Regulatory Recon: Heron's Chemotherapy-Induced Nausea Drug Approved by FDA Update to FDA Quality Metrics Guidance Expected This Year (10 August 2016)

Posted 10 August 2016 | By Michael Mezher 

Regulatory Recon: Heron's Chemotherapy-Induced Nausea Drug Approved by FDA Update to FDA Quality Metrics Guidance Expected This Year (10 August 2016)

Welcome to Regulatory Reconnaissance, your adaily 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 To Update Quality Metrics Guidance (Pink Sheet-$)
  • FDA approves Heron's therapy for chemotherapy-induced nausea (Reuters) (Press)
  • Lilly cancer drug hits hurdle, panel recommends study continue (Reuters)
  •  Accepts NDA for Marathon Pharmaceuticals' DMD Drug, Grants Priority Review (Press)
  • Califf: Advances in Cardiology Will be Made by Integrating New Data Sources and Technologies (Focus)
  • Texas infant's death linked to travel-related Zika infection (Reuters)
  • Clinton urges Congress to reconvene, pass Zika bill (Reuters)
  • Florida says four new locally transmitted Zika cases, Congress must act on funds (Reuters)
  • In the dark of night, a hunt for a deadly bug in the name of science (STAT)
  • Industry Comments on FDA's Draft Data Integrity Guidance Reveal Regulatory Challenges (IPQ)
  • FDA's Pursuit Of A National Medical Device Evaluation System (Law360-$)
  • Shortage of estrogen drugs in US worries trans women: 'It's my peace of mind' (The Guardian)
  • Workers At Big Companies Won't See Obamacare Sticker Shock (Forbes) (KHN)
  • Eight Individuals Charged in Multimillion-Dollar Compounding Pharmacy Fraud Scheme (DoJ)
  • Biogen dubs publicly traded hemophilia spinoff Bioverativ, aims for early 2017 (Fierce)
  • Myriad Genetics Shares Fall Amid Dour Outlook (WSJ-$)
  • Coherus submits BLA for Neulasta biosimilar (BioCentury)
  • Policy Changes Needed to Prevent Disparities in Genetically Based Medicine (GenomeWeb)

In Focus: International

  • Thousands of women took Sanofi epilepsy drug despite risk to fetuses: media (Reuters)
  • FDA, Health Canada Look to Implement Common Electronic Submission System (Focus)
  • CDSCO, PvPI to come out with guidelines on good pharmacovigilance practices for Indian cos (Pharmabiz)
  • Australia Outlines Major Drug Label Changes (Focus)
  • Bayer recalls Kogenate lots in Spain after out of spec stability results (BioPharmaReporter)
  • Pfizer Sees Bright Long Term Biosimilar Future In China (SCRIP-$)
  • NICE rebuffs Adcetris for Hodgkin's lymphoma (BioCentury)
  • Medical devices regulator issues alert on faulty glucose test strips (MHRA)
  • Mylan Backs Year View After Sales Rise 8% (WSJ-$) (Bloomberg)
  • Oncology Dominates Japan Approvals, Though Overall Tally Is Lower (Pink Sheet-$)
  • The Opioid Epidemic Hits The European Union (Forbes)
  • Will Turkey Ever Regulate Its OTC Market? (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Valeant's Dermatology Sales Strategy: Teenage Zits (SCRIP-$)
  • Results of the majority of breast cancer trials remain hidden (AllTrials)
  • ISO Gives Pharmaceutical Industry New Management Tool to Improve Patient Safety (GxP Lifeline)
  • Young Inventors Work On Secret Proteins To Thwart Antibiotic-Resistant Bacteria (NPR)
  • Quality Manufacturing Key to Stemming Drug Shortages (PharmTech)
  • Claris Said to Start Sale of $500 Million U.S. Injectables Unit (Bloomberg)
  • USPSTF Punts on Universal Screening for Lipid Disorders in Kids (MedPageToday)
  • Going for emotion: Pharma takes a page from consumer marketers for Olympic ads (Fierce)
  • Teva recalls injectable antibiotic in US over contamination concerns (InPharmaTechnologist)
  • IBM Watson, in minutes, solves patient care problem that stumped doctors for months (Fierce)
  • Shares of Endo International surge after Q2 results beat estimates, expands management (CNBC)
  • FDA Approves Updated ONJ Warning for Prolia, Xgeva (MPR)
  • Researchers find new info on ovarian cancer drug resistance (PharmaTimes)
  • Investors Sue AbbVie Over Abandoned Shire Buyout (Pharmaceutical Manufacturing)

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

  • Sage's Phase III epilepsy readout delayed (BioCentury)
  • AstraZeneca Announces Positive Top-Line Data from Two Phase III SYMBICORT Studies (Press)
  • Lilly Provides Update on MONARCH 2 Phase 3 Trial of Abemaciclib (Press)
  • Moberg Pharma announces approvals to start Phase 3 study for MOB-015 in U.S. and Canada (Press)
  • CORRECTING and REPLACING vTv Therapeutics Announces Positive Topline Results from Phase 2b Study of Glucokinase Activator TTP399 in Type 2 Diabetes (Press)
  • Kitov Announces Issuance of U.S. Patent Securing Long-Term Exclusivity for KIT-302 Ahead of New Drug Application to the FDA (Press)

US: Medical Devices

  • FDA plans advisory panel meeting on antimicrobial dressings (MassDevice)
  • Share Trial Data? JNJ Says Yes, Others Hesitate (MDDI)
  • Nevro losses shrink, sales explode in Q2 (MassDevice)
  • Postmarket Surveillance Under Section 522 (imarc)
  • AncestryDNA sees huge growth in demand for genetic testing (MedCityNews)
  • ConforMIS Q2 beats the street, raises guidance (MassDevice)
  • Synapse Biomedical wins VA nod for NeuRx diaphragm pacing system (MassDevice)
  • ArcherDx NGS Assays Receive Conditional Approval From NY State Department of Health (GenomeWeb)

US: Assorted & Governmentw

Upcoming Meetings & Events


  • Pharming acquires rights for its own drug Ruconest from Valeant (PharmaLetter-$)            
  • Takeda slams NICE rejection of Adcetris (PharmaTimes)
  • Accuray wins CE Mark for Radixact platform (MassDevice)
  • Marketing authorisation granted in July 2016 (MHRA)
  • Parallel import licenses granted in July 2016 (MHRA)


  • BMS pays Singapore's ASLAN $10M and reacquires gastric cancer candidate rights (Fierce)
  • Magellan Diagnostics Receives CFDA Clearance for LeadCare II in China (Press)


  • Cochlear shares dip despite huge gains in profit for FY2016 (MassDevice)


  • Does This Under-the-Radar Company Hold the Key to a Zika Vaccine? (The Street)
  • While NIH Argues with Congress for Zika Funding, FDA Gives Green-Light to Investigational Release of Genetically Engineered Mosquitos (FDA Law Blog

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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