Regulatory Recon: Drug Spending Slows in 2015, Opioid Concerns Linger Ahead of Califf Confirmation (23 February 2016)

Posted 23 February 2016 | By Michael Mezher 

Regulatory Recon: Drug Spending Slows in 2015, Opioid Concerns Linger Ahead of Califf Confirmation (23 February 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

  • Califf Headed for Confirmation as Next FDA Commissioner (Focus) (MassDevice) (STAT) (SCRIP-$) (MedpageToday)
  • Drug Spending Slowed in 2015 After Discounts, CVS Health Says (Bloomberg) (Forbes)
  • The Long, Rocky Road From Idea To Successful Biotech (C&EN)
  • Is the Science Really There Yet? Abbvie Urges FDA to Slow Rush to Biosimilar Interchangeability Guidance (Thomson Reuters)
  • The biosimilar ploy that could save billions in health care costs (STAT)
  • Should you edit your children's genes? (Nature)
  • A Do-It-Yourself Revolution in Diabetes Care (NYTimes)
  • FY2013 – 2015 CDER Inspection Observations and Warning Letters (Unger Consulting)
  • The Perennial Perils of Aseptic Manufacturing (FDA Law Blog)
  • Not Every Drop of a Person's Blood Is the Same, a Study Says (NYTimes)

In Focus: International

  • Novartis offices in South Korea raided over bribery concerns (STAT)
  • Seven pharma giants join Parkinson's consortium (PharmaTimes)
  • Keeping Track Of IDMP Moves In The EU, US And Beyond (SCRIP-$)
  • Experts Speculate On Cause Of Neurological Damage in FAAH Inhibitor Study (SCRIP-$)
  • British nurse who recovered from Ebola back in hospital again (Reuters)
  • A portable device for rapid and highly sensitive diagnostics (PhysOrg)

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US: Pharmaceuticals & Biotechnology

  • The Good News on Generic Drugs (Marginal Revolution)
  • The Good News on the FDA and ANDAs (Marginal Revolution)
  • Fixing potholes with PDUFA (BioCentury-$) (DrugWonks)
  • FDA should warn of risks of opioid, benzo combo, say public health experts (STAT) (Focus)
  • Galderma Acne Ingredient Switch Receives NDAC Review In April (Pink Sheet-$)
  • Overdoses on anti-anxiety meds such Valium and Xanax are on the rise (Washington Post)
  • Slow Down. Don't Sprint To More Aggressive BP Treatment (CardioBrief)
  • Valeant Pharmaceuticals May Restate Earnings After Board Review (Fobres) (WSJ-$)
  • FDA Orphan Designations At Record Levels; Resources Need To Keep Up (RPM Report-$)
  • Biopharma CEO confidence levels wavering (Outsourcing-Pharma)
  • Jacobus and Catalyst Continue to Race for Approval of LEMS Drug (Harvard Bill of Health)
  • The top 20 drugs in 2020--worldwide sales (Fierce)
  • Rare disease drugs facing questions over prices, incentives (MM&M)
  • Top 25 orphan drugs, by 2015 global sales (MM&M)
  • Walgreens makes naloxone available without a prescription across Indiana and Ohio (DSN)
  • Newly Discovered HIV Genome Modification May Put a Twist on Vaccine and Drug Design (ICT)
  • What a year it's been already in biotech! (Forbes)

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

  • Merck to submit once-daily version of HIV drug Isentress (PharmaPhorum)
  • OPKO Health Announces Dosing of First Patient in Phase 2a Clinical Study of a Long-Acting Factor VIIa for the Treatment of Hemophilia (Press)
  • Aratana Therapeutics Receives Technical Section Complete Letter for Effectiveness for AT-002 (Press)
  • OBI breast cancer therapy misses Phase II/III endpoint (BioCentury)
  • Positive Top-Line Results From The Phase 3 Study Of Romosozumab In Postmenopausal Women With Osteoporosis (Press)
  • FDA Accepts For Review Supplemental New Drug Application for XTANDI (enzalutamide) Capsules in Metastatic Castration-resistant Prostate Cancer with Data from Head-to-Head Studies of Enzalutamide Versus Bicalutamide (Press)

