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Regulatory Recon: FDA Approves Abbott Absorbable Heart Stent Sanofi Teams Up With US Army to Develop Zika Vaccine (6 July 2016)

Posted 06 July 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Abbott Absorbable Heart Stent Sanofi Teams Up With US Army to Develop Zika Vaccine (6 July 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

  • FDA Approves Abbott's Absorbable Heart Stent (WSJ-$) (Reuters) (FDA) (Press)
  • Obama's Top Scientist Talks Shrinking Budgets, Donald Trump, and His Biggest Regret (Nature)
  • Medivation Opens Door to Takeover Talks With Sanofi (WSJ-$) (Fierce) (Financial Times)
  • Biosimilar 'Patent Dance': Federal Circuit Rules 180-Day Notice is Mandatory (Focus) (Law360-$) (STAT)
  • Pfizer agrees to truth in opioid marketing (Washington Post)         
  • Life After The Street: Why Biotech Is Winning Over Wall Street Talent (LifeSciVC)
  • No Scientific Method, They Say (In the Pipeline)
  • DeepMind's First Medical Research Gig Will Use AI to Diagnose Eye Disease (MIT Technology Review)
  • Sexual desire: Risky drugs with minimal benefit being used to treat dubious conditions (Journal Sentinel)
  • In clinical trials, for-profit review boards are taking over for hospitals. Should they? (STAT)
  • Merck Invests in RNA Startup to Target Cancer (MIT Technology Review)
  • Pfizer Might Buy Bind Therapeutics From Bankruptcy for $20M (Xconomy)
  • FDA Warns Zimmer Over Quality System Issues at Montreal Plant (Focus) (MassDevice)
  • Sarepta Stock Price Lifted by 'No Bad News Is Good News' Argument (The Street)
  • Lion the first beneficiary of NCI's trial resumption (EP Vantage)
  • FDA Approves Insys Therapeutics' 2nd Cannabis-Based Drug (Forbes) (Fierce)
  • A New "Greater Safety" Orphan Drug Clinical Superiority Precedent: PURIXAN (FDA Law Blog)
  • Sanofi Teams Up With U.S. Army on Zika Vaccine (WSJ-$) (Reuters)

In Focus: International

  • AstraZeneca, STEMI India collaborate (Economic Times)
  • UK's MHRA Introduces Re-Manufacturing of Single-Use Devices (Focus)
  • The morality and ethics governing CRISPR–Cas9 patents in China (Nature)
  • Valeant's New CEO Brings Familiar Prescription (WSJ-$)
  • EMA goes electronic for PDCO opinions and subsequent EMA decisions (EMA)
  • Some Malaysians' rejection of vaccines fans fears of disease surge (Reuters)
  • Russian drugmakers to increase investments in clinical trials (PharmaLetter-$)
  • WHO urges use of polio detection systems to screen for Zika-linked disorder (Reuters)
  • EU clears Bial's new Parkinson's drug (PharmaTimes)
  • Will Turkey's Strong Biotech Development Steps Be Effective? (PharmAsiaNews-$)

US: Pharmaceuticals & Biotechnology

  • Tropical or Rare Pediatric Disease Priority Review Vouchers: Update and Use the 505(b)(2) Pathway (The 505(b)(2) Blog)
  • Industry/Regulator Dialogue on Knowledge Management is Intensifying in Wake of ICH's Q12 Initiative (IPQ)
  • Shortage of stress-test dye leads to more invasive heart procedures (Reuters)
  • Medication Assisted Treatment for Opioid Use Disorders, Reporting Requirements, Education and Training  (HHS 1, 2, 3)
  • MIT-based startup nabs $30M for first 3-D printed drug approved by FDA (Fierce)
  • Evotec Enters Licence Agreement for Access to CRISPR-CAS9 Gene Editing Technology (Press)
  • Getting Inside the Accounting at Gilead, Sirius and Netflix (The Street)
  • Venture-Backed Biotechnology Companies Continue to Lead Charge to Public Markets as Tech Companies Remain on Sidelines (National Venture Capital Association)
  • Clinical Trial Recruitment Planning: FDA and Others Provide Tips and Tools (GxPLifeline)
  • Two component 'bio-ink' could help advance 3D printing of tissues (BioPharmaReporter)
  • Shelf life issue halts trial of Scancell's cancer vaccine SCIB1 (InPharmaTechnologist)
  • Sky's The Limit On Savings For New NIH-Funded Innovative Trials Center (Pink Sheet-$)

