Recon: Senate Passes Opioids Package; Viking Spikes on Positive Ph. II Results for NASH Candidate

• Viking shares surge after fatty liver drug trial (Reuters) (STAT) (Endpoints) (Press)
• What’s in, what’s out, and what’s still on the table in the opioids package passed by the Senate (STAT)
• Final opioid bill may come by Friday (Politico)
• Senate passes bill to ban ‘gag clauses’ and free pharmacists to discuss drug pricing options (STAT)
• Senate Passes 'Pay-For-Delay' Bill For Biosimilars (BioCentury)
• Allergan, Sosei halt development for Alzheimer’s drug following toxic reaction in a non-human primate (Endpoints) (PharmaTimes) (Fierce)
• Pfizer, Glaxo, Novo, Novartis plants unfazed by hurricane, resume production; Merck not as lucky (Fierce)
• The Federal Agency That Fuels the Opioid Crisis (NYTimes)
• Merger of Cigna and Express Scripts Gets Approval From Justice Dept. (NYTimes)
• A Crazy, Murky System for Pricing HIV Drugs (NYTimes)
• FDA's HQ Expansion Plans Include Office High-Rises, New Conference Center (Pink Sheet-$)
• The Quest to Create and Perfect an Artificial Heart (NYTimes)
• Will insurers have to cover the controversial contraception app Natural Cycles (STAT)
• Pot producer Tilray gets high after US approves product for clinical study (Financial Times)

• Pharmaceutical companies avoiding $215m a year in Australian tax, Oxfam says (The Guardian)
• Prescription for Poverty (Oxfam)
• WHO Releases Global Tuberculosis Report 2018 (WHO)
• Gates Foundation warns a decades-long progress in fighting disease and poverty may reverse (CNBC)
• Novo Nordisk is whacking 400 R&D jobs, reorganizing global R&D ops around 4 “transformational” units (Endpoints) (Fierce)
• Servier shrugs off a multimillion-dollar investment, abandoning a failed MS drug developed by GeNeuro (Endpoints)
• WuXi AppTec files for public listing in Hong Kong four months after explosive Shanghai IPO (Endpoints)
• CR UK invests £14m in London cancer biotherapeutics hub (PharmaTimes)
• Rates of vaccination decline in England, study shows (Pharmafile)
• Novartis revamps bonus pay as ethics rise to top priority at scandal-hit drugmaker (Fierce)
• Eight New Filings At EMA: Three Granted Fast Track Status (Pink Sheet-$)
• Russia discussing the possibility of producing generic Sovaldi with Gilead (PharmaLetter-$)
• Nigeria to launch pilot cancer drug access program (PharmaLetter-$)
• A child dies every five seconds, and most are preventable deaths - U.N. (Reuters)
• Sun marches ahead with its specialty pipeline, announces European approval for Tildra (Economic Times)

• United’s Martine Rothblatt endorses a biotech unicorn’s CEO and antes up for US rights to an IPF drug (Endpoints)
• Harvard Professor's Attack On Pharma's Clinical Trials Is Absurd (Forbes)
• Changes in Drug Pricing After Drug Shortages in the United States (Annals of Internal Medicine)
• With latest data, can AstraZeneca's COPD triple combo rival Glaxo's Trelegy? (Fierce) (Press)
• Biosimilar Sponsors: We Need To Do A Better Job Educating Physicians And Patients (Pink Sheet-$)
• Many cancer patients' relatives might get gene tests if price is right (Reuters)
• Organ wait list shortcut: Patients accepting kidneys, hearts infected with hepatitis C (USA Today)
• Medical Society Files FDA Citizen Petition Seeking Removal of Boxed Warnings on Ultrasound Contrast Agents (Press)
• Pfizer 'all in' on advancing next-generation pneumococcal vaccine candidate: CFO (Fierce)
• One neat trick for forcing pharma to set lower drug prices (Vox)
• Mylan biosimilar to stress test Amgen Neulasta franchise, analyst predicts (BioPharmaDive)
• Could real world evidence replace controlled experiment data? (Outsourcing Pharma)
• Is Quarterly Dosing For Teva's Ajovy Enough To Differentiate It From Other CGRP Inhibitors? (SCRIP-$)
• The Quality Lowdown: A Contagion Of Dubious Sterility Assurance? (Pink Sheet-$)
• What Manufacturers Should Know About Triclosan Findings (Law360-$)
• Roche’s NAVIFY decision support portfolio unlocks relevant content from clinical trial and medical publication databases (Press)
• FDA To Re-Examine Diabetes CVOT Requirements (BioCentury)

