Recon: FDA Approves First Blood Thinner for Pediatric Use

• FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots (FDA)
• Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia (Reuters) (Press)
• Gilead CEO to testify before a House committee about pricing for its HIV prevention pill (STAT)
• Novartis may be close to settling a kickback case on the eve of a trial (STAT)
• Analysts spotlight the winners — and losers — on ASCO preview night (Endpoints)
• Biotech in the spotlight as pharma takes back seat at ASCO (BioPharmaDive)
• Genentech lines up a new autoimmune R&D alliance on a ‘potentially transformative’ tech (Endpoints)
• A Rival to Botox Invites Doctors to Party in Cancun, With Fireworks, Confetti and Social Media Posts (NYTimes)
• FDA schedules Aimmune's peanut allergy drug for September expert review (BioPharmaDive) (Press)
• The Met Will Turn Down Sackler Money Amid Fury Over the Opioid Crisis (NYTimes)
• Swarms of Bugs, Missing Data Plague Firms Now Making Heart Drug (Bloomberg)
• US drug pricing is in need of an overhaul (Financial Times)
• House Democrats ready to jam GOP on drug pricing vote (Politico)

• UK cancer programme to target treatment resistance (Financial Times) (BBC) (Endpoints) (Reuters)
• Pharma is making progress addressing global health, but it’s still a mixed bag (STAT) (Financial Times)
• Opioids crisis has spread beyond United States: OECD (Reuters)
• Nestlé Enters Exclusive Talks to Sell Skin-Health Business (WSJ) (Fierce)
• Will drugs companies follow EU agency from London to Amsterdam? (Financial Times)
• EMA Undertook 14 RWE Studies In 2018 To Complement Company Data (Pink Sheet-$)
• Brexit Relief For Pharma As EMA Grants Most Batch Testing Exemptions (Pink Sheet-$)
• EC Approves Celgene’s Revlimid and Imnovid Regimens for Multiple Myeloma (Press)
• European Commission Confirms Quality of South Korean Active Substances (Focus)
• J&J to invest €100 million into Limerick manufacturing facilities creating 100 new jobs (Pharmafile)
• Thermo Fisher snaps up GSK site in Ireland as part of its expansion campaign (Fierce)
• New HIV Map Offers Most Detailed Look Yet At The Epidemic (NPR)
• 'Hidden health crisis' of snakebites gets $100 million funding injection (Reuters)

• People should be able to get health care without going bankrupt, GoodRx co-CEO says (CNBC)
• Shaped like a tennis ball, this cancer protein was thought ‘undruggable.’ Amgen found a way to target it (STAT) (Fierce)
• FDA to Follow DOJ Memo on Limiting its Regulation of Execution Drugs (Focus)
• FDA Unveils 34 New and Revised Product-Specific Draft Guidances (Focus)
• Risk-Based Monitoring: Pfizer and BMS Seek Clarity on FDA Draft Guidance (Focus)
• Gottlieb: Lack Of Compromise On Right-To-Try Bill Is 'Interesting Lesson In Politics' For Stakeholders (Pink Sheet-$)
• Gilead seeks to keep the CAR-T ball rolling at ASCO (PharmaLetter-$)
• Defining REMS Success An Unanswered Question For Daiichi's Pexidartinib (Pink Sheet-$)
• Anything You Can Do I Can Do (Better?): Demonstrating Biosimilar Interchangeability (FDA Law Blog)
• ASCO data won't help AZ's Calquence rival Imbruvica in CLL: analyst (Fierce)
• Drug Prices In TV Ads: How Transparent Are They? (Forbes)
• Why a pharma investor quit his day job to follow a vision (Guest interview) (EFPIA)
• Best Pathway To Interchangeable Insulins Is In The Eye Of The Beholder (Pink Sheet-$)
• Insulin Biosimilars: US FDA Hears Wide Range Of Views From Small Set Of Sponsors (Pink Sheet-$)
• Installment payments could be used across gene therapy space, Spark CEO says (MedCity)
• Xellia to produce antibiotics for hospital-backed Civica Rx (Fierce)
• As Daiichi Sankyo-partnered breast cancer drug marches toward finish line, AstraZeneca brings in Canadian scientist Sunil Verma to rev up R&D (Endpoints)
• Essa strikes deal to buy Realm, gaining cash to fund cancer R&D (Fierce)
• Can a little known drug in AstraZeneca’s pipeline make a comeback as a PARP add-on? Yale scientists explain how (Endpoints)
• After a long march with Cabo, Exelixis is expanding its focus with an antibody-drug conjugate deal (Endpoints)
• Benzodiazepines in early pregnancy tied to heightened risk of miscarriage (Reuters)

