Regulatory Focus™ > News Articles > Regulatory Recon: Roche’s Zika Test Wins Emergency Authorization From FDA (29 August 2016)

Regulatory Recon: Roche’s Zika Test Wins Emergency Authorization From FDA (29 August 2016)

Posted 29 August 2016 | By Zachary Brennan 

Regulatory Recon: Roche’s Zika Test Wins Emergency Authorization From FDA (29 August 2016)

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

In Focus: US

  • Innovators vs Exploiters: Drug Pricing And The Future Of Pharma (Life Sci VC)
  • NIH collaboration helps advance potential Zika treatments (NIH)
  • All U.S. Blood Donations Should Be Screened For Zika, FDA Says (NPR) (WSJ-$)
  • Roche Zika Test Wins FDA Emergency Authorization (GEN) (Reuters) (FDA)
  • Pharmaceutical Compounding: The FDA Is Not The Problem (Forbes)
  • FDA Issues a Significantly Improved Draft Guidance Regarding 510(k) Modifications (FDA Law Blog)
  • Drugmakers create own 'hurricanes' to gouge consumers: Ex-FDA official (CNBC)
  • FDA Guidance: Bioequivalence Recommendations for Risperidone (Federal Register) (FDA)
  • Bad pharma and the canary in the coalmine for problems in modern medicine (Cosmos)
  • Form 483 for Hybrid Pharma (FDA)
  • Editorial: The unaffordable cost of M&A-driven drug prices (Modern Healthcare-$)
  • FTC Charges Academic Journal Publisher OMICS Group Deceived Researchers (FTC)
  • DWPE for drugs for potentially hazardous microbial contamination (FDA)

In Focus: International

  • German economy minister says EU-US trade talks have failed (AP)
  • NICE backs non-surgical option for fibroids (PharmaTimes)
  • NICE set to recommend device to help spot heart disease using 3D models of blood vessels (NICE)
  • U.K. regulator MHRA updates guidelines on medical app requirements (Mass Device) (Focus)
  • Takeda: No decision yet on shutdown of Cambridge, UK unit (PMLive)
  • Zika Starts to Take Hold in Singapore (Reuters) (CNBC) (Singapore Ministry of Health)
  • Southeast Asia needs to up its game to combat Zika: experts (Reuters)
  • Guess How Many Zika Cases Showed Up At The Olympics? (NPR)
  • Yellow fever vaccination drive in Congo's capital hits target (Reuters)
  • WHO Yellow fever situation report (WHO)
  • NAFDAC confirms falsified anti-malarials in Cameroon and DRC (NAFDAC)

US: Pharmaceuticals & Biotechnology

  • Glaxo Bets It Can Shake Up HIV Treatment (WSJ-$)
  • Stealthy Arcus emerges with $120M to make personalized I/O therapy a reality (FierceBiotech)
  • Ferring buys rights to PhIII pain drug from Seikagaku (FierceBiotech)
  • The XX Factor: Fixing Biotech’s Gender Imbalance in the C-Suite (Xconomy)
  • AstraZeneca puts Fairfax HQ on market (News Journal)
  • The HDA Bar Code Quick Start Guide For Meeting The DSCSA And Other FDA Regulations (RxTrace)
  • Behind the stealth ad campaigns for the EpiPen and other drugs (Stat)
  • IMS Health, Quintiles Name Key Officers for Merged Co. (Contract Pharma)
  • To help cancer patients, lawmakers pushed access to a controversial doctor (Stat)
  • An open letter to Mylan CEO Heather Bresch about EpiPen pricing (Stat)
  • Mylan CEO sold $5m worth of stock while EpiPen price drew scrutiny (Guardian)
  • Price Hike For One Diabetes Drug Costs CalPERS Millions (CaliforniaHealthLine)
  • Third-Party Payors Say GSK Skews Avandia Claims (Law360-$)
  • PhRMA Fact Check: The truth about biopharmaceutical patents (PharmaLetter-$)

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

  • With 11 drugs in pipeline, Moderna wants to raise $600m (Boston Globe) (Endpoints)
  • Genzyme Petitions Federal Circuit for Rehearing in Genzyme Therapeutic Products, Inc. v. Biomarin Pharmaceutical, Inc. (Patent Docs)
  • Struggling CTI reveals new pacritinib data, misses a primary endpoint (FierceBiotech)
  • CardioCell stem cells ‘improve well-being’ of heart failure patients (FierceBiotech)
  • Cancer upstart CBT closes $9.7M Series A; OrbiMed lead investor (FierceBiotech)
  • U.S. judge will not block California school vaccination law (Reuters)
  • Martin Shkreli is no longer a stakeholder in KaloBios (MarketWatch)
  • Vaccine Delays, Refusals, and Patient Dismissals: A Survey of Pediatricians (Pediatrics)
  • Cerecor Inc. Announces Initiation of Second CERC-501 Phase 2 Clinical Trial in Smokers (PR)

US: Medical Devices

  • FDA – Industry MDUFA IV Reauthorization Meeting 15 August, 26 July (FDA) (FDA) (AdvaMed) (Focus)
  • Medtronic touts 12-month data on Micra leadless pacemaker (Mass Device)
  • Labor dispute prompts withdrawal of job offers at GE Healthcare (Mass Device)
  • Beyond the device: From producer to problem solver (PwC)
  • Alere shares fall after it sued Abbott over $5.8 billion deal (CNBC)
  • DaVita Seeks End To Dialysis Suit (Law360-$)

US: Assorted & Government

  • Obamacare Marketplaces Are in Trouble. What Can Be Done? (NY Times)

Upcoming Meetings & Events


  • Chinese developer eyes a Bay Area biotech hub (C&EN)


  • CDSCO: Upgradation of skill sets of persons employed in pharma manufacturing (CDSCO)

Zika Virus

  • A Guide to Help Pregnant Women Reduce Their Zika Risk (NY Times-$)
  • Zika Funding Delay in Congress Puts Americans at Risk, Obama Says (NBC News)
  • Zika spread through sex by symptom-free man (CBS)
  • Nicaragua confirms first microcephaly birth linked to Zika virus (Reuters)
  • Singapore mass sprays residences as Zika expected to spread (Reuters)

Other International

General Health & Other Interesting Articles

  • Opioids: Whatever happened to ‘first, do no harm’? (Globe and Mail)
  • Newly Discovered Virus Has Multi-Part Genome (TheScientist)
  • Devastating bird flu strain found in U.S. wild duck – USDA (Reuters)
  • A Chocolate Pill? Scientists To Test Whether Cocoa Extract Boosts Health (NPR)
  • Why do scientists commit misconduct (Retraction Watch)

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.

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

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