Regulatory Focus™ > News Articles > Regulatory Recon: ASCO Kicks Off in Chicago; Plan to Synthesize Human Genome Raises Questions (3 Jun

Regulatory Recon: ASCO Kicks Off in Chicago Plan to Synthesize Human Genome Raises Questions (3 June 2016)

Posted 03 June 2016 | By Michael Mezher 

Regulatory Recon: ASCO Kicks Off in Chicago Plan to Synthesize Human Genome Raises Questions (3 June 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

  • Promising drugs stoke talk of eventual cancer 'cure' (Reuters)
  • Cancer therapy re-engineers cells to hunt and destroy (Financial Times)
  • FDA Looks to Revitalize Compassionate Use Program With Simplified Form, Final Guidance (Focus) (Medpage) (Reuters)
  • The FDA isn't listening to patients pleading for drug approvals. Nor should it (STAT)
  • Immunomedics Kicked Out of Prestigious ASCO Cancer Conference (The Street)
  • ICH Genomic Sampling Guidance: FDA Begins Consultation (Focus)
  • FDA Evaluating Risk of Burns and Scars With Migraine Patch (Focus)
  • Stanford researchers 'stunned' by stem cell experiment that helped stroke patient walk (Washington Post)
  • Plan to Fabricate a Genome Raises Questions on Designer Humans (MIT Technology Review) (IEEE Spectrum)
  • Johnson & Johnson Is Urged to Slim Down (NYTimes)

In Focus: International

  • Botswana gets GSK's modern HIV drug in largest ever Africa tender (Reuters)           
  • FDA Bans Imports From Teva's Hungary Plant Except Two Drugs in Shortage (Focus)
  • Regulation of advanced therapy medicines (EMA)
  • European Commission Unveils Four New Public Consultations on Clinical Trials (Focus)
  • European Regulatory Roundup: EMA Plans Ways to Curb Antibiotic Resistance (Focus)
  • Brazilian Regulators Move to All-Electronic Medical Device Importation Process (Emergo)
  • EU Conditional Approval Should Be A Drug Development Tool, Not A Rescue Remedy (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • In fight for GSK's Advair, generic firms step carefully on price (Reuters)
  • Government watchdogs 'turn a blind eye' to pharma corruption, report says (Fierce)
  • NIH Offers License for CAR Therapy MGA271 (NIH)
  • Outcomes-Based Contracts Aren't So Easy, Harvard Pilgrim Cautions (Pink Sheet-$)
  • McKesson Considers Separation of Information-Technology Unit (WSJ) (Reuters)
  • CVS diabetes program recalls ill-fated AMA-Sunbeam deal (MedCityNews)
  • Gene test may prevent kidney damage after heart surgery (OnMedica)
  • Through The Looking Glass: A Clinical Trial From The Patient's Side (Cutting Edge Info)
  • Froedtert & the Medical College of Wisconsin Taps Watson for Clinical Trial Matching (Press)
  • ​Why does Biogen need a sixth drug for multiple sclerosis? (Boston Biz Journal)
  • Monoclonal antibodies and the challenge of substitution (GaBI)
  • Bridging the 'cultural gap in drug development' with Silicon-Valley technology (Outsourcing-Pharma)             

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

  • Astellas And Medivation Initiate Phase Iii Trial Of Enzalutamide In Patients With Triple-Negative Breast Cancer (Press)
  • Samsung Bioepis to Present Eight New Abstracts on Three Anti-TNF-α Biosimilar Molecules at the Annual European Congress on Rheumatology (EULAR 2016) (Press)
  • CellAct Pharma Phase 2 CAP7.1 Population Pharmacokinetic Data Supports Efficacy Results in Biliary Tract Cancers (Press)
  • SanBio Publishes Interim 12-Month Phase 1/2a Clinical Trial Results in the Peer-Reviewed Medical Journal, Stroke (Press)
  • San Antonio Researchers Plan Trials for Drug Combo to Treat Ebola (Xconomiy)
  • Eisai partners with Novartis in renal cell carcinoma collaboration (Pharmafile)
  • MiNA Therapeutics kicks off first-ever PhI saRNA nanoparticle trial (Fierce)
  • Bayer, Orion to start Phase III trials for prostate cancer drug (Pharmafile)

US: Medical Devices

  • Risks of X-rays for cancer diagnosis may be a mystery to most patients (Reuters)
  • FDA clears Esco Medical's Miri TL embryo incubator (MassDevice)
  • Medtronic recalls Midas Rex sagittal saws on leaky seals risk (MassDevice)
  • Zoo's Tasmanian Devil gets pacemaker (MassDevice)

US: Assorted & Government

  • FDA Recruiting Chief Information Security Officer (USAJOBS)
  • California drug transparency bill latest to advance (BioCentury)

Upcoming Meetings & Events


  • Northern Ireland lifts ban on gay men donating blood (OnMedica)
  • DoH: NHS patients benefit from cutting edge life science innovations (GOV.UK)
  • Intarcia, Numab log milestones for autoimmune drug-device combo (MassDevice)
  • NICE invites angry J&J to make a Cancer Drugs Fund case for Imbruvica (Fierce)
  • Shire completes Baxalta takeover (Pharmafile)
  • Occlutech wins CE Mark for LAA occlude (MassDevice)
  • Gore wins CE Mark for Excluder stent graft (MassDevice)



  • Natco Pharma's partner MylanInc gets USFDA nod for cancer drug (Economic Times)
  • Soon, AIIMS to launch 'adopt a patient' policy (Economic Times)
  • Sanofi India board elects Aditya Narayan as Chairman (Economic Times)
  • HC reserves verdict on pleas against ban on 344 FDCs (Economic Times)
  • Pharma companies to see moderation in growth in US market: Icra (Economic Times)


  • Australia Lab Company Rebuffs Bain and Advent (WSJ-$)
  • TGA presentations: National Medicines Symposium, 19-20 May 2016 (TGA)
  • Medicines Safety Update Volume 7 Number 3, June 2016 (TGA)

General Health & Other Interesting Articles

  • Prince Died From Accidental Overdose of Opioid Painkiller (NYTimes)
  • The Surging Cost of Basic Needs (The Atlantic)
  • My husband is dying. Caring for him is an emotional roller coaster. (Washington Post)
  • Zika Discoverer Tells Of 'Human Bait,' Draws Monkeys In Overlooked Archive (NPR)

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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