• Amgen, Sandoz begin biosimilar trial with top-selling Enbrel at stake (BioPharmaDive)
• FDA Grants Lin BioScience Rare Pediatric Disease Status for LBS-008 to Treat Stargardt Disease (Press)
• Racing UCB and Roivant, Argenx clears phase 2 in primary immune thrombocytopenia (Fierce)
• Roivant launches lung-focused Respivant with phase 2 IPF drug (Fierce)
• New Sub-group Analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) Study Presented at 2018 HFSA Annual Scientific Meeting (Press)
• DFB Soria Completes a Phase 2 Clinical Trial of Submicron Particle Paclitaxel Anhydrous Ointment for Actinic Keratosis (Press)
• Experimental nasal influenza vaccine tested in kids, teens (NIH)

• Breast Implant Study Should Be Taken with a Grain of Salt, FDA Says (MDDI)
• For Endotronix, a digital health medtech startup, FDA has dual identities (MedCity)
• AliveCor previews next product: A 6-lead smartphone ECG (mobihealthnews)
• Livongo touts first connected BP monitor (Medical Design & Outsourcing)
• Medtronic joins initiative to bring more women into the board room (MassDevice)

• Surveying The Cannabis Patent Litigation Landscape (Law360-$)
• E-Cigarette Math And The FDA's Regulatory Dilemma (Forbes)
• Valeant Must Face Deceptive Pricing Claims By Hedge Funds (Law360-$)
• Insys Wants Out Of Off-Label Fentanyl Prescription Suit (Law360-$)
• Opioid MDL Stakes Rise For Pharmacy Benefit Cos. (Law360-$)
• No Kickback Fines For Implant Refunds, HHS Watchdog Says (Law360-$)
• E.D. Missouri Saves Manufacturing Defect Claim; Sacrifices Good Sense (Drug & Device Law)
• Finding Nemo's Genome (Patent Docs)
• What 13,000 Patents Involving the DNA of Sea Life Tell Us About the Future (NYTimes)

• FDA Advisory Committee Calendar
• Patient-Focused Drug Development Guidance: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments – 15-16 October 2018

• Macron injects cash to fix France's healthcare system (Reuters)
• Opening speech of the Sixty-eighth session of the WHO Regional Committee for Europe (WHO)
• Highlight report of the 3rd Industry stakeholder platform on research and development support (EMA)
• European Medicines Agency Validates Bristol-Myers Squibb’s Application for Empliciti (elotuzumab) Plus Pomalidomide and Low-Dose Dexamethasone in Patients with Multiple Myeloma (Press)
• Class 4 defect information: Caspofungin 70mg powder for concentrate for solution for infusion (MDR 11-09/18) (MHRA)

• Gene Therapy INDs In China: Five Things To Consider (Pink Sheet-$)
• Astellas launches Dafclir against C-difficile in Japan (PharmaLetter-$)

• Innovation from pharma industry in India and globally spurs better health outcomes: Gagan Singh Bedi (Pharmabiz)
• Daiichi Sankyo moves NCLT to stay insolvency plea against RHC Holding (Economic Times)
• Aurobindo Pharma gets nod from South African health authority for HIV drug (Economic Times)

• GlaxoSmithKline expands Canada plant, adds production of topical pain reliever (Fierce)

• Consultation: Benzocaine: proposed advisory statements for medicines (TGA)
• Medicines Safety Update, Volume 9, Number 3, August-September 2018 (TGA)

• Cancer spreads from organ donor to 4 people in "extraordinary case" (CBS)
• This Rapper Tried To Use Neuroscience To Get Over Her Ex (NPR)