Regulatory Recon: Specialized Inspectors, a New Skin Cancer Combo and Guido Rasi's Second Chance (1 October 2015)

Posted 01 October 2015 | By Michael Mezher 

Regulatory Recon: Specialized Inspectors, a New Skin Cancer Combo and Guido Rasi's Second Chance (1 October 2015)

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

  • Be Careful What You Wish For: Specialized FDA Inspectors Don’t Necessarily Mean Happier Inspections (FDA Law Blog) (Pink Sheet-$)
  • Counterpoint: Two Perspectives on Drug Price Regulation (Forbes) (Health Business Blog)
  • FDA approves Bristol-Myers drug combination for skin cancer (Reuters) (Press)
  • New cholesterol drugs won't be budget busters: Express Scripts (Reuters)
  • FDA approves ultra-orphan drug on a 4-patient trial (Nature-$)

In Focus: International

  • A Second Chance? EMA Board Nominates Guido Rasi to Lead Again (Focus)
  • Pacific trade ministers aim to seal TPP trade pact (AFP)
  • Health Canada warning on Gilenya safety (PharmaLetter-$) (Health Canada)
  • Kerala DC dept unable to conduct inspections & detect DPCO violations due to shortage of regulatory staff (PharmaBiz)

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US: Pharmaceuticals and Biotechnology

  • How can Pradaxa, Xarelto and Eliquis finally unseat warfarin? Safety data, analyst says (FiercePharma)
  • FDA Adding Managers, With Goal Of Quicker Inspection Reports (Pink Sheet-$)
  • Amgen and Allergan are close to Avastin biosimilar filing (Biosimilar News)
  • 10 top trends driving the biopharma industry today (BioPharma Dive)
  • US FDA rule: banned drugs will be destroyed (In-PharmaTechnologist)
  • Denying Inappropriate PCSK9 Prescriptions Keeps Costs In Check For Express Scripts (Pink Sheet-$)
  • Pharmas factor green considerations into sourcing decisions say experts (Outsourcing-Pharma)
  • Newron Pharmaceuticals says late-cycle review meeting for Xadago NDA completed with FDA (Reuters)
  • Clinical trial data transparency is the right thing to do (The Catalyst)

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

  • Racing AstraZeneca, Clovis gets a speedy FDA review for its lung cancer drug (FierceBiotech)
  • Jazz eyes a quick FDA nod for its $1B rare disease drug (FierceBiotech)
  • Sarepta gets creative in bolstering its case for quick eteplirsen approval (FierceBiotech) (Press)
  • Synthon reports promising initial results from Phase I trial with anti-HER2 ADC (Biosimilar News)
  • New England Journal of Medicine publishes results of head-to-head studies of brodalumab versus ustekinumab in psoriasis (Press)
  • Positive data from RPL554 clinical study in COPD patients (MNT)
  • U.S. FDA Approves JUVEDERM® ULTRA XC for Use in Lips (Press)

US: Medical Devices

  • Screen-film mammography: Headed the way of xeromammography? (FDA)
  • Implant Could Bypass Brain Damage, Restore Long-Term Memory (MedDeviceOnline)
  • Pew Says Feds Should Create Standards, Require Unified UDI System (Gray Sheet-$) (Pew Report)
  • Hackers Flock to Fake Medical Devices (MDDI)
  • Smart capsule to target colon diseases (Reuters)
  • Podcast: Medical Device Change Management: Letter-To-File Vs. Special 510(k)/PMA Supplement (MDDI)
  • Feds to diagnostics companies: We're here to help (you lose money) (SF Business Times)
  • Sniffing out cancer with improved 'electronic nose' sensors (MNT)
  • Monteris Medical announces data reinforcing clinical efficacy of NeuroBlate laser ablation in patients with brain lesions (MNT)
  • Oraya radiation tech reduces need for eye injections in AMD patients (FierceMedicalDevices)
  • Theranos CEO quietly upends an industry, may change the world (Beaker)
  • Smart inhaler boosts medication adherence 144 percent in small study (MobiHealthNews)

US: Assorted and Government

  • No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPA (FDA Law Blog)
  • US FDA, NIH Saved From Shutdown - For Now (SCRIP-$)
  • New Hampshire AG launches investigation into opioid marketing (FiercePharma)
  • Walking the Regulatory Compliance Path Defeats Punitive Damages (Drug and Device Law)
  • Hagens Berman To Appeal Sanctions In Thalidomide Litigation (Law360-$)
  • Medtronic Escapes Investors' Claims Of Tainted Studies (Law360-$)
  • Sandoz, UTC Settle Generic Remodulin Patent Suit (Law360-$)
  • 1st Circ. Gives Whistleblower Redo In Covidien FCA Suit (Law360-$)
  • Sanofi Vaccine Customers Get Class Cert. In Antitrust Case (Law360-$)
  • BioMarin Scores Patent Board Win; Sarepta To Appeal (SCRIP-$)

Upcoming Meetings and Events              


  • Draft: Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins (EMA)
  • Flu vaccination programme in primary schools put on hold (The Guardian)
  • Call for civil society members to join two EMA committees (EMA)
  • Reva finishes CE trial enrollment for drug-eluting scaffold (MassDevice)
  • EU Law On Fake Drug Detection Device Draws Nearer (SCRIP-$)
  • New WHO Guidelines For HIV Could Boost Single Tablet Uptake In EU (SCRIP-$)
  • EMA Seeks Industry Feedback On New Scheme For Supporting Drugs For Unmet Needs (SCRIP-$)
  • European Commission Seeks To Facilitate Innovative Orphan Drug Entry; Avoid Delays For Generics (SCRIP-$)
  • European regulator recommends drug targeting relapsed multiple myeloma (Pharmaceutical Journal)
  • Hospi Corporation receives European regulatory approval for novel medication administration device (MassDevice)
  • SpineGuard wins CE Mark approval for DSG platform (MassDevice)


  • IPA demands permission for pharmacists to prescribe medicine for common ailments (PharmaBiz)


  • PMDA September Update (PMDA)


  • Proposal for the re-scheduling of Codeine products (TGA)
  • Safety review: Codeine use in children and ultra-rapid metabolisers (TGA)
  • Consultation: Proposed Amendments to Poisons Standard (TGA)

Other International

  • End In Sight For Makeover Of Device Quality Standard ISO 13485 (SCRIP-$)
  • ANVISA Updates List of Technical Standards Required for INMETRO Certification (Emergo)
  • Long Hot Summer For Vaccines Policies In Turkey (PharmAsiaNews-$)
  • Drug Development Outlook: Evaluating the High Growth MENA Market for Generic & Manufacturing Expansion (Life Sciences Connect)

General Health and Other Interesting Articles

  • Scientists create world’s largest catalog of human genomic variation (NIH)
  • WHO: Number of people over 60 years set to double by 2050; major societal changes required (WHO)

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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