Regulatory Recon: Theranos Withdraws Zika Test After FDA Inspection Novartis Lays Off 120 From CAR-T Unit (31 August 2016)

Posted 31 August 2016 | By Michael Mezher 

Regulatory Recon: Theranos Withdraws Zika Test After FDA Inspection Novartis Lays Off 120 From CAR-T Unit (31 August 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

  • Theranos Halts New Zika Test After FDA Inspection (WSJ) (Reuters)
  • Portola touts new data on recently rejected Xarelto, Eliquis antidote (Fierce) (BioCentury) (Reuters)
  • FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel (Focus) (FDA)
  • Novartis bid to sell new biosimilar crimped by US court battles (Reuters)
  • Scoop: Novartis disbands its pioneering cell and gene therapy unit (Endpoints) (Forbes)
  • The DEA Is Placing Kratom And Mitragynine On Schedule I (Forbes)
  • FDA Finalizes New Regulations for Drugmakers a Decade After First Proposal (Focus)
  • Abandoned in PhIII, Onconova sacrifices more staffers to its survival strategy (Endpoints)
  • Cuba-U.S. Life Sciences Collaborations Grow Slowly as Embargo Remains (Bloomberg)
  • FDA solicits opioid, antibacterial research (BioCentury)
  • Competition and Drug Pricing (PharmTech)
  • Cancer Moonshot report to land on Sept. 7 (BioCentury)
  • Lobbyists Say Chaffetz Probe Into EpiPen Price Is A Bad Sign For Rx Makers (InsideHealthPolicy)
  • Ebola virus lasts in semen for up to 565 days: study (Reuters) (CDC)
  • Pfizer Wins Dismissal Of Zoloft Birth Defects Suit (Law360-$)
  • AstraZeneca Agrees to Pay $5.5 Million to Settle Alleged Bribery Probe (WSJ) (Law360-$)
  • Big Pharma's Punishment in Court of Public Opinion (The Street)
  • Experts Weigh In On The Decline In Cardiovascular Drug Development (CardioBrief)
  • Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study (PLOS)

In Focus: International

  • Inside Celltrion: A Biosimilar Success Story Built on a Landfill (BioPharmaReporter)
  • Flying Insects and Chipping Paint: FDA Warns Chinese API Manufacturer (Focus)
  • Google DeepMind targets NHS head and neck cancer treatment (BBC)
  • Struggling Vaccines From Novartis Turn Into Sales Boon for Glaxo (Bloomberg)
  • Asia Regulatory Roundup: India's DCGI Orders Manufacturers to Assess GMP, GLP Compliance (Focus)
  • WHO Updates Antibiotic Treatment Guidelines for Three STIs (Focus) (NPR)

US: Pharmaceuticals & Biotechnology

  • New Opioid Compound Isn't Addictive, Researchers Say (Forbes)
  • Biosimilar FDA Approvals on Horizon As More States Enact Substitution Laws (National Law Review)
  • Catalent to add two 2,000L bioreactors in $34m WI biologics plant expansion (BioPharmaReporter)
  • Neurocrine submits valbenazine NDA early, set for 2017 approval (Fierce)
  • FDA Renews Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • FDA Renews Cardiovascular and Renal Drugs Advisory Committee (FDA)
  • Ameet Sarpatwari on 'The Week in Health Law' Podcast (Harvard Bill of Health)
  • Clovis defers Pfizer rucaparib payments to save cash ahead of FDA decision (Fierce)
  • More teens get needed vaccines in 'blue states' (Reuters)
  • The Medicines Company sees shares slide on key trial not stopping early (Fierce)
  • Teva to lay off 236 in Pomona, New York (Pharmafile)
  • General and Plastic Surgery Advisory Panel September 20-21 Meeding Summary (FDA)
  • Pending trial results, Karyopharm investors take heart from trial expansion (Boston Biz Journal)

