Regulatory Recon: FDA Expands Use of Edwards Sapien Heart Valves NICE Rejects Bayer's Nexavar for Liver Cancer Over Cost Concerns (19 August 2016)

Posted 19 August 2016 | By Michael Mezher 

Regulatory Recon: FDA Expands Use of Edwards Sapien Heart Valves NICE Rejects Bayer's Nexavar for Liver Cancer Over Cost Concerns (19 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

  • FDA widens use of Edwards' devices for heart valve replacement (Reuters) (MassDevice) (FDA 1,  2, 3)
  • T. Rowe Price sues Valeant over 'fraudulent scheme' (Reuters) (Financial Times) (Bloomberg)
  • Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches (Focus)
  • Welcome Casebia, the $335M gene editing JV hatched by Bayer and CRISPR Therapeutics (Endpoints) (Press)
  • Lost in Translation: The Death of Basic Science (ACS Chemical)
  • The vaccine crisis we're facing isn't the one that you think (Medpage)
  • Volunteers sought as race to develop a Zika vaccine heats up (Modern Healthcare)
  • J&J is to appeal Remicade patent ruling in US (PM Live)
  • FDA Reiterates Concerns on Citizen Petitions Delaying Drug Approvals (Focus)
  • FDA issues safety alert for popular hair care product over hair loss complaints (CBS)
  • Following another PhII failure, cash-strapped Cerulean chops half its staff (Endpoints) (Fierce)
  • Immune System and Spirit Kept Cancer at Bay for a Year (NYTimes)
  • USP: Senate Language Could Disrupt Public Process For Biologic Naming (InsideHealthPolicy)
  • Hacking life: Scientists 'recode' DNA in step toward lab-made organisms (STAT)
  • Amgen and Sanofi hit back on PCSK9 price criticisms (PharmaLetter-$)
  • With Two Pending DMD Products, FDA Faces Community Anxiety (Pink Sheet-$)
  • The UDI Rule: Are Private Label Distributors to be Considered Labelers? (FDA Law Blog)
  • T. Rowe Price sues Valeant over 'fraudulent scheme' (Reuters) (Financial Times) (Bloomberg)
  • HeartWare recalls some HVAD implantable heart pumps on electrical fault risk (MassDevice)
  • The Potential Zika Threat to Adult Brain Cells (The Atlantic) (WSJ-$)
  • Antipsychotics During Pregnancy Not Tied to Birth Defects (NYTimes)
  • New Brain-Mapping Technique Captures Every Connection Between Neurons (MIT Technology Review)

In Focus: International

  • European Regulatory Roundup: Clinical Trial Delays Prompt EMA to Consider Revising Guidance (Focus)
  • NICE rejects Bayer's Nexavar for liver cancer (BioCentury) (PharmaTimes) (Pharmafile)
  • British Ebola nurse 'concealed temperature' on return from Sierra Leone: media (Reuters)
  • Brexit: Government Statement on EU Nationals in UK (National Law Review)
  • Poor Sanitation Persisted at U.N. Missions Long After Haiti Cholera Crisis (NYTimes) (NPR)
  • EMA's PRIME Scheme: Why Nearly Four Out Of Five Fail To Make The Grade (Pink Sheet-$)
  • Genotyping market projected to reach $37.1 bn by 2024 (BioSpectrum)
  • What Would It Take To Attract Global Pharmas To Korea? (SCRIP-$)
  • Sun Faces Price Pressures In US On Generic Gleevec (SCRIP-$)
  • Toshiba Medical Systems enters the race for Takeda's chemicals subsidiary (MassDevice)
  • NPPA sets ceiling price of 123 drugs in July (Economic Times)
  • Roche takes Zydus Cadila to court over breast cancer drug (Economic Times)