US: Medical Devices

  • Last day to renew FDA medical device registrations for FY 2016 (MassDevice)\
  • FDA's thumb on the scale (Thomson Reuters)
  • FDA Extends Comment Period for Device Interoperability Guidance (FDA)
  • FDA Ortho Panel Says 'No' To Medtronic DIAM Spine Device (Gray Sheet-$)
  • Podcast - Why Using Proper Standards for Your Regulatory Submission is So Important (Eisner)
  • How 3-D imaging could change heart surgery in the future (Washington Post)
  • Software Helps Gene Editing Tool CRISPR Live Up to Its Hype (IEEE Spectrum)
  • The Legacy Device Loophole (MDDI)
  • FDA Asks If Faulty Blood Monitor Tainted Xarelto Approval (NYTimes)
  • Vantage point – How to fix the medtech venture crunch (EP Vantage)
  • Scientists Collaborate On Point-Of-Care Diagnostic Device For Zika Virus (MedDeviceOnline)
  • Accelerating genome analysis (MNT)
  • ReCor Medical to launch U.S. trial for Paradise renal denervation device (MassDevice)
  • Boston Scientific Receives U.S. FDA Approval For Quadripolar Leads And Initiates Global Trial To Expand MRI Labeling To The U.S. And Asia (Press)
  • FDA approves trial for low-risk patients with MDT's CoreValve Evolut R (MassDevice)
  • Class 1 Device Recall Maquet Flowi (FDA)

US: Assorted & Government

  • Biomet Hip Implant MDL Judge Upholds Fraudulent Joinder Removal Based on Sealed Container Doctrine (Drug and Device Law)
  • With Scalia's Passing, Device Industry Loses Preemption Supporter On Supreme Court (Gray Sheet-$)
  • Senate Committee Investigates FDA's Compassionate Use (Focus)
  • Healthcare orgs call for Congress to pass 'crucial' MEDTECH Act (Fierce) (Letter)
  • GSK Wants To Know If MDL Plaintiffs Took Generic Zofran (Law360-$)
  • 1st Circ. Revives Loestrin Pay-For-Delay Suit (Law360-$)
  • Markey opposes FDA nominee because of stance on opioids (Boston Globe)
  • Senator: Pharma Caused 'Opioids' Epidemic, Should Pay Tax (SCRIP-$)
  • Sanders Health Plan Renews Debate On Universal Coverage (NPR)
  • Genetic information as "perceived disability": Chadam v. PAUSD (Genomics Law Report)
  • Keating, fellow Congessmen urge speedy approval of Duchenne drugs (Boston Business Journal)

Upcoming Meetings & Events


  • AstraZeneca and Glaxo sign letter warning of European exit (PharmaPhorum)
  • Final NICE nod for Opdivo in skin cancer (PharmaTimes)
  • Ibuprofen patch heralds side effect free drug future (Reuters)
  • Statistical Analysis of Cumulative Serious Adverse Event Data From Development Safety Update Reports (Study)
  • UK Medtech Survey Underlines Notified Body Flaws (SCRIP-$) (Clinica-$)
  • Brexit Vote Just Four Months Away, But What's At Stake For Pharma?  (SCRIP-$)
  • Real world evidence workshop report published (ABPI)
  • Medtronic wins CE Mark for line of MR-safe CRT-Ds (MassDevice)
  • Mitralign wins CE Mark for namesake heart repair device (MassDevice)
  • Boston Scientific wins CE Mark for Eluvia peripheral stent (MassDevice)
  • XTL Biopharmaceuticals Receives European Medicines Agency's SME Status (Press)


  • Asia Regulatory Roundup: CFDA Consults on Good Supply Practices, Traceability (Focus)


  • Sandoz Inc, Macleods Pharma recall two drugs made in India (Economic Times)
  • As Parliament session begins, skepticism among industry regarding fate of Bills related to health and pharma sectors (PharmaBiz)
  • India Restores Duty Exemptions For Selected Drugs (PharmAsiaNews-$)
  • Pharma Partnering Models And Some Uncomfortable Truths?  (SCRIP-$)
  • Hemoteq, Maker Of Drug-Device Combo Products, Receives 9th Patent In India (24 Insight)


  • Luminex Receives Canadian Medical Device License for Aries System, Herpes Assay (GenomeWeb)
  • Canadian experts say 'no' to colonoscopy for colon cancer screening (Reuters)

Zika Virus

  • Cuba deploys 9,000 troops in effort to ward off Zika virus (Reuters)
  • Brazil to fight Zika by sterilizing mosquitoes with gamma rays (Reuters)
  • White House presses Congress for emergency funds for Zika (Reuters)

Other International

  • NZ's PHARMAC calls for proposals on insulin glargine supplies (PharmaLetter-$)
  • Vaginal ring provides partial protection from HIV in large multinational trial (NIH)

General Health & Other Interesting Articles

  • 'Pandemic' Asks: Is A Disease That Will Kill Tens Of Millions Coming? (NPR)
  • Why Pertussis is Making a Comeback (NYTimes)
  • Scientists expose superbug defenses (MassDevice) (Washington Post)

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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