Regulatory Focus™ > News Articles > Regulatory Recon: Returns on Pharma R&D Hit Six-Year Low; Lilly to Offer Insulin Discounts (13 D

Regulatory Recon: Returns on Pharma R&D Hit Six-Year Low Lilly to Offer Insulin Discounts (13 December 2016)

Posted 13 December 2016 | By Michael Mezher 

Regulatory Recon: Returns on Pharma R&ampD Hit Six-Year Low Lilly to Offer Insulin Discounts (13 December 2016)

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

In Focus: US

  • As drug approvals dive in 2016, returns on R&D deteriorate (Reuters) (Financial Times) (Endpoints)
  • Trump considering Dr. Scott Gottlieb to head FDA (Reuters) (Fierce)
  • FDA nod for Boehringer/Lilly's once-daily diabetes combo (PharmaTimes) (Press)
  • Lilly to offer insulin at discounted prices (Reuters) (Press)
  • Rhetoric vs. Reality: The hypes of Cures (Politico­­)
  • PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications (Pink Sheet-$)
  • Supreme Court declines to hear biologic drug patent fight (Reuters) (Law360-$)
  • FDA to Publicly Disclose 'Emerging Signals' Info for Medical Devices (Focus)
  • Approve Drugs for Safety Only – it's Like "Back to the Future" – Not for Me (Lachman Consultants)
  • FDA, NIH Unveil Initial Framework for Biomarker Qualification (Focus)
  • HHS Inspector General to Examine Medicaid Drug Rebate Program in Wake of EpiPen Fiasco (Focus)
  • Companies Producing Drugs Only for INDs Exempt From FDA Registration (Focus)
  • The Year In Review: Merck Can Look Back And Smile (Forbes)
  • We Need To Tame The Price Of New Cancer Drugs (Forbes)
  • Philips to offload 80% stake in Lumileds for $1.5B (MassDevice)
  • Express Scripts adds Harvoni, expands indication-based pricing (BioCentury)
  • Faster Information from FDA Means Improved Drug Safety for Patients (FDA Voice)
  • Purdue and Exicure sign deal worth up to $790M (MedCityNews) (BioCentury)
  • Proteon Therapeutics kidney drug fails key study, shares slump (Reuters)
  • FDA Affirms Bladder Cancer Warning for Pioglitazone (Medpage) (FDA)
  • One in 6 American Adults Say They Have Taken Psychiatric Drugs, Report Says (NYTimes)
  • Pfizer takes major stake in new cancer immunotherapy company (PharmaLetter-$) (BioCentury)
  • Neurodegenerative market to be worth $45 billion by 2022 (Pharmafile)
  • CMS' chief data officer is leaving in January (Politico)

In Focus: International

  • FDA finds quality control problems at Sun Pharma's Halol plant (Reuters) (Economic Times) (Pharmafile)
  • TGA international engagement strategy 2016-2020 (TGA)
  • Major fire ravages Biocon subsidiary complex in India (Pharmafile)
  • EU Pharma Patent Settlements Still Limiting Entry of Generics (Focus)
  • SMC welcomes Jevtana but turns four others away (PharamaTimes) (Pharmafile)
  • Investment Plan for Europe - Curetis obtains EIB debt financing totaling up to EUR 25 million to further expand its diagnostic platform (European Commission)
  • Korea Lays Essential Drug Plans Amid Ongoing Supply Concerns (Pink Sheet-$)
  • UK Drug Payment Plan To Save £90m Yearly Progresses Thru Parliament (Pink Sheet-$)
  • British Officials Issue a Report Card on Aid Organizations (NYTimes)
  • Canada cracks down on opioid abuse amid record deaths (PharmaLetter-$)
  • Brazilian ANVISA Issues Clinical Data Requirements for Novel Medical Devices (Emergo)
  • EMA hosts workshop on adaptive pathways (EMA)
  • Malaria control improves for vulnerable in Africa, but global progress off-track (WHO)

