Regulatory Recon: FDA Approves Gilead's Epclusa for HCV Pfizer to Invest $350M in China Biotech Center (28 June 2016)

Posted 28 June 2016 | By Michael Mezher 

Regulatory Recon: FDA Approves Gilead's Epclusa for HCV Pfizer to Invest $350M in China Biotech Center (28 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

  • Pediatric Vouchers Could Limit Adult Rare Disease Development, FDA Says (Pink Sheet-$)
  • Biosimilar User Fees: FDA and Industry Reach Agreement (Focus)
  • FDA approves Epclusa for treatment of chronic Hepatitis C virus infection (FDA) (Press)
  • AstraZeneca Pushes to Protect Crestor From Generic Competition (NYTimes)
  • Researchers may have found second 'superbug' gene in US patient (Reuters)
  • An NYU Study Gone Wrong, and a Top Researcher Dismissed  (NYTimes)
  • Senate Democrats Say They'll Reject Zika Bill Over Provisions (NYTimes) (Reuters)
  • Biden holding cancer summit to pump up support for 'moonshot' effort (Washington Post)
  • The Alternative Medical Bill: $30.2 Billion (NYTimes)
  • Roche's new multiple sclerosis drug set for early FDA approval (Fierce) (Reuters) (Press)
  • Kite opens commercial CAR T-cell plant ahead of anticipated 2017 therapy launch (BioPharma-Reporter)  
  • How EnChroma's Glasses Correct Color-Blindness (MIT Technology Review)
  • California Drug Price Measure Fiercely Opposed By Pharmaceutical Industry (KHN)
  • FDA places Regulus' Hep C drug on clinical hold; shares dive (Reuters) (Fierce)
  • Medicines Co's antibiotic succeeds in late-stage trial (Reuters) (Press)

In Focus: International

  • Shire and Glaxo Offer Prescription to London's Woes (The Street)
  • What will Brexit mean for medical device companies? (Emergo)
  • How Brexit Might Impact The Pharma Supply Chain (RxTrace)
  • WHO appoints ex-UNICEF health expert to head new emergency unit (Reuters)
  • Regulatory System Changes in Russia: A Historical Review and Future Perspectives (DIA Journal)
  • Pfizer to invest $350 million in China biotech hub, first in Asia (Reuters) (Bloomberg) (Press)
  • Congo says aims to vaccinate 11.6 mln against yellow fever (Reuters)
  • MHRA Mulling Brexit Implications as UK's BSI Says it Will Remain an EU Notified Body (Focus)
  • Asia Regulatory Roundup: India Releases Lengthy Draft Legislation on Medical Devices; CFDA Proposes Review Process for High-Priority Devices (Focus) (Pharmabiz) (Emergo)
  • Swissmedic ramps up ad hoc inspections in 2015 (In-PharmaTechnologist)
  • Scotland's NHS needs a Sunshine Act to make pharma links transparent (The Guardian)

US: Pharmaceuticals & Biotechnology

  • Patentability Of Biotech Inventions Remains Uncertain As Supreme Court Declines Case (Pink Sheet-$)
  • Reporting Adverse Drug Reactions in Product Labels (DIA Journal)
  • Full Access To HCV Drugs Would Save Money Long-Term, Study Finds (Pink Sheet-$)
  • Cyborg Enzymes Make New Reactions Possible (Forbes)
  • Here's Why AWS Cloud Matters For Life Sciences (Geeks Talk Clinical)
  • Marijuana-Based Drug Helps Kids With Rare Forms Of Epilepsy In Studies (Forbes)
  • After Failed Schizophrenia Trial, Forum Pharma To Shutter This Week (Xconomy)
  • AbbVie scraps Infinity collab in wake of weak data, biotech slashes jobs (Fierce)

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

  • FDA Grants Priority Review for Genentech's OCREVUS (ocrelizumab) Biologics License Application (Press)
  • Priority Review for Advanced Accelerator's Lutathera (BioCentury)
  • Bayer's Regorafenib Significantly Improves Overall Survival in Patients with Unresectable Liver Cancer (Press)
  • MDCO's Carbavance meets in Phase III cUTI study (BioCentury)
  • GlycoMimetics Doses First Patient in Phase 2 Portion of Clinical Trial of GMI-1271 in Newly Diagnosed Acute Myeloid Leukemia (Press)
  • MOLOGEN AG: First patients enrolled in extension phase of the HIV study TEACH (Press)
  • BioLineRx Announces Regulatory Submissions for Phase 2a Trial of BL-8040 in Combination with KEYTRUDA (pembrolizumab) for Treatment of Pancreatic Cancer (Press)
  • Teva Announces FDA Acceptance of New Drug Applications for Fluticasone Propionate/Salmeterol and Fluticasone Propionate RespiClick Inhalers (Press)

