Recon: Top-line results for Phase III trial of cholesterol drug

Posted 07 March 2018 | By Zachary Brennan 

Recon: Top-line results for Phase III trial of cholesterol drug

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

In Focus: US
  • Probe Into Generic Drug Price Fixing Set To Widen (NPR)
  • Opioid overdoses spike 30 percent, hospitals report (CBS News) (The Hill)
  • FDA chief wants more mail inspectors to stem opioid influx (AP)
  • Liquid Biopsies Not Ready for Prime Time (MedPage Today)
  • How the ‘right-to-try’ movement muscled its way into Washington (Stat)
  • Opioids vs. NSAIDs for chronic back or arthritis pain (Reuters) (JAMA)
  • HIV approval thrusts Theratechnologies into the limelight (EP Vantage)
  • Esperion Announces Positive Top-Line Results from First Pivotal Phase 3 Study of Bempedoic Acid (Press) (Endpoints) (CardioBrief)
  • FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world (FDA) (Mass Device)
  • FDA approves first tests to screen for tickborne parasite in whole blood and plasma to protect the U.S. blood supply (FDA)
  • Kratom additional death adverse events (FDA)
In Focus: International
  • EMA recommends immediate suspension and recall of multiple sclerosis medicine Zinbryta (EMA) (Reuters)
  • Ristempa withdrawal in the European Union (EMA)
  • Regulatory information – adjusted fees for applications to EMA from 1 April 2018 (EMA)
  • Nigerian Lassa fever outbreak tops 1,000 suspected cases (CIDRAP)
  • Martin Shkreli ran unmonitored drug trial in Cyprus: court docs (NY Post) (Endpoints)
Pharmaceuticals & Biotechnology
  • Cell therapy flotations could follow Kite and Juno buyouts (EP Vantage)
  • Why can’t the drug industry solve its gender diversity problem? (C&EN)
  • Policy Proposal: Revising Medicare’s Protected Classes Policy (Pew)
  • Michigan Governor Signs Legislation Allowing Biosimilar Substitution (Center for Biosimilars)
  • Novartis expands alliance with Science 37 to advance virtual clinical trials program (Press) (Reuters)
  • Gene therapy had banner year in 2017 with 164% funding boost to $4.5 billion (MedCity News)
  • SF tech startup Atomwise gets $45M for AI-powered drug design software (Endpoints) (Xconomy)
  • Metavant makes a debut: Vivek Ramaswamy launches biotech #7 and builds a diabetes pipeline with Ligand deal (Endpoints) (Fierce)
  • STEMCELL Technologies Signs Exclusive License with IU Innovation and Commercialization Office for Inner Ear Organoid Technology (Press)
  • PE-backed CMO expands syringe filling capabilities (Outsourcing-Pharma)
  • Drug compounder seeks FDA restraining order, agency takes legal action (Outsourcing-Pharma)
  • Marinus Pharma finds the biotech imitation game can only last so long (Stat-$)
  • Aptose Biosciences Announces Exclusive License Agreement for Dual BET/Kinase Targeting Program With OHM Oncology (Press) (Fierce)
  • Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Methylprednisolone Sodium Succinate for Injection, USP, 40mg, 125mg, and 1g Due to High Out of Specification Impurity Results (FDA)
  • AGC Biologics expands capacity (Contract Pharma)
  • Preparing for the Next Public Health Emergency (BIO)
  • Clearside Biomedical floats $75m public offering (Mass Device)
  • Perrigo Announces Final FDA Approval and Planned Launch for the Store Brand OTC Equivalent of Mucinex DM Maximum Strength Extended Release Tablets (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Gilead backs Biktarvy charge with new switching data (PharmaLetter-$)
  • GlaxoSmithKline's Fluarix protects young children in large phase 3 test (Fierce)
  • Lilly, Boehringer add two Jardiance heart failure studies to examine effects on exercise (Fierce)
  • Building a CAR Garage: Preparing for the Delivery of Commercial CAR T Products at Memorial Sloan Kettering Cancer Center (Biology of Blood and Marrow Transplantation)
  • Heart benefit now a baseline for Invokana and all diabetes drugs (EP Vantage)
  • Summit Expands Enrolment in PhaseOut DMD Phase 2 Clinical Trial to Include Planned Additional Group (Press)
  • Seattle Genetics Initiates New Phase 1 Study in Relapsed or Refractory Multiple Myeloma (Press)
  • Anti-TNF Therapy Holds Promise for Patients With Coexisting Lupus and RA (Center for Biosimilars)
  • Aevi Genomic Medicine Expands Collaboration with Kyowa Hakko Kirin (Press)
  • Global, regional, and subregional trends in unintended pregnancy and its outcomes from 1990 to 2014: estimates from a Bayesian hierarchical model (The Lancet)
Medical Devices
  • 23andMe Will Now Test for BRCA Breast-Cancer Genes (Atlantic) (Focus) (NYT)
  • Stryker’s Spine Division Receives FDA Clearance for 3D-Printed Tritanium TL Curved Posterior Lumbar Cage (Press)
  • Not All Tests Created Equal: AdvaMedDx Response to JAMA Oncology Article (AdvaMed) (JAMA)
  • Orthofix Secures FDA and CE Mark Approvals for New PhysioStim Bone Growth Stimulators (Press)
  • 9 orthopedic products from AAOS 2018 you need to know (MassDevice)
US: Assorted & Government
  • FDA Releases DSCSA Draft Guidances on Standardization of Data and Documentation Practices for Product Tracing and Definitions of Suspect and Illegitimate Products; FDA Hints at a New Proposed DSCSA Preemption Regulation (FDA Law Blog)
  • HHS official who spread conspiracy theories allowed back on job (Politico)
  • Science & Technology Highlights in the First Year of the Trump Administration (White House)
Upcoming Meetings & Events
  • FDA Advisory Committee Calendar
  • Study Design Considerations for Devices Including Digital Health Technologies for Sleep Disordered Breathing in Adults; Public Workshop; Request for Comment (Federal Register)
  • Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza (E&C)
  • Cancer vaccine startup Oxford Vacmedix taps Asian syndicate for series A cash (Fierce)
  • Special Report: The Smoke & Mirrors Surrounding the Approval of Bedaquiline (SpicyIP)
  • Retail prices of syringes marked up as much as 664%, shows new report (Economic Times)
General Health & Other Interesting Articles
  • The Parent Has a Cancer Gene—Should the Child Get Surgery? (WSJ-$)
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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