Regulatory Focus™ > News Articles > Regulatory Recon: J&J Warns of Insulin Pump Cybersecurity Vulnerability; Samsung BioLogics Could Rai

Regulatory Recon: J&J Warns of Insulin Pump Cybersecurity Vulnerability Samsung BioLogics Could Raise $2bn With IPO (4 October 2016)

Posted 04 October 2016 | By

Regulatory Recon: J&J Warns of Insulin Pump Cybersecurity Vulnerability Samsung BioLogics Could Raise $2bn With IPO (4 October 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

  • J&J warns diabetic patients - Insulin pump vulnerable to hacking (Reuters)
  • ICER on PD-1 Immunotherapies to Treat Lung Cancer: Lower the Prices (Focus)
  • Cheaper EpiPen May Not Come Until End of Year, Mylan Says (Bloomberg)
  • For Developers of New Genome Sequencing Analytical Tools, FDA Launches 'App-a-Thon' (Focus) (FDAVoice)
  • Death, Kickbacks And A Billionaire: The Story Of A Dangerous Opioid (Forbes)
  • Alnylam CEO: Four Things To Learn From Medicine Development (Forbes)
  • This could be the worrisome reason why new cancer patients are not using a lifesaving medicine (Washington Post)
  • House Committee Taps Mylan for More Information on EpiPen Price Figures (WSJ-$)
  • A Flu Season Without FluMist? Making Shots Less Painful for Children (NYTimes)
  • Jazz begins Vyxeos NDA submission (BioCentury)
  • Duke Report: Real-World Data Pilots Must Gain Buy-In From Device Makers (InsideHealthPolicy)
  • Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation (JAMA)
  • Novartis' global study shows 57% of psoriasis patients didn't reach clear skin treatment goal (EPR) (PharmaLetter-$)
  • Allergan shows it has stomach for more GI dealmaking (EP Vantage)
  • Supreme Court Again Refuses to Clarify Scope of Hatch-Waxman Safe Harbor (Patent Docs) (Law360-$)
  • Big Pharma vs Big Pharma in court battles over biosimilar drugs (Reuters)
  • Risk test may put too many in unhelpful 'prediabetes' category (Reuters)
  • Amgen strikes early-stage oncology, neuroscience R&D pact with Nuevolution (Fierce)
  • Should cost-effectiveness analysis ignore the price of the drug? (Healthcare Economist)

In Focus: International

  • EC Report Calls for New Network of Reference Labs for Human Pathogens (Focus)
  • Modi government planning a major overhaul of country's drug policy (ETHealthworld)
  • NICE to Charge up to £282,000 for Each New Drug Assessment (Focus)
  • Health Canada Looks to Raise the Bar for Regulating Natural Health Products (Focus)
  • Europe Strengthens Collaborations with Japanese Pharmacopoeia (PharmTech)
  • Bayer receives EU approval for new five-year contraceptive (Reuters)
  • Samsung Bioepis seeks Europe approval for copy of Herceptin breast cancer drug (Reuters) (PharmaTimes)
  • Samsung BioLogics IPO Could Value Firm at $8.2 Billion (WSJ-$) (Reuters)
  • Sanofi's dengue vaccine scores 11th worldwide approval in Singapore (HSA) (Pharmafile) (Reuters)
  • Spectral Medical's sepsis treatment fails late-stage study (Reuters)
  • NICE and the CDF: Are they still up to scratch? (Pharmafile)
  • First new cancer drug introduced under Cancer Drugs Fund (OnMedica)
  • NICE punts Tagrisso to Cancer Drugs Fund (BioCentury) (Pharmafile) (NICE)
  • Another failed trial knocks back AZ's plan to grow Brilinta (PMLive) (PharmaTimes)
  • Vantage point – What Brexit means for medtech regulation (EP Vantage)
  • TTIP locking Europe and USA into higher drug prices, new report claims (PharmaLetter-$)
  • Social media sourced Real World Evidence: A new wave in collecting data (European Pharmaceutical Review)

US: Pharmaceuticals & Biotechnology

  • Investor's Guide to This Week's Clovis, Tesaro Ovarian Cancer Drug Updates (The Street)
  • Merrimack Pharmaceuticals Cuts Jobs; CEO Resigns Amid Restructuring Effort (WSJ-$)
  • Biotech PR Needs to Deliver More Signal, Less Noise (Forbes)
  • Request for Nominations for Voting Members for the Patient Engagement Advisory Committee (FDA)
  • Case Studies In FDA's Regulatory Interpretation Of Clinical Trials (Pink Sheet-$)
  • Upcoming Biosimilars Conferences (Big Molecule Watch)
  • Half of U.S. business R&D concentrated in five states (National Science Foundation)
  • New ISO 14644 series cleanroom standard now available (ManufacturingChemistPharma)
  • Does a luxury fashion line inspired by prescription pills glamorize addiction? (STAT)
  • Dermatology OTC Switches Loom Next For Consumer Health Growth (Pink Sheet-$)
  • Google Docs for life sciences startup Benchling raises $7 million in growth funding from Thrive Capital (TechCrunch)
  • How the Nation's Opioid Epidemic Is Morphing — and Growing (ProPublica)
  • As right-to-try laws gain wider adoption, is stronger federal legislation needed? (MedCityNews)
  • Dynavax pops on FDA approval optimism for HBV vaccine (Fierce)
  • FDA Chemical Regulation: Anti-Anti-Bacterials? (National Law Review)
  • Regeneron failure is one in the eye for Ophthotech (EP Vantage)
  • Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications (FDA)

