Regulatory Recon: CDC: Zika Causes Microcephaly US Prescription Drug Spending hit Record in 2015 (14 April 2016)

Posted 14 April 2016 | By Michael Mezher 

Regulatory Recon: CDC: Zika Causes Microcephaly US Prescription Drug Spending hit Record in 2015 (14 April 2016)

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

In Focus: US

  • Regulators Propose Banning Theranos Founder Elizabeth Holmes for at Least Two Years (WSJ-$) (Reuters)
  • Republican, signaling a shift, says more money needed for Zika fight (Reuters) (Rubio)
  • US lawmakers' effort on Zika too 'meager': White House (Reuters)
  • The Samumed Story (In The Pipeline)
  • Prescription Drug Spending Hits Record $425 Billion in U.S. Before Discount(Bloomberg) (WSJ-$) (Reuters) (Medpage)
  • The Virtues and Vices of Single-Payer Health Care (NEJM)
  • Eliminating the Public Health Problem of Hepatitis B and C in the United States: Phase One Report (National Academies)
  • From Star Wars to Real Life: New Prosthesis Transforms Lives (MIT Technology Review)
  • In JAMA editorial, Nightscout opens up about dealings with FDA (MobiHealthNews) (JAMA)
  • Video Shows Paralyzed Man Move Hand with Brain Implant (MIT Technology Review) (NYTimes)
  • Merck says Zepatier showed better efficacy and safety compared with competition in Phase III trials (Pharmafile) (Press)
  • Ransomware, Cyberattacks, and Hacking in the Health Care Industry: Lessons from a Letter to the FBI (Forbes)

In Focus: International

  • CDC Confirms Link Between Zika Virus and Birth Defects (WSJ-$) (NYTimes) (Reuters)
  • China to punish officials in vaccine scandal (Financial Times)
  • Antimicrobial resistance a 'greater threat than cancer by 2050' (The Guardian)
  • NICE issues guidance to improve controlled drug safety (PharmaceuticalJournal-$) (Pharmafile)
  • High level Indian delegation visits US FDA to resolve issues faced by pharma exporters (PharmaBiz)
  • The Looming Threat of the Avian Flu (NYTimes)
  • Hepatitis C treatment for under $300 coming soon (The Guardian)
  • Zika May Be Scary, But a Yellow Fever Outbreak Is Underway and It's Far More Deadly (MIT Technology Review)
  • Spanish regulators suspend Inmunotek's manufacturing license and order recall (In-PharmaTechnologist)

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US: Pharmaceuticals & Biotechnology

  • Warning Letter Trends for the First Half of FY2016 (Unger)
  • Seamless Oncology-Drug Development (NEJM)
  • Learning Something New – Limits To Human Tissue Liability (Drug and Device Law)
  • Unifying On Immunotherapy: Will It Pay Off?  (SCRIP-$)
  • More Women Scientists Needed, Obama Demands (SCRIP-$)
  • Briefing Summary: US FDA Posts Advisory Committee Materials for a Review of Proposed Over the Counter Use of Galderma's Adapalene Gel for Acne – APR 15, 2016 (NDAC) (Tarius)
  • Current Hepatitis C Virus Testing Guidelines Miss Too Many Cases, Study Suggests (ICT)
  • A Common Painkiller May Inhibit Your Ability To Detect Mistakes (Forbes)
  • FDA Advisors to Review OTC Option for Rx Acne Treatment (Medpage)
  • Where Is The Patient Voice In Alzheimer's Disease Drug Development? (Pink Sheet-$)
  • Pharmacy Startup PillPack To Be Terminated By Express Scripts (Forbes)
  • NEJM: What Do I Need to Learn Today – The Evolution of CME (Policy and Medicine)
  • AstraZeneca, Genentech fund PatientsLikeMe research into cancer patient experiences (PharmaPhorum)
  • Orexigen Terminates Another Cardiovascular Outcomes Trial (CardioBrief)
  • Hospira Issues A Voluntary Recall For One Lot Of 50% Magnesium Sulfate Injection, USP Due To The Presence Of Particulate (FDA)
  • Patients Wary When Docs Recruit for MS Trials (Medpage)
  • Pharma primed to invest in services, but will patients get the message? (Fierce)
  • Cancer "Moonshot" Launch Team Announced: Uncomfortable Ties To Anti-Industry Headlines (RPM Report-$)
  • Chiasma's Acromegaly Drug Headed for FDA Rejection, Investor Says (The Street)
  • Cydan, NEA's Orphan Drug Accelerator, Targets Sickle Cell With Startup Imara (Xconomy)
  • Why It's Getting Harder To Decide When To Treat High Blood Pressure (NPR)
  • ANDA Backlog: FDA Climbs The Mountain, Will Need To Climb It Again (Pink Sheet-$)
  • Gene Variant Explains Racial Disparities in Urate-Lowering Drug Reactions (DD&D)
  • Opioid Crisis: Scrap Pain as 5th Vital Sign? (Medpage)
  • RareCyte CTC Liquid Tissue Biopsy Technology Showcased At AACR Annual Meeting (BioProcessOnline)
  • 'Secret Sauce' for Personalized, Functional Insulin-Producing Cells (DD&D)

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

  • Blood cancer cell therapy shows promise in early trial says CGTC (BioPharma-Reporter)
  • AbbVie announces positive Phase III results in hepatitis C drug (Pharmafile)
  • FDA Accepts for Priority Review Bristol-Myers Squibb's Supplemental Biologics License Application for Opdivo (nivolumab) for the Treatment of Classical Hodgkin Lymphoma Patients (Press)
  • Cydan Development Announces Formation of Imara Inc. with $31M Series A Funding to Develop Therapeutic for Sickle Cell Disease (Press)
  • Reformulated Metronidazole Granted Orphan Drug for CDI in Children (MPR)
  • Cytori Therapeutics to Present Preliminary Safety and Efficacy Preclinical Data at the 2016 American Burn Association Meeting (Press)

