Recon: AbbVie, Voyager Partner on Gene Therapy for Alzheimer's; Aimmune's Peanut Allergy Drug Meets Goals in Phase III

Posted 20 February 2018 | By Michael Mezher 

Recon: AbbVie, Voyager Partner on Gene Therapy for Alzheimer's; Aimmune's Peanut Allergy Drug Meets Goals in Phase III

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

In Focus: US

  • AbbVie steers past the wreckage, reserves $224M to kick off once-and-done gene therapy with Voyager to fight Alzheimer's (Endpoints) (Fierce) (Xconomy)
  • Aimmune's peanut allergy drug meets main goal, shares surge (Reuters) (Endpoints) (Financial Times) (Fierce) (Press)
  • Did the FDA just leave the door cracked open for PTC's Duchenne drug? (Endpoints) (Press)
  • Medtronic Moves to a New Health-Care Model: Pay Only if It Works (WSJ)
  • Trial Tests FTC's Power to Referee Drug Makers' Fight Against Generics (WSJ)
  • Biogen CEO Calls Share Slump an Overreaction to Alzheimer's Trial (WSJ)             
  • AstraZeneca: hoist the sales (Financial Times)
  • House Republicans Plan Legislative Hearings As First Step to Fight Opioid Crisis (WSJ)
  • The changing face of medical-device design (McKinsey)
  • She Survived Breast Cancer, But Says A Treatment Side Effect 'Almost Killed' Her (NPR)
  • Forget the Amazon announcement: Roche acquiring Flatiron Health is the biggest looming healthcare disruption. (Medium)

In Focus: International

  • Shire, Microsoft and EURODIS form rare diseases alliance (PharmaTimes)
  • Philippines threatens to sue Sanofi for refusing to issue refunds for unused dengue vaccine (STAT)
  • EU Advocate General Sides With Pfizer Over Orifarm's Parallel Importing Of Enbrel (Pink Sheet-$)
  • Roche and Takeda try on Emulate's 'organ chip' tech for R&D (Endpoints)
  • Takeda rides the neuro R&D Wave with latest biotech pact (Fierce)
  • Astellas adding 'off-the-shelf' stem cell tech in $102.5m acquisition (BioPharmaReporter)
  • With medicine running out, Venezuelans with transplants live in fear (Reuters)
  • Hikma appoints new CEO at 'pivotal' time (Financial Times)
  • EFPIA Picks Holes In EMA's Pediatric Extrapolation Proposals (Pink Sheet-$)
  • SMC approves NHS funding for UCB's Vimpat in children (PharmaTimes)
  • Johnson & Johnson picks up French robot-assisted surgery firm Orthotaxy (MassDevice) (Press)
  • Japan's Oncolys invests £3m in adenovirus firm Unleash Immuno Oncolytics (Pharmafile)

Pharmaceuticals & Biotechnology

  • How can the US catch up on biosimilars? (MedCityNews)
  • CAR-T growing up with big pharma's big bet (BioPharmaDive)
  • AstraZeneca hauls kidney disease drug into the clinic after handing Ionis $30M in cash, $300M in milestones (Endpoints)
  • Can the popular vaccine FluMist make a comeback in the U.S.? (STAT)
  • This Vaccine Can Prevent Cancer, But Many Teenagers Still Don't Get It (NPR)
  • Scientists Explore Ties Between Alzheimer's And Brain's Ancient Immune System (NPR)
  • Did Pox Virus Research Put Potential Profits Ahead of Public Safety? (NPR)
  • Powerful Antibiotics Found in Dirt (NIH)
  • Exploring Sanofi's Revamped IO Pipeline (SCRIP-$)
  • Amid buzz around a short seller's FBI visit, MiMedx stock craters following internal investigation (Endpoints)
  • New report shows 200 medicines in development for heart disease and stroke (PhRMA)
  • FDA Panel To Review Volanesorsen From Akcea, Ionis (BioCentury)
  • FDA To Hold Patient Meeting On Opioid Use Disorder (BioCentury)
  • Potentially Lethal Drug Found In Popular Dog Food Brands: What You Need To Know (Forbes)
  • How Tumor Kinetics Modeling Is Informing Dose And Candidate Selection (BioCentury)
  • Anthem Calls On Eye Surgeons To Monitor Anesthesia During Cataract Surgery (KHN)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • AAD 2018: Treatment with Lilly's Taltz® (ixekizumab) Resulted in Improvement in Impact of Genital Psoriasis on Sexual Activity (Press)
  • Acorda Announces FDA Acceptance of New Drug Application for INBRIJA™ (levodopa inhalation powder) (Press)
  • GenSight Biologics Announces Publication of Positive Data from Phase I/II Trial and Long-Term Follow-up of GS010 in Ophthalmology, the Journal of the American Academy of Ophthalmology (Press)
  • Mylan Receives Tentative Approval for Combination HIV Treatment DTG/FTC/TAF Under FDA's PEPFAR Program (Press)

Medical Devices

  • US FDA Rolling Out Updates to UDI Database in 2018 (Emergo)
  • AI Diagnostics Move Into The Clinic (IEEE)
  • Medtronic's quarterly profit meets expectations (CNBC) (Press)
  • Siemens Healthineers is preparing to file IPO (MedCityNews)
  • FDA Grants EAP Designation To Guardant's NGS-Based Liquid Biopsy (BioCentury)
  • FDA Grants Humanitarian Use Designation for Nativis Voyager Pediatric System (Press)
  • Corindus Receives FDA Clearance for CorPath GRX System in Peripheral Vascular Interventions (Press)
  • NeoTract Announces FDA Clearance of Expanded Indications for UroLift® System (Press)

US: Assorted & Government

  • Time to Release Medicare Advantage Claims Data (JAMA)
  • HHS issues rule on short-term plans (Politico) (Reuters) (KHN)
  • Amazon, Berkshire & JPMorgan Can Fix Healthcare With Technology - And By Studying Winners (Forbes)
  • Stuck in an Opioids Crisis, Officials Turn to Acupuncture (NYTimes)
  • Federal Court Reconfirms No Strict Liability for Prescription Drugs in Pennsylvania (Drug & Device Law)
  • DC District Court Denies Ferring Motion to Enforce Judgment After FDA's Surprise Change on NCE Exclusivity for PREPOPIK (FDA Law Blog)
  • Who's in Charge Here? Or Is the PTAB Bound by USPTO Guidances? (Patent Docs)

Upcoming Meetings & Events


  • EudraVigilance Release Notes v.1.8 (EMA)


  • Private hospitals making profits of up to 1,737% on drugs, consumables and diagnostics: Study (Times of India)
  • Can Sanofi's Toujeo Prickle Tresiba In India? (SCRIP-$)


  • TGA presentation: Scheduling working group meeting one, 9 February 2018 (TGA)

Other International

  • Zambia cholera epidemic continues to slow as number of deaths declines (Reuters)
  • Study finds new superbug typhoid strain behind Pakistan outbreak (Reuters)
  • Malawi cholera cases pass 500, eight people dead (Reuters)
  • Urgent need to scale up health services in Cox's Bazar: WHO (WHO)

General Health & Other Interesting Articles

  • Günter Blobel, Nobel Laureate Who Found Cell 'ZIP Codes,' Dies at 81 (NYTimes)
  • Can't get new lungs? Try refurbished ones instead. (MIT Technology Review)

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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