Regulatory Focus™ > News Articles > Regulatory Recon: Novartis Gets Complete Response Letter for Neulasta Biosimilar; UK's First Ministe

Regulatory Recon: Novartis Gets Complete Response Letter for Neulasta Biosimilar UK's First Minister of Life Sciences Moves On, Future of Office in Question (19 July 2016)

Posted 19 July 2016 | By Michael Mezher 

Regulatory Recon: Novartis Gets Complete Response Letter for Neulasta Biosimilar UK's First Minister of Life Sciences Moves On, Future of Office in Question (19 July 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

  • Novartis' Gets Complete Response Letter from FDA for Neulasta Biosimilar Application (Fierce) (Novartis Q2 Report)
  • Rise And Fall Of Theranos In A Biotech Cartoon (NPR)
  • FDA: Electroshock has risks but is useful to combat severe depression (Washington Post)
  • Blog: BMJ medical errors paper fuels growing debate (Modern Healthcare )
  • Old pharma sees new profit cure in cancer drugs (Reuters)
  • Companies Try New Ways to Attract Patients to Drug Trials (WSJ)
  • Sun and heat can make some drugs dangerous while making others less potent (Washington Post)
  • FDA's Mutual Reliance Initiative – Saving FDA Some Money at the Expense of Inspectional Quality? (FDA Law Blog)
  • Public-Health Officials Across U.S. Race to Build Defenses Against Zika Virus (WSJ)
  • Why Placebos Really Work: The Latest Science (WSJ)
  • Valeant Finally Able to Close One Troubled Door with Salix Settlement (Policy and Medicine)

In Focus: International             

  • Freeman no longer U.K.'s Minister of Life Sciences (BioCentury)
  • FDA, EMA reviewing Opdivo for head/neck cancer (BioCentury)
  • MSF calls on Pfizer and GSK to lower vaccine prices for refugee children (PharmaLetter-$)
  • Something Went Right In Brazil (Drug and Device Law)
  • Improved drug access and innovation needed, Canadian trade group says (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Scripts sink for Valeant's troubled female libido drug in wake of rep cuts (Fierce)
  • Prescription Drug User Fee Act; Public Meeting; Request for Comments (FDA)
  • E2C(R2) Periodic Benefit-Risk Evaluation Report and E2C(R2) Periodic Benefit-Risk Evaluation Report-Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability (FDA)
  • I thought melanoma would kill me. Here's why it didn't. (Washington Post)
  • Juno trial restart positive, but CAR-T sector still on a learning curve says TxCell (InPharmaTechnologist)
  • Ex-Epizyme CEO's New Startup, Fulcrum, Nabs $55M For Gene Control Drugs (Xconomy)
  • Q&A: FDA's Elizabeth Mansfield Addresses Concerns After Release of Draft Guidances on NGS Testing (GenomeWeb)
  • Ziopharm investigating death in Ph I trial of brain cancer gene therapy (InPharmaTechnologist)
  • Women on osteoporosis drugs still need bone density screenings (Reuters)
  • 'Dense breast' definition varies widely (Reuters)
  • Ziopharm hopes gene therapy is still a going concern (EP Vantage)

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

  • Bristol-Myers Squibb Announces Regulatory Updates for Opdivo (nivolumab) in Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (Press)
  • Evoke fails out of Phase III, falling 75% (Fierce)
  • Seattle Genetics and Takeda Announce Publication of Final Data from ADCETRIS® (Brentuximab Vedotin) Monotherapy Pivotal Phase 2 Clinical Trial in Relapsed or Refractory Classical Hodgkin Lymphoma in Blood (Press)
  • ANI Pharmaceuticals Announces FDA Approval and Immediate Launch of Nilutamide Tablets, the First Generic Competitor to Nilandron® (Press)
  • Perrigo Announces FDA Final Approval And Launch Of The Store Brand Equivalent To Zegerid OTC® Capsules (Press)
  • U.S. FDA Approves CSL Behring's Berinert® as the First and Only Pediatric Treatment for Hereditary Angioedema (HAE) (Press)

US: Medical Devices

  • What's Behind Medtech's Recall Epidemic? Part 3: Production Controls (MDDI)
  • Medtronic wins FDA nod for 2-level cervical fusion with Prestige LP spine implant (MassDevice) (Press)
  • Allergan asks FDA to approve Oculeve neurostim device (MassDevice)
  • Syneron Candela Announces FDA Clearance of High Energy UltraShape Power for Fat Destruction (Press)
  • Bexion Pharmaceuticals Receives FDA Clearance for the First Clinical Trial Using BXQ-350 to Dose Patients with Cancer (Press)

US: Assorted & Government

  • CMS Issues Release to Manufacturers Regarding Value-Based Purchasing Arrangements (FDA Law Blog)
  • Reality Check: 340B is 4% (not 2%) of the U.S. Drug Market—And Growing Quickly (DrugChannels)
  • Medicare fraud investigators wary of soaring compounded drug prices (MedCityNews)
  • 5 health and medicine issues to watch for at the GOP convention (STAT)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Public Workshop - Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016 (FDA)


  • Meeting with EuropaBio on Health Technology Assessment (European Commission)
  • Meeting with PPTA (Plasma Protein Therapeutics Association) on Health Technology Assessment (European Commission)
  • Essential Medical wins CE Mark for Manta vascular closure device (MassDevice)
  • Zimmer finally gets into robotics game with French deal (MedCityNews)


  • U.S. FDA  Approves Belviq Xr, A Once-Daily Formulation Of Lorcaserin For Chronic Weight Management (Eisai)


General Health & Other Interesting Articles

  • Dozens of wrestlers sue WWE over neurological injuries (Reuters)
  • These Medical Experiments Were Just Blasted Up To The International Space Station (Forbes)

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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