Regulatory Focus™ > News Articles > 2019 > 8 > Recon: Trump’s Canada Drug Import Plan Needs Pharma’s Cooperation; Top HHS Drug Pricing Advisor to D

Recon: Trump’s Canada Drug Import Plan Needs Pharma’s Cooperation; Top HHS Drug Pricing Advisor to Depart

Posted 13 August 2019 | By Michael Mezher 

Recon: Trump’s Canada Drug Import Plan Needs Pharma’s Cooperation; Top HHS Drug Pricing Advisor to Depart

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Deciphera shares skyrocket as cancer drug improves progression-free survival (Reuters) (Endpoints) (Press)
  • Trump’s Canada Drug Import Plan Can’t Happen Without Big Pharma (Bloomberg)
  • Trump's key drug pricing advisor O'Brien makes HHS exit (Endpoints)
  • Senator Grassley seeks info on Novartis's Zolgensma data issues (Reuters) (Endpoints) (Letter)
  • Questions Pile up for Novartis as Senators Call on FDA to Take Action (Focus)
  • DNA Data Shared in Ways Patients May Find Surprising (WSJ)
  • Hepatitis A Races Across The Country (KHN)
  • Ads Pitching CBD as a Cure-All Are Everywhere. Oversight Hasn’t Kept Up. (NYTimes)
  • Vertex, known for cystic fibrosis drugs, sets its sights on taming pain (STAT)
  • Humana lawsuit targets Mallinckrodt's 'billion-dollar golden goose' (PMLive)
  • Eli Lilly's Taltz bests J&J rival Tremfya in head-to-head psoriasis tilt (Fierce)
Sponsored Content: Hear from the first Notified Body designated to the new EU-MDR In Focus: International
  • Novartis offloads a late-stage PI3Kẟ rare disease program in a discount deal (Endpoints) (Fierce)
  • Boehringer Ingelheim forms ‘virtual research’ alliance with MD Anderson (PMLive)
  • UK Seeks Cargo Planes To Fly In Post-Brexit Medicines Supplies (Pink Sheet-$)
  • Embattled Sun Pharma’s Dilip Shanghvi, with Rs 1 salary, ranks among lowest-paid pharma CEOs (Fierce)
  • Excessive Drug Pricing: Biogen’s Spinraza Referred To Italian And Belgian Competition Authorities (Pink Sheet-$)
  • Janssen Announces EC Approval of Imbruvica for Expanded Use in Two Indications (Press)
  • ICH Hires Trainers As Emerging Authorities Strive To Harmonize (Pink Sheet-$)
  • Daiichi-Sankyo, Bayer, Otsuka and Others Called Out for UK Advertisement Breaches (Focus)
Pharmaceuticals & Biotechnology
  • Ground rules for embryo edits (Politico)
  • It's The Go-To Drug To Treat Opioid Addiction. Why Won't More Pharmacies Stock It? (NPR)
  • To Find The Next Antibiotic, Scientists Give Old Drugs A New Purpose (NPR)
  • New Research Questions FDA’s Reliance on and Inability to Enforce Postmarketing Requirements (Focus)
  • Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity (Focus)
  • First chlamydia vaccine tested in humans shows early promise (NBC)
  • Toddler denied $2.1m gene therapy will now get it for free (STAT)
  • Intensive blood pressure control may slow age-related brain damage (NIH)
  • FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo) (FDA)
  • Enterovirus antibodies detected in acute flaccid myelitis patients (NIH)
  • Regeneron's pre-filled Eylea syringe makes the FDA cut; CureVac inks pact with Yale (Endpoints) (Fierce)
  • Plugging in the last piece to its gene therapy puzzle, AskBio acquires Scottish synthetic promoter company (Endpoints)
  • Gilead, US FDA Ponder Innovative Designs For Descovy HIV Prevention Study In Women (Pink Sheet-$)
  • Combination Product Reporting Rule Set For 2020 Enforcement (Pink Sheet-$)
  • Do Black Boxes Work? US FDA Survey Would Test Impact On Prescribers (Pink Sheet-$)
  • Biosimilars Sponsors Seek Changes In US FDA Guidance On Comparative Analytical Assessments (Pink Sheet-$)
  • MSD teams up with Harvard University to discover novel immune system pathways to fight cancer (Pharmafile)
  • Few Americans took obesity drugs thanks to doctor doubts and spotty insurance (STAT)
  • Making things personal: Roche and personalised medicine (Pharmafile)
  • Make that 2 new US Big Pharma chiefs today, as Novartis remakes top team (Endpoints)
  • IBD startup Landos lands $60M Series B in first test case of Chris Garabedian's lean and mean model at Xontogeny (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Terns Pharmaceuticals Announces Positive Interim Results From Ongoing Phase 1 Clinical Trial of TERN-201, a SSAO Inhibitor in Development for NASH (Press)
Medical Devices
  • FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB (MassDevice) (Press)
  • Misonix lands CE Mark for Nexus ultrasonic platform (MassDevice)
  • Novocure’s Optune wins innovative medical device designation from China (MassDevice)
  • FDA slaps Class I label on Fresenius Kabi USA infusion pump recall (MassDevice)
  • Class 1 Device Recall Centurion Primary Set Pack Convenience Kit, Centurion Primary Warmer Pack Convenience Kit (FDA)
  • Class 1 Device Recall Medline Primary Warmer Pack (FDA)
  • Class 1 Device Recall Vigilant Agilia, Vigilant Drug'Lib (FDA)
  • Class 1 Device Recall VOLUMAT MC AGILIA US (FDA)
US: Assorted & Government
  • Amgen Wins Enbrel Patent Suit Preventing Sandoz Biosimilar Launch (Focus)
  • Grassley Calls for More Unannounced Foreign Drug Inspections From FDA (Focus)
  • Seema Verma warns on individual insurance market (Politico)
  • Drinking bleach will not cure cancer or autism, FDA warns (NBC) (FDA)
  • Screen All Adult Patients for Drug Abuse, National Panel Urges (NYTimes)
  • Bringing transparency to the notion of price transparency (STAT)
  • Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019) (Patent Docs)
  • Clean Sweep of Plaintiffs’ Causation Experts in Gadolinium Litigation (Drug & Device Law)
  • Akorn Seeks OK On $30M Deal Over Failed Merger (Law360-$)
Upcoming Meetings & Events Europe
  • Romanian Agency Reorganizes To Boost Performance & Face Brexit Challenge (Pink Sheet-$)
  • Asia Regulatory Roundup: China Approves Gilead HIV Drug Within 18 Months of EMA and FDA (Focus)
  • Health ministry asks medical device manufacturers to register at information sharing portal as part of MvPI (Pharmabiz)
  • Exporters ask govt to reduce timeline for granting manufacturing license for pharma producers (Pharmabiz)
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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