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January 21, 2019
by Michael Mezher

Recon: Chinese Scientist May Face Criminal Charges After Editing Babies' Genes

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • The Warren bill could promote beneficial public-private partnerships in the life sciences (STAT)
  • Tufts to review ties to Purdue Pharma after ‘deeply troubling’ disclosures (STAT)
  • AbbVie's Imbruvica fails to meet main goal in pancreatic cancer study (Reuters) (Evaluate) (Press)
  • Study Links Drug Maker Gifts for Doctors to More Overdose Deaths (NYTimes) (Reuters)
  • The Insulin Wars: How insurance companies farm out their dirty work to doctors and patients (NYTimes)
  • Grassley to test GOP on lowering drug prices (The Hill)
  • Big Pharma Less Concerned About Industry Disruption This Year (Forbes)
  • As Shutdown Enters Second Month, Public Health Risks Rise (Forbes)
  • FDA's Banner Year For Approvals: Will Market Access To New Drugs Follow Suit? (Forbes)
In Focus: International
  • Chinese scientist who edited genes likely to face criminal charges (Financial Times) (Reuters) (SUSTech)
  • GlaxoSmithKline chair Philip Hampton to step down (Financial Times)
  • UK businesses leaning towards second Brexit vote (PMLive)
  • The Biotech VC View: What Does 2019 Hold For European Health Startups? (Forbes)
  • 'Well-oiled machine': how Brexit disruption could hit medicine supplies (The Guardian)
  • Stockpiling insulin for no-deal: 'If I run out, I have no idea what to do' (The Guardian)
  • Revealed: UK patients stockpile drugs in fear of no-deal Brexit (The Guardian)
  • Trivalent gets UK green light for flu in over 65s (PharmaTimes)
  • EC approves expanded label for Orkambi (PharmaLetter-$) (Press)
  • NICE recommends Pierre Fabre's Braftovi in BRAF V600-mutated advanced melanoma (Pharmafile)
  • Winners Of China's Centralized Procurement To Secure Over 60% Market Share (BioCentury)
  • Just 10% of those harmed in clinical trials in India receive compensation (Pharmafile)
  • NHS England sees off AbbVie's Hep C legal challenge (PMLive)
  • Roche case against NMRA dismissed: Judgment strengthens regulator’s resolve (Daily Mirror)
Pharmaceuticals & Biotechnology
  • Should You Bet On Transdermal Drug Delivery? (Forbes)
  • The new drugs of 2018 (C&EN)
  • When Cancer Meets the Internet (NYTimes)
  • What Will FDA Do With All Those “Violative” Stem Cell Clinics Once Enforcement Discretion Tolls in November 2020? (FDA Law Blog)
  • Pro-Vaccination Message Should Be Apolitical, As NYT Argues But Fails To Demonstrate (Forbes)
  • Swiss team develop 'microswimmer' robot to deliver drugs through the body (Reuters)
  • Possible link seen between opioids and a birth defect that's on the rise (CBS)
  • Q4 Pharma Earnings Preview: J&J, Bristol And AbbVie (Scrip-$)
  • Immunocore lifer leaves to head research at TCR rival Scancell (Fierce)
  • Novo Holdings' antibiotic resistance fund backs 3 biotechs (Fierce)
  • How CAR-Ts Are Changing The Lifecycle Paradigm For ATMPs (Pink Sheet-$)
  • FDA's OTC Naloxone Model Labels Confirmed In CONFER Study (Pink Sheet-$)
  • Insomnia treatment may help ease depression during menopause (Reuters)
  • ALS researchers at Harvard uncover new biomarker and drug target (Fierce)
  • Prinston Pharmaceutical Inc. issues Voluntary Nationwide Recall of Irbesartan and Irbesartan HCTZ Tablets Due to detection of a Trace Amount of Unexpected Impurity, N- nitrosodiethylamine (NDEA) in the Products (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Johnson & Johnson, AbbVie superstar Imbruvica flunks pancreatic cancer test (Fierce)
  • Antibe Therapeutics Receives Approval to Initiate Part Two of Phase 2B Dose-Ranging, Efficacy Study for ATB-346 (Press)
  • Redx cleared to start Wnt cancer trial again after safety scare (Fierce)
  • BerGenBio Announces Start of Phase I Trial Evaluating ADCT-601, a Novel Anti-AXL ADC, in Patients With Advanced Solid Tumours (Press)
  • Lilly Phase 3 REACH-2 Trial Data Published in The Lancet Oncology Shows Improvement in Overall Survival with CYRAMZA® (ramucirumab) in Second-Line AFP-High Hepatocellular Carcinoma Patients (Press)
Medical Devices
  • Fitbit and NIH boost precision medicine research partnership (MedCityNews)
  • Verily's research wearable lands FDA clearance for on-demand ECG (mobihealthnews)
US: Assorted & Government
  • The US Biosimilars Patent Litigation Outlook For 2019 (Law360-$)
  • BIO's Comment on Advanced Notice of Proposed Rulemaking Regarding Review of Controls for Certain Emerging Technologies (BIO)
  • FDA chief threatens to take e-cigarettes off the market (NBC)
  • FDA: Level of young people addicted to vaping may require drug therapies (The Hill)
  • Hospitals Stopped Readmitting So Many Medicare Patients. Did That Cost Lives? (NYTimes)
  • Shopko Bankruptcy Puts 146 Pharmacies In Play For CVS, Walgreens And Kroger (Forbes)
  • FDA May Call Back Furloughed Staff for Food-Safety Checks (Bloomberg)
  • Theranos Execs' Days Of Reckoning Draw Nearer (Law360-$)
  • UnitedHealth Sues Generic-Drug Makers For Price-Fixing (Law360-$)
  • PTAB Denies Novartis' Challenge To Cancer Drug Patents (Law360-$)
  • Breast Implant Litigation – The Defense Wins a … Couple (Drug & Device Law)
  • Trump administration approves Medicaid work requirements in Arizona (The Hill)
Upcoming Meetings & Events Europe
  • Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo, Troubles Analysts (Pink Sheet-$)
Asia
  • Rare But Real: How One Startup Is Willing Itself To Lift China Orphan Drug Market (Scrip-$)
  • Aum Bets On Asia-To-Global Oncology Model (Scrip-$)
India
  • Why Sun Pharma is under a cloud: Decoding Aditya Medisales link (Economic Times)
  • Sun sinks 13% after reports of 2nd whistleblower letter (Economic Times)
  • Sub-committee on compensation related to medical devices to meet industry associations next week (PharmaBiz)
  • MSF, Lawyers Collective seek removal of Rule 3(f) from draft Patents Amendment Rules 2018 (PharmaBiz)
  • Lupin, Sun Pharma, Glenmark recall products in US (Economic Times)
  • Wockhardt gets USFDA nod for generic cancer drug (Economic Times)
  • India bans 80 more FDCs, calling them ‘irrational’ and ‘unjustified’ (PharmaLetter-$)
General Health & Other Interesting Articles
  • Dr. John Mendelsohn, 82, Researcher Who Led Top Cancer Center, Dies (NYTimes)
  • Helping Children Conquer Chronic Pain (NYTimes)
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 [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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