Regulatory Focus™ > News Articles > Regulatory Recon: FDA Advisers in Favor of Over-the-Counter STI Diagnostics; Report Claims PCSK9 Dru

Regulatory Recon: FDA Advisers in Favor of Over-the-Counter STI Diagnostics Report Claims PCSK9 Drugs Could Add $120 Billion to Annual Health Spending (17 August 2016)

Posted 17 August 2016 | By Michael Mezher 

Regulatory Recon: FDA Advisers in Favor of Over-the-Counter STI Diagnostics Report Claims PCSK9 Drugs Could Add $120 Billion to Annual Health Spending (17 August 2016)

Welcome to Regulatory Reconnaissance, your adaily 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

  • Obamacare Will Survive Aetna's Retreat (NYTimes)
  • Read the Label on Pharma's New Drug Sales (Bloomberg)
  • FDA Advisors: Over-the-Counter Tests for STIs Offer Benefits (Medpage)
  • FDA Warns 14 International Medical Device Companies (Focus) (Law360-$)
  • Insurer Exits From Obamacare Turn Few Choices Into None (Bloomberg)
  • Aetna CEO Threatened Obamacare Pullout If Feds Opposed Humana Merger (Huffington Post)
  • Slimmed-down big pharma starts growing again (EP Vantage)
  • Regulatory Uncertainty, Reimbursement Challenges Seen Harming Investments in LDT Developers (GenomeWeb)
  • FDA to Reclassify Pharmaceutical Co-Crystals (Focus)
  • 3-Bromopyruvate: What a Mess (In the Pipeline)
  • Rules for Modern Drug Development (In the Pipeline)
  • How to fail well in biotech: shed a tear, grab a trophy, and move on (STAT)
  • Judge denies petition by supporters of California drug pricing ballot (STAT)
  • NIST and Frederick National Laboratory for Cancer Research Help Ensure Accurate Clinical Measurements of HER2 Breast Cancer Gene (NIST)
  • PCSK9 Inhibitors' First Birthday Brings Sluggish Sales And More Bad Press (Scrip-$) (Press)
  • New cholesterol drugs could add $120 billion to annual U.S. health costs (USA Today)
  • Antibiotic resistance most imminent threat to humanity, says bacteriophage maker (BioPharmaReporter)
  • Osteoporosis, a Disease With Few Treatment Options, May Soon Have One More (NYTimes)
  • Chinese Drugmaker Hid Data That May Show Contamination (Bloomberg) (South China Morning Post) (Fierce) (Warning Letter)
  • MSD to cut 148 jobs at Pennsylvania plant (Pharmafile)
  • PDUFA Again: Still Trying to Get It Right (Medpage) (Focus)
  • OCP's Pre-RFD Process: Different Process, Same Outcome (FDA Law Blog) (Focus)

In Focus: International

  • Asia Regulatory Roundup: CFDA to Punish Clinical Trial Data Fraudsters (Focus)
  • Make Data Sharing Routine to Prepare for Public Health Emergencies (PLOS)
  • Why There's New Hope About Ending Blindness (National Geographic)
  • UK's MHRA Cautions Diabetics on Roche's Leaky Insulin Cartridge (Focus) (MHRA)
  • What The Debate Over Zika At The Olympics Ignores (Forbes)
  • Japanese MHLW Aligns ISO 13485:2016 with Its Own QMS Requirements (Emergo)
  • StemCells Inc picked up by Israeli medical devices firm (BioPharmaReporter)
  • Medicine labels: Guidance on TGO 91 and TGO 92 (TGA)
  • Untested cancer drug suspected cause of three deaths at German alternative medicine centre (Pharmafile)
  • EMA Clarifies Compliance With ALCOA Principles Is Key To Meeting Data Integrity Expectations (Pink Sheet-$)
  • Amgen, Sanofi cholesterol medicines "not cost-effective", need to drop price by two-thirds (Pharmafile)
  • Proposed new drug guidelines for the PBS put cost-cutting before patients (The Guardian)

