Regulatory Focus™ > News Articles > Regulatory Recon: Medtronic Warns Doctors After 19 Deaths Reported; China to Invest $1B in US Biotec

Regulatory Recon: Medtronic Warns Doctors After 19 Deaths Reported China to Invest $1B in US Biotech Site (18 August 2016)

Posted 18 August 2016 | By Michael Mezher 

Regulatory Recon: Medtronic Warns Doctors After 19 Deaths Reported China to Invest $1B in US Biotech Site (18 August 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

  • Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? (Focus)
  • In CRISPR Fight, Co-Inventor Says Broad Institute Misled Patent Office (MIT Technology Review) (STAT)
  • FDA Rejects Portola's New Anti-Anticoagulant (CardioBrief) (PharmaLetter-$) (Endpoints)
  • Birth: An Epic Day Of Bacterial Invasion (LifeSciVC)
  • Exclusive: Merck enters race for cancer drugmaker Medivation – sources (Reuters)
  • What Does Getting an 483 or Warning Letter Really Cost You? (FDA Zilla)
  • What's Thermo Fisher Planning? (Bloomberg)
  • China's Greenland, Ping An, Agile to invest $1 bln in U.S. biotech site (Reuters)
  • Study Of Sudden Cardiac Death Exposes Limits Of Genetic Testing (NPR) (CardioBrief) (WSJ-$)
  • Drug companies win round over pricing in California Legislature (Sacramento Bee) (KHN)
  • Survey shows broad support for national precision medicine study (NIH)
  • Genetic Tests for a Heart Disorder Mistakenly Find Blacks at Risk (NYTimes)
  • Six Years Into Obama's Health Care Law, Who Are the Uninsured? (NYTimes)
  • FDA: Custom Ultrasonics' Endoscope Reprocessors Still Unsafe (Focus)
  • Medtronic warns doctors on heart valve delivery system after 19 deaths reported (Star Tribune) (MassDevice)
  • Pharma and medtech sectors struggle in first half of 2016; report (PharmaLetter-$)
  • Why Big Pharma Gets A Failing Grade On Clinical Trial Transparency (Forbes)
  • NIH's Zika Vaccine Faces Funding Challenge After Skipping Industry Partnership (Pink Sheet-$)
  • Court Says Pfizer's Biosimilar of J&J's Remicade Doesn't Infringe Patent (WSJ-$) (Reuters) (Big Molecule Watch) (Bloomberg)
  • A Big Step Forward in the Quest for a Better Painkiller (MIT Technology Review) (NPR) (Bloomberg)
  • More evidence ties insurance coverage to cancer survival (Reuters)
  • US personalized-medicine industry takes hit from Supreme Court (Nature)
  • CRISPR's hopeful monsters: gene-editing storms evo-devo labs (Nature)
  • The FDA, Juno Therapeutics, and the ethical imperative of transparency (The BMJ)
  • Panel Takes Step In Adding UDIs To Claims, But FDA Says Timing Unclear (Inside Health Policy)

In Focus: International

  • U.N. Admits Role in Cholera Epidemic in Haiti (NYTimes)
  • Turkey's investigation into drugmaker Novartis 'ongoing': official (Reuters)
  • WHO appoints former NY mayor Bloomberg as global health ambassador (Reuters) (WHO)
  • German giant Boehringer Ingelheim battles India's Gennova Biopharma over stroke treatment (Economic Times)
  • European Commission Offers Guidance on Standalone Software as a Medical Device or IVD (Focus)
  • Auris's tinnitus drug misses main goals in study; shares sink (Reuters)
  • Lilly's European Medical Director On Brexit And Fair Value Assessments For New Drugs (SCRIP-$)
  • Turkey's pharmaceutical industry forecast to reach $5.53 billion by 2020; report (PharmaLetter-$)
  • NICE recommends removal of two drugs from CDF (BioCentury) (OnMedica)
  • Pfizer's Xalkori price drop secures NICE recommendation (Pharmafile) (BioCentury) (NICE)
  • Cancer drug companies cut prices to win NHS approval (The Guardian)
  • Getting GSK back to growth (PharmaLetter-$)
  • Thousands queue in Congo for emergency yellow fever vaccinations (Reuters)