US: Medical Devices

  • Abbott Test Cleared by FDA as Companion Dx for CLL Drug (GenomeWeb)
  • Medtronic touts insulin pump study (MassDevice)
  • How to Spend Your Medical Device Tax Savings (MDDI)
  • A Blueprint for More U.S. Early Feasibility Studies (MDDI)
  • Vascular Solutions Recalls Guardian II Hemostasis Valve Due to Low Pressure Seal Defect (FDA)
  • Focus Diagnostics Recalls Laboratory Examination Kits Due to Inaccurate Test Results (FDA)
  • Scientists report on novel method for extending the life of implantable devices in situ (MNT)
  • FDA clears AtriCure's CryoForm cryoablation probe (MassDevice)
  • FDA Approves Epigenomics' Blood-Based Colorectal Cancer Screening Test (GenomeWeb)
  • Boston Biomedical Associates Partners with CardioFocus in Premarket Approval of HeartLight System (Press)
  • Epigenomics' Epi proColon Blood Test Finally Makes The Grade With FDA (Gray Sheet-$)

US: Assorted & Government

  • California Lawmakers Take Step Toward Outlawing 'Ransomware' (Reuters)
  • Pennsylvania poised to legalize medical marijuana use (Reuters)
  • Schedules of Controlled Substances: Placement of AH-7921 into Schedule I (DEA)
  • Pharmaceutical Transparency Bills: Targeting Disclosures Purposefully (Harvard Bill of Health) (National Law Review)
  • The Zubik Supplemental Briefs: The Objectors Push for Second-Class Coverage, With a Smile (Harvard Bill of Health) (Health Affairs Blog)
  • Health Affairs Web First: Significant Shifts Detected In Public Opinion About The ACA (Health Affairs Blog)
  • Opportunities Exist to Recover Potential Overpayments to Providers with Criminal Backgrounds (GAO)
  • Florida man gets jail term for medicines counterfeiting (Securing Industry)

Upcoming Meetings & Events


  • Post-orphan medicinal product designation procedures (EMA)
  • Deadlines for submission of applications for orphan medicinal product designation (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016 (EMA)
  • Merck appoints Maya Martinez-Davis as global head of oncology (Pharmafile)
  • February sees worst NHS A&E performance in six years (PharmaTimes)
  • Sanofi opens UK bioscience partnering office (PMLive)
  • Green light for UK T-cell immunotherapy trial (PharmaTimes)
  • Synthon's generic Copaxone gets European approval (BioCentury)
  • EC adds Cellnovo to R&D project to add artificial intelligence in Type 1 diabetes management (Fierce)
  • Redx to move HQ and development ops to ex-AstraZeneca site in Cheshire (In-PharmaTechnologist)


  • Aricept Approved In The Philippines For New Indication As Treatment For Dementia With Lewy Bodies (Press)
  • Exclusive: Takeda Tsunami hits Japan pharma (PharmaLetter-$)
  • Launching a healthcare startup in Asia: Challenges and opportunities (MedCityNews)
  • Orchid receives FDA nod for Rasagiline generic formulation (BioSpectrum)
  • Orphan Drugs Korean Pharmas' Ticket To Global Success? (PharmasiaNews-$)


  • Prime Minister Narendra Modi urged to revamp Medical Council of India (Economic Times)
  • Indian Pharma Companies Received 16 First-Time USFDA Generic Drug Approvals In 2015 (24 Insight)
  • Changes proposed in norms to speed up approvals for biosimilars (Economic Times)
  • Exclusive: In health warning showdown, tobacco industry turns to India's top court (Reuters) (WSJ-$)
  • Experts advocate informed risk assessment for maintaining product quality (PharmaBiz)
  • Case related to ABS non-compliance to come up for hearing soon at Nagpur bench of Bombay HC (PharmaBiz)
  • Karnataka pharma companies get relief from Karnataka High Court for Centre's ban on 344 FDCs (PharmaBiz)
  • Akorn Pharma Granted USFDA Final Approval For Generic Naropin Injection (24 Insight)
  • Pharmexcil to collect data from member exporters on payment delays by overseas firms (PharmaBiz)
  • Nppa Revises Re-Labeling Requirements For Price-Controlled Medicines In India (24 Insight)


  • Canada's Liberal government to allow free vote on euthanasia: report (Reuters)


  • ACSMD meeting statement, Meeting 11, 5 November 2015 (TGA)


  • Brazilian Zika doctors find severe brain damage in babies: study (Reuters)
  • CDC Adds Saint Lucia to Interim Travel Guidance Related to Zika Virus (CDC)
  • Zika Highlights Weaknesses In Public Health (Forbes)

Other International

  • New method to preserve microfluidic devices for HIV monitoring in developing countries (MNT)

General Health & Other Interesting Articles

  • Many doctors still don't talk to older patients about death (Reuters)
  • The science of a good cry: In evolutionary terms, it signals two things (Washington Post)
  • Fast food may expose consumers to phthalates (Reuters)
  • Stroke survivors may face invisible obstacles returning to work (Reuters)
  • A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis (NEJM)
  • Must a Mental Illness Be Revealed on a First Date? (NYTimes Magazine)
  • Mental health care in emergencies 'not an optional luxury': experts (Reuters)
  • New Analysis Of Old Study Delivers Another Blow To Traditional Diet Advice (CardioBrief)

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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