Recon: CRISPR, Vertex Therapy Shows Early Benefit in First Two Patients; Donors Pledge $2.6B for Polio Eradication

• First CRISPR treatment for blood diseases shows early benefits in two patients (STAT) (Endpoints) (Press)
• Novo Nordisk’s parent company to launch research incubator in Boston (STAT) (Xconomy)
• Inside Purdue Pharma’s Media Playbook: How It Planted the Opioid “Anti-Story” (ProPublica)
• Amarin releases interim EVAPORATE data — and mineral oil makes another appearance (STAT)
• Medicines Co. Is Said to Attract Suitors Including Novartis (Bloomberg) (Endpoints)
• Hit by copycat meds, Amgen trims 172 more jobs, this time in operations, R&D and sales (Fierce)
• Trump vaping reversal may dominate Hahn hearing (Politico)
• Mailing Free Home HIV Tests Helps Detect More Infections (AP)
• US Congress seeks answers on patient privacy in Google, Ascension cloud deal (Reuters) (Letter)
• Doctors Who Helped Develop Heart Drug Now Balk at $225,000-a-Year Price (Bloomberg)
• Experimental Drug Requests Rising Faster Than Previously Thought (Bloomberg)

• Donors pledge $2.6 billion for 'last mile' of polio eradication (Reuters) (WHO)
• Portuguese foundation launches world's largest cancer award (Reuters)
• Morphosys to boost size of tafasitamab drug trial on encouraging interim data (Reuters)
• TGA joins ICMRA campaign against antimicrobial resistance (TGA)
• Calling on the EU to remain on the front line of the global battle against AMR – industry stands ready to play its part (EFPIA)
• AZ, Merck and Novartis top Big Pharma's Q3 growth charts. Teva and Pfizer? Not so much (Fierce)

• Top 10 pharma settlements since 2018 (Fierce)
• Biogen under fire over $88,000 Vumerity annual price (PMLive)
• The Startlingly High Cost Of The ‘Free’ Flu Shot (KHN)
• As uterine race with AbbVie heats up, Myovant eyes FDA approval with trial results from prostate cancer (Endpoints) (Evaluate)
• ICER Will Explore Value Pricing For Cures In Context Of ‘Shared’ Health System Savings (Pink Sheet-$)
• Exposure to HIV drug in the womb may increase risk of microcephaly, developmental delays in children (NIH)
• Colchicine cuts odds of new heart attack, stroke in heart attack survivors (Reuters)
• Statin Drugs Not Linked to Memory Decline in Study (NYTimes)
• Wellington lines up a $393M bankroll for its next round of private biotech bets — and they’re likely thinking big (Endpoints)
• A decade of optimizing drug development for rare neuromuscular disorders through TACT (Nature)
• Here's a $25M seed fund aimed at backing some brash new drug ideas out of the Broad (Endpoints)
• AstraZeneca loses another executive to biotech, as Badrul Chowdhury moves to Savara (Endpoints)
• London AI upstart, which counts Novartis as a customer, can teach your computer to read (Endpoints)
• AZ’ Brilinta causes less bleeding as monotherapy (PharmaTimes)
• Janssen pilots wearable technology in clinical trial (PharmaTimes)
• Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) (FDA)

• Alkermes Submits New Drug Application to U.S. Food and Drug Administration for ALKS 3831 for Treatment of Schizophrenia and Bipolar I Disorder (Press)
• Newron Receives FDA Rare Pediatric Disease Designation for Sarizotan for the Treatment of Rett Syndrome (Press)
• FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate (Press)
• FDA Grants Breakthrough Device Designation Status for BioVentrix Revivent TC Transcatheter Ventricular Enhancement System for Heart Failure (Press)
• Viking Therapeutics Announces Initiation of Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH) (Press)
• Sangamo Announces UK Authorization of a Phase 1/2 Clinical Trial Evaluating the CAR-Treg Cell Therapy TX200 for Kidney Transplantation (Press)
• Antisense Therapeutics Announces Additional preliminary data from the ATL1102 Phase II DMD trial presented at the 2019 Action Duchenne International Conference (Press)
• BioArctic Announces Results From Interim Analysis of the Phase 1/2 Study of SC0806 in Patients With Complete Spinal Cord Injury (Press)

• Medtronic Q2 results beat The Street (MassDevice)
• Abiomed's Impella may be associated with higher costs, more adverse events than balloon therapy, studies find (MedtechDive)
• In stents v. statin debate, analysts call potential impact of ISCHEMIA trial overhyped (MedtechDive)
• Edwards recalls Pascal valve guide sheath in Europe amid potential for embolizations (MedtechDive)

• Stop-gap legislation would fund health programs (Politico)
• Comparison of Average Sales Prices and Average Manufacturer Prices: Results for the Second Quarter of 2019 (HHS OIG)
• Supreme Court denies ‘pharma bro’ Martin Shkreli’s appeal request (CNBC) (Endpoints)
• California sues e-cigarette maker Juul for selling nicotine products to youth (Reuters)
• Elizabeth Warren proposes using compulsory licensing, antitrust actions to break biopharma’s control of drug pricing — and here are the blockbusters she’s targeting first (Endpoints)
• Where Democratic presidential candidates stand on 'Medicare for All' ahead of next debate (Reuters)
• CRISPR Motions Day at the PTAB: Broad Files Its Substantive Motion No. 2 (Patent Docs)
• Not All California Trial Rulings Are Horrible (Drug & Device Law)
• US Cattlemen Petition USDA to Address “Made in USA” and “Product of USA” Claims (FDA Law Blog)
• GAO Dismisses Becton, Dickinson and Company Protest (GAO)
• US Trustee Says Sackler Ties Bar E&Y From Purdue Ch. 11 (Law360-$)

• FDA Advisory Committee Calendar
• 2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program – 5 December 2019

• EMA SOP for Handling Requests for Access to Information (EMA)
• Ranitidine Oral Solution and Tablets recall (MHRA)

• CDSCO mandates processing of applications of non-notified medical devices through Sugam portal (PharmaBiz)
• Govt to initiate talks with stakeholders on drug trade margins (Economic Times)
• Niti Aayog has not rejected proposal to bring medical devices under CDSCO: Govt (Economic Times)
• NPPA fixes retail prices of 12 formulations under DPCO 2013 (PharmaBiz)

• Therapeutic Goods (Complementary and OTC Medicines - Application Form for Approval of an Advertisement) Approval (No. 2) 2019 (TGA)
• Therapeutic Goods (Permissible Indications) Determination (No. 2) 2019 (TGA)
• Complementary medicines advertisers: 19 November 2019 update (TGA)