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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Chi-Med and Lilly’s cancer drug Elunate a milestone for China (PMLive)

• 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 Clarifies New Drug Shortages Reporting Rule For Sponsors (Pink Sheet-$) (TGA)

• Indivior Announces Health Canada Approval of SUBLOCADE™ (Buprenorphine Extended-Release) Injection for Patients with Moderate to Severe Opioid Use Disorder (Press)