Regulatory Recon: FDA Approves Humira for 10th Indication Unproven Stem Cell Centers Spreading Across the US (1 July 2016)

Posted 01 July 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Humira for 10th Indication Unproven Stem Cell Centers Spreading Across the US (1 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

  • Clinics Offering Unproven Stem Cell Therapies Are Proliferating Across the U.S. (MIT Technology Review)
  • Are Copay Coupons Actually Making Drugs More Expensive? (ProPublica)
  • FDA Promises Shorter, Quicker Drug GMP Warning Letters (Gold Sheet-$)
  • Breakthrough Therapies: FDA Official Calls for More Transparency on Designation Requests, Denials (Focus) (SCRIP-$)
  • U.S. doctors, hospitals paid billions by drug, device makers: government (Reuters) (MassDevice)
  • Trial by Fire: CRISPR takes the next step (Harvard Bill of Health)
  • FDA Warns Two Chinese Drugmakers for Data Integrity Violations (Focus)
  • A Call for Action on Toxic Chemicals (NYTimes)
  • One last U.S. medical school still killed animals to teach surgery. But no more. (Washington Post)
  • FDA Issues New Draft Guidance on Elemental Impurities (Focus)
  • FDA Approves Humira for Adults with Non-Infectious Intermediate, Posterior and Panuveitis, Weeks before Advisory Committee for Biosimilar (Press) (Advisory Committee Meeting)
  • The Difference Between Manufacturing and Design Defects (Drug and Device Law)
  • Top Officials Aim To Reshape The FDA To Prepare For 'Avalanche' Of Cancer Products (Forbes)
  • The Public Health Implications Of The FDA's Update To The Medication Abortion Label (Health Affairs Blog)
  • FDA Places Roadblock On Approval Path Of Novel Cholesterol Drug (CardioBrief)
  • More U.S. babies with Zika-related birth defects reported by health agency (Reuters)

In Focus: International

  • The final text of the IVDR: first impressions (MedicalDevicesLegal)
  • Brexit: Scientists urged to look for positives (Financial Times)
  • Action plan to combat illegal fresh cell therapies (SwissMedic)
  • SwissMedic Reports Risk of Cervical Cancer in Women Treated with Remicade and Biosimilars (SwissMedic)
  • AstraZeneca sells two dermatology drug rights to LEO Pharma (Reuters)
  • WHO Calls for Manufacturers to Submit Malaria Products to Prequalification Scheme (WHO)
  • UK drugs regulator halts approvals for Indian clinical trials firm (Reuters)
  • Anti-Vaccine Couple Found Guilty in Toddler's Death Must Post Ruling to Facebook (Vice)
  • Database shines light on pharma payments to UK doctors (Financial Times)
  • Doctors want more details in biosimilars labelling (GaBI)
  • Health officials race to prevent Congo yellow fever disaster (Reuters)

US: Pharmaceuticals & Biotechnology

  • International Pharmaceutical Supply Chain Imperiled Like Never Before: A Webinar Summary (FDA Law Blog)
  • Biotech's Top 5 Losers, and Winners, From Q2 2016 (Forbes)
  • KaloBios emerges from bankruptcy, raises $14M in recap (Fierce)
  • NIH Refuses to March In—Again—And National Academies Challenge Human Subjects Regulation (Genomic Law Report)
  • NIH-led effort uses implementation science approaches to reduce mother-to-child HIV transmission (NIH)
  • FDA to hold EPP workshop (BioCentury)
  • Family history biggest predictor of heart attacks in people with psoriasis (Reuters)
  • Advaxis: Manufacturing, safety and efficiency key to developing cancer drugs (BioPharmaReporter)
  • Mom Launches Nonprofit To Serve Daughter And Others With Poorly Understood Condition (Forbes)
  • Updated: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry (FDA)
  • Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability (FDA)
  • Vulvovaginal Candidiasis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability (FDA)
  • Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention; Draft Guidance for Industry; Availability (FDA)

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

  • First Patients Enrolled in ORBERA Intragastric Balloon U.S. Post-Approval Study (Press)
  • Phase III data: Merck KGaA's Erbitux plus FOLFOX improves outcomes in RAS wild-type metastatic colorectal cancer (PharmaLetter-$)

US: Medical Devices

  • FDA Making Progress on NGS Panels Draft Guidance (GenomeWeb)
  • FDA Panel To Ponder Approval Factors For OTC Infectious Disease Diagnostics (Gray Sheet-$)
  • Sparo Labs gets FDA nod for its app-connected lung function monitor, Wing (MobiHealthNews)

US: Assorted & Government

  • Another Prescription Drug Warnings Preemption Decision (Drug and Device Law)
  • PerkinElmer Faces Suit Over 'Dismal' Drug Test Devices (Law360a-$)
  • FDA Fifth Biannual Progress Report on Judicious Use of Antimicrobials in Food-producing Animals (FDA)
  • Federal judge blocks Indiana abortion law (Reuters)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • Webinar - An Update on the FDA's Medical Device Clinical Trials Program - July 14, 2016 (FDA)
  • Draft Agenda: Part 15 Hearing: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products 12 September 2016 (FDA)


  • EMA: Strengthening interaction with academia (EMA)
  • Biotronik wins CE Mark for Edora MRI-adaptable pacers (MassDevice)
  • UK MHRA Human Factors Guideline Aligns Regulatory Expectations With US (Clinica-$)
  • SRS Medical wins CE Mark for Spanner prostate stent (MassDevice)


  • China forecasted as the fastest growing biologics market over the next decade (BioSpectrum)


  • Torrent Pharma buys Glochem Unit in Vizag (Economic Times)
  • Biosimilar drugs are priced too high and do little to improve accessibility: Doctors (Economic Times)


  • Fees and charges: summary - from 1 July 2016 (TGA)


  • Draft Guidance Document - Cancellation of a Drug Identification Number (DIN) and Notification of the Discontinuation of Sales (Health Canada)


  • Zika Fears Are Growing Among Women in U.S. (WSJ-$)

General Health & Other Interesting Articles

  • Estimate of U.S. Transgender Population Doubles to 1.4 Million Adults (NYTimes)

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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