Recon: Gilead Enlists Insitro to Develop Experimental NASH Drugs

• Gilead teams up with Insitro for experimental NASH treatments (Reuters) (STAT) (Endpoints) (Press)
• J&J’s first-quarter earnings drop 14% as legal costs soar (CNBC)
• FDA’s Woodcock on developing neuromuscular drugs: ‘We have to change our approach’ (STAT)
• The health policy experts shaping Nancy Pelosi’s approach to drug pricing (STAT)
• Amgen sets $21,900 annual price for new Evenity bone drug (Reuters) (Endpoints)
• Don’t Count on 23andMe to Detect Most Breast Cancer Risks, Study Warns (NYTimes)
• Patients, Doctors Must Be Warned About Risk of Spinal Fractures Soon After Stopping Osteoporosis Medication (Public Citizen)
• First US Patients Treated With CRISPR As Gene-Editing Human Trials Get Underway (NPR)
• Months after Regeneron secured FDA approval for 12-week Eylea regimen, Novartis buys speedy US review for its rival (Endpoints)
• Gottlieb, Biosimilars Companies And Consultants Reject Price Control Proposal (BioCentury)
• Achaogen Eyes Sale in Bankruptcy Auction a Year After FDA Approval (Xconomy) (Fierce) (Endpoints)
• Families Use Apps to Track Relatives With Dementia (WSJ)
• Brooklyn parents sue over measles vaccination mandate (The Hill)

• Chinese pharmaceutical manufacturer in spotlight after welding accident kills 10 (Endpoints) (Fierce)
• Researchers claim they've 3D-printed artificial heart using patient's cells (CBS)
• DNDi and Atomwise Collaborate to Advance Drug Development Using AI for Neglected Diseases (DNDi)
• In African Villages, These Phones Become Ultrasound Scanners (NYTimes)
• Pharma Told To Maintain Drug Stockpiles Despite Six-Month Brexit Delay (Pink Sheet-$)
• Government will 'review its position' on no-deal Brexit drug stockpiles (Pharmaceutical Journal)
• EMA closed 18-22 April 2019 (EMA)
• Akcea steals march on Alnylam with NICE approval (PMLive)
• EU Clarifies Interplay Between CTR And GDPR (Pink Sheet-$)
• Doubts Over Impartiality Trigger New EMA Estradiol Cream Safety Review (Pink Sheet-$)
• Ionis' Tegsedi gets a U.K. boost after NICE reverses initial guidance (Fierce)
• Pharmacy regulator sets safety rules for online drugs purchases (The Guardian)
• Genomics England completes first phase of liquid biopsy study (PharmaTimes)
• Invossa Gene Therapy Controversy Grows As Government, Patients Take Action (Pink Sheet-$)

• Industry Calls for Changes in Two REMS Guidances (Focus)
• Study Finds No Benefit for Dietary Supplements (NIH)
• Cannabis users may need more anesthesia for surgery (Reuters)
• Janssen's Invokana combo smashes primary and secondary endpoints in chronic kidney disease (Pharmafile)
• E-labeling: BIO Comments on Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (BIO)
• June Wasser Departs Reagan-Udall Foundation for the FDA (Reagan-Udall Foundation)
• Vocabulary Change: CDER Eliminating 'Review' For NDAs And BLAs (Pink Sheet-$)
• Insys Therapeutics names current CFO Andrew Long as company's new CEO (Pharmafile)
• US FDA's Complex Trial Design Pilot May Change 'Ambitious' Timelines (Pink Sheet-$)
• Life-course vaccination can protect adults from infectious disease (STAT)
• FDA Urged to Clarify Voluntary Quality Standards for Combination Products (FDANews-$)
• As Drug Resistance Grows, Amplyx Tests New Antifungal Drug (Xconomy)
• What Will Happen When Rebates Go Away? Look At Authorized Generics (Pink Sheet-$)
• ACRO expands membership with addition of three digital technology companies (ACRO)
• Big spending from AbbVie, Pfizer pushes pharma's 2018 ad spend to $6.5B (Fierce)
• Don't Just Blame Drug Companies for the Opioid Crisis... (Medpage)
• Ophthotech becomes Iveric in pivot to gene therapies (Fierce)
• Non-Hodgkin lymphoma therapy landscape (Nature)
• Half of patients have sub-optimal response to statins, research shows (Pharmafile)
• Ex-Blueprint R&D exec takes up CMO post at Meeker's CRISPR biotech (Fierce)
• Early Alzheimer's biotech, late-stage heart drug company gun for $86M IPOs (Fierce)
• Startup Spotlight: Flagship reveals Kintai Therapeutics — yet another microbiome company (STAT) (Endpoints)
• Adverum Bio offers a late notification about FDA hold on lead gene therapy for wet AMD (Endpoints)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review (FDA)
• FDA Cites Hawaii PET Drugmaker for Quality Violations (FDANews-$)

