Regulatory Focus™ > News Articles > 11 > Recon: Chinese Researcher Claims Birth of First CRISPR Gene-Edited Babies

Recon: Chinese Researcher Claims Birth of First CRISPR Gene-Edited Babies

Posted 26 November 2018 | By Michael Mezher 

Recon: Chinese Researcher Claims Birth of First CRISPR Gene-Edited Babies

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Patients shocked, burned by device touted to treat pain (AP) (ICIJ)
  • Spinal-cord stimulators help some patients, injure others (AP)
  • Medtech Giant Pushes Boundaries As Casualties Mount And Sales Soar (ICIJ)
  • Patient Hopes Rise And Fall As An Industry Balances Progress And Profit (ICIJ)
  • Supreme Court sets high bar for medical device lawsuits (AP)
  • A SCOTUS case on ‘cobra sexual energy’ supplements highlights FDA’s oversight of a growing industry (STAT)
  • Trump administration accuses China of unfairly using venture capital to acquire American biotech (STAT)
  • Trump Administration Invites Health Care Industry to Help Rewrite Ban on Kickbacks (NYTimes)
  • US benefits manager baulks after Novartis values gene therapy at $4-5 million (Reuters)
  • Sales Reps May Be Wearing Out Their Welcome In The Operating Room (NPR)
  • Dangerous Infection Tied To Hospitals Now Becoming Common Outside Them (NPR)
  • FDA puts Zafgen's diabetes trial on hold (Reuters) (Endpoints) (Fierce)
In Focus: International
  • Claim of CRISPR’d baby girls stuns genome editing summit (STAT) (AP) (MIT Technology Review)
  • CRISPR inventor Feng Zhang calls for moratorium on gene-edited babies (MIT Technology Review)
  • Chinese university to investigate after academic claims to have edited twins’ genes (Reuters)
  • Exporting pain: US-made medical devices cause serious injuries, pain overseas (NBC) (The Guardian)
  • Medical device rules need 'drastic change' to protect patients (BBC) (BMJ)
  • Surgeons call for compulsory registers of all new medical devices (BMJ)
  • How Lobbying Blocked European Safety Checks For Dangerous Medical Implants (ICIJ)
  • Firm pays out to NHS over defective hip replacements (The Guardian)
  • Novartis's pricing might be tested with costly eye therapy (Reuters)
  • Roche and Novartis lose a court battle in Europe over off-label use of repackaged drugs (STAT) (PharmaLetter-$)
  • Ebola in Congo now infecting newborn babies, UN says (STAT)
  • Congo approves clinical trials for Ebola treatments (Reuters)
  • China pharma crackdown leads to flu vaccine shortage (Financial Times)
  • Vectura drops severe asthma treatment after poor trial results (Reuters) (Endpoints) (Press)
  • Increase in NHS drugs budget capped at 2% in pharma deal (Financial Times) (PMLive)
  • Not a drug: why EU rules on diet pills mean fewer safety checks (The Guardian)
Pharmaceuticals & Biotechnology
  • Keeping Up With “The Energizer Bunny”: US FDA Commissioner Gottlieb As A Boss (Pink Sheet-$)
  • Playing a hot hand in cancer R&D, Pfizer scores its 4th drug approval in just 2 months (Endpoints)
  • Lilly's Lasimiditan NDA Review Could Hinge On US FDA's Migraine Guidance (Pink Sheet-$)
  • Astellas makes another gene therapy play with Juventas deal (PMLive)
  • Generic threat looms to J&J’s blockbuster Zytiga in US (PMLive)
  • Sun Pharma's New Jersey manufacturing overhaul puts 96 jobs at risk (Pharmafile)
  • Oxford BioMedica unveils digital initiative to streamline manufacturing (PharmaTimes)
  • Alphamab Oncology To Push Several Programs Through The Clinic With $100m A Round (BioCentury)
  • Vir starts trial of RNAi drug for hep B seeking functional cure (Fierce) (Press)
  • Rolling up its sleeves, Axovant scoops up five gene therapy vets to propel new pipeline (Endpoints)
  • After falling off a cliff, Edge Therapeutics provides cancer-focused PDS Biotech a reverse merger onto Nasdaq (Endpoints)
  • FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species (FDA)
  • Fresenius Kabi recalls sodium chloride injections over latex concern (Drug Delivery)
  • FDA on Gene-Edited Plants and Animals: “We’ve Got This” (FDA Law Blog)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Perrigo Announces Tentative FDA Approval For The First To File Generic Version Of Ultravate Lotion 0.05% (Press)
  • Forbius’ AVID200, a novel TGF-beta 1 & 3 Inhibitor, Cleared by the FDA to Commence Phase 1 Clinical Trial in Solid Tumors (Press)
  • Poxel Announces Initiation of Part 2 of Phase 1a Study for PXL065, which is being Developed for the Treatment of NASH (Press)
Medical Devices
  • Does More FDA Oversight Equal Better Compliance? (MDDI) (Law360-$)
  • Medtronic acquires Israeli nutrition data startup Nutrino Health (MedCity)
  • Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing (FDA)
  • Innovative Health Receives FDA Clearances to Reprocess St. Jude Medical’s Advisor FL, Two Medtronic Diagnostic Catheters and Biosense Webster’s DECANAV (Press)
  • FDA Classifies Field Action Related to Fc 500™ And Epics® As Class 1 Recall Beckman Coulter Life Sciences Committed to Helping Customers Take Prompt, Appropriate Actions (FDA)
US: Assorted & Government
  • Brand Vs. Generic Supreme Court Fight: Does Sale Of Secret Invention Bar Its Patenting? (Pink Sheet-$)
  • More Americans trust Democrats than GOP to lower drug prices (The Hill)
  • Pro-Plaintiff Hijacking Attempt Against New York Statute of Limitations (Drug & Device Law)
Upcoming Meetings & Events Europe
  • NHS hospitals paying 167% more for drugs since 2010/11 (Pharmafile)
  • UK pharma industry reacts to outcome of European Council meeting (ABPI)
  • Lords ask Minister for clarity on access to medicine after Brexit (PharmaTimes)
  • More EMA staff expected to move to Amsterdam (Pharmaceutical Journal)
  • Health At A Glance Report Highlights Public Value Of Generic, Biosimilar And Value Added Medicines (medicinesforeurope)
  • MHRA Final Update on Devices Made by Silimed (MHRA)
  • Analysis of the valsartan batches recalled in July 2018 confirms NDMA contamination (Swissmedic)
  • UK Smooths Clinical Trial Pathway To Reassure Companies With Brexit Jitters (Pink Sheet-$)
  • Brexit Declaration Offers Scant Comfort On Future UK-EU Regulatory Links (Pink Sheet-$)
  • EU Explores Key Principles For Using Electronic Leaflets, SmPCs (Pink Sheet-$)
  • Sweden's Combigene Readies Gene Therapy For Epilepsy Trials (Scrip-$)
  • Mundipharma's Neulasta biosimilar approved in EU (Pharmafile)
  • European Commission approves first and only long-acting opioid dependence therapy (Pharmafile)
Asia
  • Chi-Med and Lilly’s cancer drug Elunate a milestone for China (PMLive)
India
  • Made-in-India drugs based on weed soon (Times of India)
  • Eisai Seeks To Block Dr Reddy’s Over Belviq Plans In India (Scrip-$)
  • Glenmark Pharma gets tentative USFDA nod for skin treatment drug (Economic Times)
  • A month after 3 letters to Health Ministry, J&J faulty implant victims await response (Economic Times)
  • Leading 50 Indian pharma companies post strong net profit growth of 22% in first half of 2018-19 (PharmaBiz)
  • AiMeD slams suggestion to increase MRP of medical devices, says importers' lobby tries to mislead govt (PharmaBiz)
Australia
  • Australia Clarifies New Drug Shortages Reporting Rule For Sponsors (Pink Sheet-$) (TGA)
Canada
  • Indivior Announces Health Canada Approval of SUBLOCADE™ (Buprenorphine Extended-Release) Injection for Patients with Moderate to Severe Opioid Use Disorder (Press)
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.
 
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