US: Pharmaceuticals & Biotechnology

  • EpiPen Price Hike Has Parents of Kids With Allergies Scrambling Ahead of School Year (NBC)
  • A morphine alternative with less overdose risk? (Reuters)
  • Valeant Pharmaceuticals Rallies on Morgan Stanley Upgrade (The Street)
  • Valeant Secures Another Debt Amendment (WSJ-$)
  • Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing: cross sectional ecological study (The BMJ)
  • How animal models will advance precision medicine (OutsourcingPharma) (PharmaTimes)
  • The Pill That Made Northwestern Rich (Bloomberg)
  • Gilead: breaking the fever (Financial Times-$)
  • ExAC project pins down rare gene variants (Nature)
  • Announcing the Exome Aggregation Consortium paper (MacArthur Lab)
  • 'Super vaccine' guards against all strains of pneumococcal disease (Manufacturing Chemist)
  • Orphan Drugs Should Be Rarer, Insurers Urge, Citing Price Increases (Pink Sheet-$)
  • Fetal Cells Offer Promise in Prenatal Testing (MIT Technology Review)
  • A Brief Overview of the Use of Electronic Informed Consent in Clinical Investigations (CATO)
  • Sage Products Expands Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination (FDA)
  • Influenza Virus Vaccine for the 2016-2017 Season (FDA)
  • PhRMA plans expanded post-election ad blitz (Fierce)
  • Adaptive designs: patient value and commercial benefits (OutsourcingPharma)
  • GE patents anti-counterfeit system for bioprocessing kit (Securing Industry)

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

  • New BLA for Genmab's multiple myeloma med Darzalex submitted to FDA (PharmaLetter-$)
  • Pulmatrix Receives Orphan Drug Designation from the FDA for Inhaled Drug to Treat Pulmonary Fungal Infections in Cystic Fibrosis Patients (Press)
  • FDA Grants Soligenix Orphan Drug Designation for Dusquetide for Treatment of Macrophage Activation Syndrome (Press)
  • Indivior's addiction therapy passes Phase III test (BioCentury)
  • Cerulean Announces Results from Phase 2 Clinical Trial of CRLX101 and Avastin® Combination in Relapsed Renal Cell Carcinoma (Press)
  • Zymeworks Receives FDA Acceptance of IND Application for ZW25, a Novel Bi-Specific Antibody, for the Treatment of HER2-Expressing Cancers (Press)
  • Zymeworks' ZW25 and ZW33 Granted Orphan Drug Designation for Ovarian Cancer by U.S. Food and Drug Administration (Press)
  • ARCA biopharma Announces 100th Patient Randomized into the GENETIC-AF Phase 2B/3 Clinical Trial (Press)
  • Nordic Nanovector completes recruitment of the first cohorts of Arm 3 and Arm 4 of expanded Phase 1/2 study of Betalutin® in NHL patients (Press)

US: Medical Devices

  • Don't Hold Back on UDI Compliance (MDDI)
  • McDonald's to stop giving out activity trackers in Happy Meals (CBS)
  • Like pharma, medtech players seek to go beyond the device (MedCityNews)
  • FDA Approves Quidel's Solana Trichomoniasis Assay (GenomeWeb)
  • Molex buys Phillips-Medisize (MassDevice)
  • Cancer Genetics Receives NY State Approval for NGS-Based Cancer Panel (GenomeWeb)
  • Fresenius Kabi unveils $250m expansion for Ill. Plant (MassDevice)
  • Another InVivo Therapeutics spinal scaffold implant patient improves (MassDevice)
  • FDA adds new clearance for Cianna Medical's Savi Scout breast cancer locator (MassDevice)

US: Assorted & Government

  • Tobacco companies get partial win in FDA labeling fight (Reuters)
  • Clinton Transition Team Includes Tanden, Underscoring Rx Pricing Focus (Pink Sheet-$)
  • Pulse Check: Obamacare's CEO talks insurer recruitment after Aetna's pullback (Politico)
  • Still Seeking Contraceptive Compromise After Zubik v. Burwell (Harvard Bill of Health)
  • Jury convicts ex-banker in healthcare insider trading trial (MassDevice)
  • Did You Search Your Jurors' Social Media? There Are Rules (Drug and Device Law)
  • Shkreli Seeks Escape From KaloBios Securities Litigation (Law360-$)
  • DEA Policy Expands the Number of Marijuana Cultivators for Research (FDA Law Blog)
  • Aides: Senate Cosmetics Bill Likely to Move Forward, House Bill Stalled (Inside Health Policy)

Upcoming Meetings & Events


  • Teva gets EU nod for severe asthma drug Cinqaero (PM Live)
  • Avacta opens UK facilities to bolster antibody alternative development (BioPharmaReporter)


  • Singapore Joins 21 Countries in the International Missing Type Campaign to Raise the Need for More Blood Donors (HSA)



  • FDA Issues Emergency Use Authorization for ZIKV Detect™ IgM Capture ELISA (InBios International, Inc.) (FDA)
  • Guatemala confirms first case of newborn with microcephaly linked to Zika (Reuters)

General Health & Other Interesting Articles

  • Calcium supplements tied to higher dementia risk for some women (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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