Regulatory Focus™ > News Articles > Regulatory Recon: Trump Picks Tom Price as HHS Secretary; Apple Emails Hint at Plans for FDA-Regulat

Regulatory Recon: Trump Picks Tom Price as HHS Secretary Apple Emails Hint at Plans for FDA-Regulated Devices (29 November 2016)

Posted 29 November 2016 | By Michael Mezher 

Regulatory Recon: Trump Picks Tom Price as HHS Secretary Apple Emails Hint at Plans for FDA-Regulated Devices (29 November 2016)

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

In Focus: US

  • Donald Trump Chooses Tom Price as Health Secretary (WSJ) (Forbes) (NYTimes) (Reuters) (Sen. Alexander)
  • Even If Donald Trump Changed The FDA Drug Approval Process, Patients Wouldn't Benefit (Forbes)
  • Tackling high drug costs in the Trump era (Politico)
  • ICYMI: Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA (Focus)
  • 'Cures' Act Expected to Sail Through House Vote (Reuters) (NYTimes)
  • Reactions to 'Cures' Act (Sanders) (AdvaMed) (Public Citizen)(STAT)
  • Apple Emails Show Plans for FDA-Regulated Devices (MobiHealthNews 1, 2, 3, 4)
  • FDA Sees Better Industry Compliance With Postmarket Requirements (Focus)
  • Deadly Infections Linked To Heart Surgery Device Highlight Holes In FDA Monitoring (KHN)
  • Rebates to pharmacy benefit managers are a hidden contributor to high drug prices (STAT)
  • Momenta's Humira biosimilar succeeds in key psoriasis study (Reuters)
  • German Merck, Pfizer get FDA priority review for cancer drug (Reuters) (Fierce) (Press)
  • Disease 'Subsetting' Not Driving Jump In Orphan Designations, US FDA Says (Pink Sheet-$)
  • All Americans Must Benefit From The Golden Age Of Medicine (Forbes)
  • Formatting failings set to delay FDA ruling on cancer drug (Fierce)
  • Amicus Tumbles on Lengthy Delay to US Fabry Drug FDA Filing Plan (The Street) (Fierce)
  • Pharma giants see future of lower healthcare profits (Financial Times)
  • Big Pharma healthcare R&D steps out into the open (Financial Times)
  • Genome sequencing makes way out of healthcare lab into clinical practice (Financial Times)
  • How tech-enabled consumers are reordering the healthcare landscape (McKinsey)
  • Big Data Coming In Faster Than Biomedical Researchers Can Process It (NPR)
  • Theranos Sued for Alleged Fraud by Robertson Stephens Co-Founder Colman (WSJ 1, 2)
  • Patheon acquires state-of-the-art manufacturing facility from Roche (Pharmafile)

In Focus: International

  • Teva starts post-Actavis cost squeeze, will eliminate 210 jobs in Malta (Fierce)
  • Authorities, Regulators And Pharma Industry From India And Europe Meet To Strengthen Regulatory Cooperation (Medicines for Europe)
  • Pfizer's Ibrance faces tough review at NICE, UK exec worries (Fierce)
  • WHO group finally tames fake medicines tongue-twister (Securing Industry) (WHO)
  • New French Clinical Trial Rules Focus on Phase I (Pink Sheet-$)
  • Sun Pharma launches first branded drug BromSite in US (Economic Times)
  • European Regulatory Roundup: Report Calls to Minimize Amount of Data Generated by Sponsors (Focus)
  • CFDA Minister Bi Jingquan meets Minister of Public Health of Cuba (CFDA)
  • Japan's PMDA Hits Markers On Path To Key Performance Targets (Pink Sheet-$)
  • Grünenthal New CEO: My Strategic Priorities (SCRIP-$)
  • Daiichi case: Delhi HC to hear main arguments in March (Economic Times)
  • Indian State Authorities Report 27 Drugs from Leading Firms Failed Quality Tests (FDANews-$)
  • EMA opens its data vaults (Nature)
  • Britain to ratify single European patent system (Financial Times)