US: Pharmaceuticals & Biotechnology

  • Rare biotech buying opportunity, says Morgan Stanley (CNBC)
  • Rare Drug Developer Chiasma Lays Off More Workers After FDA Impasse (Xconomy)
  • Entrepreneur seeks to change clinical trial paradigm (MedCityNews)
  • Here's a new gene editing strategy to treat genetic blood disorders (CIRM)
  • GSK's Flonase Sensimist (Veramyst) Switches Name On Way To OTC (PinkSheet-$)
  • Irvine launches yield-boosting growth system for viral vector production (BioPharmaReporter)
  • With New Name and $86M, Tioma To Explore Anti-CD47 Cancer Therapy (Xconomy) (Pharmafile)
  • Walgreens wants you to take your pills (Chicago Business)
  • Is Cyberspace Where Health Goes To Die? (Forbes)
  • FDA Approves Nocita, a New Animal Drug for Local Post-operative Pain in Dogs (FDA)
  • Pharma's Productivity Problem: Finding More Blockbuster Drugs (Xconomy)
  • Decision time for Acacia as US filing approaches (EP Vantage)
  • With new president and focus on big investors, Cellceutix aims for the Nasdaq (Boston Biz Journal)
  • Orlistat-ART Interaction Warning Added to Labeling (MPR)

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

  • J&J therapy for suicidal depressives 'a breakthrough', says FDA (PM Live) (Fierce) (Press)
  • OncoGenex' custirsen fails in late-stage prostate cancer trial (PharmaLetter-$) (Scrip-$)
  • Inspyr Therapeutics Announces the Initiation of a Phase 2 Clinical Trial of Mipsagargin for Newly Diagnosed Prostate Cancer Patients (Press)
  • Late-phase opioid addiction success sparks surge in Indivior's stock price (Fierce)
  • ViiV takes two-drug cocktail for first-line HIV into phase III (PM Live)

US: Medical Devices

  • How crowdsourcing can improve med device security (Fierce)
  • Arch Therapeutics touts 1st-in-human for novel blood control device (MassDevice)
  • Medical device industry makes a comeback, poised to see first yearly funding increase since 2014 (MedCityNews)
  • CS Medical inks U.S. distribution deal with GE Healthcare (MassDevice)
  • Magnetic Surgical System by Levita Magnetics Receives FDA Clearance (Press)
  • Outside developers suspend Sport medical 'bot program until Titan Medical can pay its bills (MassDevice)
  • New Startup Aims to Commercialize a Brain Prosthetic to Improve Memory (IEEE Spectrum)
  • William Demant moves hearing aid production from U.S., Denmark to Poland, Mexico (MassDevice)
  • Intuitive Surgical touts robot-assisted hernia surgery study (MassDevice)

US: Assorted & Government

  • Pfizer Unit's Patent For Antibiotic Drug OK'd By Fed. Circ. (Law360-$)
  • Ky. AG Hits J&J With Pelvic Mesh Deceptive Marketing Suit (Law360-$)
  • U.S. prosecutors dealt setback in medical marijuana cases (Reuters)
  • Janssen Faces Mixed Prospects In Immuno Drug IP Suit (Law360-$)
  • Even with a Road Map, Only One Dubious Claim Navigates Preemption (Drug and Device Law)

Upcoming Meetings & Events


  • Danish GCP Inspectors Get Full Access To Electronic Patient Data (PinkSheet-$)i
  • ALK-Abello rises as 2nd-qtr revenues grow more than 40% (PharmaLetter-$)
  • Eight tips for buying medicines and medical devices online safely (MHRA)
  • Dodgy diet pills: Dying to lose weight? (MHRA)
  • Longtime Stada Chief to Depart Drugmaker After Medical Leave (Bloomberg)


  • Cipla names Umang Vohra its new boss as Subhanu Saxena departs (PharmaLetter-$)
  • Strides Shasun completes acquisition of Generic Partners (Economic Times)
  • Piramal Enterprises to acquire Ash Stevens Inc for more than Rs 350 crore (Economic Times)


  • Australian Industry Concerned Over Comparator Drug, Differing Evidence Levels, As New PBS Guidance Draws Near (PinkSheet-$)
  • Updating medicine ingredient names (TGA)
  • Changes to sponsorship of therapeutic goods (TGA)


  • Summary Safety Review - Atypical antipsychotics - Assessing the Potential Risk of Sleep Apnoea (Health Canada)


  • Pregnant Women In Miami Take Extra Precautions Against Zika (NPR)

Other International

  • Stigma 'killing' South Africans living with HIV (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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