Regulatory Recon: Lilly Alzheimer's Drug Fails in Phase III Juno CAR-T Study Halted After Additional Deaths (23 November 2016)

Posted 23 November 2016 | By Michael Mezher 

Regulatory Recon: Lilly Alzheimer's Drug Fails in Phase III Juno CAR-T Study Halted After Additional Deaths (23 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

Note: We will resume publishing Recon after the Thanksgiving holiday on 28 November 2016.

In Focus: US

  • Eli Lilly's Experimental Alzheimer's Drug Failed in Large Trial (NYTimes) (Reuters) (STAT) (Financial Times) (The Street) (Press)
  • Despite a Lilly flop, Wall Street wags remain bullish on a Biogen Alzheimer's drug (STAT)
  • Juno Therapeutics CAR-T Study Halts Following Additional Patient Deaths (The Street) (STAT) (Reuters) (Fierce) (Press)
  • Allergan buys Chase Pharma (PharmaTimes) (Pharmafile) (Drug Delivery)
  • The Downside of Early FDA Approval (MDDI)
  • Trump Health-Care Plans Trouble Industry, Jefferies Survey Finds (Bloomberg)
  • Precision Medicine Has Bipartisan Support, Proponents Assure Amid Trump Administration Transition (GenomeWeb)
  • Precision Medicine In Trump Era? California Presses Own Modest Program (Xconomy)
  • Cel-Sci responds to US FDA clinical hold on Multikine study (BioPharmaReporter)
  • The Next HHS Secretary: Who's on the Short List? (Medpage)
  • Fentanyl Billionaire Comes Under Fire as Death Toll Mounts From Prescription Opioids (WSJ)
  • Long-Stalled FDA Reform Sits On Senate's Lame-Duck Calendar (KHN)
  • House Republicans Ask to Put on Hold Case Against Obama's Health-Care Law (WSJ)
  • Law firm that believes FDA is 'broken' highlights Cures Act fears (Fierce) (Emord & Associates)
  • FDA Revises Guidance on Safety Testing of Drug Metabolites (Focus)
  • FDA Warns Wockhardt Subsidiary Over Aseptic Production Issues (Focus)
  • FDA Finalizes Contract Manufacturer Quality Arrangement Guidance From 2013 (Focus)
  • Companies Collaborate on DSCSA Guideline as Deadlines Approach (Focus)
  • FDA outlines data needed for over-the-counter sunscreen additives (Reuters)
  • Abuse-Deterrent Exemption From Medicaid Rebates Hinges On FDA Standards (Pink Sheet-$)
  • Pfizer set to develop new $200 million Missouri site (Pharmafile)

In Focus: International

  • USA's BIO slams Japan's pharma reimbursement and pricing system (PharmaLetter-$) (BIO)
  • India – patent challenges and compulsory licensing (PharmaLetter-$)
  • Review of Australia's Gene Technology Regulations: Opportunity to Strengthen Australia's Biotechnology Industry (National Law Review)
  • In Brief: Russian Regulators Expand List of Implantable Medical Devices (Emergo)
  • Vietnam bans 39 Indian drug firms (Economic Times)
  • Sanofi Pasteur confirms plant problems prompted TheraCys decision (InPharmaTechnologist)
  • Asia Regulatory Roundup: TGA Consults on Accelerated Assessments for Devices (Focus)
  • Include older children in malaria prevention treatment to cut transmission: experts (Reuters) (PLOS 1    , 2)
  • EU approves Opdivo for Classical Hodgkin's Lymphoma (PharmaTimes) (Press)
  • NICE finds cost-effective use for Celgene's Imnovid (PharmaTimes)
  • Sun Pharma makes strategic Russian firm acquisition (Pharmafile) (Economic Times)
  • Tax break hint for funds investing in UK biotech (Financial Times)
  • North China City Halts Pharma, Steel Plants to Curb Pollution (Bloomberg)

US: Pharmaceuticals & Biotechnology

  • BIO taps Booth for government affairs post (BioCentury)
  • Alaska's Novel Plan to Cut Health Premium Costs (WSJ)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Galapagos, Gilead start PhIII trial of filgotinib in Crohn's (Fierce)

US: Medical Devices

  • Interview – Blackberry plans to shake up medtech cybersecurity (EP Vantage)
  • Why Quest is chasing the consumer testing market (MedCityNews)
  • Baxter touts blood purification efficiency in EBP studies (MassDevice)
  • Corvia Medical touts 1-year data for InterAtrial shunt (MassDevice)
  • SentreHeart recalls FindrWIRZ Guidewire System over coating separation issues (MassDevice) (FDA)

US: Assorted & Government

  • How Trump's post-Obamacare plans could hurt the bottom lines of insurers and hospitals (CNBC)
  • Amicus Briefs Not So Friendly to California Supreme Court's Dreadful BMS Personal Jurisdiction Decision (Drug and Device Law)
  • HHS OIG's Latest Work Plan: What to Look Out for in FY2017 (FDA Law Blog)
  • CPSC Magnet Ban/Standard Vacated by 10th Circuit (FDA Law Blog)

Upcoming Meetings & Events


  • UK pharmaceutical industry response to 2016 Autumn Statement (ABPI)
  • EFPIA opinion on the Annual Growth Survey and recommendations for the European Semester 2017 (EFPIA)



  • Skyline Medical wins Health Canada nod for Streamway medical fluid disposal device (MassDevice)
  • Regulatory decision summary for VOLIBRIS (Health Canada)


  • AusPAR user survey results (TGA)


  • Florida lifts Zika transmission zone in parts of Miami Beach (Reuters)
  • Babies exposed to Zika developed microcephaly after birth: study (Reuters) (CDC)
  • FDA Grants Emergency Use Authorization to Abbott RealTime Zika (FDA)
  • Asia outbreaks prompt question: Is all Zika dangerous? (Reuters)

General Health & Other Interesting Articles

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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