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

  • Ariad finishes rolling NDA for lung cancer; wants sped-up review (Fierce) (BioCentury)
  • Rigel's fostamatinib meets in first ITP Phase III (BioCentury)
  • CardioCell reports Phase IIa heart failure data (BioCentury)
  • Genmab's sBLA for Arzerra approved by FDA (PharmaLetter-$)
  • Kamada's inhaled AAT meets in U.S. Phase II (BioCentury)
  • Amgen's bone drug Prolia nabs data for new use on its way to blockbuster sales (Fierce)
  • FDA reviewing CSL's CSL830 for HAE prophylaxis (BioCentury)
  • Medimetriks Pharmaceuticals' New Drug Application for Ozenoxacin Cream, 1% Accepted for Review by FDA (Press)
  • Betagenon AB: Start of Phase IIa Proof-of-Concept Clinical Trial of AMPK Activator O304 in Type 2 Diabetics (Press)

US: Medical Devices

  • Study finds flaws in criticism of St. Jude cyber security (Reuters)
  • UDI: When the Rule is Not Enough (GxP Lifeline)
  • FDA: Data show no benefit for anti-microbial wound dressings (MassDevice)
  • FDA Issues Separate Draft Guidance Regarding Software Modifications (FDA Law Blog)
  • FDA releases June 2016 510(k) clearances (MassDevice)
  • A Case Study of Usability Requirements Generation and Testing (MDDI)
  • FDA clears Siemens' Somatom Drive CT scanner (MassDevice)
  • PharmaJet inks pact with World Health Organization for polio vaccine (MassDevice)
  • Intralink-Spine touts early safety data for Réjuve cross-linking device (MassDevice)

US: Assorted & Government

  • Mother and Son Plead Guilty to Orchestrating $16 Million Medicare Fraud Scheme at Two Miami Pharmacies (DoJ)
  • Naloxone price hike hinders Baltimore's drug overdose prevention efforts (Modern Healthcare)
  • Merck Patent For Contraceptive NuvaRing Nixed As Obvious (Law360-$)

Upcoming Meetings & Events


  • XALKORI® (Crizotinib) Receives Approval In European Union For The Treatment Of Patients With ROS1-Positive Advanced Non-Small Cell Lung Cancer (Press)
  • Surfacer Inside-Out Central Venous Access System Approved in EU (medGadget)
  • Risk assessment report on a new psychoactive substance: methyl 2-[[1-(cyclohexylmethyl)-1H-indole-3-carbonyl]amino]-3,3-dimethylbutanoate (MDMB-CHMICA) (EU Council)


  • Takeda takes on multiple myeloma outcomes study, as Ninlaro flounders (Fierce)
  • CFDA authorizes registrational trials at two hospitals (BioCentury)
  • Announcement: The 5th AHWP Administration Services Limited (ASL) AGM will be held in Cebu, Philippines on 25 Nov 2016 (AHWP)


  • Aurobindo, Intas in race for $1 billion buyout of Teva UK, submit binding offers (Economic Times)
  • India Mandates Formal Certification Of Personnel In Manufacturing (Pink Sheet-$)
  • Delhi govt caps chikungunya test cost (Economic Times)


  • Scheduling delegate's final decisions: Cannabis and Tetrahydrocannabinoils, March 2016 (TGA)
  • General process for amending the Poisons Standard: Cannabis and Tetrahydrocannabinols (TGA)


  • U.S. Funding for Fighting Zika Virus Is Nearly Spent, C.D.C. Says (NYTimes)
  • Three new cases of local Zika transmission in Florida: officials (Reuters)
  • Zika causes deafness in about 6 percent of cases: study (Reuters)
  • Singapore confirms 26 more local transmission Zika cases (Reuters)
  • CDC adds Singapore to interim travel guidance related to Zika virus (CDC)
  • CDC adds The British Virgin Islands to interim travel guidance related to Zika virus (CDC)

Other International

  • More than 300 million at risk of life-threatening diseases from dirty water: U.N. (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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