US: Pharmaceuticals & Biotechnology

  • Final Guidance On Non-Inferiority Studies Lacks Industry-Sought Changes (Pink Sheet-$)
  • Creative Minds: Modeling Neurobiological Disorders in Stem Cells (NIH)
  • FDA drops Veltassa's black box warning (BioCentury)
  • FDA Clarifies Steps for Sponsors to Submit Alternative ICH Postmarket Reports (FDANews-$) (FDA)
  • How Direct-to-Consumer Advertising for Prescription Drugs Affects Consumers' Welfare (Journal of Advertising Research)
  • MedImmune and Abpro launch bispecific antibody spinout (Fierce)
  • Another BE Guidance Revised – This Time, Sprinkle it With Fairy Dust! (Lachman Consultants)
  • MedImmune and Abpro launch bispecific antibody spinout (Fierce)
  • Celgene Invests More in GNS Healthcare For Machine Learning Software (Xconomy)
  • Returns hint at gradual decline in quality of biotech floats (EP Vantage)
  • Mixed late-stage data for Santen eye drug, but still plots FDA submission (Fierce)
  • Biosimilars and Generics: A no-brainer for treatment? (Pharmafile)
  • US FDA clears Lupin to supply US with meds made in Goa (InPharmaTechnologist)
  • 10 Keys For Responding To An FDA Warning Letter Or Form 483 (imarc)
  • Does a Trump presidency mean changes for pharma advertising? (Fierce)
  • Can't Get to Sleep? Lay Off the Drugs (WSJ)
  • FDA orphan drug designation doubles PhaseRx shares (Pharmafile)
  • Sunscreen Industry Asks FDA For Flexibility Despite Guidances' Rigidity (Pink Sheet-$)
  • Prospective Grant of Exclusive Patent License: Development and Commercialization of Dopamine D3 Receptor Selective Antagonists/Partial Agonists for the Treatment of Opioid Use Disorder, Schizophrenia Bipolar Disorder and Tetrahydrocannabinol Dependence (NIH)

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

  • Vtesse Receives Rare Pediatric Disease Designation by the FDA for VTS-270 for the Treatment of Niemann-Pick Type C1 Disease (Press)
  • Nivalis fails phase 2 cystic fibrosis test, but vows to continue on (Fierce)
  • ARIAD Announces FDA Full Approval and Label Update for Iclusig® (ponatinib) Based on Long-Term Efficacy and Safety Data from Phase 2 PACE Clinical Trial (Press)

US: Medical Devices

  • Fires prompt warning on Medtronic's Bellco Formula dialysis device (MassDevice)
  • FDA Calls Out Unproven Claims of Unapproved Blood Device (Focus)
  • As revenue falls, a pioneer of cancer gene testing slams rivals with overblown claims (STAT)
  • Summer Project Turns Into Leukemia Testing Breakthrough (NYTimes)
  • Global Health Solutions Announces 510k FDA Approval of PolyPlex Wound Dressing (Press)
  • Clinically Validated Tinnitus Treatment Gets FDA Clearance (Press)
  • Recro's IV meloxicam passes second Phase III test (BioCentury)
  • Mitigating the Risk of Cross-Contamination From Valves and Accessories Used for Irrigation Through Flexible Gastrointestinal Endoscopes; Guidance for Industry and Food and Drug Administration Staff; Availability (FDA)

US: Assorted & Government

  • Roxane Laboratories, Inc. v. Camber Pharmaceuticals Inc. (Fed. Cir. 2016) (Patent Docs)
  • Grassley Opposes Weakening of Physician Payments Sunshine Act Reporting Provisions (Sen. Grassley)
  • $2.75M Deal Settling 9-Year-Old Amgen ERISA Suit Nears OK (Law360-$)
  • Plaintiffs Learn Supplementing Isn't a Second Bite at the Apple (Drug and Device Law)
  • FDA's Efforts to Evaluate and Respond to Business Concerns Regarding the Produce Rule (GAO)
  • FDA Acts on Dietary Fiber: Issues Draft Guidance and Report of Evidence for Twenty Six Isolated and Synthetic Non-digestible Fibers (FDA Law Blog)
  • Theranos Wants Most Claims Tossed In $96M Hedge Fund Suit (Law360-$)
  • UnitedHealth Gives Upbeat Outlook for 2017 (WSJ)
  • Testimony Shows Anthem and Cigna at Odds Over Proposed Merger (WSJ)

Upcoming Meetings & Events

Europe

  • Expert advisory board to support the Global AMR Innovation Fund (UK DOH)
  • GSK's digital transformation strategy is bigger than tech for tech's sake: exec (Fierce)
  • Medtronic First to Receive European Approval for Less-Invasive HVAD® Implant Procedure (Press)

Asia

  • Presentations at 21st AHWP Annual Meeting, Cebu, Philippines, 21-25 November 2016 (AHWP)

India

  • Pfizer withdraws Corex syrup, extends line to new products (Economic Times)
  • Cipla appoints Ireena Vittal as independent director (Economic Times)
  • Natco Pharma gets USFDA nod for Armodafinil tablets (Economic Times)

Canada

  • Canadian lab worker released after Ebola infection scare (Reuters)

Australia

  • TGA business plan 2016-17 (TGA)
  • ASR XL total hip replacements (TGA)

Zika

  • Texas confirms local Zika transmission (CNN)

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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