Recon: FDA Panel Backs GSK's OTC Nicotine Spray; Swiss Competition Watchdog Raids Makers of Stomach Drug

• Industry groups push back against ‘troubling’ FDA crackdown on genetic tests used to predict response to drugs (STAT)
• GSK's over-the-counter nicotine oral spray gets FDA panel backing (Reuters)
• Ginkgo Bioworks scores an eye-popping valuation with latest fundraise (STAT)
• Insys Bankruptcy Plan Comes Up Short in Paying Justice Department (WSJ)
• Bristol joins the pharma buyers club (Evaluate)
• J&J finds competitive edge with latest Erleada approval (BioPharmaDive) (FDA)
• Biotech is going to the dogs - and big profits await (Reuters)
• Factbox: Animal health sector aims to emulate Zoetis biotech leap (Reuters)
• Bluebird bio reveals further encouraging data for CALD gene therapy (PMLive) (Press)
• Why prescription drugs cost so much more in America (Financial Times)
• Regulatory barriers limit state alternative Rx payment models (HealthcareDive)

• Flawed trials supported half of recent approvals of cancer drugs in Europe, study says (STAT) (Fierce) (BMJ)
• Novartis halts distribution of its Zantac versions amid probe into impurities (Reuters) (STAT)
• British baby's death not due to SMA gene therapy: Novartis (Reuters)
• Swiss raid stomach ache drug ingredient makers in competition probe (Reuters)
• Why didn’t nonprofits and the NIH require ‘reasonable’ pricing for Zolgensma? That may happen in France (STAT)
• ‘Demystify’ Pricing, Say UK Parliamentarians (Pink Sheet-$)
• Poor diabetes control costing NHS £3bn in avoidable treatment (Pharmafile)
• Sanofi to exit Bangladesh, reports say, leaving 1,000-plus jobs up in the air (Fierce)
• Tanzania tells WHO it has no Ebola cases – statement (Reuters)
• More women and children survive today than ever before – UN report (WHO)

• A biotech startup hopes to disarm cancer by targeting a genetic bandolier (STAT)
• Wrecking Purdue Pharma Won’t Help Opioid Victims (Bloomberg)
• Biogen ramps up its SMA rivalry with Novartis with new Spinraza trial (Fierce)
• One pill with four drugs may lower heart risks in poor population (Reuters)
• Focusing on cystic fibrosis, Translate Bio to raise $90M (BioPharmaDive)
• Do generic drugs cost too little? (Healthcare Economist)
• Citizen Petitions Delaying Approvals: FDA Finalizes Guidance (Focus)
• FDA Lays Out Tech Modernization Action Plan (Focus)
• OGD Explains How it Reviews and Conducts Pre-ANDA Meetings (Focus)
• Study quantifies impact of NIH-sponsored trials on clinical cancer care (NIH)
• Pain/Addiction Products Need Regulatory Streamlining To Incentivize Development, Sponsors Say (Pink Sheet-$)
• Novo’s Ozempic trumps Jardiance, Januvia, Victoza in type II diabetes (PharmaTimes)
• 'A fourth revolution in cancer therapies': ARCH-backed Boundless Bio flashes big check, makes bigger promises in debut (Endpoints)
• BenevolentAI draws $90M from Temasek amid reports of halved valuation (Endpoints)
• Bayer leads OneDrop's $40M Series B, companies ink commercial licensing agreement (mobihealthnews)
• AI in drug development: ACRO, DIA, and Owkin to talk use cases and what comes next (Outsourcing Pharma)
• FDA’s Comprehensive Response to HIV — Part I (FDA)
• Alexion's CFO steps down in surprise departure (BioPharmaDive) (Endpoints)
• Medicxi founds biotech to Divide & Conquer tough solid tumors (Fierce)
• Could a combo treatment boost KRAS inhibitors in lung cancer? (Fierce)
• Jeff Kindler's Centrexion renews bid to make public debut (Endpoints)
• Success of nearly half of European cancer drug trials ‘exaggerated’ due to bias: Report (Fierce)
• vTv Therapeutics reports additional positive PhII data; Shanghai Henlius prices $410 million IPO at bottom of range (Endpoints)
• Young anti-aging field takes big step with Mayo Clinic senolytics showcase (Endpoints)
• Biotech boards burdened: bridging the success gap (Endpoints)

