Recon: J&J Returns Rights to Hanmi Diabetes Drug; NICE Backs Pfizer’s Vizimpro

• Trump Says ‘Favored Nations’ Drug Plan Would Lower US Prices (Bloomberg) (STAT) (CNBC)
• Cancer deaths cost the U.S. $94 billion in lost earnings in a single year (STAT)
• Okla. Opioid Case 'Should End Here And Now,' J&J Says (Law360-$)
• Reflux Drugs Tied to Bone Fractures in Children (NYTimes)
• New Markers For Alzheimer's Disease Could Aid Diagnosis And Speed Up Drug Development (NPR)

• Glaxo’s ViiV Healthcare tussles with Kazakhstan over an AIDS drug (STAT)
• UK biotech looks for life beyond Woodford (Financial Times)
• J&J dumps $915M development deal with Hanmi as another Big Pharma abandons disaster-prone Korean drugmaker (Endpoints) (PharmaTimes)
• EU approval for Alexion's PNH drug Ultomiris (PharmaTimes)
• NICE backs CDF funding for Sanofi/Regeneron’s skin cancer drug Libtayo (PMLive)
• NICE backs Pfizer's Vizimpro, rejects AstraZeneca's Tagrisso, in NSCLC (Pharmafile)
• AstraZenca to appeal NICE rejection of Tagrisso (PMLive)
• Spanish NB Applies for EU MDR Designation (Focus)
• ICH Quality Discussion Group Canvasses Members, Prepares New Guideline Proposals (Pink Sheet-$)
• EU experience of biosimilars a sign of what’s to come in US - Samsung Bioepis CEO (PharmaLetter-$)

• Controlling CAR T toxicity with BMS's Sprycel (BioCentury)
• Body-on-a-chip for anticancer drug testing (Nature)
• Pressing the pause button on CAR-T cells with Bristol-Myers’ leukemia drug (Fierce)
• How Common Are Accutane-Related Psychiatric Events? (Medpage)
• Hormone Therapy for Prostate Cancer Tied to Dementia (NYTimes)
• Phage Display to Detect and Identify Autoantibodies in Disease (NEJM)
• Rituximab or Cyclosporine in the Treatment of Membranous Nephropathy (NEJM)
• Esketamine for Treatment-Resistant Depression — First FDA-Approved Antidepressant in a New Class (NEJM)
• Subtle chemical shift reverses prediabetes in Merck-partnered mouse trial (Fierce)
• Top Alzheimer’s researcher Paul Aisen apologizes for ethics, integrity breach as USC pays $50M to settle poaching lawsuit (Endpoints)
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens (FDA)
• PharMEDium Services, LLC Issues Voluntary Nationwide Recall of 0.5 mg/mL HYDROmorphone HCl in 0.9% Sodium Chloride 1 mL in 3 mL BD Syringe Due to Presence of Sulfite (FDA)
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products (FDA)

• GSK launches PhIII programme for otilimab in RA (PharmaTimes)
• Cyxone Submits First Application to Start Clinical Phase IIb Trial With Rabeximod (Press)
• Grifols Announces FDA Approval of Xembify®, 20% Subcutaneous Immunoglobulin for Primary Immunodeficiencies (Press)
• Ipsen and Servier Announce Initial Phase 1/2 Clinical Data Evaluating Liposomal Irinotecan (ONIVYDE®) as an Investigational First-line Treatment for Metastatic Pancreatic Cancer at ESMO 21st World Congress on Gastrointestinal Cancer (Press)
• VALBIOTIS Announces Positive Results From the Phase IIA Clinical Study of VALEDIA®, Now the First Product Proven Effective in People With Prediabetes (Press)
• Puma Biotechnology Presents Interim Results from the Biliary Tract Cohort of its Phase II SUMMIT Basket Trial of Neratinib at the ESMO World Congress on Gastrointestinal Cancer 2019 (Press)

• FDA Ends Months-Long FOIA Battle Over Medical Device Failures, Says Putting Database Online ‘Satisfies’ KHN Request (KHN)
• Medtronic, J&J Back Surgical Stapler Reclassification but Raise Concerns Over New Controls (Focus)
• Edwards warns on tracking issue reported with Centera TAVR (MassDevice)
• Senators question proposed device approval changes (MassDevice)
• Advent Access wins CE Mark for dialysis device (MassDevice)

• Biden vows to bring back Obamacare’s individual mandate penalty for not having insurance (CNBC)
• Doctors Slow To Adopt Tech Tools That Might Save Patients Money On Drugs (NPR)
• Most Claims Dismissed with Prejudice in N.D. Cal. Amiodarone Case (Drug & Device Law)

• FDA Advisory Committee Calendar
• Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting – 12 August 2019
• FDA-AACR Workshop: Real-world Evidence – 19 July 2019
• Qserve / Axon EU MDR and IVDR pop-up conference in Boston MA on 18 July 2019

• Novel manufacturing technologies ‘fit poorly’ into regulatory models, says EMA (InPharmaTechnologist)
• European Regulators Urge Sponsors to Publish Clinical Trial Results (Focus)
• ABPI Chief Executive Mike Thompson to retire by the end of 2019 (Pharmafile)
• UK Government call for more research into medicinal cannabis (Pharmafile) (Pink Sheet-$)
• EMA confirms WeWork as new sub-tenant for 30 Churchill Place; EMA also settles court case with Canary Wharf Group (EMA)
• Defining & Reporting Drug Shortages in the EU - New Guidance (Pink Sheet-$) (EMA)
• Implementing the Falsified Medicines Directive: Safety Features (MHRA)

• Indian pharma industry to grow at 11-13 pc in FY2020: Icra (Economic Times)
• Novartis-Amgen’s Aimovig Poised for India Debut (Scrip-$)
• VDeadline to submit information on 324 irrational FDCs to health ministry extended till August 16 (PharmaBiz)

• Drug and medical device highlights 2018: Helping you maintain and improve your health (Health Canada)
• Notice of clarification to drug manufacturers and sponsors - Risk Management Plans (Health Canada)

• Moroccan deal marks first foray into Africa for Grifols (PharmaLetter-$)
• Lessons From Mercosur Multi-Country Pricing Negotiations (Pink Sheet-$)