Regulatory Focus™ > News Articles > Regulatory Recon: FDA Panel Narrowly Supports Removing Chantix Boxed Warning; FDA Approves New Heart

Regulatory Recon: FDA Panel Narrowly Supports Removing Chantix Boxed Warning FDA Approves New Heart Drug Yosprala (15 September 2016)

Posted 15 September 2016 | By Michael Mezher 

Regulatory Recon: FDA Panel Narrowly Supports Removing Chantix Boxed Warning FDA Approves New Heart Drug Yosprala (15 September 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 and Access to Medications (FDA Voice)
  • Parents may misuse results of infant genetic testing (Reuters)
  • Rob Califf May Be the Most Qualified Commissioner in FDA's History (Forbes)
  • Aralez finally gets an FDA OK for its cardio drug Yosprala, starts hiring sales reps (Endpoints) (Press)
  • Pfizer Moves Closer to FDA Removing Suicide Warning From Smoking Cessation Pill Chantix (WSJ) (Reuters) (Press) (Tarius)
  • Pharma and Academia: What We Have Here Is a Failure to Communicate (Cell Metabolism) (In the Pipeline)
  • New House, Senate Bills Would Require Companies to Justify Drug Price Hikes of More Than 10% (Focus)
  • Bayer's Monsanto acquisition to face politically charged scrutiny (Reuters)
  • Prostate Cancer Study Details Value of Treatments (NYTimes) (Washington Post)
  • Price Increases To Help Drug Hit $15 Billion In Sales (Forbes)
  • After Setbacks, a Pioneering Stem-Cell Technology Is Back in Human Trials (MIT Technology Review)
  • FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date (Focus)
  • Spectrum bladder cancer drug not effective: U.S. FDA panel (Reuters) (Fierce) (Tarius)
  • Apotex Biosimilar Cleared Of Infringement But Pre-Marketing Notice Still Required (National Law Review)
  • CIMZIA Does Not Infringe Yeda's Monoclonal Antibody Patent (Biologics Blog)
  • Company Stops Sales Of Ovarian Cancer Screening Test After FDA Warns Women Not To Use It (Forbes)
  • FDA Panels To Mull Opioid Painkillers In Children (Law360-$) (Medpage) (Tarius)
  • What Trump And Clinton Need To Know (And Do) About Healthcare: Part 1 (Forbes)
  • Novartis says 'never say never' to Alcon disposal (Reuters)

In Focus: International

  • Europe proposes copyright reform to help scientists mine research papers (Nature) (European Commission)
  • European Parliament Report on Improving Access to Medicines (Report)
  • Long-Awaited UN Report Calls for Breaking Link Between Drug R&D Costs and Prices (Focus)
  • Biopharmas bite back at UN's scathing life science R&D report (Fierce) (EFPIA)
  • GSK shingles vaccine remains effective after four years: study (Reuters)
  • Teva, Intel to develop wearables to monitor Huntington's disease (Reuters)
  • Invest more to defeat killer diseases, Kenyan president tells African nations (Reuters)
  • Eisai's Kisplyx approved in EU for kidney cancer (PharmaTimes) (Press)
  • Addressing challenges of innovative cancer immunotherapy medicines (EMA)
  • Changes to Australian regs will improve access to new medicines (PharmaLetter-$)
  • Roche to topple Novartis as industry's biggest seller (EP Vantage)
  • Scottish nurse who had Ebola cleared of hiding symptom(Reuters) (NYTimes)
  • Emergency contraceptive affected by other medicines - regulator issues new guidance (MHRA)
  • Fresh Challenge To EMA's Access To Documents Policy Raises Hopes For Clarity (Pink Sheet-$)