US: Pharmaceuticals & Biotechnology

  • AML advances (BioCentury)
  • ANDA Submission Wave Continues; Is A Crest Near? (Pink Sheet-$)
  • Identify and Evaluate Manufacturer-Level Drug Utilization and Switching Patterns in Sentinel (Sentinel)
  • New Data Show Prescription Profits Under Pressure at Independent Pharmacies (Drug Channels)
  • Cempra CEO Fernandes retires (BioCentury)
  • Ipsen R&D chief stepping down (BioCentury)
  • Phillips-Medisize to build drug delivery manufacturing facility in Wisconsin (Drug Delivery)
  • Rare challenges: Meeting patient needs and delivering medical innovation in ultra-rare diseases (Pharmafile)
  • Payers may see biosims as a no-brainer, but marketing them won't be (Fierce)
  • Glenmark launches generic version of Zetia in US market (Economic Times) (Fierce)
  • GDUFA, Take II (Pharmaceutical Manufacturing)
  • Rise in Infant Drug Dependence Is Felt Most in Rural Areas (NYTimes)
  • Growth in biologics and vaccines leading injectables business, Aptar Pharma (OutsourcingPharma)
  • How to make precision medicine more patient-friendly (MedCityNews)
  • Social support tied to better breast cancer outcomes (Reuters)
  • Opioid-abuse treatment eludes most who need it in Rhode Island (Reuters)
  • Determination of Regulatory Review Period for Purposes of Patent Extension; NUCALA (FDA)

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

  • Flexion seeks FDA nod for osteoarthritis steroid injection (Drug Delivery)
  • Novocure Presents Second Cohort of Phase 2 Pilot PANOVA Trial Results Suggesting Tumor Treating Fields Plus Nab-Paclitaxel and Gemcitabine may be Safe as First-Line Treatment and may Improve One-Year Survival Rate of Patients with Advanced Pancreatic Cancer (Press)
  • Novocure Presents Phase 2 Pilot INNOVATE Trial Results Suggesting Tumor Treating Fields Plus Paclitaxel may be Safe as First-Line Treatment and may Improve Survival of Patients with Recurrent Ovarian Cancer (Press)
  • Pharnext Presents Positive Exploratory Phase 2 Data From PXT864 at the 9th Clinical Trials on Alzheimer's Disease (CTAD) Conference in San Diego, United States (Press)
  • Sage Therapeutics Announces Initiation of Phase 2 Clinical Development for SAGE-217 in Movement Disorders (Press)
  • Innocrin Pharmaceuticals Presents Data from the Ongoing Phase 2 Trial of Seviteronel in Estrogen Receptor-positive or Triple-negative Breast Cancer (CLARITY-01) at the San Antonio Breast Cancer Symposium (Press)
  • U.S. FDA approves Synjardy® XR (empagliflozin/metformin hydrochloride extended-release) tablets for adults with type 2 diabetes (Press)
  • Eagle Pharmaceuticals Reports Positive Results from Pivotal Animal Study Supporting the Efficacy of RYANODEX for Exertional Heat Stroke (Press)
  • MetaStat Presents Positive Data from Two Clinical Studies of MetaSite Breast™ at 2016 San Antonio Breast Cancer Symposium (Press)
  • Aurinia Confirms Receipt of FDA End of Phase 2 Meeting Minutes (Press)

US: Medical Devices

  • Medtech M&A in 2016: Deals and Dilemmas (MDDI)
  • Quest Diagnostics says personal health information of 34,000 customers hacked (CBS)
  • In a study with Pfizer, Akili's neurocognitive assessment video game can detect biomarkers of Alzheimer's (MobiHealthNews)
  • Lumendi Receives FDA Clearance to Market DiLumen™ for Endolumenal Therapy (Press)

US: Assorted & Government

  • Demystifying Obamacare for 2017: It's No Gamble (Forbes)
  • The FTC Grants Summary Decision in Proceeding Regarding All Natural Sunscreen (FDA Law Blog)
  • District Court Applies Law of Would-Be Filing Court in Fee Dispute in Hip Implant Case Filed Directly Into MDL (Drug and Device Law)
  • Boston Scientific fires neurmod patent infringement suit at Nevro in ongoing spat (MassDevice)
  • 38 dead: Animal Welfare Institute criticises 'Weak settlement' in US CRO primate case (OutsourcingPharma)

Upcoming Meetings & Events


  • Call for expressions of interest establishing the HTA Network Stakeholder Pool (European Commission)
  • EMA to review Sanofi and Regeneron's dermatitis drug application (EPR)
  • Adherium's smart inhaler tech chosen for EU mobile health program (MassDevice)


  • Pharma cos to drive growth, diversify products via M&As: Moody's (Economic Times)


  • Pediapharm wins Health Canada nod for antibiotic, steroid combo ear drop (MassDevice)

Other International

General Health & Other Interesting Articles

  • Drinking, drug use largely down among U.S. teens in 2016 (Reuters)
  • NIH awards aim to understand molecular changes during physical activity (NIH)

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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