Regulatory Recon: FDA Rejects Digital Pill Combo Novartis Periodic Fever Drug Wins Three Breakthrough Designations (27 April 2016)

Posted 27 April 2016 | By Michael Mezher 

Regulatory Recon: FDA Rejects Digital Pill Combo Novartis Periodic Fever Drug Wins Three Breakthrough Designations (27 April 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

  • The Complex Math Behind Spiraling Prescription Drug Prices (NYTimes 1, 2)
  • FDA Issues Complete Response Letter for Digital Medicine New Drug Application (Press) (PharmaTimes)
  • Senate Nears Deal for at Least $1.1 Billion to Fight Zika Virus (NYTimes)
  • White House urges Congress to move on Zika funding (Reuters)
  • New Cardio Drugs Off To Very Slow Start (CardioBrief)
  • Chinese drug dealers are outsmarting the FDA by creating new opioids (Quartz)
  • FDA Breakthrough status for Novartis drug in Periodic Fever Syndromes (PharmaPhorum) (PharmaTimes)
  • Here's how hospitals can protect themselves from ransomware attacks (STAT)
  • Theranos' Lab Problems Go Way Deeper Than Its Secret Tech (Wired)
  • Don't Blame Silicon Valley for Theranos (NYTimes)
  • Rep. Doggett: FDA Should Test Whether Drugs Are Better Than Existing Treatments (IHP-$)
  • Sen Markey Questions Califf on Generally Recognized as Safe Ingredients (Letter)
  • Third Drug Combo Approved for COPD (Medpage) (BioCentury)
  • Collegium Pharma's opioid painkiller wins U.S. approval (Reuters) (BioCentury)

In Focus: International                                                                                            

  • Whatever Happened to the ASEAN Medical Device Directive? (Emergo)
  • MHRA responds to misleading Sunday Post article (MHRA)
  • Global pharma growth to remain steady despite cost pressures: Moody's (Economic Times)
  • Biopharma 'future is better in Europe,' says UK life science minister (BioPharma-Reporter)
  • China to set up a new vaccine tracking system (BioSpectrum)
  • India Compulsory Licensing: What USTR Hearing Transcripts Say (SCRIP-$)
  • Genetically Modified Mosquitoes: What Could Possibly Go Wrong? (The Atlantiic)
  • EU membership best for cancer patients and research, say leading oncologists (OnMedica)
  • Novartis aims to save $1bn by 2020 with integrated manufacturing plan (In-PharmaTechnologist)
  • Reprocessing Provisions Could Be Dropped To Ensure Timely EU Reform Resolution (Gray Sheet-$)
  • Warning on liferafts containing unauthorised medical kits (MHRA)

US: Pharmaceuticals & Biotechnology

  • Partnerships leading the way for Biopharma's immuno-oncology pipeline (BioPharma-Reporter)
  • Only Human: A Birth That Launched The Search For A Down Syndrome Test (NPR)
  • Immunotherapy Tablets For Dust Mite Allergy Reduce Asthma Risk (NPR)
  • Biogen Appoints Michael Ehlers Executive Vice President, Research and Development (Press)
  • Putting the Patient in Labeling (And Drug Approval Decisions) in ODE 1 (RPM Report-$)
  • Microsoft Buys Into DNA Data Storage (IEEE)
  • Looking Towards 2030 in Patient Safety (Harvard Bill of Health)
  • How is the Federal Government's Pain Strategy Faring? (Medpage)
  • FDA Probes Fluconazole Risks in Pregnancy (Medpage) (FDA) (Focus)
  • Fecal Transplant Stool Banks Face Potential Regulatory Changes; May Affect Physicians, Patients (GenomeWeb)
  • Norovirus Costs Over $60 Billion Each Year (Forbes) (PLOS)
  • Eisai poaches senior Pfizer and Sanofi execs for neurology group (Pharmafile)
  • Development and Validation of a New Prognostic System for Patients with Hepatocellular Carcinoma (PLOS)
  • Breaking barriers: Can continuous manufacturing prevail despite hurdles? (In-PharmaTechnologist)
  • BARDA talks medical countermeasure manufacturing (Outsourcing-Pharma)
  • Visible Glass Particulate Discovered in Anesthesia Medication (MPR) (FDA)
  • SPARK Project to Examine DNA of 50,000 Autistic Kids, Looking for Solutions (DD&D)
  • FDA's Opioid REMS Review Puts Brakes On Mandatory Education Push (Pink Sheet-$)
  • CDC Warns of Counterfeit Opioid Poisoning Outbreak (MPR)
  • Controlled substances: fewer CMOs, more regulations (Outsourcing-Pharm)

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

  • Cerebain Biotech Today Announced It Plans to Seek FDA Approval (Press)
  • FDA approves Exelixis' Cabometyx (DSN)
  • Cytori Announces Timing for Full Enrollment in U.S. Phase III Scleroderma Trial (Press)
  • Bococizumab SPIRE-2 Cardiovascular Outcome Study Fully Enrolled (Press)
  • AM-Pharma receives FDA fast track designation for recAP in Acute Kidney Injury, and reports completion of first stage in Phase II trial (Press)
  • FDA approves ORFADIN (nitisinone) Oral Suspension (Press)