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

  • NIH launches largest-ever study of breast cancer genetics in black women (NIH)
  • Merck KGaA, Darmstadt, Germany, and Pfizer Initiate Phase III Trial to Evaluate Avelumab as First-line Treatment for Ovarian Cancer (Press)
  • Sanofi Genzyme Begins Pivotal Phase 2/3 Trial of Olipudase Alfa for Adult Patients with Acid Sphingomyelinase Deficiency (Press)
  • Varithena Earns FDA Approval for 30 Day Post-Activation Shelf Life (Press)
  • Teva and the Huntington Study Group Announce Publication of Pivotal Phase III Data on Deutetrabenazine (SD-809) in Huntington Disease from First-HD Trial in JAMA (Press)
  • XBiotech sinks on Phase III colorectal data (BioCentury)
  • PREVAIL IV – a trial to investigate if GS-5734 eliminates Ebola virus from semen (EPR)
  • FDA accepts Cempra NDAs (BioCentury)
  • Initiation of Phase 1 Clinical Study with Novel Immuno-Oncology Candidate Triggers US$10 Million Milestone Payment from AstraZeneca to Heptares (Press)

US: Medical Devices

  • Class 1 Device Recall Hummi Micro Draw Blood Transfer Device (FDA)
  • Syncardia files for Chapter 11 bankruptcy (MassDevice)
  • J&J's Ethicon wins FDA nod for Harmonic HD 1000i surgical shears (MassDevice)
  • Luminex Receives FDA Clearance, CE-IVD Mark for Aries M1 System (GenomeWeb) (Press)
  • Medtronic warns on wire fracture risk with Activa DBS devices (MassDevice)
  • Image Navigator automated microscope receives FDA 510(k) clearance (Press)
  • Prism Medical & Design Earns FDA Clearance for Its ProteXsure Safety Capsule System- Looks to Add International Distributors (Press)
  • Cartiva wins PMA for big toe synthetic cartilage implant (MassDevice)
  • EndoGastric Solutions touts U.S. reimbursement win (MassDevice)

US: Assorted & Government

  • CMS' Open Payments Program Posts 2015 Financial Data (CMS)
  • Why is Federal Question Jurisdiction Such a Mess? (Drug and Device Law)
  • Wyden Concerned by National Academy Committee Ties to Opioid Manufacturers (Senate)
  • FTC Says AbbVie Must Produce Board Docs In AndroGel Fight (Law360-$)
  • HHS establishes two metrics to evaluate 'widespread interoperability' under MACRA (Fierce)
  • Drug Price Control Proposals Pared Down In Democrats' Draft Platform (Pink Sheet-$)
  • VA Health-System Overhaul Urged by Commission (WSJ-$)

Upcoming Meetings & Events


  • Burt to step down as health minister (Pharmaceutical Journal-$)
  • EC expands Kyprolis label (BioCentury)
  • MDR Analysis: Does your medical device fall under the scope of new European regulations? (MassDevice)
  • EC grants marketing authorisation for Zinbryta in multiple sclerosis (EPR)


  • Tigenix the latest to find stem cell appetite in Japan (EP Vantage)
  • South Korea's biotech scene grows up with new venture capital launch (STAT)
  • The 21st AHWP Annual Meeting will be held in Cebu, Philippines, November 2016 (AHWP)
  • Taisho Pharma completes buy of 24.5% stake in Duoc Hau Giang Pharma (PharmaLetter-$)
  • Fast And Furious: Lessons From China FDA's Innovation Push (SCRIP-$)
  • Chinese Pharma Firm Raises $150M From Private Investors (Law360-$)



  • TGA: James Leckey Design Mygo Stander (TGA)


  • Notice: eCTD Pilot for Clinical Trial Regulatory Activities (Health Canada)
  • Guidance Document Harmonized Requirements for the Licensing of Vaccines and Guidelines for the Preparation of an Application (Health Canada)

Other International

  • Merck Animal Health Expands in Brazil in Quest to Overtake Zoetis as World Animal Health Leader (The Street)

General Health & Other Interesting Articles

  • More Americans living with congenital heart defects (Reuters)
  • Apple urges organ donation via new iPhone software (STAT)

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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