US: Pharmaceuticals & Biotechnology

  • Withers Guides Creation Of Trans-Atlantic Stem Cell Venture (Law360-$)
  • Rigel Pharmaceuticals Eliminates 46 Jobs, 38% of Workforce (GEN)
  • Biologic and Clinical Perspectives on Thyroid Cancer (NEJM)
  • Helping Patients Make the Right Decisions (NYTimes)
  • FDA Offers New Guidance on Qualified Biomarker for COPD Trials (Focus)
  • Vertex exec says CF sales weaker than expected (BioCentury)
  • Lice no longer stopped by common drugstore remedies (Reuters)
  • Parents of children with cancer sometimes regret decisions (Reuters)
  • FDA delays PDUFA date for Lexicon's telotristat etiprate (PharmaLetter-$)
  • Switch to public insurance tied to shorter survival after heart transplant (Reuters)
  • J&J: 'We can't stop Pfizer launching Remicade biosimilar in the US' (BioPharmaReporter)
  • Richard Gaynor retires from Lilly Oncology; Dana-Farber's Garraway steps up (Fierce) (Press)
  • Recall: CHF Pill Discovered in ADHD Drug Bottle (MPR)
  • Virtus Pharmaceuticals Opco II, LLC Issues Voluntary Nationwide Recall of Hyoscyamine sulfate Due to Superpotent and Subpotent Results (FDA)

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

  • AcelRx's opioid painkiller succeeds in key study (Reuters)
  • FDA approves Shire's Cuvitru (BioCentury)
  • Aerie's ophthalmic combo passes first Phase III test (BioCentury) (Reuters) (Press)
  • Merck and Pfizer Announce Investigational Ertugliflozin Met Primary Endpoint of A1C Reduction When Added to Sitagliptin and Metformin in People with Type 2 Diabetes (Press)
  • Zymeworks Doses First Patient in Phase 1 Trial of ZW25, a Novel Bi-Specific Antibody for the Treatment of HER2-Expressing Cancers (Press)
  • FDA Advisory Committee Votes that Qapzola™ (apaziquone) Has Not Shown Substantial Evidence of a Treatment Effect Over Placebo (Press)
  • New Data Presented at ECTRIMS Reinforce Efficacy of ZINBRYTA™ (Daclizumab) and Support Long-Term Safety Profile (Press)
  • FDA Grants QIDP Designation to VT-1598 for Treatment of Valley Fever (Press)

US: Medical Devices

  • The IoT Is Coming To Healthcare (Forbes)
  • FDA approves Carl Zeiss Meditec's VisuMax femtosecond laser (MassDevice)   
  • FDA Adjusts 510(k) Third Party Review Program Ahead of MDSAP (Emergo)
  • Here Are the Device Sectors That Pay the Most—and the Least (MDDI)
  • The Journal of the American Medical Association Publishes Medtronic's Hybrid Closed Loop System Pivotal Trial Results (Press)
  • Varian Medical Systems Receives FDA 510(k) Clearance For Nexus DR Digital X-Ray Imaging System (Press)

US: Assorted & Government

  • Is it time for public option? Senate Dems lead new push today (Politico)
  • More Employees Getting Full-Time Work Thanks To Obamacare (Forbes)
  • Guest Post – With No General Causation Experts, Denture Cream Plaintiffs Drop Like Leaves In Autumn (Drug and Device Law)
  • Has the Ninth Circuit Criminalized Malpractice, Adulteration, and Off-Label Use? (Drug and Device Law)
  • Massachusetts District Court Guts Discount Safe Harbor (FDA Law Blog)
  • Average Cost of Employer Health Coverage Tops $18,000 for Family in 2016 (WSJ)
  • California Moves to Allow Undocumented Immigrants to Buy Insurance (NYTimes)

Upcoming Meetings & Events


  • ABPI praises UK's £816 million investment into biomedical research (PharmaLetter-$)
  • Exelixis gets milestone on Cabometyx's EU approval (BioCentury)
  • Applications to NICE's prestigious Fellows and Scholars Programme are open. (NICE)
  • Pharma Industry apprenticeships double in 2015 (ABPI)
  • Cocir Strategic Research Agenda: Fully Aligned With EU 2020 Priorities (COCIR)
  • State of the Union: Open Letter from EFPIA and EPHA on AMR (EFPIA)
  • France to lift bird flu restriction zone on Thursday (Reuters)


  • US nod for ChemChina-Syngenta deal (BioSpectrum)
  • Japan Issues Strong Warning Over Brexit (SCRIP-$)



  • Medicines and medical devices regulation review (TGA)


  • Florida Gets Help to Deal With Backlog of Zika Tests (NYTimes)
  • What Doctors Learned From 42 Infants With Microcephaly (NPR)
  • Miami Beach Protesters Shout Down Zika Meeting Over Pesticide Use (NBC)

Other International

  • Teva's trying to weasel out of its Mexican generics deal, new Rimsa lawsuit says (Fierce)

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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