Regulatory Focus™ > News Articles > 5 > Recon: Trump Admin Cracks Down on Drug Price Hikes

Recon: Trump Admin Cracks Down on Drug Price Hikes

Posted 14 May 2018 | By Ana Mulero 

Recon: Trump Admin Cracks Down on Drug Price Hikes

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US [Paid Advertisement]
Currently, approximately 70% of IVDs on the market are sold without the involvement of a Notified Body. The IVDR will change that while also making sweeping changes to medical device regulations, all aimed at protecting end users.
Join us on May 16th at 11:00am EDT for our complimentary webinar Overview of the New European IVDR and find out how you can prepare your business for the transition.

Register now

In Focus: International Pharmaceuticals & Biotechnology
  • Blood, sweat and tears in biotech — the Theranos story (Nature)
  • From old behemoth Lipitor to new king Humira: Best-selling U.S. drugs over 25 years (Fierce)
  • Stephen Eck leaves Aravive CEO job to join Immatics (Fierce)
  • Seven drug pricing proposals that will happen and a couple that won’t (EP Vantage)
  • Vantage view – how biopharma is meeting the next payer challenge (EP Vantage)
  • Why does Wall Street love Trump’s ineffective drug-price plan? (STAT)
  • The holes in Trump's drug pricing plan (Axios)
  • Trump's new prescription drug plan is incomplete -- here are two ways to make it better (Fox)
  • Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With (PharmExec)
  • Trump’s drug price retreat adds to list of abandoned populist promises (The Washington Post)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Viagra and many other drugs were discovered by chance. Now science is hoping to change that. (The Washington Post)
  • Targeting the tricky PI3K pathway in cancer, MEI gets $75M to push program through registration study (Endpoints)
  • Attacking the common cold by unshielding its genome (Fierce)
  • Head of Biden Cancer Initiative draws on own diagnosis to speed research (STAT)
  • RXi Pharma inks research pact with Iovance to evaluate potential synergies with new sd-rxRNA therapeutic compounds & autologous cell therapy based on TILs to treat cancer (Pharmabiz)
  • Hemogenyx collaborates with undisclosed global pharmaceutical firm on CDX antibodies development (Pharmaceutical Business Review)
  • Association of Pharmaceutical Industry Marketing of Opioid Products to Physicians With Subsequent Opioid Prescribing (JAMA)
  • Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits Due to Risk of Malfunction Caused by Error in Product Design (FDA)
  • Perrigo Confirms First To File Patent Challenge For Generic Version Of Ultravate Lotion (Press)
  • Entasis Therapeutics Initiates Clinical Studies of the Oral Extended-Spectrum Beta-Lactamase Inhibitor ETX0282 (Press)
  • ICON Announces Clinical Research partnership with DuPage Medical Group (Press)
  • Beam Therapeutics Founded by Gene Editing Pioneers to Create Precision Genetic Medicines with Base Editing (Press)
  • Arrowhead Doses First Hepatitis B Patients in Multiple Dose Portion of Phase 1/2 Study of ARO-HBV (Press)
Medical Devices
  • Google sister company Verily is working on a device that collects blood using tiny exploding needles (CNBC)
  • SurModics acquires Embolitech thrombectomy tech for $5m (MassDevice) (Press)
  • PAVmed licenses cell-sampling device, test to diagnose Barrett’s esophagus (Fierce) (Press)
  • Pierre Fabre forms connected underwear collaboration (Fierce)
  • Boston Scientific presents positive real-world data of SMART Pass on the S-ICD system at Heart Rhythm 2018 (Pharmabiz) (Press)
  • NIH scientists develop novel technique to study brain disease (NIH)
  • Medical Device Co. Owes $2M For Contract Breach, Suit Says (Law360-$)
  • Immunicom's Immunotherapy Product Receives U.S. FDA Breakthrough Device Designation for the Treatment of Cancer (Press)
  • CurveBeam Announces FDA 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System (Press)
  • QT Medical Receives U.S. FDA 510(k) Clearance for Home-use 12-lead ECG (Press)
  • OrthoPediatrics Corp. Announces FDA 510(k) Clearance for its 25th Surgical System, Pediatric Nailing Platform |FEMUR (Press)
  • Agilent Completes Acquisition of Genohm (Press)
  • Baxter Announces U.S. FDA Clearance of New Spectrum IQ Infusion System (Press)
  • Ancora Heart Expands Enrollment of U.S. Early Feasibility Study for the AccuCinch System for Left Ventricular Repair (Press)
  • New Study Demonstrates Feasibility of Novel Mechanical Sensor in Medtronic Micra Transcatheter Pacing System to Detect Atrial Contractions and Restore AV Synchrony (Press)
US: Assorted & Government
  • Addressing Needs of Patients While Stemming the Tide of the Opioid Crisis (FDA)
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices (FDA)
  • June 12, 2018: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • HHS Secretary Remarks on Drug Pricing Blueprint (HHS)
  • Blue districts have higher uninsured rates and more poverty (Axios)
  • Questions Surround ‘America First’ Plan on Overseas Drug Prices (Roll Call)
  • States Ease More Restrictions To Physician Assistants As Team Care Takes Hold (Forbes)
  • Insulin Access and Affordability Working Group: Conclusions and Recommendations (American Diabetes Association)
  • Kushner-backed health care project gets ‘devastating’ review (Politico)
Upcoming Meetings & Events Europe
  • Price cuts secure NHS place for MS drugs (PharmaTimes)
  • Coeliac UK, Innovate UK launch research competition (PharmaTimes)
  • France extends cheese recall after E.coli cases in children (Reuters)
  • Pharmacovigilance Risk Assessment Committee (PRAC): Draft agenda for the meeting on 14-17 May 2018 (EMA)
  • Updated: Human and veterinary medicines: register of licensed manufacturing sites (MHRA)
  • Manipal-TPG make fresh offer for Fortis Healthcare: Sources to ET Now (Economic Times)
  • China's Sinobioway Biomedicine says it will invest nearly $500M on massive biologics site (Fierce)
  • Oxford Performance Materials and JSR Corporation Announce Partnership to Advance OPM Technology Platform Throughout Asia (Press)
  • Pharma exporters still waiting for Rs.1,000 crore IGST refund from govt (Pharmabiz)
  • Industry faces new challenges with the implementation of GST: Badri Narayanan (Pharmabiz)
  • Healthcare sector may touch Rs 8.6 tln by FY22: Report (Economic Times)
  • The Worries of 'Log Kya Kahenge?' on Mental Health (The Wire)
  • CGMP Violations Found at India Facility (PharmTech)
  • Medical Devices Regulatory Priorities In India (Med Device Online)
  • Local medical devices industry wants Modi to encourage indigenous manufacturing (Business Times)
  • As sector grows, medical device makers cry for attention (The New Indian Express)
Australia Canada
  • Canada's Innomar buys regulatory consulting firm Therapeutic Products (The Pharma Letter)
  • Notice: Publication of Update to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations (Health Canada)
General Health & Other Interesting Articles
  • Preventing PTSD: calling Dr. Tetris? (STAT)
  • The obvious way to reduce drug prices that the US is missing (CNBC)
  • Patient Number One At The Front Door Of Free Healthcare In America (Forbes)
  • Initiative Reduces Days Spent in Hospitals and Other Inpatient Facilities (NEJM)
  • New coalition urges greater support for independent docs in value-based payment models (Modern Healthcare)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top 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? Email us at

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

Categories: Recon

Regulatory Focus newsletters

All the biggest regulatory news and happenings.