US: Pharmaceuticals & Biotechnology

  • Reflections on Mergers and Acquisitions in the Healthcare Product Industry (Focus)
  • Caribou claims CRISPR-Cas9 advance on DNA repair (Fierce) (Press) (Paper)
  • Fresenius Kabi set for tax breaks after commiting to invest $250m in US plant (InPharmaTechnologist)
  • Intellia Therapeutics' Preclinical Data Show Continued Progress in In Vivo Gene Editing With Systemic Lipid Nanoparticle Delivery of CRISPR/Cas9 components (Press)
  • Medicines in Development for Vaccines (PhRMA)
  • Nosing around for new antibiotics (Nature)
  • Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack (FDA)
  • Ex-Insys salespeople plead not guilty in Subsys kickbacks scheme (Fierce)
  • 'Nothing Nefarious' About Alleged Kickbacks, Supplier Says (Law360-$)
  • Life Sciences Community Joins Rep. Charlie Dent to Discuss State of the Industry and Positive Impact on Pennsylvania (Bio)
  • Allergan chief's $140M-plus golden parachute tops pharma--and most other industries, too (Fierce)
  • Patent Term Extension Not A 1-Trick Pony For Animal Drugs (Law360-$)
  • CDC Reports Historic Low In U.S. Fertility Rates; New FDA Cleared & At-Home Alternative From Conceivex Now Available To Help Millions Who Want To Start A Family (Press)
  • Crucial patent ruling on Copaxone and PDUFA for Parsabiv (EPVantage)
  • Washington Must Pay For State Employees' Hep C Treatment (Law360-$)
  • FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission (Focus)
  • Shares fall after trial fail for Juniper Pharmaceuticals (Boston Biz Jouurnal)

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

  • Nordic Nanovector wraps up enrollment in pre-dosed arms of NHL trial (Fierce)
  • ARCA biopharma Announces 100th Patient Randomized into the GENETIC-AF Phase 2B/3 Clinical Trial (Press)
  • AMERIGEN announces final approval from FDA for generic version of Temodar® (Press)

US: Medical Devices

  • What's Next for Transcatheter Heart Valve Delivery Systems? (MDDI)
  • FDA Corrects Timeline for Acting on Medical Device Guidnaces (FDA)
  • 4 Tips for a Smooth 510(k) Submission Process (MDDI)
  • The Difference Between IT Cybersecurity and Product Cybersecurity (MDDI)
  • Spectral Medical eyes final PMA bid by year-end for Toraymyxin anti-sepsis device (MassDevice)
  • Sloppy Spinal Stimulation Studies Scrutinized (IEEE Spectrum)
  • After 60 years in Utah, Becton Dickinson to put $20m into Sandy facility (MassDevice)

US: Assorted & Government                                                                                  

  • U.S. Opens Probe Into Concerns Over Health-Provider Payments (WSJ-$)
  • Pfizer Ducks Lipitor Fraud Claims Suit Again In 2nd Circ. (Law360-$)
  • Bayer, Global Product VP Hit With Gender Bias Suit In NJ (Law360-$)
  • Obamacare Hits a Bump (NYTimes)
  • Think Your Obamacare Plan Will Be Like Employer Coverage? Think Again (NYTimes)
  • Hillary Clinton Pushed From Left and Right on Health Care (WSJ-$)
  • Guest Post – Through the Dictionary, and What One Court Found There: Adventures in the BAAA (Drug and Device Law)
  • The King of 'Political Intelligence' Faces a Reckoning (WSJ-$)
  • Hospitals, practices differ in cybersecurity preparedness (Fierce)
  • Ex-Novartis Worker's Suit Tossed For Deceiving NJ Court (Law360-$)

Upcoming Meetings & Events


  • Vela Dx Zika Assay Receives CE Mark (GenomeWeb)
  • Pharmacovigilance of biologicals in Denmark (GaBI)
  • Europe Clears FA100 SCCD Sequential Contraction Compression Device (medGadget)
  • Spaces filling fast for MHRA's GCPGLP Symposium (MHRA)
  • Masimo Announces CE Marking for RAS-45 Sensor for rainbow Acoustic Monitoring® of Respiration Rate (Press)


  • Chinese FDA Grants MammaTyper Innovative Product Status for Expedited Approval (Press)


  • Medical device industry distraught over health ministry's lackadaisical attitude to issue FSC to exporters (PharmaBiz)


  • Notification of a change in sponsorship (TGA)
  • Breakthrough in cancer cell screening advances personalised treatment of childhood leukaemia (MNT)


  • Rare Zika Complication Hits 30 in Puerto Rico; CDC Expects More (NBC)
  • The Zika Funding Fight Isn't Over Planned Parenthood (Forbes)
  • Locally transmitted Zika virus identified in Miami Beach: source (Reuters)

General Health & Other Interesting Articles

  • Anemia tied to worse survival odds after stroke (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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