The RAPS store will be under maintenance Saturday, 7 December between 6 AM and 12 PM.  Store functionality may be unavailable at times during this window.
We apologize for any inconvenience caused during this time.

  • ReconRecon

    Recon: Novartis, Gilead CAR-T Therapies Win Swiss Coverage; FDA Reviewers Express Concerns About Correvio Heart Drug Ahead of Advisory Panel

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Is Green-Lighting Drugs at Breakneck Speed and Raising Alarm ( Bloomberg ) FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns ( Reuters ) ( Fierce ) ( STAT ) Correvio slumps after FDA staffers say benefits of heart drug do not outweigh risks ( Reuters ) Activists seek to block a Gilead patent extension on a lucrative HIV drug (...
  • ReconRecon

    Recon: Sage Depression Drug Fails in Phase III; China’s NMPA Approves Lynparza for Ovarian Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sage depression therapy fails much-awaited trial, stunning investors ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Eli Lilly to put Loxo executives in charge of new cancer research unit ( Reuters ) ( STAT ) ( Press ) Biogen to make case to skeptics for its controversial Alzheimer's drug ( Reuters ) Acadia Pharma's psychosis drug proven better than placebo in de...
  • ReconRecon

    Recon: Novartis Pairs With Amazon for AI in Manufacturing; Rising Pleads Guilty in Generic Price Fixing Case

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A second generic drug maker admits to price fixing as part of a far-reaching probe into generics ( STAT ) ( Law360 -$) ( The Inquirer ) ( DoJ ) Roche wins FDA approval for immunotherapy cocktail against lung cancer ( Reuters ) ( Endpoints ) ( Press ) White House claims Speaker Nancy Pelosi’s drug-pricing bill would result in 100 fewer drugs over a decade ( CNBC...
  • ReconRecon

    Recon: Astellas to Buy Gene Therapy Developer Audentes for $3B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate Committee Advances Nomination of Hahn as FDA Commissioner ( Focus ) US Considers Easing Drug Protections to Break Logjam Over Trade Pact ( WSJ ) ( Reuters ) Medical Device Failures Brought To Light Now Bolster Lawsuits And Research ( KHN ) Merck Cyberattack’s $1.3 Billion Question: Was It an Act of War? ( Bloomberg ) States fight bonus pay for CEO of O...
  • ReconRecon

    Recon: Drugmakers Cut Prices to Make China’s Reimbursement List; Baxter Buys Sanofi’s Seprafilm for $350M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Baxter picks up Sanofi's Seprafilm adhesion barrier for $350M ( MedtechDive ) ( Endpoints ) Lexicon Pharma shares plummet after FDA denies appeal against drug rejection ( Reuters ) Incyte claims FDA priority review for bile duct cancer drug ( PMLive ) AstraZeneca's Imfinzi gets speedy FDA review for small cell lung cancer ( Reuters ) ( PMLive ) Merck’s Keytru...
  • ReconRecon

    Recon: Pfizer, Novartis Lead Global Gene Therapy Manufacturing Investment; US Prosecutors Open Opioid Criminal Probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen will offer discounts to a health plan if patients say its multiple sclerosis drugs don’t work ( STAT ) Judge partly vacates convictions of opioid maker Insys' founder, executives ( Reuters ) SEC charges ex-MiMedx execs with defrauding investors ( Fierce ) ( Endpoints ) US prosecutors open criminal probe of opioid makers, distributors ( Reuters ) ( WSJ )...
  • ReconRecon

    Recon: Japan’s Asahi Kasei to Buy Veloxis for $1.3B; Spanish Antitrust Regulator Probes Merck

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How a billionaire couple greased the skids for Nancy Pelosi’s drug pricing bill ( STAT ) FDA approves Global Blood Therapeutics sickle cell disease drug ( Reuters ) ( STAT ) ( FDA ) Pharma execs tell researchers that multiple sclerosis drug pricing is based on competition, not R&D costs ( STAT ) FDA approves J&J spinout's device for kids with recurring ear inf...
  • ReconRecon

    Recon: Novartis to Buy Medicines Company for $9.7B; Blackstone, Ferring Announce $570M Gene Therapy Venture

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis to Buy the Medicines Company for $9.7 Billion ( AP ) ( Financial Times ) ( WSJ ) ( STAT ) ( Reuters ) The big drug hunters: Novartis’ $28B-plus deal spree makes Vas Narasimhan one of the top dealmakers of our time ( Endpoints ) Adamis shares slump as FDA declines to approve opioid overdose treatment  ( Reuters ) ( Press ) FDA approves Aquestive's ALS ...
  • ReconRecon

    Recon: FDA Approves SK Life Science’s Seizure Drug Xcopri; Rewrite Coming for Grassley-Wyden Drug Pricing Bill

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Changes coming to Grassley-Wyden drug bill ( Politico ) ( Senate Finance ) FDA approves new epilepsy therapy, a first for Korea's SK Life Science ( BioPharmaDive ) ( FDA ) ( Press ) AstraZeneca wins FDA approval for Calquence in chronic lymphoma ( PMLive ) ( Endpoints ) ( Press ) ViiV inks bNAb deal with National Institutes of Health ( PharmaTimes ) ( Endpoint...
  • ReconRecon

    Recon: Sanofi Reportedly Weighing Sale of Consumer Health Unit; J&J Loses Australian Pelvic Mesh Suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pricing Tactics Slow Uptake of Generic Drugs by Medicare Plans ( Bloomberg ) Gilead CEO Daniel O’Day says company is in an ‘acquisitive mode’ ( STAT ) Hospitals Push Back on Price-Disclosure Rule ( WSJ ) Trump, senators push for drug price disclosures despite setbacks ( The Hill ) Where top 2020 Democrats stand on drug pricing ( The Hill ) Charity to pay $4 ...
  • ReconRecon

    Recon: FDA Approves Alnylam’s Givlaari to Treat Acute Hepatic Porphyria; Vertex Lands French Reimbursement for Orkambi

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Generic-Drug Approvals Soar, But Patients Still Go Without ( WSJ ) A $5 Billion Cholesterol Bet May Be an Overreach ( Bloomberg ) FDA Approves Alnylam’s Givlaari to Treat Acute Hepatic Porphyria ( Focus ) Bankrupt biopharmas are rare. 2019 has some worried that’s changing. ( BioPharmaDive ) ( Axios ) 31 biopharmas at high risk of bankruptcy in 2020 ( BioPharm...
  • ReconRecon

    Recon: CRISPR, Vertex Therapy Shows Early Benefit in First Two Patients; Donors Pledge $2.6B for Polio Eradication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US First CRISPR treatment for blood diseases shows early benefits in two patients ( STAT ) ( Endpoints ) ( Press ) Novo Nordisk’s parent company to launch research incubator in Boston ( STAT ) ( Xconomy ) Inside Purdue Pharma’s Media Playbook: How It Planted the Opioid “Anti-Story” ( ProPublica ) Amarin releases interim EVAPORATE data — and mineral oil makes anot...