Recon: Ziopharm CAR-T Trial Put on Clinical Hold; DMD Trial Hold Lifted

• Elizabeth Holmes indicted on wire fraud charges, steps down from Theranos (CNN) (Slate Magazine) (NYT) (CNBC) (Reuters) (WSJ) (USA Today)
• PTC Therapeutics Up Most Since 2016 on Rare-Disease Drug Results (Bloomberg) (Reuters) (Endpoints) (BioSpace)
• Indivior shares rise after U.S. court order blocks generic rival drug (Reuters) (Fierce)
• After a crushing PhIII failure, Cytokinetics says its next-gen muscle drug is lining up well in PhII — but big challenges loom (Endpoints) (BioSpace)
• FDA hits Ziopharm CAR-T trial with clinical hold (Fierce) (BioSpace) (Endpoints)
• FDA Lifts Clinical Hold on Solid Bio DMD Gene Therapy Trial: Shares Jump (BioSpace) (Endpoints)
• CAR-T startup Allogene Therapeutics picks up veteran analyst Eric Schmidt as CFO (STAT) (Fierce)

• Sanofi Agrees to Transfer Infectious Disease Unit, 100 Employees to Evotec (GEN) (Fierce)
• Displaying confidence in plant upgrades, Celltrion hustles application for Herceptin biosimilar back to the FDA (Fierce) (Korea Biomedical Review) (The Korea Herald)
• May's NHS 'Brexit dividend' claim draws scepticism and doubt (The Guardian) (BBC News) (The Independent) (Reuters) (Bloomberg) (PharmaTimes)
• WHO classifies 'gaming disorder' as mental health condition (CNN) (BBC News) (Reuters)
• Statement from WHO Director-General on the humanitarian situation in Yemen (WHO)
• WHO Classifications: ICD-11 is here (WHO)
• Global pharma bleeds talent to China start-ups (Financial Times)
• Opening statement and global update of human rights concerns (UN)

• Go deeper: The new drugs and therapies keeping us alive longer (Axios)
• Female Sex Drive Booster Addyi Is Back, But Will Second Time Around Be Different? (Forbes)
• Biotech firm Kymab in battle over ‘human mice’ secrets (The Times)
• Cannes Lions Health: Merck, Novartis, Pfizer and 15 more pharmas nab shortlist honors (Fierce)
• Johns Hopkins spinout WindMIL grabs $32.5M to fuel its work on a next-gen approach to cell therapy (Endpoints)
• Donations of $4,500 overdose antidote were PR gold for drug maker — but some kits were close to expiring (STAT)
• Empty desks, squabbles, inexperienced staff: Exactly who is coordinating White House drug policy? (STAT)
• New Gardasil ad campaign gets it (mostly) right. It shouldn’t have taken a decade (STAT)
• Eisai accelerates dementia drug discovery research (pharmaphorum)

• New trial results suggest CAR-T effects are durable in lymphoma (PMLiVE)
• FDA declines to approve Valeant's plaque psoriasis lotion (Reuters)
• FDA Letter May Not Hamper Valeant for Long (Barron’s)
• Catalyst Bio shares sideswiped as neutralizing antibodies force investigators to freeze hemophilia cohort work (Endpoints)
• Daiichi says it’s ready to change the standard of care for acute myeloid leukemia — but it’s a work in progress (Endpoints)
• AbbVie unveils high undetectable disease rates for venetoclax/rituximab combo (PharmaTimes)
• Medivir delays pivotal HDAC trial as FDA discussions stall (Fierce)
• Using CRISPR to predict heart disease risk (Fierce)
• ObsEva Therapeutic Shows Reduction of Pain in Mid-Stage Endometriosis Trial (BioSpace)
• FDA issues CRL on Duobrii (The Pharma Letter)
• Richard Lehman’s journal review—18 June 2018 (The BMJ)
• EHA – Daiichi data set quizartinib up for regulatory review (EP Vantage)
• Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone Reduces the Risk of Disease Progression by 46% Versus Pomalidomide/Dexamethasone Alone in Patients with Relapsed or Refractory Multiple Myeloma (Press)
• TG Therapeutics, Inc. Presents Phase 2 Data Evaluating Umbralisib in CLL Patients Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy at the 23rd Congress of the European Hematology Association (EHA) (Press)
• Protagonist Announces Phase 1 and Pre-clinical Data on Hepcidin Mimetic PTG-300 Presented at European Hematology Association Annual Meeting (Press)
• BioLineRx Presents New Overall Survival Data From Phase 2a Study for BL-8040 in r/r AML Patients (Press)
• ObsEva SA Achieves Primary and Secondary Endpoints for EDELWEISS Phase 2b Clinical Trial of Linzagolix (OBE2109) in Women with Endometriosis (Press)
• Stemline Therapeutics Announces Positive Clinical Data from ELZONRISTM (tagraxofusp; SL-401) Trials in BPDCN, CMML and MF Delivered at the EHA Congress (Press)
• Agios Announces Initiation of Global Phase 3 Trial (ACTIVATE) of AG-348 in Adults with Pyruvate Kinase Deficiency Who Are Not Regularly Transfused (Press)
• Rhythm Pharmaceuticals Announces New Topline Clinical Data from Ongoing Phase 2 Basket Studies Evaluating Setmelanotide in Rare Genetic Disorders of Obesity (Press)

