Regulatory Recon: Shkreli Arrested on Securities Fraud Charges (17 December 2015)

Posted 17 December 2015

placeholder+image

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

  • Shkreli, CEO Reviled for Drug Price Gouging, Arrested on Securities Fraud Charges (Indictment)(Bloomberg) (New York Times) (Reuters)
  • FDA Schedules Advisory Committee to Review Sarepta DMD Drug (FDA)
  • HHS OIG Report on Generic Drug Price Increases (HHS)
  • FDA approves Eli Lilly's Basaglar diabetes drug (Reuters) (Press) (FDA)
  • Even with smaller ‘donut hole,’ Medicare cancer pill costs stay high (Reuters)
  • FDA lifts clinical hold on Advaxis' cancer compounds (Reuters)
  • FDA Removes Avandia REMS (BioCentury) (MedPageToday) (FDA)
  • NIH unveils FY2016–2020 Strategic Plan (NIH)

In Focus: International

  • Australia’s TGA Updates Biosimilar Guidelines (TGA)
  • Reformed ICH advances work on several key new guidelines (ICH)
  • ICH MedDRA Management Board Notes New SOC and New SMQs for MedDRA Version 19.0 (ICH)
  • China watchdog to strengthen drug trial inspections (Reuters)
  • Lawmakers call for British trials of genetically modified insects (Reuters)
  • Kaketsuken Scandal Prompting Japan Regulatory Tightening (PharmAsiaNews-$)
  • Uganda facing HIV drugs shortage, govt seeks cash for imports (Reuters)
  • Lee Presses Indian Case For Saxagliptin Compulsory License (SCRIP-$)
  • As China’s Generic Market is Poised to Become World’s Largest, Eisai Buys in (Thomson Reuters)

US: Pharmaceuticals and Biotechnology

  • CDC Finds a Cure and Publishes Draft Opioid Prescribing Guidelines, Seeks Comments (FDA Law Blog)
  • What the Letters "USP" Mean on the Label of Your Medicine (USP)
  • 'Orphans' Hit Historic High At US FDA; More 'Me-Too' Drugs Urged (SCRIP-$)
  • US FDA's Stellar Drug Review Performance Is Straining Workforce (SCRIP-$)
  • Many unexpected genetic variants hamper personalised medicine (MNT)
  • Families can safely choose antibiotics over appendix surgery for kids (Reuters) (NYTimes)
  • How pharma can keep up as healthcare goes digital (mobihealthnews)

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

  • GSK's sirukumab headed for RA submission (BioCentury) (Press) (SCRIP-$)
  • Array gains after binimetinib meets in Phase III (BioCentury)
  • Trinity Biotech Announces FDA Submission of High Sensitivity Troponin I Product (Press)
  • ANI Pharmaceuticals Announces FDA Approval of Polyethylene Glycol 3350 Powder for Oral Solution, 17mg/Scoopful (Press)

US: Medical Devices

  • Five predictions for medtech in 2016 (MassDevice)
  • For Home Healthcare Devices, the Power Supply Matters (MDDI)
  • Medtronic CEO Welcomes Outcomes-Based Reimbursement (MDDI)
  • Developing High-Performing Leaders For The Medical Device Industry (MedDeviceOnline)
  • An alarming device trend: Why getting 510(k) clearance alone is not enough (MedCityNews)
  • Pathologists' Group Accuses FDA of Making 'Dubious Claims' in LDT Harms Report (GenomeWeb)
  • Viatom wins FDA nod for Checkme multi-diag ‘tricorder’ device (MassDevice)
  • St. Jude Touts Positive Data From BURST Neurostimulation Trial (MedDeviceOnline)

US: Assorted and Government

  • Medical device tax delay would cost $3.4B (MassDevice)
  • How Martin Shkreli is driving down drug prices (Health Business Blog)
  • New Drugs Chief: Vouchers Put FDA In 'Distasteful' Situation (SCRIP-$)
  • Impossibility Preemption Possible For Brand-Name Drugs (Law360-$)
  • Bookends – Prof. Jewell’s Opinions Also Excluded in Lipitor MDL, and More (Drug and Device Law)
  • Spending Deal’s Adjustments to Health Law Seen as Step to Permanent Change (WSJ-$)
  • Let The Scapegoating Begin: Senate Price Hearing Hits Safe Themes For Innovators (RPM Report-$)
  • HHS Price Forum: Surprisingly Good Context For Pharma Ideas For Regulatory Changes (RPM Report-$)
  • Question: What do Sodium Reduction, FOP Labeling, and Medical Foods Have in Common? (FDA Law Blog)

Upcoming Meetings and Events              

Europe

  • NICE expands recommendations on treatment of juvenile idiopathic arthritis (MNT)
  • EFPIA Welcomes new Agreement on General Data Protection Regulation (EFPIA)
  • EU Commission Takes Preliminary Action In Response to French EtO Concerns (Clinica-$)
  • NICE recommends elosulfase alfa for Morquio A syndrome (PharmaLetter-$)
  • Final NICE OK for Biomarin's Vimizim (PharmaTimes)

India

  • Indian Government Imposes Anti-Dumping Duty on Bulk Drug Imports of Gliclazide From China (24 Insight)
  • USFDA approves Aurobindo's drugs for diarrhoea, allergy (Economic Times)
  • UPFDA recruits 16 drug inspectors following HC directive (PharmaBiz)

Other International

  • New symptoms surface in Ebola patients months after initial recovery (Reuters)

General Health and Other Interesting Articles

  • Ethnic differences in cystic fibrosis genetic coding not addressed in screening tests for nonwhite patients (MNT)
  • Georgetown Researcher Leads Effort to Decode Anti-Malarial Drug Resistance (ICT)
  • Seeking an End to Viral Hepatitis (ICT)
  • Scientists Study Why the Flu Vaccine is Less Effective in the Elderly (ICT)

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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Share this article:

Categories: Biologics and biotechnology, Combination products, Drugs, Medical Devices, Business Skills, Crisis management, Distribution, Ethics, Government affairs, Manufacturing, Quality, News, US, Canada, Europe, Asia, Latin America and Caribbean, Africa, Oceania, FDA, DOJ, EMA, MHRA, CDSCO, Anvisa, TGA

Tags: Shkreli, generic drug pricing, Sarepta, biosimilars

Regulatory Exchange: Latest Updates From the Community