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Regulatory Recon: PaxVax Gets Priority Review Voucher for Cholera Vaccine Walgreens Ends Theranos Deal (13 June 2016)

Posted 13 June 2016 | By Michael Mezher 

Regulatory Recon: PaxVax Gets Priority Review Voucher for Cholera Vaccine Walgreens Ends Theranos Deal (13 June 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

  • Walgreen Terminates Partnership With Blood-Testing Firm Theranos (WSJ-$) (NYTimes) (Forbes)
  • Understaffed and Underfunded: FDA Begins to Hear Opinions on Crafting an OTC Drug User Fee Program (Focus) (DSN)
  • FDA Kicks Pharma, Device Rule Finalizations Down the Road, Past Obama's Presidency (Focus)
  • Should social media decide whether a child gets a lifesaving drug? (Washington Post)
  • Gene Therapy Is Curing Hemophilia (MIT Technology Review)
  • Orlando shooting sparks calls to end limits on gay men donating blood (STAT)
  • FDA approves PaxVax's Cholera Vaccine Vaxchora, grants voucher (BioCentury) (FDA) (Medpage) (Press)
  • Drug Maker's Former Employees Accused of Shady Dealings With Doctors (NYTimes) (STAT)
  • Monitoring doctors cuts opioid prescriptions (Reuters)

In Focus: International

  • Counting down to the final text of MDR and IVDR; more on software (MedicalDevicesLegal)
  • EU Ombudsman Calls on EMA to Release Redacted Humira Study Data (Focus)
  • Mylan raised prices for some drugs by huge amounts (STAT)
  • The cancer drugs in your bathroom cabinet (The Guardian)
  • Doctor's Plan for Full-Body Transplants Raises Doubts Even in Daring China (NYTimes)
  • India's Dr Reddy's in $350 million deal to buy eight US drugs from Teva, Allergan (Reuters) (Economic Times)
  • China's FDA signs MoU on strategic cooperation with the Gates Foundation (PharmaLetter-$)
  • How Parallel Distribution Of Medical Devices Could Be Impacted By German Cases (Clinica-$)
  • Fake vaccination papers let yellow fever spread in Angola (Reuters)
  • Studies find 'super bacteria' in Rio's Olympic venues, top beaches (Reuters)
  • Colombia To Lower Price Of Novartis Cancer Drug Gleevec, PhRMA Responds (Law360-$) (PharmaLetter-$) (PhRMA)
  • Chile Wants $15.5M Antitrust Fine For Pfizer Subsidiary (Law360-$)

US: Pharmaceuticals & Biotechnology

  • Bill Gates: Some People Think Eradicating Mosquitoes With Genetics Is Scary, But I Don't Think It Will Be (Forbes)
  • Califf's big idea: Build a database for research done before clinical trials (STAT)
  • FDA Prescription Drug User Fee Program Will Get OIG Appraisal (Pink Sheet-$)
  • Drugs may not deserve reputations for sleep disruption (Reuters)
  • Asco event analyser – 2016's winners and losers (EP Vantage)
  • Changing the Subject (Part 4): Project Re-CLAIM (RPM Report-$)
  • Investors See Big Opportunities In Opioid Addiction Treatment (NPR)
  • NIH Awards $2M Grant for Development of Genomic Medicine Legal Framework (GenomeWeb)
  • 5 Attractive Biotechnology Stocks For Healthy Long-Term Returns (Forbes)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; POMALYST (FDA)

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

  • Marinus tanks as adult focal onset seizure drug fails late stage (Reuters)
  • Global Blood Therapeutics Shares Jump After Positive Results for Pivotal Drug (WSJ-$) (BioCentury)
  • Novo Nordisk presents Tresiba data showing significantly lower hypoglycaemia rates (Pharmafile)
  • Shire gets FDA breakthrough therapy designation for two rare disease drugs (Pharmafile) (Press)
  • Sanofi says LixiLan diabetes drug trials meet targets (Reuters) (Press)
  • Eisai Presents Latest Phase I/II Data On In-House Developed Anti-Fractalkine Antibody E6011 (Eisai)
  • Successful Switch To Sanofi's Toujeo Evaluated In A Real-World Setting (Press)
  • Stem cell transplant after chemotherapy halted MS lesions (BioCentury)
  • FDA gives Upsher-Smith tentative approval for new Qudexy XR indication (DSN)
  • Concert Pharmaceuticals Presents CTP-656 Phase 1 Results at European Cystic Fibrosis Conference (Press)
  • Phase III data show Blincyto's survival benefit (BioCentury)
  • New Data Show Lilly's Once-Weekly Trulicity (dulaglutide) in Combination with Insulin Glargine Improves Glycemic Control in People with Type 2 Diabetes (Press)
  • Melior Pharmaceuticals Announces Positive Phase 2A Results in Type 2 Diabetes Study (Press)
  • Merck and Pfizer Announce Two Pivotal Phase 3 Studies for Ertugliflozin, an Investigational SGLT-2 Inhibitor, Met Primary Endpoints, Showing Significant A1C Reductions in Patients with Type 2 Diabetes (Press)
  • Lannett Receives FDA Approval For Neomycin Sulfate Tablets USP, 500 mg (Press)
  • Pfizer's leukaemia drug beats chemotherapy in Phase III trials (Pharmafile) (Press)
  • GI Dynamics Announces Results of EndoBarrier® Therapy Studies at Digestive Disease Week Meeting (Press)
  • ARIAD Announces Long-Term Safety and Efficacy Data of Ponatinib from Phase 2 Pace Clinical Trial (Press)
  • New study results show Tradjenta (linagliptin) reduces blood sugar in adults with type 2 diabetes at risk for kidney impairment (Press)
  • Medtronic touts shorter stays, less retreats with cryoablation for treating paroxysmal AF (MassDevice)
  • GlycoMimetics' GMI-1271 Receives FDA Fast Track Designation for Treatment of Acute Myeloid Leukemia (Press)
  • Agios heralds hemoglobin rise in first batch of PhII data for anemia drug (Fierce)
  • ANI Pharmaceuticals Announces FDA Approval of Oxcarbazepine Tablets (Press)