• Boston Scientific wins third Mass. pelvic mesh trial (MassDevice)
• Are Genetic Testing Sites the New Social Networks? (CNBC)
• Israel's DreaMed gets FDA ok for diabetes management software (Reuters) (DDBN)
• US FDA approves BlueWind's pivotal trial design of Renova iStim implantable tibial nerve neuromodulator for OAB (Pharmabiz)
• FDA Approves the Next Generation of Customized LASIK Treatment with iDESIGN Refractive Studio (Press)
• PerkinElmer’s EUROIMMUN Receives 510(k) Clearance for Crithidia luciliae and Crithidia luciliae Sensitive Diagnostic Tests (Press)
• Helius Medical Technologies, Inc. Provides Update on its Anticipated Submission for FDA Clearance of the PoNS Device (Press)
• CE Mark and Health Canada Regulatory Approvals for Datum Dental's OSSIX Bone (Press)

• CMS seeking comment for crucial data sharing rule (Politico)
• Congress tackles mounting opioid epidemic (The Hill)
• Republicans give up on Medicare overhaul (Politico)
• Apple to improve 911 location sharing in iOS 12 (Axios)
• Exclusive: BetterDoctor being acquired (Axios)
• US needs to invest 'tens of billions or hundreds of billions' to fight opioid epidemic  (CNBC)
• More Doctor Pay Tied To Patient Satisfaction And Outcomes (Forbes)
• State appeals court reinstates California’s right-to-die law (AP News)
• Growing recognition of gray areas in gender identity leads to changes in EHRs (Modern Healthcare)
• DEA Issues Decisions in Pharmacy Cases (FDA Law Blog)
• Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals (FDA)

• FDA Advisory Committee Calendar

• Gene therapy with 'off switch' restores hand movement in rats with spinal cord injury (Fierce)
• EMA’s PRAC held public hearing on quinolone and fluoroquinolone antibiotics (The Pharma Letter)
• AMG Int’l wins CE Mark for Archimedes bioresorbable biliatric stent (MassDevice)
• HPV vaccine reduces cancer-causing infection by 86 per cent (Public Health England)
• Faster medicine: £56 million innovation centre for Scotland (UK Government)
• Government to end unnecessary PIP reviews for people with most severe health conditions (UK Government)
• Public consultation: HPRA invites comments on draft framework for multi-stakeholder approach to handling medicines shortages (HPRA)
• Updated Guidance: Make a payment to MHRA (MHRA)
• Updated Guidance: Notify MHRA about a clinical investigation for a medical device (MHRA)
• Vertex Announces Long-Term Access Agreement in Sweden for Cystic Fibrosis Medicine ORKAMBI (lumacaftor/ivacaftor) (Press)

• China's Vaccine Tourists Drain Hong Kong's Supply of Cancer Drug (Bloomberg)
• High-profile Chinese investor Vincent Cheung plays a lead role in raising $100M round for a Boston start-up (Endpoints)
• Companies enter pharma biz through equity investment, acquisition (Korea Biomedical Review)
• BMS Korea presents trial results for Baraclude (Korea Biomedical Review)
• SNUH develops liver cancer marker analysis technology (Korea Biomedical Review)

• CDSCO to accept only online applications for new drugs, SNDs and FDCs from June 22 (Pharmabiz)
• KIHT ties up with JBI to boost research in medical devices & diagnostics (Pharmabiz)

• Updates to the Permissible Ingredients Determination for listed medicines (TGA)

• Hologic’s New Panther Fusion System, Flu and Respiratory Assays Now Approved by Health Canada (Press)

• Special report: The next health care wars (Axios)
• Video Game Addiction Tries to Move From Basement to Doctor’s Office (NYT)
• Aging in place vs. assisted living … It’s complicated (CNBC)
• 5 biggest risks of sharing your DNA with consumer genetic-testing companies (CNBC)
• Creating New Worlds for People with Dementia (Forbes)
• Rise of the machines: has technology evolved beyond our control? (The Guardian)