• ReconRecon

    Recon: FDA Rejects Daiichi Sankyo Blood Cancer Drug After Japanese Approval

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA declines to approve Daiichi Sankyo's blood cancer treatment ( Reuters ) ( Endpoints ) FDA Expands Approval of Treatment for Cystic Fibrosis to Include Patients Ages 6 and Older ( FDA ) Merck CEO sees legal challenge if US adopts drug pricing based on other countries ( Reuters ) Merck says it has plenty in the pipe beyond Keytruda ( PMLive ) ICER says Nova...
  • ReconRecon

    Recon: Sanofi to Lay Off 466 in France and Germany in Shift to Cancer, Gene Therapies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Billions at Stake in Opioid Suits, But It's No Tobacco Windfall ( Bloomberg ) Boston drug-pricing watchdog group is ‘mouse that roared’ ( Boston Globe ) Cities, States Denied Committee Seats in Opioid Maker’s Bankruptcy ( WSJ ) Deadly Superbugs Win as Wall Street Flees Makers of Antibiotics ( Bloomberg ) FDA Lays Out Plan for Comparing New Opioids to Previous...
  • ReconRecon

    Recon: Gilead Partners With Nurix for Protein Degradation Drugs; NICE Backs Blincyto for Acute Lymphoblastic Leukemia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck Seeks More Deals as It Expands Its Cancer Treatments Portfolio ( WSJ ) Low prices of some lifesaving drugs make them impossible to get ( Washington Post ) Key senators release bipartisan package to lower health care costs ( The Hill ) Combatting misinformation on biosimilars and preparing the market for them can save the U.S. billions ( STAT ) Drug Indu...
  • ReconRecon

    Recon: Roche Notches First Approval for Personalized Cancer Drug Rozlytrek in Japan

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US There’s a fight brewing in Congress over pharma’s patents ( STAT ) With eyes on Gilead, lawmakers want details on how HHS reviews possible patent infringement ( STAT ) ( House Oversight ) No provisions in USMCA to change U.S. pharmaceutical patent laws: Lighthizer ( Reuters ) ( AAM ) Why Democrats reopened the debate about germline gene editing ( STAT ) Merck...
  • ReconRecon

    Recon: Pfizer to Acquire Array Biopharma for $11.4B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer to boost cancer treatment portfolio with $11.4B Array deal ( Financial Times ) ( STAT ) ( Endpoints ) ( CNBC ) ( Press ) Pfizer CEO gets 61% pay raise—to $27.9 million—as drug prices continue to climb ( Ars Technica ) Gene therapy R&D deals turn red hot as Big Pharma steps up to play ( Endpoints ) Drug Prices Are a Populist Campaign Issue. Here Are the ...
  • ReconRecon

    Recon: Bluebird Prices Gene Therapy Zynteglo at €1.575M Over 5 Years

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House allies rally for looming rebate rule ( Politico ) Global Blood’s sickle cell disease drug heads to the FDA, but questions about benefit linger ( STAT ) ( Endpoints ) Facing progressive pressure, Pelosi could expand her drug pricing plan to negotiate prices for $118B worth of drugs ( STAT ) Allscripts is buying ZappRx, a prescription drug start-up (...
  • ReconRecon

    Recon: GSK Teams up With CRISPR Pioneers for New Drug Discovery Lab

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GSK signs up gene-editing pioneers in drug discovery alliance ( Reuters ) ( Financial Times ) ( Endpoints ) Trump Offers to Negotiate Price of J&J Anti-Depressant for VA ( Bloomberg ) ( Endpoints ) Nebraska’s AG is lone holdout in pursuing opioid cases ( AP ) A CRISPR startup is testing pig organs in monkeys to see if they’re safe for us ( MIT Technology Revie...
  • ReconRecon

    Recon: France’s Dassault to Buy Medidata for $5.8B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Move Over, Martin Shkreli: This Pharma Exec Is Accused Of Fixing Prices On 107 Drugs ( Forbes ) Daily HIV Prevention Pill Urged for Healthy People at Risk ( AP ) ( CNBC ) J&J ‘Did Everything’ to Push Opioids, Oklahoma Witness Says ( Bloomberg ) Judge holds up Teva's $85M opioid settlement, sinking shares back to pre-2000 levels ( Fierce ) ( Law360 -$) Acciden...
  • ReconRecon

    Recon: Merck’s Keytruda Picks up Two New Indications for Head and Neck Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck's Keytruda wins FDA approval to treat head & neck cancer ( Reuters ) ( Endpoints ) ( Press ) ( FDA ) Startup offering free DNA sequencing signs first pharma sponsor ( STAT ) How pharma could benefit from one of Congress’ signature drug pricing ideas ( STAT ) Jacobus prices its rare disease drug at half of what Catalyst charges, but will doctors prescribe...
  • ReconRecon

    Recon: Merck to Acquire Tilos for $773; Roche Gets Accelerated Approval for Lymphoma Drug Polivy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck to buy Tilos Therapeutics for up to $773 million ( Reuters ) ( STAT ) ( Endpoints ) ( Press )  Merck’s Baby Biotech Splurge Won’t Fix Its Reliance on Keytruda ( Bloomberg ) In a boost to Rituxan franchise, Roche nabs quick approval for Polivy ( Endpoints ) ( Press ) ( FDA ) Co-owner, ex-employee of pharmacy in U.S. meningitis outbreak acquitted ( Reuters...
  • ReconRecon

    Recon: Sanofi Names Novartis’ Hudson as CEO; FDA Panel Backs TB Alliance’s TB Treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vertex Pharmaceuticals expands into Duchenne gene therapy with new deals ( Reuters ) ( PMLive ) ( Endpoints ) ( Fierce ) FDA advisory panel recommends approval of TB Alliance's tuberculosis treatment ( Reuters ) In a surprise, Hans Bishop takes over as CEO of Grail, the liquid biopsy startup ( STAT ) ( Endpoints ) AIDS groups criticize Express Scripts for excl...
  • ReconRecon

    Recon: Insys, Mallinckrodt Settle Opioid Cases; Takeda Drops Late-Stage Amyloidosis Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Third Rock raises $770 million in new funding round ( STAT ) ( Endpoints ) ( Fierce ) Liberals fight their own party over drug prices ( Politico ) ( The Hill ) Insys to pay $225 million, plead guilty in US over opioid kickbacks ( Reuters ) ( NYTimes ) ( STAT ) ( Endpoints ) ( Law360 -$) ( DoJ ) Mallinckrodt to settle U.S. drug marketing probe, fight kickback c...