• FDA Grants Orphan Drug Designation Status to NeoImmuneTech’s Hyleukin-7 for Idiopathic CD4+ Lymphocytopenia Treatment (Press)
• Aprea Therapeutics Receives FDA Fast Track Designation and Orphan Drug Designation for APR-246 for the Treatment of Myelodysplastic Syndromes (MDS) (Press)
• Novartis announces FDA filing acceptance and Priority Review of brolucizumab (RTH258) for patients with wet AMD (Press)
• Sinovac Announces Positive Results From Phase III Trial Of a Sabin Strain-Based Inactivated Polio Vaccine (sIPV) Published in the Journal of Infectious Disease (Press)
• BioTime to Present Data from OpRegen® Phase I/IIa Clinical Study at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2019) (Press)
• Phase 2B GI Safety Results For ATB-346 Published in British Journal of Pharmacology (Press)
• Cortexyme Announces Phase 2/3 Clinical Trial Based on Transformational Understanding of Alzheimer’s Disease Now Open for Enrollment (Press)
• First patient dosed in Phase III GEMSTONE-303 study for CS1001 in combination with chemotherapy in first-line gastric adenocarcinoma and gastro-esophageal junction adenocarcinoma (Press)
• Audentes Therapeutics Announces Upcoming Presentations at 22nd Annual Meeting of the American Society of Gene and Cell Therapy Including New Data from ASPIRO, the Phase 1/2 Clinical Trial of AT132 in Patients with X-Linked Myotubular Myopathy (Press)

• Sterilization Facility Closure Leads to First Device Shortage (Focus)
• Brainlab AG Recalls Spine & Trauma 3D Navigation Due to Inaccurate Display That May Result in User Misinterpretation (FDA)
• Investigational site and personnel selection for medical device clinical studies (Emergo)
• Inova Decides to End PGx Test Offerings in Response to FDA Warning Letter (GenomeWeb)
• Class 1 Device Recall Spine & Trauma 3D Navigation 1.0 (FDA)
• Penumbra VR device wins FDA clearance (MassDevice)
• Glaukos touts 5-year study of glaucoma stents (MassDevice)
• US FDA issues finalized list of Class I medical device accessories (Emergo)

• Judge Will Let Cameras Roll In Okla. Opioid Trial (Law360-$)
• UnitedHealth beats first-quarter profit estimates and raises its 2019 forecast (CNBC)
• Partnership For Safe Medicines Launches Advertising Campaign In Florida To Oppose Importation (Press)
• The Road to 2020: Understanding the Regulatory Timeline for Part D Rebate Reform (Drug Channels)
• After Bernie’s Tweet, UnitedHealth’s CEO Describes ‘Wholesale Disruption’ Of Medicare For All (Forbes)
• Watchdog calls on CMS to improve nursing home oversight (Politico)
• Hard to Stay Ahead of the Wins . . . Good Problem to Have (Drug & Device Law)

• FDA Advisory Committee Calendar
• FDA-PDS Symposium – 17 April 2019
• Statistical Issues in Regulatory Submissions: Learning from the MHRA experience – 10 June 2019
• Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities – 12 June 2019

• EU Device Coordination Group Offers Eudamed Guidance (Focus)
• Medicines and Healthcare products Regulatory Agency spending over £25,000: 2018 to 2019 (MHRA)
• Annual review of good clinical practice referrals (MHRA)

• Report: Taiwan’s NHIA accuses hospitals of overbilling for da Vinci procedures (MassDevice)

• Health Canada Implements ICH Guideline on Multi-Regional Clinical Trials (Focus)