Regulatory Recon: Plan to Reduce Medicare Drug Payments Widely Panned EU Lifts Warning on Pfizer Smoking Cessation Drug (23 May 2016)

Posted 23 May 2016 | By Michael Mezher 

Regulatory Recon: Plan to Reduce Medicare Drug Payments Widely Panned EU Lifts Warning on Pfizer Smoking Cessation Drug (23 May 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

  • Entresto Gets Boost in Updated HF Guidelines (CardioBrief) (Pharmafile)
  • Medical Research Bill Stuck in Limbo (Washington Examiner)
  • US healthcare: Power to the patients? (Financial Times)
  • FDA staffers air concerns over Novo's Victoza-Tresiba combo (Fierce) (SCRIP-$) (BioCentury)
  • FDA Rejects "Extraordinary" Position in Battle Over BUTRANS Patent Term Extension (FDA Law Blog)
  • Criminal Trials of Former Health-Care Executives Set to Begin (WSJ-$)
  • Proposal to Reduce Medicare Drug Payments Is Widely Criticized (NYTimes)
  • Opioid Prescriptions Drop for First Time in Two Decades (NYTimes)
  • FDA staff question utility of Sanofi diabetes drugs (Reuters) (Fierce) (Bloomberg)

In Focus: International

  • Europe lifts warning on Pfizer smoking cessation drug (Reuters)
  • France faults Bial and Biotrial over fatal drug trial (Reuters 1, 2) (STAT)
  • China aiming to align with global naming rules for biologics, biosimilars (BioWorld)
  • China's drugs watchdog struggles as senior staff lured away by industry (Reuters)
  • World Bank launches first insurance market for pandemic risk (Financial Times) (World Bank)  (Devex)
  • Bayer's $62 Billion Bid for Monsanto (The Atlantic) (WSJ-$)
  • First EC Borderline Decision: Does it Answer or Raise Questions? (Inside Medical Devices)
  • Russia to compensate drugmakers for price freeze (PharmaLetter-$)
  • The Other Canadian Drug Company That Has Pushed Up Drug Prices (Forbes)

Sponsored Content: Earn a MS in Regulatory Science in as little as two years – ONLINE

US: Pharmaceuticals & Biotechnology

  • Health Outcomes Among Individuals Exposed to Medical Products Details (Mini Sentinel)
  • Study Suggests Salt Restriction Only Beneficial In People With Hypertension (CardioBrief)
  • After gastric bypass, use of psychiatric drugs may rise (Reuters)
  • Arbor Pharmaceuticals to Acquire XenoPort (Press)
  • It's tasty and easy to take. And that's why a new ADHD drug alarms some psychiatrists (STAT)
  • Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off (BioProcessOnline)
  • Cutting-edge findings in cannabis research (MNT)
  • Drug switching could save US health system billions (Pharmaceutical Journal-$)
  • With First Trials On Horizon, Value Of Growing Philly Xarelto Claims Uncertain (Forbes)
  • Crestor Discounting Keeps Allergan's Generic Off UnitedHealth Formulary (Pink Sheet-$)
  • How You Can Help Make Clinical Trials Happen (Forbes)
  • Will Fortune Favor The Brave? Biosimilar Sponsors Need High Tolerance For Uncertainty (Pink Sheet-$)
  • US FDA Biologic Transition Plan Creates 'Dead Zone' For Applications, Sponsors Fear (SCRIP-$)
  • Retail Clinics Drive New Health Care Utilization And That Is A Good Thing (Health Affairs Blog)
  • What Comes First? FDA Excessive Claims Finding Or Facility Inspection? (Tan Sheet-$)
  • Acorda Drops Epilepsy Candidate Once Central To Its Revenue Forecasts (Pink Sheet-$)
  • 3 Reasons a Clinical Evidence Database for Multiple Sclerosis is Important (RxView)
  • CDER Talks Switches, Monograph 'More Than Ever,' But Mum On Changes (Tan Sheet-$)
  • Harvard Law Advocates for Patient Access to Hepatitis C Cure (BIO)
  • GPhA, IPEC Call on FDA to Establish Working Groups With Industry (FDANews-$)
  • FDA Status Updates On Citizen Petitions Would Not Signal Decision Pending (Tan Sheet-$)

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

  • New HIV vaccine trial aims to build on earlier modest success (Reuters)
  • Akebia Announces Positive Vadadustat Data Demonstrating No Clinically Significant Drug-Drug Interaction (Press)
  • ​H3 Biomedicine to begin trials of first-ever gene-splicing cancer drug (Boston Business Journal)
  • Janssen's Single-Agent DARZALEX (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM) (Press)
  • ResQ Pharma Submits Investigational New Drug (IND) Application for LipidRescue Therapy to FDA (Press)
  • Exelixis Announces Results from Randomized Phase 2 Trial CABOSUN Demonstrate Cabozantinib Significantly Improved Progression-Free Survival versus Sunitinib in Previously Untreated Advanced Renal Cell Carcinoma (Press)