US: Medical Devices

  • A new frontier in the war on brain cancer with NovoCure chairman Bill Doyle (MassDevice)
  • FDA to Massachusetts Group Home: Stop Shocking Disabled Residents (ProPublica) (Focus)
  • Phthalates, chemicals used in some medical devices, could be creating attention deficit in children (MedCityNews)
  • Positions Diverge In Cost-Conscious User-Fee Negotiations (Gray Sheet-$)
  • Boston Scientific Earns FDA Approval for MR-Conditional Pacing System (MDDI) (MedCityNews)
  • NIH Hosts Discussion On Emerging Artificial Pancreas Technology (MedDeviceOnline)
  • Potrero wins FDA 510(k) for Accuryn system (MassDevice)
  • Intuity Medical's All-In-One Glucometer FDA Cleared (medGadget)
  • AtriCure Receives FDA Clearance for New AtriClip Device (Press)
  • Hansen pursues neurological indication for Magellan robot-assisted surgery device (MassDevice)
  • Fourth patient converts from complete to incomplete spinal cord injury in InVivo trial (MassDevice)
  • AtriCure wins FDA 510(k) for AtriClip Pro2 LAA device (MassDevice)

US: Assorted & Government

  • Senate HELP Committee Moves Forward With Companion Legislation to 21st Century Cures (Inside Medice Devices)
  • NY Lawmakers Discuss Tougher Oversight for Nurses (ProPublica)
  • FTC Approves Final Order Preserving Competition for Generic Drugs that Treat Bacterial Infections and Ulcerative Colitis (FTC)
  • Supreme Court Outcome Unlikely To Dent IPR Popularity (SCRIP-$)
  • Clinton Advisor Highlights Candidate's Health Priorities (Medpage)
  • Does FDA's Per Se Prohibition Against Off-Label Promotion Have a Future? (FDA Law Blog)
  • Implied Certification and the Problem of Interpretation Under the False Claims Act (Harvard Bill of Health)
  • Handy-Dandy Checklist for Admissibility of Electronic Evidence (Drug and Device Law)

Upcoming Meetings & Events


  • Draft guideline on clinical investigation of new medicinal products for the treatment of acute coronary syndrome (EMA)
  • NICE backs Novartis' Entresto (BioCentury)
  • Article 58: How EMA Helps Increase Access to Drugs in Low- and Middle-Income Countries (Focus)
  • Call For Experts On Ad Hoc Rapid Risk Assessment Of Chemical Threats (EC)
  • GlaxoSmithKline rebound gathering pace, says outgoing CEO (Reuters)
  • George Freeman: New meds and delivery methods a regulatory challenge (In-PharmaTechnologist)
  • Community pharmacists should be able to substitute cheaper drugs, says PSNC in proposals to counter government cuts (Pharmaceutical Journal-$)
  • EFPIA to extend collaboration with Lithuania on pharmaceutical policy (EFPIA)
  • EC grants marketing authorisation to Lilly's ixekizumab (EPR)
  • EU commission grants marketing authorization for Descovy (emtricitabine, tenofovir alafenamide) for treatment of HIV (MNT)
  • 3D printing can save drug manufacturers time and money says UK expert (In-PharmaTechnologist)
  • NICE backs BMS' paclitaxel in ovarian cancer; drops Eli Lilly's Gemzar, J&J's Yondelis (Pharmafile)
  • Remaining in the EU is vital for UK's cancer research strength, say leading oncologists (Pharmafile)


  • TN drug Dept prosecutes 460 drug traders, cos for flouting D&C Act in last fiscal (PharmaBiz)
  • Even tiny Burundi spends more percentage of GDP on health than India (Economic Times)
  • ICMR, Sun Pharma to work on new drug development  (Economic Times)
  • Hilleman Laboratories begins clinical trials of rotavirus vaccine (Economic Times)
  • Strides Shasun Clarifies WHO Notice Of Concern For CRO Semler Won't Impact Business (24 Insight)
  • Nearly 7 crore cases of diabetes in India in 2015: Government (Economic Times)
  • Health Groups raise alarm over intellectual property and investment provisions in RCEP negotiations (PharmaBiz)
  • Another Data Integrity Issue For An Indian Generic Drug Manufacturer (24 Insight)
  • Aurobindo Lands USFDA Approval For Exforge (Amlodipine And Valsartan) Tablets (24 Insight)


  • China A Key Driver Of Roche's International Growth (PharmasiaNews-$)
  • AdvaMed Praises Successful USTR Enforcement Action Over China Export Subsidies (AdvaMed)


  • Canadian Regulators Issue Guidance for IVD Device Labeling (GenomeWeb) (Focus)


  • Brazil says Zika-linked microcephaly cases stable at 4,908 (Reuters)
  • Zika Virus in the Americas: A Review for Clinicians (Mayo Clinic)

General Health & Other Interesting Articles

  • Childhood obesity not down in US (Reuter)
  • Rotating night shifts tied to heart disease risk (Reuters)
  • Better to get your flu shot in the morning (Reuter)
  • Notifications About Dense Breasts Can Be Hard to Interpret (NYTimes)
  • Weight loss may limit diabetes-related brain changes (Reuters)
  • This gene helps prevent cancer. Did it also give rise to all complex life? (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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