Regulatory Recon: Theranos Backs Out of Blood Testing, Lays Off Hundreds Alnylam Ends Revusiran Development After Patient Deaths (6 October 2016)

Posted 06 October 2016 | By Michael Mezher 

Regulatory Recon: Theranos Backs Out of Blood Testing, Lays Off Hundreds Alnylam Ends Revusiran Development After Patient Deaths (6 October 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US

  • Final FDA Rule Clarifies Pharma Patent Process With Aim of Reducing Unnecessary Litigation (FDA) (FDA Law Blog) (Pink Sheet-$) (Focus)
  • Alnylam ends development of drug due to patient deaths in trial (Reuters) (WSJ)
  • Theranos Retreats From Blood Tests (WSJ) (Washington Post) (Reuters) (STAT)
  • Progress in Myeloma — A Monoclonal Breakthrough (NEJM, Study)
  • Data Monitoring Committees — Expect the Unexpected (NEJM)
  • Tracking Who Makes Money On A Brand-Name Drug (KHN)
  • Judge Grants Gilead Motion To Invalidate Remicade Patent For Obviousness-Type Double Patenting (National Law Review)
  • Judicious Animal Antibiotic Use Requires Changes to Drug Labels (Pew)
  • Amid Big Pharma manufacturing squeeze, Merck cuts 112 jobs in Florida plant shutdown (Fierce)
  • U.S. government health plans spent over $1 billion on EpiPens over five years (Reuters) (WSJ) (CMS Letter) (InsideHealthPolicy-$)
  • Secret Rebates: Why Patients Pay $600 for Drugs That Cost $300 (Bloomberg)
  • Teva Stumbles, Actelion Rises In MS: Clinical Protocols Lost And Gained (Pink Sheet-$)
  • Higher Naloxone Doses Narrowly Favored By FDA Panel (Pink Sheet-$) (Tarius)
  • Novartis Pays $35M To End Elidel Off-Label Marketing Suit (Law360-$)
  • Pfizer Wields Ferring Win To Extend Combo Drug Exclusivity (Law360-$)
  • Company That Ran Fateful Drug Trial In France Opens Test Facility In US (NPR)
  • The Pill Makers Next Door: How America’s Opioid Crisis Is Spreading (WSJ)
  • AstraZeneca licenses respiratory drug to Insmed (Reuters)

In Focus: International

  • Colombia Allows Faster Renewals for Lower-risk Medical Devices (Emergo)
  • Saudi FDA to Regulate Borderline Products as Pharmaceuticals (Emergo)
  • U.K.'s May calls for life sciences support (BioCentury)
  • Patient Safety: Single European Code and EU Web Platform improve traceability of donated tissue and cells (Europa – Scroll Down)
  • Pediatric Oncology Drug Development: Maximizing Efficiency While Complying with FDA & EMA Regulations (Tufts)
  • Australian government makes venture capital pot sweeter for biotech investments (BioWorld)
  • Report: Drug device market to reach $1.8B by 2024 (MassDevice)
  • NICE says Truvada is effective as PrEP but identifies issues to consider (Pharmaceutical Journal) (PharmaLetter-$)
  • Canada denies patients access to ovarian cancer drug Lynparza (PharmaLetter-$)
  • Interview – Boehringer beats a brave route with oncolytic virus deal (EP Vantage)
  • Vantage point – What Brexit means for drug regulation (EP Vantage)

US: Pharmaceuticals & Biotechnology

  • With New Program, DARPA To Encourage Safety “Brakes” For Gene Editing (Xconomy)
  • Merck, NewLink nab up to $76M BARDA contract to back Ebola vaccine (Fierce)
  • Activities Report of the Generic Drug Program (FY 2016) (FDA)
  • NEJM challenge seeks to demonstrate clinical trial data sharing's potential (OutsourcingPharma)
  • Lexicon to settle up with Symphony as it aims for early 2017 FDA approval (Fierce)
  • External R&D Is Up, But Which Companies Are Reaping The Most Benefit? (SCRIP-$)
  • Making medications safer for newborns (MNT)
  • Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences -- Part VII, The Microbiology of the Built Environment (Patent Docs)
  • Shire: Patent Trial and Appeal Board Upholds the Validity of LIALDA® Patent (Press)

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

  • Orexo: FDA Approves Unique Low Dosage of Zubsolv® (Press)
  • Bone Therapeutics posts interim PhIIa data, building case for bone-forming cell therapy (Fierce)
  • Karus Therapeutics doses first lymphoma patients in Phase I KA2237 clinical study (EPR)
  • The Medicines Company Provides Progress Update on Ongoing ORION-1 Study of PCSK9si (Press)
  • Velicept Therapeutics Announces FDA Acceptance of IND Application of Novel, Once-Daily Formulation of Solabegron for the Treatment of Overactive Bladder (Press)

US: Medical Devices

  • PMA Approvals for September 2016 (FDA)
  • Animas OneTouch Ping Insulin Pump Vulnerabilities (DHS ICS-CERT)
  • State of the U.S. Gastrointestinal Endoscopic Device Market (MDDI)
  • Voice box prostheses may only last three months (Reuters)
  • Twin-Pass Dual Access Catheters by Vascular Solutions: Recall - Potential for Excess Manufacturing Material At The Tip (FDA)

US: Assorted & Government

  • Trump’s Risk For A Cardiac Event Is Seven Times Hilary Clinton’s Risk (CardioBrief)
  • Marketers of Joint Pain Supplement Agree to Settle FTC Charges of Deceptive Advertising, Endorsements (FTC)

Upcoming Meetings & Events


  • St. Jude launches EnSite Precision cardiac mapping system in EU (MassDevice)



  • Zydus enters in-licensing pact with Neovii to market transplant-immuno therapies, Grafalon in India (PharmaBiz)
  • Union Cabinet approves amendments to HIV and AIDS (Prevention and Control) Bill, 2014 (PharmaBiz)
  • CCMB to establish ‘Innovation hub’ in Hyderabad to boost start-ups in medical biotechnology (PharmaBiz)
  • Maha FDA to prosecute manufacturers of steroid-laden creams for violating labeling conditions (PharmaBiz)
  • Acute shortage of Wilson’s disease drug, D-Penicillamine, supply of API from China dries up (PharmaBiz)


  • Consultation on the Health Canada Draft Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New Drug Submissions (ANDSs) (Health Canada)


  • Abortion legal in Thai birth defect cases linked to Zika, officials say (Reuters)

General Health & Other Interesting Articles

  • What’s the Longest Humans Can Live? 115 Years, New Study Says (NYTimes) (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.

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