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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• The Parent Has a Cancer Gene—Should the Child Get Surgery? (WSJ-$)