Regulatory Recon: Report Says Global Drug Spending to Hit $1.5 Trillion in 2021 Sanofi Weighing Counterbid for Actelion (6 December 2016)

Posted 06 December 2016 | By Michael Mezher 

Regulatory Recon: Report Says Global Drug Spending to Hit $1.5 Trillion in 2021 Sanofi Weighing Counterbid for Actelion (6 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • FDA's Office of New Drugs Director to Retire (Focus)
  • Global prescription drug spend seen at $1.5 trillion in 2021: report (Reuters) (IMS Health)
  • Senate Clears Path for Bill to Speed FDA Drug Approvals (WSJ) (BioCentury) (Senate HELP)
  • The 21st Century Cures Act: A huge handout to the drug industry disguised as a pro-research bounty (LA Times)
  • A comprehensive map of molecular drug targets (Nature)
  • Vermont Drug Price Transparency: New Law Calls Out Egregious Price Spikes (Focus)
  • The FDA just signed off on a Formula 1 pivotal track for Sage's postpartum depression drug (Endpoints)
  • How the CRISPR Patent Dispute Became So Heated (The Atlantic) (WSJ)
  • GW Pharmaceuticals Delivers Positive Seizure Data, Worries About Trump (Forbes) (Pharmafile)
  • Precision Oncology: Epigenetic Patterns Predict Glioblastoma Outcomes (NIH)
  • Celebrating BioPharma: Of Triple Crowns And Unicorns (LifeSciVC)
  • GOP leaders want Collins to stay at NIH helm (BioCentury)
  • Sanofi to Explore Counterbid for Actelion Amid J&J Talks (Bloomberg)
  • Novo Nordisk Sheds New Light on PBM Rebates, the Gross-to-Net Bubble, and Warped Channel Incentives (Drug Channels)
  • Bristol-Myers' Mike Burgess Talks R&D Challenges, Portfolio Developments In 2017 (SCRIP-$)
  • User Fee Reauthorization Prompts More Intensive FDA Assessment of Its Growing Biosimilar Regulatory Experience (IPQ)
  • Teleflex-Vascular takes 2016's medtech merger total to $73bn (EP Vantage)
  • Theranos Foresaw Huge Growth in Revenue and Profits (WSJ)
  • Life in Obamacare's Dead Zone (NYTimes)
  • Cancer Trials: Broader Eligibility Criteria Could Mean Novel Labeling Claims (Pink Sheet-$)
  • AstraZeneca pill slashes lung cancer progression in study (Reuters) (Press)
  • Jardiance's Cardiovascular Benefit Claim Bodes Well For Other Products Too (Pink Sheet-$)

In Focus: International

  • Exclusive: Novartis in talks to sell some central nervous system drugs – sources (Reuters)
  • Novo Nordisk seeks EU and U.S. approval for new diabetes treatment (Reuters) (PharmaLetter-$)
  • New Japan Price Cut Push Has Industry Worried (Pink Sheet-$)
  • WHO Prequalifies First Hepatitis C Diagnostic (Focus)
  • CDSCO Asks for Feedback on its Online Systems (CDSCO)
  • Japanese doctors take to courts in row over HPV vaccine (Financial Times)
  • Novartis' drug tops chemotherapy in untreated lung cancer patients (Reuters)
  • Merck and Roche extend distribution ties (Pharmafile)
  • EMA PRIME Rejects Told: 'Add Something New' If You Resubmit (Pink Sheet-$)
  • PHARMAC funding for Roche and Pfizer drugs (PharmaLetter-$)
  • Franco-Sino deal for biosimilars in China (PharmaLetter-$)
  • Israel's Bonus says lab-grown bones successfully transplanted (Reuters)
  • Mexican Regulators Allow Greater Third Party Reviewer Involvement for Stalled Medical Device Applications (Emergo)
  • GSK insider Waterhouse to head drugmaker's HIV unit ViiV (Reuters)
  • Productivity: The route to Brexit success (McKinsey)
  • French connection: Vaccine biomanufacturing service providers Accinov and Biodextris merge (OutsourcingPharma)

US: Pharmaceuticals & Biotechnology

  • FDA's Draft Quality Metrics Guidance, Version 2.0 (FDA Law Blog) (Focus)
  • A New Antibody For Treating Acute Lymphocytic Leukemia? (Forbes)
  • At Late-Night ASH Talk, Juno Execs Look Beyond Stalled "Rocket" Trial (Xconomy)
  • Enigma Reveals Insights Into Big Health Data (Forbes)
  • Hybrid Pharma Lands FDA Form 483 Over Sterility, Quality Controls (FDA News-$)
  • AbbVie, Northwestern collaborate on cancer research (Chicago Business)
  • CMO of OncoMed Pharma resigns (Pharmafile)
  • Ash interview – Seattle's aspirations versus big pharma's appetites (EP Vantage)
  • Ash – Early data for next generation of Imbruvica's challengers (EP Vantage)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL 9
  • (FDA)

