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)
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