• ReconRecon

    Recon: Biogen, Eisai Scrap Two Late-Stage Alzheimer’s Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen scraps Alzheimer drug trials, wiping $17 billion off its market value ( Reuters ) ( WSJ ) ( Endpoints ) CRISPR is ascending again, after scientists find ‘elegant’ fix for cancer worry ( STAT ) Roche sues US executives in fight over diabetes test strips ( Reuters ) ( Forbes ) Feng Zhang, heavyweight collaborators unveil latest CRISPR upstart — a diagnost...
  • ReconRecon

    Recon: Pfizer Buys Stake in French Gene Therapy Developer Vivet

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Flagship Pioneering raises $824 million in venture capital round, its most ever ( STAT ) Julie Dohm, FDA’s top compounding official, set to leave agency ( STAT ) Their tissue turns to bone. Their joints freeze in place. And, finally, their hopes for treatment may be realized ( STAT ) J&J and Sientra get FDA warning letters over breast implants ( Focus ) ( Reut...
  • ReconRecon

    Recon: FDA Places Partial Hold on Trials for AbbVie’s Venclexta

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA puts partial hold on clinical trials of AbbVie's cancer drug ( Reuters ) ( Endpoints ) ( Press ) A drug pricing mystery: Who’s behind all the outrage over rebates? ( STAT ) The astounding 19-year journey to a sea change for heart patients ( STAT ) Ohio accuses UnitedHealth's OptumRx of drug overcharges in lawsuit ( Reuters ) Efforts to import drugs from C...
  • ReconRecon

    Recon: Apple Watch Identifies Irregular Heart Beat in Large Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Apple Watch detects irregular heart beat in large US study ( Reuters ) ( STAT ) The policy initiatives Scott Gottlieb championed at the FDA will remain after he departs ( STAT ) Amarin’s Vascepa prevents second and third heart attacks in analysis, fueling debate ( STAT ) ( Endpoints ) ( Reuters ) Going Generic: Big Brands Poised To Lose Marketing Exclusivity I...
  • ReconRecon

    Recon: EC Approves Roche’s MabThera for Rare Autoimmune Indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senator asks two pharma CEOs to clarify discrepancies in recent testimony about drug samples ( STAT ) The Family That Profited From the Opioid Crisis ( NYTimes ) Alex Azar's confusing claim on Medicaid work requirements ( Politico ) Grassley on the President's 2020 Budget W/ HHS Sec. Azar ( Senate Finance ) An ICU staple has exponentially spiked in price. Can...
  • ReconRecon

    Recon: PTAB Rejects Bid to Challenge Celgene’s Revlimid Patent

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US court rejects Alvogen's patent challenge for Celgene's cancer drug ( Reuters ) ( Endpoints ) How the not-for-profit Civica Rx will disrupt the generic drug industry ( STAT ) FDA faces test under new chief ( The Hill ) A believer in biotech and big data: How Ned Sharpless vaulted to the top of the FDA ( STAT ) Leading scientists, backed by NIH, call for a g...
  • ReconRecon

    Recon: Senate Committee Calls on PBMs to Testify at Next Drug Pricing Hearing; FDA Approves New Generic Valsartan Amid Shortage

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate committee invites PBMs to third drug pricing hearing ( Reuters ) ( STAT ) ( Endpoints ) Wyden probes a patient advocacy group over its ties to opioid makers ( STAT ) FDA approves generic valsartan amid drug shortage ( Reuters ) ( NBC ) ( NYTimes ) ( FDA ) Key Republican says Dems left him out of process on drug pricing bills ( The Hill ) Hedge fund inv...
  • ReconRecon

    Recon: Report Finds Hundreds of Thousands of Deaths Tied to Fake Drugs; Pfizer Pays $1M to Settle Misleading Copay Coupon Claims

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Exclusive: Lawsuit says Johnson & Johnson was opioid "kingpin" ( Axios ) Pfizer pays $975,000 to settle charges over misleading copay coupons ( STAT ) ( Law360 -$) Regeneron/Sanofi wins US approval for expanded use of skin drug ( Reuters ) ( Endpoints ) ( Press ) FDA Approves 18th Biosimilar, 4th for Herceptin ( Focus ) ( Reuters ) ( Press ) Upcoming market c...
  • ReconRecon

    Recon: Department of Justice Investigating Acadia’s Nuplazid Marketing Practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New Parkinson's psychosis drug target of DOJ investigation ( CNN ) ( Pharmafile ) Roche's Tecentriq notches win in breast cancer with US approval ( Reuters ) ( AP ) ( STAT ) ( Endpoints ) ( Press 1 , 2 ) Trump's 2020 budget to be unveiled ( Politico ) ( Alliance for a Stronger FDA ) Bristol scrambles to push Celgene deal, but are the odds as high as some thin...
  • ReconRecon

    Recon: Monthly Injection of ViiV, J&J HIV Combo Successful in Two Phase III Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Monthly shots control HIV as well as pills in 2 big studies ( AP ) ( Financial Times ) ( Endpoints ) ( Press ) FDA experts gun down a big part of Sanofi’s pitch for their controversial vaccine ( Endpoints ) ( STAT ) ( Fierce ) FDA Rescinds Two Breakthrough Therapy Designations ( Focus ) FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonpr...
  • ReconRecon

    Recon: Allergan Depression Drug Fails Three Phase III Trials

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices ( KHN ) FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonproprietary Names ( Focus ) J&J prices ketamine-like depression treatment at $590-$885 for two doses ( Reuters ) Allergan depression treatment fails studies, shares slip ( Reuters ) ( STAT ) ( Endpoints ) The Atul ...
  • ReconRecon

    Recon: FDA Approves J&J’s Antidepressant Nasal Spray; Vertex’s Second Triple-Drug CF Combo Hits Phase III Goals

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gottlieb to Resign as FDA Commissioner ( Focus ) ( Washington Post ) ( NYTimes ) ( Politico ) Scott Gottlieb’s sudden resignation will give biotech a panic attack ( STAT ) Side effects of Alnylam's gene-silencing drug raise concerns, shares slip ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) J&J nasal spray gets US approval as first new type of anti-depressant i...