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

  • Wilson's Decuprate heading for Phase III (BioCentury)
  • Updated KEYTRUDA® (pembrolizumab) Findings in Patients with Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma Presented at 58th Annual Meeting of the American Society of Hematology (Press)
  • Updated KEYTRUDA® (pembrolizumab) Data in Small Cell Lung Cancer and Mesothelioma Presented at 17th World Conference on Lung Cancer (Press)
  • KEYTRUDA® (pembrolizumab) Treatment Results in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) Presented at 58th Annual Meeting of the American Society of Hematology (Press)
  • Juno Therapeutics Presents Data From TRANSCEND Study Showing 60% Complete Response in Patients with Relapsed or Refractory Aggressive CD19+ Non-Hodgkin Lymphoma (Press)
  • Early Data Demonstrate Clinical Activity of Acalabrutinib in Difficult-to-Treat Chronic Lymphocytic Leukaemia (Press)
  • BerGenBio Presents Promising Phase I Clinical & Biomarker Data From First In Class Axl Inhibitor BGB324 In AML at ASH 2016 (Press)
  • Celltrion Healthcare presents positive results for biosimilar rituximab candidate CT-P10 (BiosimilarNews)
  • TherapeuticsMD Announces Positive Top-Line Results from Pivotal Phase 3 Replenish Trial in Postmenopausal Women with Moderate to Severe Vasomotor Symptoms (VMS) Treated with TX-001HR (Press)
  • Acceleron and Celgene Announce Updated Results from Phase 2 Studies of Luspatercept in Beta-Thalassemia Presented at the 58th Annual Meeting of the American Society of Hematology (Press)
  • H3 Biomedicine Announces Data from Lead Development Program of H3B-8800 in Pre-Clinical Models of Hematologic Cancers (Press)
  • Kiadis Pharma presents positive 1-year follow-up data of its pivotal  (Press)
  • Verastem Presents Phase 2 DYNAMO® Clinical Data at ASH 2016 Annual Meeting (Press)
  • Seattle Genetics and Bristol-Myers Squibb Highlight First Data from Phase 1/2 Study Evaluating ADCETRIS® (Brentuximab Vedotin) in Combination with Opdivo (nivolumab) in Relapsed or Refractory Hodgkin Lymphoma at ASH Annual Meeting (Press)
  • Opdivo (nivolumab) Alone or Combined With Yervoy (ipilimumab) Shows Encouraging Response and Survival Rates in Recurrent Small Cell Lung Cancer, From Phase 1/2 Study CheckMate -032 (Press)
  • Sage Announces Expedited Development Plan for SAGE-547 in the Treatment of Postpartum Depression based on FDA Breakthrough Therapy Meeting (Press)
  • TAGRISSO® (osimertinib) Demonstrates Superiority over Chemotherapy in EGFR T790M Mutation-Positive Non-Small Cell Lung Cancer (Press)
  • Kadmon Submits Abbreviated New Drug Application Filing for Trientine Hydrochloride to FDA (Press)

US: Medical Devices

  • FDA Classifies Post-Concussion Test (Focus)
  • Sunovion launches clinical trial for anti-epileptic drug with wearable tech (Drug Delivery)
  • Basal insulin dosage management tool for Type 2 diabetes gets greenlight from FDA (MedCityNews)
  • Nerve Treatment When Drugs Fail (WSJ)
  • Nanowear gets FDA clearance for cardiac-monitoring clothing (mobihealthnews)
  • FDA clears Kyocera Medical's Initia hip implant (MassDevice)
  • Biotronik launches BioMonitor 2 subcutaneous heart monitor trial (MassDevice)

US: Assorted & Government

  • US court puts Obamacare case on hold until Trump takes office (Reuters)
  • Crossing State Lines Is No Easy Jaunt for Insurers and Local Regulators (WSJ)
  • J&J Asks 1st Circ. To Halt Hip Implant FCA Suit (Law360-$)
  • US attorneys argue Aetna-Humana deal violates antitrust law (Reuters)
  • Aetna and Humana Defend Merger, as Antitrust Trial Begins (WSJ)
  • The Causation Question Left Unanswered By Actavis (Law360-$)
  • Eli Lilly Sues Tenth Drugmaker for Infringement of Cialis Patent (FDANews-$)
  • Drug Cos. Urge High Court To Nix State Law Claims On Reglan (Law360-$)
  • Pennsylvania Federal Court Uses Tincher to Find Claim for Strict Liability Manufacturing Defect in Medical Device Case (Drug and Device Law)

Upcoming Meetings & Events


  • Europe must remain the world leader in excellent and responsible biomedical research (EFPIA)
  • Shire given permission for $400 million biologics manufacturing facility (Pharmafile)
  • Medtronic's Endurant(TM) II/IIs Stent Graft System Receives CE Mark for Use with ChEVAR Parallel Graft Technique (Press)
  • ENYO Pharma Receives a €2.5 Million Grant from EU under the Horizon2020/SME Instrument Phase 2 Programme for Its Project MIMESIS (Press)
  • Invendo Medical wins CE Mark for Invendoscope SC200 (MassDevice)


  • Korea's pharma workforce up by 27 percent (BioSpectrum)


  • Indian Medical Association may collate list of combination drugs that are 'irrational' & 'unsafe' (Economic Times)
  • 'Make in India' strategy to kickstart domestic biomanufacturing, Biocon (BioPharmaReporter)
  • Lupin gets USFDA nod for Diclofenac capsules' generic version (Economic Times)
  • Cipla's inhalable insulin fails to get approval for trials on Indian patients (Economic Times)


  • TGA presentation: given at the Parenteral Drug Association end of year event, 29 November 2016 (TGA)
  • Australia's biggest clinical trial part of A$483 million health research grants (PharmaLetter-$)
  • Phenytoin (Dilantin) bottles of capsules and tablets (TGA)

Other International

General Health & Other Interesting Articles

  • Diagnosing Disease with a Snapshot (MIT Technology Review)
  • Mumps Outbreaks Are Worst in a Decade (WSJ)
  • Even with one cigarette a day, odds of early death are higher (Reuters)
  • Richest Americans live seven to 10 years longer than poorest (Reuters)

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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