Regulatory Recon: New Precedent on NDA Approval Dates Walgreens May Pull Theranos Deal (11 February 2016)

Posted 11 February 2016 | By Michael Mezher 

Regulatory Recon: New Precedent on NDA Approval Dates Walgreens May Pull Theranos Deal (11 February 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

  • NDA Approval Date Resets: More Than a One-Off (FDA Law Blog)
  • FDA Looking to License H1N1 Influenza Antibody IP to Industry (Federal Register)
  • CDC, NIH 'Working Closely' With FDA on Zika Response (Focus)
  • Walgreens Threatens to End Theranos Agreement (WSJ)
  • Data Mining for Deadly Drug Combinations (Chicago Tribune)
  • FDA Presses Medical Device Makers to OK Good Faith Hacking (CSMonitor)
  • Can Pharma Learn to Stop Worrying and Love Biosimilars? (Forbes)
  • Solution to Drug Prices is Not as Simple as Clearing FDA's Generic Backlog (Thomson Reuters)

In Focus: International

  • New Study Links Zika Virus to Microcephaly (WSJ) (NEJM)
  • WHO DG Addresses Ministerial Conference on Antimicrobial Resistance (WHO)
  • US FDA Inspections in China: An Analysis of Form 483s From 2015 (Focus)
  • EMA Accepts Sandoz Application for Pegfilgrastim Biosimilar (Reuters)
  • O'Neill Says New Vaccines Needed as Alternatives to Antibiotics (SCRIP-$) (BioCentury)
  • ICMRA Pledges Support to Tackle Zika Virus (ICMRA)

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US: Pharmaceuticals & Biotechnology

  • Scripps Florida researchers develop 'LIGHTSABR' -- a cheap, portable drug-discovery system (MNT)
  • Starting Materials Remains a Challenging Issue for Both Regulators and Industry; FDA DMF Assessments Show SM Information Gaps (IPQ)
  • On the Road (to a Cure?) — Stem-Cell Tourism and Lessons for Gene Editing (NEJM)
  • Imprimis Pharma to make cheaper alternative to Retrophin's Thiola (Reuters)
  • BIO CEO 2016: What it will take to achieve Cancer MoonShot 2020 (BioPharmaDive)
  • Xeljanz Released from REMS Requirement (MPR)
  • Care and Cure: Engineering the future of diabetes treatment (Reuters)
  • GSK's Ribeiro On Flexible Pricing And Seretide Growth In Ems (SCRIP-$)
  • Health Affairs Vaccines Briefing Recap (Health Affairs Blog)

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

  • Lannett Receives FDA Approval For Temozolomide Capsules (Press)
  • Puma Biotechnology's ExteNET Phase III Study Published Online in The Lancet Oncology (Press)
  • Aerpio Therapeutics Announces Presentation of Positive Results of AKB-9778 in Patients with Diabetic Retinopathy from TIME-2 Phase 2a Study (Press)
  • FDA Lifts Heat Biologics Partial Clinical Hold (Biospace)
  • Video Interview: Nabriva Plans Second Phase III Trial (SCRIP-$)
  • Incyte to stop testing Jakafi in some cancers (Reuters)
  • AbbVie plans NDA for endometriosis therapy (BioCentury) (Press)
  • Priority Review for KemPharm's pain candidate (BioCentury)

US: Medical Devices

  • Five Things to Consider when Adding Bluetooth to Medical Devices (Emergo)
  • FDA clears BioGaming's Microsoft Kinect-based physiotherapy software (MobiHealthNews)
  • Conducting International and U.S. Clinical Research (Medical Device CRO Blog)
  • Internet of Things: New Cyber Worries for Healthcare Sector (HealthcareInfoSecurity)
  • TransEnterix finalizes response to FDA over 510(k) for SurgiBot (MassDevice)
  • Class I Recall: Dräger Emergency Transport Ventilators Recalled Due to a System Error that may lead to a Halt in Ventilation Therapy (FDA)
  • FDA: Dräger Med transport ventilator recall is Class I (MassDevice)
  • World's First 3D-Printed Titanium Cranial Implant Cleared By FDA (MedDeviceOnline)
  • 23andMe enters infertility space with Celmatix partnership (MedCityNews)
  • FDA to mHealth Firm: You Need a New 510(k) for Every New Phone. What?!! (MDDI)
  • BD wins FDA nod for HIV/AIDS diagnostic (MassDevice)
  • PTAB Institutes Trial On Previously Challenged Cabilly Patent (National Law Review)
  • Deciphering Final AMP Rule – Key Provisions Impacting Pharmacies, PBMs, and Manufacturers (National Law Review)
  • Medtronic treats first patient with its investigational graft for aortic aneurysm repair (Fierce)
  • Wenzel Spine Announces FDA Clearance (Press)
  • MX Orthopedics Receives FDA Clearance on the dynaMX Compression Staple (Press)
  • Solvay's New PESU Material Offers ISO 10993 Biocompatibility For Demanding Healthcare Applications (MedDeviceOnline)
  • Dow Corning Launches New Family Of Silicone Skin Adhesives For Medical Device Applications (MedDeviceOnline)

