Regulatory Focus™ > News Articles > 2019 > 7 > Recon: Trump Pulls Plan to Eliminate Certain Drug Rebates; Reckitt Benckiser to Pay $1.4B to Settle

Recon: Trump Pulls Plan to Eliminate Certain Drug Rebates; Reckitt Benckiser to Pay $1.4B to Settle US Opioid Probes

Posted 11 July 2019 | By Michael Mezher 

Recon: Trump Pulls Plan to Eliminate Certain Drug Rebates; Reckitt Benckiser to Pay $1.4B to Settle US Opioid Probes

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • President Trump Withdraws Plan to Eliminate Drug Price Rebates (NYTimes) (STAT) (Reuters) (WSJ) (Politico)
  • Reckitt will pay $1.4B to settle federal probes into marketing of opioid-addiction treatment (STAT) (The Guardian) (Financial Times) (WSJ)
  • Winning the Obamacare Suit Would Be a Disaster for Republicans (Bloomberg) (NYTimes)
  • Faced with a PhIII flop in NASH, Gilead is sequencing 15,000 patients to find new drugs (Endpoints)
  • Biosimilars Continue To Exhibit Market Failure (Forbes)
  • Walgreens expands epinephrine shot partnership as shortage persists (Reuters)
  • California’s stem cell research fund dries up (Science)
  • FDA recalls Medtronic 600-series MiniMed insulin pumps (Star Tribune)
In Focus: International
  • Canada case highlights possible long-term risks of experimental stem cell therapy (STAT)
  • The drugs don't work: a global antibiotics crisis (Financial Times)
  • Indivior raises guidance on strong performance of opioid treatment (Financial Times)
  • M9 Biowaivers Guidance Nearly Harmonised During ICH Meeting (Pink Sheet-$)
  • EU greenlights GSK-Pfizer joint venture (AFP) (Law360-$) (EC)
  • How Australia Could Almost Eradicate H.I.V. Transmissions (NYTimes)
  • WHO Lays Out Five-Year Regulatory Action Plan (Focus)
Pharmaceuticals & Biotechnology
  • FDA new drug approvals in Q2 2019 (Nature)
  • FDA verdict on Sanofi’s Darzalex rival is due in April 2020 (PMLive)
  • Optimizing oncolytic virotherapy in cancer treatment (Nature)
  • Sterile drug maker Nexus launches $250M U.S. manufacturing project (Fierce)
  • GSK hires Branson from Genentech to boost AI team (Fierce)
  • Tiaki hires Bruhn as CEO for Alzheimer's drug discovery push (Fierce)
  • Parexel closes San Diego office, axes 3 and offers others work-from-home roles (Fierce)
  • FDA Issues Draft Guidance on Inactive Ingredient Database (Focus)
  • New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs (Focus)
  • Can Real-World Evidence Be Used To Remove LPAD's Limited Population Designation? (Pink Sheet-$)
  • Analysis: In most of the Big Pharma world, R&D spending towers over revenue from new drugs. Guess who beat the odds (Endpoints)
  • GlaxoSmithKline recruits a new coach and top player for their AI/ML team out of Genentech and MIT (Endpoitns)
  • Alnylam’s Maraganore switches ‘perhaps the best CFO in mid-cap biotech’ with Shire vet Jeff Poulton (Endpoints)
  • After a radical downsizing, Teva beefs up US R&D campus; Tiaki recruits Suzanne Bruhn for the helm (Endpoints)
  • Scripps-led consortium scores $129M NIH grant to work on vaccine for stubborn HIV (Endpoints)
  • Astex vet Neil Thompson looks to build discovery from scratch at rare disease AI upstart out of Cambridge, UK (Endpoints)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Biohaven's CGPR antagonist migraine treatment beats placebo in Phase 3 trial (Pharmafile)
  • New England Journal of Medicine Publishes Positive Phase 3 Data for Emgality® (galcanezumab-gnlm) in Episodic Cluster Headache (Press)
  • Omeros Announces Agreement with FDA on Primary Endpoint for Narsoplimab BLA in Stem Cell Transplant-Associated TMA (Press)
  • Neurocrine Biosciences Announces FDA Acceptance of New Drug Application for Opicapone as an Adjunctive Treatment for Patients with Parkinson's Disease (Press)
  • BioTime Initiates Dosing in Phase I/IIa Clinical Study of OpRegen for Treatment of Dry-AMD Utilizing Orbit Subretinal Delivery System (Press)
Medical Devices
  • Live Case Presentations of Investigational Devices: FDA Finalizes Guidance (Focus)
  • FDA finalizes IDE broadcasting guidance, with concessions to industry (MedTechDive)
  • Cardiologist questions use of Boston Scientific Watchman device (MassDevice)
  • Human factors studies: Considerations for recruiting rare and complex user populations (Emergo)
  • RaySearch Receives FDA Clearance for RayStation 8B Including Machine Learning Functionalities (Press)
US: Assorted & Government
  • How FDA is Regulating E-Cigarettes (FDA)
  • Mass. Gov. Charlie Baker’s plan to curb drug prices strains his relationship with biotechs (STAT)
  • CMS’s new CKD payment models could be mixed bag for drug companies (BioCentury)
  • State drug importation laws undermine the process that keeps our supply chain safe (STAT)
  • No clear answers: Yes, recent actions against Chinese American scientists do pose a threat — but maybe those official concerns about espionage are valid too (Endpoints)
  • International Price Index Will Advance Under New CMMI Chief – If It’s Implemented (Pink Sheet-$)
  • Can a Medicare Advantage insurer be great at drug development for their target audience? (Endpoints)
  • CVS, Walgreens To Lead $23 Billion CBD Market By 2023 (Forbes)
  • GSK Gets 2nd Chance To Argue Preemption In Zofran MDL (Law360-$)
  • Insys May Face Restitution Above $30M Penalty For Kickbacks (Law360-$)
  • PMA Panel Votes: More Than Meets the Eye (FDA Law Blog)
  • More Confirming Than Surprising − CMS DTC Drug Pricing Diktat Fails in Court (Drug & Device Law)
Upcoming Meetings & Events Europe
  • EU Regulatory Roundup: Danish Regulator Bans Staff From Owning Shares in Pharma, Device Companies (Focus)
  • EC Issues Additional Guidance on Device Vigilance System (Focus)
  • Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 55-06/18) (MHRA)
  • Danish cannabis firm quarantines more products from CannTrust (Reuters)
India
  • Pharma players to step up regulatory compliance: Fitch Group (PharmaBiz)
Australia
  • Tocilizumab and hepatotoxicity (TGA)
  • Return unused prescription opioids to your local pharmacy (TGA)
Canada
  • Alberta joins Ontario in pulling some CannTrust weed products (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.
 
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