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

  • BioDirection, Inc. Files Pre-Submission Package With FDA (Press)
  • Roche's Alecensa receives second FDA Breakthrough Therapy Designation (Pharmafile) (Reuters) (Press)
  • Theranexus Has Obtained an Orphan Drug Designation from the FDA for THN102 in the Treatment of Narcolepsy (Press)
  • Jubilant DraxImage Receives FDA Approval for RUBY-FILL Rubidium 82 Generator and Elution System (Press)
  • Cimzia passes Phase III psoriasis test (BioCentury)
  • Phase 3 results for Sun Pharma's investigational psoriasis medicine, tildrakizumab (MNT)
  • Catabasis Pharmaceuticals Completes Target Enrollment for Part B of the MoveDMD® Trial, a Phase 2 Trial of Edasalonexent (CAT-1004) for the Potential Treatment of Duchenne Muscular Dystrophy (Press)
  • New Research From Bristol-Myers Squibb at ESMO 2016 Congress Reinforces Leadership in Immuno-Oncology and Differentiated Research Approach (Press)
  • Albireo's elobixibat meets in Japanese Phase III study (BioCentury)
  • Belviq Xr® - A New Once-Daily Formulation Of Belviq® For Chronic Weight Management Now Available In The United States (Press)

US: Medical Devices

  • Narrative of New ISO 10993-1 Standard – Part 1: "Evaluation and testing within a risk management process" (MassDevice)
  • FDA Approves Osimertinib Blood-Based T790M Companion Diagnostic Test (ASCO Post)
  • FDA approves label changes for GE's Optison (MassDevice)
  • A urine test for Creutzfeldt-Jakob Disease may be possible (Medical Research Council)
  • New prostate cancer tests aim to reduce the death rate (CNBC)
  • Center for Devices and Radiological Health Veteran Amputee Devices; Public Workshop; Request for Comments (FDA)
  • Medtronic touts 1-year data on Avalus surgical aortic valve (MassDevice) (Press)
  • FDA approves Valencia's eCoin neurostim trial (MassDevice)
  • St. Jude Medical Announces FDA Approval of BurstDR Stimulation, a New Superior Spinal Cord Stimulation Option for Patients Suffering from Chronic Pain (Press)

US: Assorted & Government

  • FDA Criticized for Moving Too Slowly (Policy and Medicine)
  • J&J Artificial Hips' Market Success Built On Lies, Jury Told (Law360-$)
  • Tax Deductibility As A Regressive Federal Subsidy (HealthAffairsBlog)
  • Patent Eligibility Rejections Are Up for Natural Products (Bloomberg)
  • FDA to Revisit the Nutrient Content Claim "Healthy" (Policy and Medicine)
  • Feds Say Shkreli, Ex-Atty Have Enough Info On Fraud Case (Law360-$)
  • Tenet Healthcare to Pay $514 Million to Settle Kickback Allegations (WSJ-$)
  • M.D. Pa. Finds No Specific Personal Jurisdiction over Parent Company (Drug and Device Law)

Upcoming Meetings & Events


  • Summit, Sarepta in $584M-plus DMD pipeline licence pact in Europe (Fierce) (Reuters) (Press)
  • New Division At Danish Medicines Agency To Put Greater Focus On Benefit-Risk Issues  (Pink Sheet-$)
  • Czech hospital bed maker LINET buys 80 pct in BORCAD Medical (Reuters)
  • Colostomy bag maker ConvaTec seeks $1.8 billion in London IPO (Reuters)
  • Profusa, Inc. Receives CE Mark to Market the Lumee Oxygen Platform™ for Continuous, Real-time Monitoring of Tissue Oxygen English (Press)
  • MundiPharma, Orexo file Zubsolv in Europe (PharmaTimes)
  • Edwards Lifesciences wins CE Mark for Acumen hypotension monitor (MassDevice)
  • Advertising investigations: August 2016 (MHRA)


  • Korea To Limit Olmutinib Usage, Monitor All Patients (SCRIP-$)
  • Grünenthal On Hunt For Asia Partner As Pain Killer Hits Phase III Endpoints (SCRIP-$)
  • Japan police probe hospital poisoning deaths (Reuters)
  • Indian Medical devices company SMT to establish European HQ in Ireland (BioSpectrum)


  • India Specifies Terms For Ceasing Supplies Of Essential Drugs (Pink Sheet-$)
  • Drug crisis in store if Sino-Indian ties worsen (Times of India
  • 483 Holds up U.S. Expansion for India's Second-Largest Drugmaker (FDANews-$)
  • Singh Bros file confidentiality application for assets to be disclosed in Daiichi case (Economic Times)
  • Indian drugmakers express concerns about bulk drug manufacturing incentives (PharmaLetter-$)           


  • Drug maker Concordia in talks to sell equity stake: sources (Reuters)


  • Zika vaccine race spurred by crisis and profit potential (Reuters)
  • More evidence for Zika virus link to damage beyond microcephaly (Reuters)
  • Zika funding delay hurt effort to fight virus: U.S. health officials (Reuters)
  • Despite new Zika funds, states might not get any for months (Washington Post)

Other International                           

  • Exclusive Licensing Agreement For In-House Developed Monoclonal Antibody Farletuzumab In Latin America Concluded With Eurofarma Laboratórios S.A. (Press)

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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