact ( Xconomy ) ( Endpoints ) Allergan Loses Appeal Over Validity of Restasis Patents ( Bloomberg ) The new Google Health unit is absorbing health business from DeepMind, Alphabet's AI research group ( CNBC ) ( Fierce ) HHS will bring in fetal tissue experts for ‘listening sess...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sobi buys rights to AstraZeneca infant drug for $1.5 billion upfront ( Reuters ) ( Endpoints ) Roche's Tecentriq wins fast FDA review in tough-to-treat breast cancer ( Reuters ) ( Press ) Some pharmacies fail to offer easy access to naloxone, or to stock it, despite anti-opioid initiatives ( STAT ) New ads push lawmakers to keep the drug pricing promises they ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drug prices and IP rights to come up at review of NAFTA ( Politico ) Gottlieb: New drug approval criteria limited to opioids ( Axios ) ( Pharmafile ) Pharma's grip on the health care economy ( Axios ) Something Happened to US Drug Costs in the 1990s ( NYTimes ) Amarin's Fish-Oil-Derived Drug Shows Great Promise—With Big Caveats ( Forbes ) ( STAT ) ( Endpoints...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cardiac devices can cost six times more in US than in Europe ( Reuters ) Azar says new mandatory oncology pay model is coming ( Modern Healthcare ) Novartis division Sandoz recalls one lot of blood pressure drug ( Reuters ) ( FDA ) Stryker closes $1.4B K2M buy ( MassDevice ) Rep. Peter Welch on drug prices, the potential for bipartisan action, and a ‘broken m...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie hatches plans for a major new R&D hub close to its partners in Bay Area’s buzzy Oyster Point ( Endpoints ) ( SF Business Times ) Meet the New Agenda Setters in the House ( WSJ ) ( NBC ) Dem overtures to Trump on drug pricing worry pharma ( The Hill ) ( Fierce ) ( STAT ) 8 burning questions for pharma, as Washington braces for a health policy shakeup ( S...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democrats' new health care math ( Politico ) ( Forbes ) ( Law360 -$) ( STAT ) ( NYTimes ) With a new Congress, a window opens to finally bring down drug prices ( STAT ) Pelosi sees possible 'common ground' with Trump on drug prices ( The Hill ) Bound to the hip with Trump, ex-Celgene chief Bob Hugin gets whipped in New Jersey Senate race ( Endpoints ) Indicte...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US Lilly to consider more acquisitions like $1.6 billion Armo buy ( Reuters ) As Election Day neared, pharma spent more heavily on Democrats ( STAT ) Insys Looks to Sell Opioid-Related Assets, Including Subsys ( WSJ ) Lilly joins forces with NextCure to fuel immuno-oncology expansion ( Fierce ) ( Endpoints ) ( GEN ) 4 months after drug approval, Achaog...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Approves Powerful New Opioid Despite Warnings of Likely Abuse ( NYTimes ) ( STAT ) ( Reuters ) ( The Hill ) ( WSJ ) ( Press ) ( Gottlieb ) Trevena opioid painkiller fails to win FDA approval, shares plunge ( Reuters ) Lilly says diabetes drug Trulicity reduces heart risks in trial ( Reuters ) ( Endpoints ) Sandoz abandons effort for US approval of biosimil...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US DNA sequencing giant Illumina just bought rival Pac Bio for $1.2 billion ( CNBC ) ( Endpoints ) ( Xconomy ) ( Forbes ) Voters don’t like ‘Big Pharma.’ But they could soon elect a Senate that includes two pharma lobbyists and a CEO ( STAT ) Pfizer Is Weighing Sale of $2 Billion-Women's Health Portfolio ( Bloomberg ) ( Fierce ) Alkermes' depression treatment fai...