Regulatory Recon: States Allege Indivior Tried to Block Generic Competition for Suboxone Novartis' Zykadia Successful in Lung Cancer Phase III (23 September 2016)

Posted 23 September 2016 | By Michael Mezher 

Regulatory Recon: States Allege Indivior Tried to Block Generic Competition for Suboxone Novartis' Zykadia Successful in Lung Cancer Phase III (23 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

  • Saluting Biotech M&A: Onward And Upward (LifeSciVC)
  • Billion Dollar Lab Scam: The Beat Goes On (MedPage)
  • U.S. states sue opioid-maker Indivior, alleging anticompetitive practices (Reuters)
  • UnitedHealth excludes Lantus, Neupogen from 2017 drug list (BioCentury)
  • UPS launches US drone test flights for urgent medical deliveries (Reuters)
  • Just How Worthless Are the Standard Alzheimer's Models? (In the Pipeline)
  • Does Axovant Have Any Hope in Alzheimer's? (In the Pipeline)
  • Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls (Focus)
  • Supplements, FDA Regulation And Social Media (Forbes)
  • FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance (Focus)
  • FDA Finalizes Guidance on Generic Drug Facility Self-Identification (Focus)
  • Parent bloggers question role in Mylan's EpiPen schools push (Reuters)
  • SRSLY: All In The [EpiPen] Family (ProPublica)
  • Finally … Rachel Sherman Takes Califf's Old FDA Job (Pink Sheet-$)
  • Newron re-submits Xadago NDA (BioCentury)
  • New Atherosclerosis Study Results Bode Well For PCSK-9 Cholesterol-Lowering Drugs (Forbes)
  • High-Containment Laboratories: Actions Needed to Mitigate Risk of Potential Exposure and Release of Dangerous Pathogens (GAO)
  • Freeze-Dried Molecules Can Be Used to Whip Up Medicines Anywhere (MIT Technology Review)
  • Breast cancer's spread may be influenced by circadian gene (Reuters)
  • Breakthrough Gene Technology Attracts Investors Amid Patent Dispute (WSJ)
  • Moments of Giants Glory: What Alzheimer's Couldn't Steal (NYTimes)

In Focus: International

  • Novartis's Zykadia gets positive results, faces Roche pressure (Reuters) (PMLive)
  • Ireland in official bid to host EMA (PharmaLetter-$)
  • GSK's Emma Walmsley set for test as UK's top businesswoman (Financial Times)
  • European Union-India joint drug inspection may take off (Economic Times)
  • AstraZeneca pulls application for ovarian cancer drug (PharmaTimes)
  • Novo Nordisk to provide discounted insulin to poorest nations (Pharmafile)
  • EU approves Allergan's IBS drug (PharmaTimes)
  • Sun Pharmaceuticals among bidders for Bayer's dermatology brands (Economic Times)
  • Election process for the new WHO Director-General (WHO)
  • PharmaMar submits Aplidin MAA (BioCentury)
  • India's Aurobindo Pharma to Launch HIV Drug in Africa (Pharmaceutical Manufacturing)

US: Pharmaceuticals & Biotechnology

  • UniQure CEO quits after 9 months in the job (Fierce) (BioCentury)
  • Priority review vouchers revisited (EPVantage)
  • Genentech, BioNTech Pact Aims To Make Targeted Cancer Vaccines (SCRIP-$)
  • Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance (FDA)
  • The riskiest drugs to develop? Diabetes treatments, says Tufts report (Outsourcing Pharma)
  • Biotech School: How to Spot Hidden Danger Signs in Clinical Trial Data (The Street)
  • Breakthrough Therapy Status, AdComms and Approvals (EyeOnFDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; BELVIQ (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; FYCOMPA (FDA)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; MYALEPT (FDA)

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

  • GSK announces US regulatory submission for sirukumab in rheumatoid arthritis (GSK)
  • Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis (Press)
  • Enanta Pharmaceuticals Announces Data on Eight-Week Treatment of AbbVie's VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) in Patients with Genotype 1b Chronic Hepatitis C (Press)

US: Medical Devices

  • Global Kinetics secures FDA clearance to market upgraded wearable for Parkinson's disease patients (MedCityNews)
  • LivaNova launches next-gen ICD, CRT-Ds in US (MassDevice)
  • Aer-O-Scope Colonoscope Now with Working Channels FDA Cleared (Medgadget)
  • Report: Big data, AI hold "greatest promise" for healthcare tech (MassDevice)
  • Bionic Arms Get A Thought-Control Upgrade (IEEESpectrum)
  • NeuroMetrix launches Quell fybromyalgia pilot study (MassDevice)
  • Draper Labs plans human study of neural implants (MassDevice)
  • Global Kinetics wins FDA nod for 2nd-gen wearable kinetigraph (MassDevice)
  • BD invests $100m in Nebraska manufacturing plant expansion (MassDevice)

US: Assorted & Government

  • Remember The 'Public Option'? Insurance Commissioner Wants To Try It In California (KHN)
  • Yeda Research and Development Co. v. Abbott GmbH & Co. (Fed. Cir. 2016) (Patent Docs)
  • Here Comes the Next Bellwether Trial in the Pinnacle Hip Implant MDL (Drug and Device Law)
  • Johnson seeking Senate vote on federal right-to-try bill (BioCentury)
  • Big Pharma urges acquittal for ex-Acclarent execs (MassDevice)
  • Teva, Apotex, Mylan Sued Over 'Extreme' Statin Prices (Law360-$)
  • The Federal Government Should Consider Medical Marijuana a Potential Ally in the Fight Against Opioid Addiction (Harvard Bill of Health)

Upcoming Meetings & Events


  • Different approaches to bioequivalence trials for EMA evaluation (GaBI)
  • Cook Medical launches Zilver PTX thumbwheel in France (MassDevice)


  • Pharma companies benefits, infrastructure cos lose out due to new accounting standards: PwC (Economic Times)
  • Natco Doubles Down On US With Ambitious ANDA Plan (SCRIP-$)
  • Piramal Enterprises looks to buy OTC business of Morepen Laboratories (Economic Times)

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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