Regulatory Focus™ > News Articles > 12 > Recon: HHS Defends Drug Pricing Proposal; Mallinckrodt to Spin Off Specialty Generics Business

Recon: HHS Defends Drug Pricing Proposal; Mallinckrodt to Spin Off Specialty Generics Business

Posted 06 December 2018 | By Michael Mezher 

Recon: HHS Defends Drug Pricing Proposal; Mallinckrodt to Spin Off Specialty Generics Business

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Highly Anticipated Moderna Listing Is Seen As Test of New IPOs (WSJ)
  • Bracing For Amazon, Walgreens Launches Next-Day Drug Delivery With FedEx (Forbes)
  • HHS defends key drug pricing proposal (Politico) (CNBC) (HHS)
  • Apple Watch can now detect your irregular heart rhythms and other problems (CNBC) (Wired) (BuzzFeed) (Apple)
  • Congress to Drug Makers: Why Stock Buybacks Over Lowered Drug Prices? (WSJ)
  • Supreme Court to decide a patent case with big implications for small drug makers (STAT)
  • A Common Childbirth Drug Doubles in Price as Shortages Drag On (Bloomberg)
  • The Trump administration called this biotech VC firm a suspicious agent of China. It’s run by U.S. citizens (STAT)
  • Top cancer center’s business deals created a web of conflicts, say ethics experts (STAT)
  • Legendary biotech VC Steven Burrill sentenced to 2.5 years for fraud (STAT) (Endpoints)
  • AbbVie halts late-stage trial for lung cancer drug Rova-T (Reuters) (Endpoints)
  • Supernus Pharma's ADHD treatment meets main goal in two studies (Reuters)
  • Infant ibuprofen recalled from Walmart, CVS, Family Dollar (CBS)
In Focus: International
  • Sanofi plans 670 job cuts in France by end 2020 (Reuters) (Fierce)
  • Bayer Lays Out Plans in Hopes of Easing Investor Headaches (WSJ)
  • Mallinckrodt plans to spin off specialty generics business (Reuters)
  • UK life sciences gets some Brexit relief with £1.3bn sector deal (PMLive) (Press)
  • EC establishes €100 million partnership to boost research into rare diseases (European Commission)
  • Genomics England reaches 100,000th genome sequencing milestone (PMLive)
  • UK MHRA Considers Additional Inspection Fees For Non-Compliance (Pink Sheet-$)
  • Doctors Without Borders Seeks To Undo Gilead Hep C Patent (Law360-$)
  • Hexal Sues EMA Over Refusal To Accept Generic Aubagio Filing (Pink Sheet-$)
Pharmaceuticals & Biotechnology
  • The Most Wonderful Mistake the FDA Ever Made (Medpage)
  • Seattle’s Impel NeuroPharma bags $67.5M crossover raise for a round of new drug/device CNS clinical trials (Endpoints) (Fierce)
  • Cost keeps many diabetics from taking needed insulin (Reuters)
  • Novo keeps adding capacity, and jobs, to its North Carolina drug plant (Fierce)
  • The Future Of Cancer Care: A 50 Minute Discussion At Forbes (Forbes)
  • New report shows nearly 300 cell and gene therapies in development (PhRMA)
  • Joining hunt for hep B cure, Brii Bio inks maiden deals featuring VBI, Vir, WuXi with a big appetite for more (Endpoints)
  • Xenotransplantation firm eGenesis hires Wes Westlin as R&D head (Fierce)
  • Drugmakers Call for Clarification of FDA’s Postapproval Change Guidance (FDANews-$)
  • In search of biotech hub glory, the Big Apple lures local startups with lab space (Endpoints)
  • Unintended Consequences Of Broad Opioid-Sparing Claims Worries US Panel (Pink Sheet-$)
  • Five Industry Trends for U.S. Drug Wholesalers in 2019 (Drug Channels)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • While we wait for NASH data, Genfit reports positive elafibranor data in PBC patients (Endpoints) (Fierce)
  • Puma Biotechnology Presents Results from the Hormone Receptor Positive Subgroup in Phase III ExteNET Trial of Neratinib for HER2-Amplified, Early Stage Breast Cancer at the 2018 San Antonio Breast Cancer Symposium (Press)
  • Puma Biotechnology Presents Results from the Phase II SUMMIT Trial of Neratinib for ERBB2 (HER2) Mutant, HER2 Non-Amplified, Metastatic Breast Cancer at the 2018 San Antonio Breast Cancer Symposium (Press)
  • Puma Biotechnology Presents Results of Patient Reported Outcomes in Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2018 San Antonio Breast Cancer Symposium (Press)
  • Iterion Therapeutics Initiates Phase I Clinical Study of Tegavivint in Patients with Desmoid Tumors (Press)
  • Spectrum Pharmaceuticals Announces Results from the RECOVER Phase 3 Study of ROLONTIS® (eflapegrastim) at the 2018 SABCS Annual Meeting (Press)
  • Sub-Group Analysis of Novocure’s EF-14 Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Published in Journal of Neuro-Oncology Demonstrating More Time on Optune® Predicted Increased Survival (Press)
Medical Devices
  • Broad Coalition of Health Care Organizations Urge Repeal of Medical Device Tax (AdvaMed) (Letter)
  • FDA panel votes in support of Impulse Dynamic’s cardiac contractility modulation pulse generator (MassDevice)
  • Medtronic updates software for Puritan Bennett 980 ventilators in FDA-labeled Class I field action (MassDevice)
  • Subtle Medical wins FDA nod, CE Mark for SubtlePet AI-powered imaging system (MassDevice)
  • Edwards prioritizes TAVR, TMTT tech in investor day presentation (MassDevice)
  • Pops Diabetes wins FDA clearance for blood glucose monitoring system (Drug Delivery)
  • Alimera Sciences wins Health Canada nod for diabetic macular edema implant (MassDevice)
US: Assorted & Government
  • OIG report catches $34m in CMS overpayments to med device suppliers over 3 years (MassDevice) (OIG)
  • Actelion to pay $360M for illegal kickbacks (DOJ)
  • Missouri governor calls for 'long-overdue' drug-monitoring database to curb opioid abuse (St. Louis Public Radio)
  • Drug Design Defect Litigation Faces Its Demise (Law360-$)
  • Sens. Set Meeting To Talk Revamp Of Patent Eligibility Law (Law360-$)
  • Fresenius Hits Akorn 'Disaster' In $4B Del. Merger Appeal (Law360-$)
  • Orphan Report: The GAO’s Report on Orphan Drug Designations and Approvals (FDA Law Blog)
  • A Couple of MDL Ideas from the Recent ACI Drug/Device Conference (Drug & Device Law)
Upcoming Meetings & Events Europe
  • Medicines: licensing time-based performance measures (MHRA)
Asia India
  • Patients unhappy with proposed compensation formula for faulty Johnson & Johnson hip implants (Economic Times)
  • IDMA seeks phase-wise implementation of pharmacovigilance inspection programmes (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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