US: Assorted & Government

  • Medicaid and the Primaries (Bill of Health)
  • Amid Federal Gridlock, Lobbying Rises in States (Public Integrity)
  • Changes to Funding Formula Could Improve Allocation of Funds to States (GAO)
  • FDA Warning Can't Bar Fresenius Dialysis Suits, Court Told (Law360-$)
  • Las Vegas Resident Indicted for Running Counterfeit and Misbranded Contact Lens Operation (DoJ)
  • President's US FDA budget a 'barren request' (In-PharmaTechnologist) (Alliance for a Stronger FDA)
  • PhRMA criticizes Obama Budget statement (PharmaLetter-$) (PhRMA)
  • US Senate Committee Advances Device Review Reform Bills (SCRIP-$) (Focus)
  • Should Medicare negotiate drug prices? Probably not (Health Business Blog)
  • J&J Hit With $13.5M Verdict In 2nd Philly Pelvic Mesh Trial (Law360-$)
  • FDA Funding Proposal Includes Cross-Cutting Oncology Focus, Disappoints Budget Advocates (Gray Sheet-$)
  • Seventh Circuit Knocks Out Claims Against Generic Manufacturer on Preemption Grounds (Drug and Device Law)
  • Three Tips For Pharma Men Who Want To Help Women (SCRIP-$)
  • USDA Declares "Do-Over" on Overhaul of Biotechnology Regulations (National Law Review)
  • Just how well do you think biopharma is handling the gender diversity issue? (Fierce)

Upcoming Meetings & Events


  • EU Pharma Has Three Years To Comply With New Safety Feature Rules (SCRIP-$) (Focus)
  • Sandoz's Carol Lynch elected to chair European Biosimilars Group (Pharmafile)
  • Recipharm to invest €40m in serialization tech ahead of EU and US track and trace rules (In-PharmaTechnologist)
  • Russian millionaire to establish leading national drug distributor (PharmaLetter-$)
  • NHS performance is worsening (OnMedica)
  • Cancer Drugs Fund consultation – an opportunity to introduce a sustainable, affordable solution that benefits patients and the economy (ABPI)
  • Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products (EMA)
  • Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products (EMA)
  • Guideline on the core SmPC for human Anti-D immunoglobulin for intramuscular use (EMA)
  • Guideline on the core SmPC for human Anti-D immunoglobulin for intravenous use (EMA)


  • India offers better opportunity for biosimilar drugs: Cadila Healthcare founder Pankaj Patel (Economic Times)
  • MSF supports people living with HIV to oppose Viiv's attempt to get patents for HIV drugs dolutegravir & cabotegravir (PharmaBiz)
  • Govt prioritises rotavirus and pneumococcal disease vaccination under immunisation programme (PharmaBiz)
  • Aurobindo gets US FDA nod for anti-infective injection (Business Standard)



  • Australian Government Steps In As Insurers Demand 45% Cut In 'Overpriced' Prostheses (Clinica-$)

Zika Virus

  • WHO advises women on Zika protection but no travel advisories (Reuters)
  • WHO urges precautions in Zika areas but reassures most births normal (Reuters)
  • Experts Study Zika's Path From First Outbreak in Pacific (NYTimes)
  • Catholic group urges pope to allow contraception to fight Zika (Reuters)
  • India, Singapore scientists race to make Zika test kit, but lack of live sample a challenge (Reuters)
  • Burwell says no Zika virus cases passed by mosquitoes in continental US (Reuters)
  • Audio conference of the HSC on the latest developments of the Zika virus outbreak (European Commission)
  • Notes from the Field: Evidence of Zika Virus Infection in Brain and Placental Tissues from Two Congenitally Infected Newborns and Two Fetal Losses — Brazil, 2015 (CDC)
  • U.S. Health Officials Expect Significant Zika Cases in Puerto Rico, Other Territories (WSJ-$)
  • Finland has had two cases of Zika virus: official (Reuters)
  • Brazilians Shrug Off Zika Fears to Revel in Carnival Fun (NYTimes)
  • As Zika fears spread, Cerus nabs American Red Cross partnership for blood pathogen reduction (Fierce)
  • Brazil links three deaths to suspected Zika-related complications (Reuters)
  • Pharma's Zika Pursuit: All About The Profits? (SCRIP-$)
  • Global Scientific Community Commits to Sharing Data on Zika Virus (ICT)
  • GOP skeptical of new funding for Zika (The Hill)

Other International

  • AstraZeneca Targets 10% Africa Sales Boost (PharmaAfrica)
  • Nigeria pharma associations warn of drugs shortage as forex scarcity persists (PharmaAfrica)
  • USP-Ghana Expands Center for Pharmaceutical Advancement and Training to Combat Poor Quality Medicines in Africa (PharmaAfrica)
  • Angola says 37 dead in yellow fever outbreak (Reuters)
  • Rabies spread by bats kills 12 in Peruvian Amazon (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.

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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