Regulatory Focus™ > News Articles > 6 > Recon: Ziopharm CAR-T Trial Put on Clinical Hold; DMD Trial Hold Lifted

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

Posted 18 June 2018 | By Ana Mulero 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US In Focus: International Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia
  • 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)
India
  • 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)
Australia
  • Updates to the Permissible Ingredients Determination for listed medicines (TGA)
Canada
  • Hologic’s New Panther Fusion System, Flu and Respiratory Assays Now Approved by Health Canada (Press)
General Health & Other Interesting Articles
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Email us at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
 

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