US: Medical Devices

  • Patient and Consumer Stakeholder Meeting on MDUFA IV Reauthorization (FDA)
  • FDA Extends Comment Period on Electrical Stimulation Device Ban (FDA)
  • Depression symptoms may improve with cochlear implants (Reuters)
  • FDA warns Eclipse Aesthetics on MicroPen personal dermabrasion device (MassDevice)
  • New Chips Propel Machine Learning (WSJ-$)
  • Medtronic buys the right kind of morcellators (EP Vantage)
  • Jury Finds For Edwards's CardiAQ in TMVR Tech Dispute (MDDI)
  • Class 1 Device Recall ABGHM1 Hummi Micro Draw Blood Transfer Device (FDA)
  • Understanding The Difference Between Sterility Assurance Level (SAL) And Log Reduction (Med Device Online)

US: Assorted & Government

  • Anthem, Cigna Privately Bicker as They Seek Merger Approval (WSJ-$)
  • FDA Approves New Nutrition Panel That Highlights Sugar Levels (WSJ-$)
  • Long Beach Hits Monsanto, Pfizer Unit With Enviro Suit (Law360-$)
  • Biotech firm fined $3.5 million for animal mistreatment (Pharmafile)

Upcoming Meetings & Events


  • Siptu fights Pfizer bid to take 1,000 staff off defined benefit pension scheme (Irish Examiner)
  • Russia – A Country In Focus (BioProcessOnline)
  • Update: Send and receive information on adverse drug reactions (ADRs) (MHRA)
  • Ireland: Price Cuts And A New Route to Market? (SCRIP-$)
  • Guidance for implementation of eligibility requirements (EMA)
  • Cancer trials to be streamlined in the UK (OnMedica)
  • Takeda's European chief hails 'turnaround year' (PharmaPhorum)
  • Italian regulator slams simvastatin-maker Krebs for GMP deviations (Outsourcing-Pharma)
  • Janssen's Darzalex approved for myeloma in Europe (PharmaPhorum)
  • Ariad to pick up $25 million from Iclusig sales after French talks (PharmaLetter-$)
  • CHAMPIX® (varenicline) European Union Label Updated to Include New Safety and Efficacy Data from the EAGLES Clinical Trial Following Endorsement from CHMP (Press)
  • Pfizer Announces European Medicines Agency Acceptance for Review of Marketing Authorization Application for TRUMENBA® (Meningococcal Group B Vaccine) (Press)
  • iVascular wins CE Mark for Luminor 18 DCB (MassDevice)


  • Innovation is the key to drive pharma industry in China (BioSpectrum)
  • Japan commits $800 million to the Global Fund (PharmaLetter-$) (BioCentury)
  • Early Stage San Antonio Drug Trial Firm START Opens Taiwan Outpost (Xconomy)
  • Japan Pharma Majors Join Hands For Biomarkers (PharmasiaNews-$) (Press)
  • Malaysia's Medical Device Registration Transition Period Winding Down (Emergo)
  • The Results From A One Year Treatment Of Repatha Presented At The Annual Meeting Of The Japan Diabetes Society (Press)
  • Indian and Japanese regulators agree to greater collaboration (PharmaLetter-$)


  • Delhi court wants more on Roche 'reputation' Avastin biosimilar claims (Fierce) (Economic Times)
  • Court Asks Pfizer To Withdraw Drug 6 Months Before Expiry (Press Trust of India) (Economic Times)
  • After 3 years of proposal, DHR yet to establish Medical Technology Assessment Board (PharmaBiz)
  • Indian Drug Regulator Urges Safety, Ethics, Quality For Clinical Trials (24 Insight)
  • Indian Govt's Bio-Design Program Launches Qora, An Affordable Medical Device (24 Insight)


  • Australia watchdog appeals $1.2 million Reckitt Benckiser fine as too light (Reuters)
  • Counterfeit Medicine Alert: BiCNU (carmustine for injection) 100mg bottle (TGA)


  • Zika looms but El Salvador stands firm on abortion ban (Reuters)
  • U.S. reports 279 Zika cases in pregnant women, Obama pushes Congress on funds (Reuters)
  • Brazil-type Zika confirmed in Africa for first time: WHO (Reuters) (WHO)

Other International

  • Statement on the 9th IHR Emergency Committee meeting regarding the international spread of poliovirus (WHO)
  • Why Doctors Without Borders Is Skipping The World Humanitarian Summit (NPR)

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles