Recon: Roche to Buy Flatiron Health for $1.9B; FDA Panel Rejects Expanded Label for Exparel

Posted 16 February 2018 | By Michael Mezher 

Recon: Roche to Buy Flatiron Health for $1.9B; FDA Panel Rejects Expanded Label for Exparel

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Roche to buy Flatiron Health for $1.9 billion to expand cancer care portfolio (Reuters) (Fierce) (Forbes) (Endpoints) (Press)
  • Celgene Spinout Celularity Raises $250 Million To Develop Placental Cells To Attack Cancer (Forbes) (Fierce)
  • The FDA May Be Opening an Alzheimer's Can of Worms (Bloomberg) (Reuters) (Endpoints)
  • Shares of Apricus tank after FDA declines to OK erectile dysfunction cream (Reuters) (Fierce) (Endpoints)
  • FDA advisory group rejects Pacira's pitch for expanded use of pain drug (Endpoints) (Pink Sheet-$)
  • Why redesigning the humble yeast could kick off the next industrial revolution (MIT Technology Review)
  • White House: Merck and others hit by NotPetya were collateral damage in Russia's cyberwar on the Ukraine (Endpoints)
  • With new CRISPR inventions, its pioneers say, you ain't seen nothin' yet (STAT) (Xconomy)
  • Is Gaming Technology 'Medicine's New Frontier?' (Forbes)
  • Gene-altering treatments are medicine's best shot yet against Huntington's disease (MIT Technology Review)
  • AbbVie shares the wealth with dividend boost, $10bn in buybacks (Financial Times)
  • How Pharma Can Minimize Political Risk From Its Repatriation Windfall (Forbes)

In Focus: International                           

  • World leaders join new drive to beat noncommunicable diseases (WHO)
  • Getting medicines to the people who need them (Financial Times)
  • Pharma groups deliver mixed performance (Financial Times)
  • Pot Pharm: Booming Canada weed sector plots next-wave medicines (Reuters)
  • Pharma urges US trade officials to place the E.U. on the bad behavior list (STAT)
  • NICE gives three nods in thyroid cancer (PharmaTimes)
  • Stada Looks East in Expansion Push (Bloomberg)
  • Updated EU Guide On Unique Identifiers May Impact Drug Distribution Strategies Post Brexit (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • The Flu Vaccine Is Working Better Than Expected, CDC Finds (NYTimes) (FDA)
  • US officials warn 'intense' flu season to continue, urge shots (Reuters)
  • FDA pilots cross-functional teams to expedite product review process (PharmaLetter-$)
  • Cancer: New path to improving immunotherapy (Nature)
  • Cancer vaccine made from stem cells could open another door in immunotherapy (STAT)
  • FDA vows to combat high drug prices and companies 'gaming the system' (KHN)
  • Well, that got awkward. Arcturus fires back at ex-CEO Joe Payne (Endpoints)
  • Ex-Axovant COO Marion McCourt lands at Regeneron; GT Biopharma elevates Shawn Cross to CEO in exec reshuffle (Endpoints)
  • The Moment Of Truth Is Coming For Struggling And Expensive Cholesterol Drugs (Forbes)
  • Johnson & Johnson's stay-out-of-jail marketing for schizophrenia blockbuster Invega Sustenna raises eyebrows (Fierce)
  • FDA Deputy On CRLs: 'It's Not Our Property To Release' (SCRIP-$)
  • JP Morgan upgrades two biotech companies amid 'optimistic' outlook (CNBC)
  • Using stem cells to generate an immune attack against cancer (Fierce)
  • A trip to 'the poopy lab' in the interest of drug development (STAT)
  • An Image To Maintain: GAO Profit Picture Of Drug Industry Is Good To Store Away For Future Debates (Pink Sheet-$)
  • Case 5-2018: A 63-Year-Old Man with Confusion after Stem-Cell Transplantation (NEJM)              

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Intralytix Receives FDA Clearance to Initiate Phase I / IIa Clinical Trials (Press)
  • Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-AAT (Press)

Medical Devices

  • Emergo Survey: Regulatory Challenges Having Bigger Impact on Smaller Medical Device Companies (Emerog)
  • Medical Devices in the Real World (NEJM)
  • FDA Clears Trevo Stent Retriever for Up to 24 Hours Post-Stroke (Medpage) (MassDevice) (FDA)
  • Smith & Nephew touts results from Allevyn Life adhesive dressing hip fracture trial (MassDevice)
  • The Guardant360® Assay Receives Expedited Access Pathway Designation for Breakthrough Devices from FDA (Press)
  • Medtronic looks to expand MiniMed 670G into pediatric diabetes (Drug Delivery) (Press)

US: Assorted & Government

  • New Health Secretary Faces First Test as Idaho Skirts Federal Law (NYTimes)
  • Washington is taking aim at drug industry middlemen. But can it break their grip on a captive market? (STAT)
  • Bayer Claims Perrigo Infringed Finacea Drug Patents (Law360-$)
  • Lawsuit Argues That Feds' Cannabis Ban Violates Our Constitutional Rights ( Forbes)
  • California Superior Court Refuses to Allow Discovery in Aid of "Litigation Tourism" in Consolidated Xarelto Litigation (Drug & Device Law)

Upcoming Meetings & Events


  • Regenerative medicine at the front line network event - information pack (GOV.UK)
  • Update on Brexit regulatory preparedness activities for veterinary companies (EMA)
  • Esmya: no new treatment courses prescribed until further notice (MHRA)
  • EMA EudraVigilance and signal management information day (EMA)

General Health & Other Interesting Articles

  • Breast MRIs may lead to more biopsies that catch fewer cancers (Reuters)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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