Recon: AbbVie Wins FDA Approval for Humira Successor Skyrizi to Treat Psoriasis

• AbbVie's Skyrizi drug to treat psoriasis wins U.S. approval (Reuters) (Endpoints) (Press)
• Novartis mulling $1.5-$5M price range for SMA gene therapy (Reuters)
• A Commerce Department report causes a stir over whether to use federal law to lower drug prices (STAT)
• Biogen sees no need for big changes in wake of Alzheimer’s drug setback (STAT) (Endpoints) (Financial Times)
• The Unseen Crisis of Drug Shortages (Bloomberg)
• Lowering Cost and Increasing Access to Drugs Without Jeopardizing Innovation (JAMA)
• Popular Heart Drugs Tainted With Carcinogens Face a Wave of Lawsuits (Bloomberg)
• BioMarin’s hemophilia gene therapy faces a crucial durability test. Here are 9 things to know (STAT)
• Pfizer shareholder meeting offers an inside look at the pharma industry (STAT)
• Medicare offers to partially raise payment for cancer CAR-Ts (Reuters) (STAT) (BioPharmaDive)
• Boston Scientific wins FDA approval for Lotus Edge TAVR (MassDevice) (MDDI) (Press)
• GSK to invest $100M in Montana vaccine manufacturing site (BioPharmaDive)
• Pharma lobbyists flood the zone in D.C., with Pfizer and Amgen leading the way (Fierce)
• Federal judge rejects Title X changes (Politico)

• Novartis CEO Narasimhan raids GlaxoSmithKline offices for his new Sandoz chief (Endpoints)
• Novartis upgrades 2019 profit guidance on strong sales growth (Financial Times) (PMLive)
• AstraZeneca chief claims vindication five years after Pfizer bid (Financial Times)
• European Immunization Week 2019: statement by Executive Director Guido Rasi (EMA)
• Drones to deliver vaccines, blood and drugs across Ghana (Reuters) (Financial Times)
• PMDA to Set Up New Consultation Services for RWD Use in Regulatory Submissions (PharmaJapan)

• FDA Works to Improve Voluntary Recall Processes (Focus)
• Arrowhead starts triple-combo hepatitis B test, triggering J&J payday (Fierce)
• Data Integrity Guidance Revisions by FDA and PIC/S Deepen Industry’s DI Resource Pool (IPQ)
• Why Reputation Is More Important Than Ever For Biotech Companies … And What You Can Do About It (LifeSciVC)
• Kite Announces Plans for New State-of-the-Art Facility to Expand Cell Therapy Production Capabilities (Press)
• What does the past generation of failure in Alzheimer’s R&D look like in one slide? (Endpoints)
• Early treatment with gene therapy: lessons from vaccines (STAT)
• Centene: RxAdvance PBM Rollout ‘Seamless’ So Far (Forbes)
• Anthem Adds 900K Members As IngenioRx PBM Rollout Proceeds (Forbes)
• Rare Disease R&D Investments Likely To Grow In Biopharma (Forbes)
• Amid Hype Over Narcan First Generic, A Plea For A Labeling Change (Pink Sheet-$)
• Gracell Bio developing faster, cheaper CAR-T production (PMLive)
• Incensed by China CRISPR scandal, US consortium amplify global call to suspend human embryo editing (Endpoints)
• Pharma and healthcare's digital ad spend to reach $10B next year: report (Fierce)
• Public Meeting to Address FDA’s Benefit-Risk Assessments (Focus)
• Industry Groups Call for Changes to ICH S11 Guideline (Focus)
• ‘Chief bluebird’ Nick Leschly nails a rich $24M compensation bounty as biotech packages soar (Endpoints)
• Pfizer immune-oncology leader joins Aduro Biotech as new CMO (Pharmafile)
• Working Life: Dr Todd Hobbs, Vice President and Chief Medical Officer, Novo Nordisk (Pharmafile)

