Regulatory Recon: Senate Schedules Vote for Califf Nomination on 22 February (12 February 2016)

Posted 12 February 2016 | By Michael Mezher 

Regulatory Recon: Senate Schedules  Vote for Califf Nomination on 22 February (12 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

In Focus: International

  • Foreign drugmakers may bear huge losses in Russia due to bureaucratic hurdles (PharmaLetter-$)
  • Drug Advertising On Social Media: US Vs. Canada (Law360-$)
  • EMA To Sit In On French FAAH Inhibitor Inquiry Meeting (SCRIP-$)
  • African nations poor at withdrawing unsafe drugs (SciDevNet)

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US: Pharmaceuticals & Biotechnology

  • FDA schedules meeting to review Intercept's OCA (BioCentury) (Fierce)
  • Biosimilars: Can the US catch up in 2016? (Pharmafile)
  • FDA Meets With Clinical Decision Support Firms To Address Challenging Cases (Gray Sheet-$)
  • Tylenol During Pregnancy Tied to Asthma in Children (NYTimes)
  • Shire's $32 Billion Takeover of Baxalta: Forging a New Rare Disease Leader (Thomson Reuters)
  • The biopharmaceutical industry's commitment to quality (PhRMA)
  • The Way Drugs Are Prescribed Is Changing [Infographic] (Forbes)
  • New Study Confirms Different Generics Have Equal Efficacy When Treating Epilepsy (Press) (Study)
  • Vaccine Makers 'Less Enthusiastic' Without US Funds (SCRIP-$)
  • Mood-Enhancing Drugs Could Also Provide Relief For Chronic Pain (Forbes)
  • COPD Drug Recalled Due to Counter Display Error (MPR)
  • Shire Marks 30th Anniversary With New Rare Diseases Program (BioprocessOnline)
  • Collaboration 2.0: Exploring the Future of Research-by-Collaboration in Medical R&D (Faster Cures)
  • When Is A CRO Not A CRO? (And why does that make enforcement hard?) (GxP Lifeline)
  • Saving Compounds from the Pharma Industry (Geeks Talk Clinical)
  • Launch of partnership for biosimilars education and access (GaBI)
  • Kitov saves time and money by filing combo pill through 505(b)(2) pathway (In-PharmaTechnologist)

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

  • Phase III Trial Results Of Eisai's Anticancer Agent Halaven In Soft Tissue Sarcoma Published In The Lancet (Press)
  • Epirus initiates pivotal global Phase 3 study for BOW015 (infliximab biosimilar) (Biosimilar News)
  • Clovis Oncology Announces Rociletinib New Drug Application Scheduled for Presentation at Upcoming FDA Oncologic Drugs Advisory Committee Meeting (Press)

US: Medical Devices

  • How threatening are cyber-security breaches currently when it comes to medical devices and the IoT? (MedCityNews)
  • GE, Banyan head to FDA meeting on TBI biomarkers as R&D hits critical mass (Fierce)
  • Oxygenation Circuit Devices Find A Class II Home With FDA (Gray Sheet-$)
  • Cook Medical recalls select single lumen caths (MassDevice)

US: Assorted & Government

  • Fourth Circuit Flubs Admissibility of 510k Clearance (Drug and Device Law)
  • Plaintiffs' Experts Out in Dietary Supplement Death Case (Drug and Device Law)
  • Chipotle and FDA's Reach (FDA Law Blog)
  • HHS considering all options for drug prices (BioCentury)
  • Senate panel backs bill addressing Rx abuse, access (DSN)
  • U.S. Authorities Investigating DaVita HealthCare Unit (WSJ-$)
  • Vampire Lab Turns To Old Trick To Grow Business: Physician Owned Labs (CardioBrief)

Upcoming Meetings & Events


  • How Can O'Neill Review Turn Into Action? (SCRIP-$)
  • UK patients get early access to Opdivo for kidney cancer (Pharmafile)
  • Chemical substance can qualify as a "new active substance" (Lexology)
  • EU watchdog: Online illegal drug sales following Amazon model (EurActiv)
  • NICE Recommends Medtronic Integrated Sensor-Augmented Insulin Pump As the Only Therapy System to Manage Glucose Levels in Type 1 Diabetes (Press)
  • Pharmacovigilance for biologicals in The Netherlands (GaBI)
  • ABPI response to AMR report on vaccines and alternatives to antibiotics (ABPI) (O'Neil Report)
  • Advertising investigations: January 2016 (MHRA)


  • Healthcare sector to see 15 pc revenue growth in FY17 (Economic Times)
  • Fear of duty hike raising drug prices unfounded (Economic Times)
  • Indian Patent Office Joins Uspto In Granting Patent To Cancer Research Technology (24 Insight)
  • IPC, IMA to come out with guidance document for community pharmacists to strengthen their role in PvPI (PharmaBiz)
  • PhRMA concerned over Sect 3(d) of India's Patents Act as it fears other emerging markets may emulate it as a model (PharmaBiz)


  • Shionogi files NDA in Japan for ADHD treatment for children (PharmaLetter-$)


  • Guidance Document - Pharmaceutical Development ICH Topic Q8(R2) (Health Canada)


  • Consultations on adoption of European Union guidelines in Australia: Outcome of previous consultation (TGA)
  • Australia To Fund New Hepatitis C Drugs From March (SCRIP-$)

Zika Virus

  • WHO sees Zika link proven in weeks as U.S., India lead vaccine race (Reuters)
  • The EU's response to Zika: Old wine in new bottles? (EurActiv)
  • Fighting the 'Cockroach of Mosquitoes' (WSJ-$)
  • Miscarriages reported in 2 U.S. women with Zika virus, CDC says (Washington Post)
  • Back to its roots: how Zika may threaten Africa (Reuters)
  • Brazil probes three deaths with Zika links, aims for vaccine in a year (Reuters)
  • Public Health Officials Press Congress to Fund Zika Battle (MedpageToday)
  • Zika pushes 38 percent of U.S. businesses surveyed to let workers defer trips (Reuters)
  • Venezuelan President says three dead from Zika-linked complications (Reuters)
  • Chart: Access To Contraception And Abortion In Zika-Affected Countries (NPR)
  • NIH officials accelerate timeline for human trials of Zika vaccine, saying they will now begin in the summer (Washington Post)
  • Scientists prepare for potential Zika virus outbreak in Southern Europe (EurActiv)
  • Interview: Why Are We Years Away From A Zika Vaccine? (Health Affairs Blog)

Other International

  • Nigeria: Applauding NAFDAC's Change Agent Role (All Africa)
  • South Africa sets up state-owned pharmaceutical firm (PharmaAfrica)

General Health & Other Interesting Articles

  • Textile workers at higher risk for rheumatoid arthritis (Reuters)
  • Better growth monitoring needed to spot childhood diseases (Reuters)
  • CDC Highlights Programs that Reduce U.S. Health Disparities (CDC)
  • Elderly patients rarely included in decision to use intensive care (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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