US: Medical Devices

  • The quest for an interoperable EHR app (MassDevice)
  • FDA lifts shipping restrictions on Terumo's Michigan plant (MassDevice)
  • Ethicon mesh plaintiffs claim company expert admitted mesh degrades (MassDevice)
  • Study backs laser prostate ablation with Medtronic's Artemis (MassDevice)
  • Innovatex wins down-classification for tear duct occluder from FDA (MassDevice)
  • Zimmer Biomet acquires Compression Therapy Concepts (MassDevice)
  • Trelleborg picks up Specialty Silicone Fabricators (MassDevice)
  • Masimo Announces 510(k) Clearance for O3™ Regional Oximetry (Press)

US: Assorted & Government

  • Health Science Funding Case – A Lesson in How Not to Address Marketing Uncertainty Surrounding Medical Foods (FDA Law Blog)
  • It Doesn't Matter That UnitedHealth Is Ditching Obamacare (Forbes)
  • Senate Votes Millions More For NIH Precision Medicine, BRAIN Initiatives (Gray Sheet-$)
  • Purdue Resisting NH Opioid Marketing Probe, AG Says (Law360-$)
  • Abortion providers, opponents brace for US high court decision (Reuters)
  • Tarceva Off-Label Marketing Caused 'Earlier' Death, DOJ Alleged (Pink Sheet-$)

Upcoming Meetings & Events


  • "EU membership enables the UK to push the boundaries of scientific progress", says (ABPI)
  • Life sciences at risk if Britain votes to leave EU, MPs warn (Financial Times-$)
  • Gang sentenced for importing unlicensed drugs (MHRA)
  • MHRA Warns Indian Manufacturer Over GMP Deficiencies (FDANews-$)
  • MHRA Delays Nordic Pharma's Attempt to Add New Indian CMO Site to Marketing Authorization (Focus)
  • Shire completes EU decentralisation procedure for Cuvitru (PharmaTimes)


  • Turkish pharma grows by 15.6%, as CPhI Istanbul shares MENA trends and challenges for 2016 (EPR) (PharmaLetter-$)
  • Joint venture company for MAb production set up in Japan (PharmaLetter-$)


  • CDSCO concludes 5 training programmes for drug inspectors on GMP compliance (PharmaBiz)
  • CDSCO to recruit 147 drug inspectors to enhance inspections of mfg units (PharmaBiz)
  • Telangana to set up Pharma City near Hyderabad (Economic Times)
  • Report: Boston Scientific to make India its largest OUS hub (MassDevice)
  • US FDA issues guidance on facility definition for outsourcing plants, Indian cos view it a positive move (PharmaBiz)
  • Pharma sector grows 7.7 per cent in May; FDC ban weighs (Economic Times)
  • Indian pharma market posts 7.7% growth in May 2016 at Rs. 8,449 crore (PharmaBiz)


  • Release of Draft (Step 2) ICH Guidance Document: S3A Q&A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure – Focus on Microsampling (Health Canada)
  • E14 Questions and Answers (R3): The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (Health Canada)
  • Summary Basis of Decision (SBD) for Praluent (Health Canada)
  • S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals and Limit Dose (Health Canada)


  • Oventus to market 3D-printed sleep apnea device in USA (BioSpectrum)


  • Scientists Say The Rio Olympics Should Be Postponed Due To Zika (Forbes)
  • Officials Preparing for Zika Virus to Spread in the US (NYTimes)
  • Zika May Place Burden On Medicaid (Harvard Bill of Health)
  • Official map finds Zika-transmitting mosquitoes in much of US (Reuters)

Other International

  • Merck Opens a Hub office In Ethiopia that will cover Sudan, Ethiopia and French-speaking African countries (PharmaAfrica)
  • South Africa confirms two separate cases of African Swine Fever (Reuters)
  • Cristália gets ANVISA nod to make burns treatment at new biomanufacturing plant (BioPharma-Reporter)

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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