• Belite Bio Announces FDA Approval of Investigational New Drug (IND) for Phase 1 Clinical Trial of LBS-008 to Treat Macular Degeneration and Stargardt Disease (Press)
• Tiziana Reports Encouraging Interim Clinical Data from an Ongoing Phase 2a Clinical Trial with Milciclib in Patients With Advanced Liver Cancer (Press)
• FDA Grants Competitive Generic Therapy (CGT) Designation to Purdue Pharma’s Investigational Nalmefene HCl Injection for the Emergency Treatment of Known or Suspected Opioid Overdose (Press)
• FDA orphan drug designation granted for Autolus’ acute lymphoblastic leukemia drug (PharmaTimes)
• Knopp Biosciences Receives FDA Orphan Drug Designation for Dexpramipexole for Treatment of Hypereosinophilic Syndrome (Press)
• Innovent Announces First Patient Dosed in Phase I Clinical Trial of IBI318 Bispecific Antibody in China (Press)
• Magenta Therapeutics Announces First Subjects Dosed in Phase 1 Clinical Trial of MGTA-145, a First-Line Stem Cell Mobilization Product Candidate (Press)
• Rexgenero Presents Update on Phase III Clinical Trials with REX-001, a Cell-based Therapy for Critical Limb Ischaemia (Press)
• Provention Bio Completes Enrollment of Phase 2a PRINCE Clinical Trial with PRV-6527 in Patients with Moderate to Severe Crohn's Disease (Press)
• TC BioPharm Initiates Phase I Trial of Allogeneic Gamma Delta T Cell Therapy in Acute Myeloid Leukemia Patients (Press)
• Cavion to Present Results of Phase 2 Essential Tremor Clinical Trial in Platform Presentation at the American Academy of Neurology (Press)

• FDA Warns Abaxis Over Adulterated, Misbranded Assay (Focus)
• FDA Proposes Reclassifying Surgical Staplers (Focus)
• FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products (Focus)
• Merit Medical’s Q1 beats push shares higher (MassDevice)
• Edwards Lifesciences post Street-beating Q1 earnings (MassDevice)
• Boston Scientific’s Q1 numbers miss the mark (MassDevice)
• Integra Lifesciences ticks up on Q1 earnings beat (MassDevice)
• FDA clears AliveCor’s KardiaMobile for bradycardia, tachycardia monitoring (MassDevice)
• Current Health Receives FDA Clearance for its Remote Patient Monitoring Solution for In-Home Care, Demonstrates Reduced Hospital Readmissions (Press)
• Could Secret Sales Bar Your Ability to Patent a Medical Device? (MDDI)

• She Was Fired After Raising Questions About a DNA Test. Now She’s Getting $1 Million (NYTimes)
• Biopharma Battling Drug Price Regulations In Massachusetts (Biocentury)
• Post Script on “Right Rebate” Law (FDA Law Blog)
• Cannabidiol Product Liability Claims Go Up in Smoke (Drug & Device Law)
• Building A Wall? The Plan To End “March In” Threat To US Drug Patents (Pink Sheet-$)
• J&J pay $9.9 million to settle surgical mesh implant case (Pharmafile)
• Allergan Drug Buyers Take One Last Shot At Class Cert. (Law360-$)

• FDA Advisory Committee Calendar
• Hearing On "The Payment Of Prescription Drugs In Medicare Parts B & D" – 30 April 2019
• Antimicrobial Drugs Advisory Committee; Notice of Meeting  - 6 June 2019
• General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting – 30 May 2019
• An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies – 9 May 2019

• LifeArc inks pain medicine development deal with Uni of Kent (PharmaTimes)
• Class 4 Medicines Defect Information: Ativan 4mg/1ml Solution for injection (MDR 57-04/19) (MHRA)

• Tencent-backed China online healthcare venture raises $250 million (Reuters)
• Asia Deal Watch: Shionogi Finds Commercial Partners For Symproic In US, Europe (Scrip-$)

• Health ministry to amend Rule 26 of D&C Rules to mandate import license holders to maintain control samples of imported drugs (Pharmabiz)
• USFDA retains OAI status for Indoco's Goa plant (Economic Times)

• Significant decrease in the amount of codeine supplied to Australians (TGA)

• WHO recommends one-hour maximum screen time per day for under-5s (Reuters)
• German scientists create see-through human organs (Reuters)