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

• 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)

• 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)

• 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• FDA Issues Draft Guidance on Inactive Ingredient Database (Focus)
• New FDA Draft Guidance Helps Sponsors Revise or Develop New USP Monographs (Focus)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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Pharma players to step up regulatory compliance: Fitch Group (PharmaBiz)

• Tocilizumab and hepatotoxicity (TGA)
• Return unused prescription opioids to your local pharmacy (TGA)

• Alberta joins Ontario in pulling some CannTrust weed products (Reuters)