• Roche’s personalised medicine entrectinib shrank tumours harbouring NTRK, ROS1 or ALK gene fusions in children and adolescents (Press)
• AZ confirms cardiovascular safety with roxadustat results (PharmaTimes)
• Pfizer Oncology to Showcase New Data from Innovative Science That Address Patient Needs at ASCO 2019 Annual Meeting (Press)
• Sanofi oncology pipeline targeting various cancers highlighted at ASCO 2019 (Press)
• Bayer presents new analyses for Vitrakvi® (larotrectinib) in adult and pediatric patients with TRK fusion cancer with solid tumors, and new data in primary central nervous system tumors and brain metastases (Press)
• Updated Libtayo® (cemiplimab-rwlc) Results Reinforce Durable and Substantial Response Rates in Advanced Cutaneous Squamous Cell Carcinoma (Press)
• Phase III Study Results for HP-3070 (Asenapine) Transdermal Patch for the Treatment of Schizophrenia to be Presented at the Society of Biological Psychiatry 74th Annual Meeting (Press)
• Tempest Therapeutics Starts Phase I/Ib Clinical Trial with First-in-Class PPAR Alpha Antagonist (Press)
• Verastem Oncology to Present New COPIKTRA™ (Duvelisib) Dose Modification Data from Patients Treated in the Phase 3 DUO Study (Press)
• ALX Oncology to Present ALX148 Clinical Data at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Press)
• New Data From the Phase I Study of Birinapant in Combination With Keytruda® Will be Presented at the ASCO 2019 (Press)
• Alligator Bioscience: ADC-1013 Clinical Phase I Data to be Presented at ASCO (Press)
• IMV to Present New Data at 2019 ASCO Annual Meeting From Its Phase 2 Clinical Trial Evaluating DPX-Survivac in Ovarian Cancer (Press)
• ImaginAb Enrolls First Patient in Phase II Clinical Trial at a World-Leading Cancer Center in Los Angeles County (Press)
• Dicerna Announces Dosing of First Patient in Phase 1 Clinical Trial of DCR-HBVS for the Treatment of Chronic Hepatitis B Virus (Press)

• FDA Updates on Essure Postmarketing Study (Focus)
• Experimental brain-controlled hearing aid can pick out voices in a crowd (STAT)
• DiaSorin Molecular Gets CE Mark for Herpes Virus Assay (GenomeWeb)
• Gene Sequencing Co. ArcherDX Scores $60M Funding Round (Law360-$)
• Medtronic Launches Telescope(TM) Guide Extension Catheter to Support Complex Coronary Cases (Press)
• Masimo Announces FDA Clearance of Radius PPG™, the First Tetherless SET® Pulse Oximetry Sensor Solution (Press)

• In Washington, a partisan approach to lowering drug costs leaves Democrats doubting their own party leadership (STAT)
• BD’s CareFusion Agrees to $3.3M DOJ Settlement Over Unapproved Devices (Focus)
• Five more US states sue Purdue Pharma over its role in opioid crisis (The Guardian)
• Federal judge orders FDA to start regulating e-cigarettes (The Hill)
• Letter to the House Committee on Oversight and Reform (Yale School of Medicine)
• Submarine Exclusivity: Unseen Risk For 505(B)(2) Applications (Lassman Law+Policy)
• Senate working group releases surprise medical bills legislation (Politico) (Cassidy)
• Trump’s Talk On Preexisting Conditions Doesn’t Match His Administration’s Actions (KHN)
• CVS Health to Require Third-Party Testing of Vitamins, Supplements (WSJ)
• Public Health Law Watch Files Amicus Brief in Opiate MDL (Harvard Bill of Health)
• Another Blow Against “Loose And Spurious” Personal Jurisdiction In Missouri (Drug & Device Law)

• FDA Advisory Committee Calendar

• Genus shares surge on deal to market gene-edited pigs in China (Reuters)

• Indian pharma at the crossroads as US cracks the whip (livemint)
• Maha FDA proposes to DCGI for inclusion of color coding to track medicines for govt healthcare institutions (PharmaBiz)

• Final Report: Fees for Drugs and Medical Devices (Health Canada)
• Performance Standards for the Fees in Respect of Drugs and Medical Devices Order (Health Canada)

• Webinar recording: SME Assist - Permitted indications for listed medicines, March 2019 (TGA)

• Brain training shows promise as a treatment for veterans’ cognitive problems after TBI (STAT)
• New Organ Transplant Rules Mean Livers Ship To Sickest Patients Not Nearest (NPR)