US: Medical Devices

  • What's Behind Medtech's Recall Epidemic? Part 1: Device Design (MDDI)
  • Spectral Medical wins compassionate use exemption for Toramyxicin (MassDevice)
  • Heart-Device Study Raises Concern for Women and African-Americans (WSJ)
  • Nanowires Offer Real-Time Monitoring and Control of Heart Tissue (IEEE Spectrum)
  • High-Tech Tools Show Promise for Stroke Recovery (WSJ)
  • Six New Medical Technologies Worth Watching (WSJ)
  • QT Vascular Receives FDA 510(k) Clearance For Chocolate XD, A Novel PTCA Balloon (Press)
  • Accuray wins FDA nod for Radixact image-guided radiotherapy (MassDevice)
  • MGC Diagnostics Corporation Receives FDA 510(k) Clearance for Resmon PRO FULL, Forced Oscillation Technique (FOT) Device (Press)
  • Masimo Announces FDA 510(k) Clearance for Radius-7 with rainbow Technology, Including Continuous SpHb (Press)

US: Assorted & Government

  • Out-of-pocket hospital costs rose between 2009 and 2013 (Reuters)
  • In Limine Gag Orders – Can We Play, Too? (Drug and Device Law)
  • Supreme Court refuses to review prenatal test patent dispute (Press)
  • PTO Prevails in Challenge to Drug Eluting Stent PTE Denial, and Encounters Some Interesting Characters Along the Way … Including a Unicorn! (FDA Law Blog)

Upcoming Meetings & Events


  • AstraZeneca's new antibiotic Zavicefta approved in the EU (EPR)
  • 5 reasons the Brexit panic is overdone (MassDevice)
  • What Does Brexit Mean For The UK's NHS And Healthcare In Europe? (Forbes)
  • Merck KGaA, Pfizer help RNA modification biotech to £12M Series A (Fierce)
  • Novo Nordisk says its insulin pump secures EMA marketing authorisation (Pharmafile)
  • Roche says EMA accepts its marketing applications for Ocrevus to treat multiple sclerosis (Pharmafile)
  • Novartis signs $150 million deal with Xencor to develop bispecific antibodies (Pharmafile) (Reuters)
  • Navigating the complex biologics and biosimilars market (ABPI)
  • Guideline on user safety of topically administered veterinary medicinal products (EMA)
  • Stem cell -based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) (EMA)
  • European biotech boss on Brexit: we won't partner with UK labs (PharmaLetter-$)
  • EFPIA Picks Holes With EMA's Revised Guidance On Risk Management Plans (SCRIP-$)
  • Puma Biotech files for EU approval of neratinib in breast cancer (PharmaLetter-$)
  • CorMatrix CanGaroo ECM Envelope Receives CE Mark Approval (Press)    
  • BioVentrix wins CE Mark approval for Revivent TC heart failure device (MassDevice)


  • 'Now is the time to include Japan' says Parexel (Outsourcing-Pharma)
  • Zydus Cadila and Eczacibasi enter into a strategic collaboration to market biosimilars in Turkey (Biosimilar News)
  • Cytori Cell Therapy gains limited approval for osteoarthritis in Japan under new law (PharmaLetter-$)



  • TGA presentation: Medical Affairs Interest Area Meeting (Webinar), 10 June 2016 (TGA)
  • IBM announces Two New Partnerships with Melanoma Institute Australia and MoleMap to Advance Research in Melanoma Identification (IBM)
  • Shortage Anticipated: Etopophos (etoposide phosphate) powder for injection vials and Vepesid etoposide capsules (TGA)


  • HHS working with Emergent on Zika vaccine (BioCentury)

General Health & Other Interesting Articles

  • Why Knowing Your Genetic Data Can Be a Tricky Proposition (WSJ)
  • Even with good healthcare, social factors affect death risk (Reuters)
  • Personal Technology and the Autistic Child: What One Family Has Learned (WSJ)
  • How Technology Can Deliver Broad Improvements in Health Care (WSJ)

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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