Regulatory Focus™ > News Articles > Regulatory Recon: US Could File Charges Over Generic Price Collusion; NICE Backs AstraZeneca's Post-

Regulatory Recon: US Could File Charges Over Generic Price Collusion NICE Backs AstraZeneca's Post-Heart Attack Drug Brillique (4 November 2016)

Posted 04 November 2016 | By Michael Mezher 

Regulatory Recon: US Could File Charges Over Generic Price Collusion NICE Backs AstraZeneca's Post-Heart Attack Drug Brillique (4 November 2016)

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

In Focus: US

  • Sarepta bemoaned 'dire' financial situation as it pushed for Exondys decision (Fierce)
  • US Charges in Generic-Drug Probe to Be Filed by Year-End (Bloomberg) (Reuters) (NYTimes)
  • FDA Staff Raise Concern Over Novel Pneumonia Drug (Medpage)
  • Off-Label Promotion: Researchers Call on Courts to Reject Caronia (Focus)
  • Bernie Sanders calls for federal investigation of insulin makers for price collusion (STAT) (Letter)
  • Novo Nordisk defends US diabetes drug pricing (Reuters)
  • The Best Beta-Secretase Inhibitor Yet in Alzheimer's (In the Pipeline)
  • The Cost Of A Cure: Revisiting Medicare Part D And Hepatitis C Drugs (Health Affairs Blog)
  • There's a New Reporting Tool in Town (FDA Law Blog) (Focus)
  • The Great 'ASH16' Abstract Drop Mostly Causes Drug Stocks to Do Same (The Street)
  • Phase II and phase III failures: 2013–2015 (Nature)

In Focus: International

  • Sanofi, Novartis, NCI, Ranbaxy top missing data list as Shire most transparent (Fierce) (Nature) (TrialsTracker) (EFPIA) (ABPI) (Alltrials)
  • MHRA: UK an Active Member of EU Networks 'Until we Left the EU' (Focus)
  • BMS' Opdivo Wins UK EAMS Approval for Hodgkin's Lymphoma (Focus)
  • WHO Releases Draft Guidance on Postmarket Changes to Biologics (Focus)
  • Indian Pharma Stocks Hit by Worries on U.S. Drug Price Pressures (Bloomberg)
  • AstraZeneca's post-heart attack drug gets NICE recommendation (Pharmafile)
  • European Regulatory Roundup: Sweden Lays Groundwork for Adoption of Adaptive Approval Pathway (Focus)
  • Brazilian Notebook: Key Themes From BIO Latin America (SCRIP-$)
  • New Belgian Innovation Office To Accelerate Availability of Novel Medicines (Pink Sheet-$)
  • Saudi Arabia Slashes Time To Market With Abridged Applications (Pink Sheet-$)
  • Glaxo wins battle for GSK trademark in India (Economic Times)
  • Mutant Ebola May Have Caused Explosive Outbreak (NPR) (NYTimes)
  • G20 Innovation Report 2016 (OECD)
  • Abbott looks to mollify EU regulators on St. Jude Medical merger; sues Alere for breach of contract (MassDevice)

US: Pharmaceuticals & Biotechnology

  • Powerful Post-Approval Operational Strategies for the 21st Century (Bioclinica)
  • A Drug Safety Data Point That No One Knows About (RxView)
  • San Antonio's Fountainhead Raising Money to Back Up Biomed Incubator (Xconomy)
  • Congressional control big biopharma risk in 2016 election (EP Vantage)
  • Astra's combo strategy comes under pressure (EP Vantage)
  • Endo pulls Patheon-made birth control pills in US over potency concerns (InPharamaTechnologist)