• SanBio Granted Regenerative Medicine Advanced Therapy Designation from the U.S. FDA for SB623 for the Treatment of Chronic Neurological Motor Deficits Secondary to Traumatic Brain Injury (Press)
• Aerie Pharmaceuticals Submits Prior Approval Supplement to the U.S. Food and Drug Administration to Allow Production of Rocklatan® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% in its Athlone Ireland Facility (Press)
• Phase I Study Results Show First-in-class NBTXR3 Could Present as a Valuable Option for Patients With Hepatocellular Carcinoma or Liver Metastasis (Press)
• Poxel Announces Detailed Imeglimin Phase 3 TIMES 1 Results Presented at 55th Annual Meeting of the European Association for the Study of Diabetes (Press)
• Compugen Presents Update on COM701 Phase 1 Study at 2019 IGCS  (Press)
• Savara to Present Comprehensive Data From Pivotal Phase 3 IMPALA Study at 2019 ERS (Press)
• IGC Announces IRB Approval of its IGC-AD1 for a Phase-2 study (Press)

• Not Quite a Breakthrough Device, FDA Introduces New Safer Technologies Program (Focus)
• FDA Finalizes Updates to the Special 510(k) Program (FDA Law Blog)
• Viseon, Inc. Announces US FDA Clearance and Clinical Use of its Advanced High-Definition Real Time Imaging Technology for Minimally Invasive Spine Surgery (Press)
• Orchestra's Drug-Eluting Balloon Wins FDA Breakthrough Device Designation (MDDI)
• FDA clears OrthoSpin’s robot-assisted external fixation device (MassDevice)

• US charges 58 in Texas with healthcare fraud, illegal opioid distribution (Reuters)
• Compounding Pharmacy, Two of Its Executives, and Private Equity Firm Agree to Pay $21.36 Million to Resolve False Claims Act Allegations (DoJ)
• Senate Subcommittee Seeks $3B Boost to NIH Budget (GenomeWeb)
• Unsound, Ongoing MDL Choice of Law Fiasco (Drug & Device Law)
• The 800-Lb. Gorilla: Drug Costs Loom Large In Medicare Oncology Care Model (Pink Sheet-$)
• Bair Hugger MDL Defendants Prevail on Daubert and Summary Judgment (Drug & Device Law)
• Pa. Judge Questions 'Economics' Of Endo Antitrust Claims (Law360-$)
• Fed. Circ. Refuses To Add Time To Intra-Cellular Patent Term (Law360-$)

• FDA Advisory Committee Calendar

• Infographic: Building the European biotech sector with world-class talent (McKinsey)
• How to draft a direct healthcare professional communication (MHRA)
• MHRA Updates No-Deal Brexit Device Guidance (Focus) (MHRA)
• All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress (MDA/2019/030) (TGA)
• Senzer Pharmaceuticals wins CE Mark for cannabinoid inhaler (MassDevice)

• Prescription Influencer Shifts In India: Is Pharma Geared Up? (Scrip-$)

• TGA regulation of faecal microbiota transplant (FMT) products in Australia (TGA)
• Submissions received: Options for the regulation of Faecal Microbiota Transplantation materials (TGA)
• Consultation: Proposed amendments to the Poisons Standard - ACMS and Joint ACCS/ACMS meetings, November 2019 (TGA)
• Fifteen men on a dead man’s medicine chest – the weird world of pirate medicine (TGA)

• Early Inflammation May Portend Early Death (NYTimes)
• Cancer Patients Tell Us About Finding Clothing to Adapt to Changing Bodies (NYTimes)
• Is digital health in an investment bubble? Absolutely say VCs from different locations (MedCity)
• Baby gut study finds bacteria different after C-section births (Reuters)
• Deadly Brain Cancers Act Like 'Vampires' By Hijacking Normal Cells To Grow (NPR)