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

  • Roche showcases new clinical data across a variety of blood diseases at American Society of Hematology 2016 Annual Meeting (Press)
  • Bristol-Myers Squibb to Present New Data at the 58th Annual Meeting & Exposition of the American Society of Hematology Demonstrating Research Advancements in Immuno-Oncology and Across Multiple Blood Cancers (Press)
  • Lilly Presents Clinical Efficacy, Safety and Patient-Reported Outcomes Data of Baricitinib in Patients with Rheumatoid Arthritis at 2016 American College of Rheumatology Annual Meeting (Press)
  • Researchers to Present New Phase 1/2 Data on ALXN1210 in Patients with PNH at ASH 2016 Annual Meeting (Press)
  • Sanofi Genzyme Begins Pivotal Phase 3 Trial of NeoGAA Investigational Second-Generation Therapy for Pompe Disease (Press)
  • Kite Pharma to Present KTE-C19 Data from Interim Analysis of the ZUMA-1 Pivotal Trial in Patients with Chemorefractory Primary Mediastinal B-Cell Lymphoma (PMBCL) and Transformed Follicular Lymphoma (TFL) at the 2016 American Society Hematology Annual Meeting (Press)
  • Data from Three GlycoMimetics Drug Candidates to Be Highlighted at 58th Annual American Society of Hematology (ASH) Meeting (Press)
  • Seattle Genetics Announces ASH 2016 Abstracts Highlighting Company's Expanding Global Leadership in the Development of Innovative Antibody-Drug Conjugates (Press)
  • Abstract Describing Imara's Sickle Cell Disease Therapy, IMR-687, Accepted for Oral Presentation at the ASH Annual Meeting (Press)
  • Nordic Nanovector: Updated Results from Phase 1/2 Trial of Betalutin® in Non-Hodgkin Lymphoma to be Presented at ASH Annual Meeting in December (Press)
  • Nordic Nanovector: Results From Preclinical Studies of Betalutin® in Combination with Rituximab in non-Hodgkin Lymphoma Model to Be Presented at ASH (Press)
  • More Than 20 Abstracts Highlighting Data from Incyte's Portfolio Accepted for Presentation at the 58th Annual ASH Meeting (Press)
  • Allergan discloses Phase II miss in LXR program (BioCentury)
  • Immune response seen in Spark hemo B study (BioCentury)
  • Innocoll crushed after PhIII diabetic foot infection flop (Fierce)

US: Medical Devices

  • Unilife confirms focus on wearables delivery tech for biologics (InPharmaTechnologist)
  • FDA releases August 2016 510(k) clearances (MassDevice)
  • Interview: Philips Plugs Into Patient Connectivity (SCRIP-$)
  • TCT 2016: The best of the rest (MassDevice)
  • InVivo adds 26th clinical site for spinal scaffold trial (MassDevice)
  • Mast Therapeutics touts interim data from pulmonary hypertension study (MassDevice)
  • Novocure reports 142% boost in sales for Q3 (MassDevice)
  • Becton Dickinson's full-year profits soar 40% (MassDevice)
  • Insulet posts beat-and-raise Q3 (MassDevice)

US: Assorted & Government

  • Federal CIO: Think of cybersecurity as a quality issue (MedCityNews)
  • Chamber Of Commerce Backs GSK In 3rd Circ. Drug Appeal (Law360-$)
  • DC Circ. Won't Revisit Takeda's Gout Drug Dispute With FDA (Law360-$)
  • Cigna, Too, Will Shrink Obamacare Footprint (Forbes)
  • Humana Says 2017 Obamacare Premium Revenue Will Drop $2B (Forbes)

Upcoming Meetings & Events


  • European Medicines Agency accepts marketing application of Biocon, Mylan product (Economic Times)
  • Woodford-backed UK biotech group faces new legal challenge (Financial Times)
  • Russian government to create conditions to increase domestic vaccines production (PharmaLetter-$)


  • Announcement: Tentative Program of the 21st AHWP Annual Meeting (AHWP)
  • Asia Attracts Manufacturing Capital As Companies Eye Expanding Needs (SCRIP-$)
  • Merck KGaA presses on with 250 million euros investment in Chinese production facilities (PharmaLetter-$)


  • Mylan Inc and Strides Shasun settle Agila payments row (Economic Times)
  • Indian Drugmakers Divided on Proposal to Extend Exclusivity to 10 Years (FDANews-$) (Pink Sheet-$)
  • Indian government to work on new pharma policy (PharmaLetter-$)



  • Sanofi's Experience With Dengvaxia May Speed Development of Zika Vaccine (Xconomy)

General Health & Other Interesting Articles

  • A Shortage of Oncologists (NYTimes)
  • Study finds gene markers for drug-resistant malaria in Cambodia (Reuters)
  • Smoking a pack a day causes 150 mutations in every lung cell, research shows (Reuters)
  • WHO recommends 29 ways to stop surgical infections and avoid superbugs (WHO)

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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