Recon: Senate Passes 'Minibus' With FDA Funding of $5.4B

• Epizyme Halts Phase II Trial of Tazemetostat in DLBCL, Continues Talks to Lift Clinical Hold (GEN)
• Special Report: Biotech incubator taps investors through in-house brokerage (Reuters)
• Opioid Prescribing Hasn't Declined In The Last Decade Despite Addiction Crisis (Forbes)
• Senate overwhelmingly passes minibus with FDA funding of $5.4B, plus riders (Bloomberg-$) (BioWorld)
• Gene Therapy Oversight To Be Streamlined By US FDA, NIH (Scrip-$)
• Carl Icahn Has Sizable Stake in Cigna, Plans to Vote Against Express Scripts Deal (WSJ)
• How Rival Opioid Makers Sought To Cash In On Alarm Over OxyContin’s Dangers (KHN)
• Karuna raises $42M to resurrect abandoned Lilly drug for schizophrenia (Fierce) (Endpoints)

• Teva Plunges as U.S. Sales Drop Amid Generic Price Erosion (Bloomberg) (Reuters) (Fierce)
• Chinese biotech BeiGene raises $903 million in HK's first secondary listing under new rules: sources (Reuters)
• Poll reveals MPs' attitudes on pharma in Brexit (PharmaTimes)
• 'Unacceptable’ EpiPen Shortage In Canada Is Health Minister's Fault, NDP Critic Says (HuffPost) (CBC News)
• Device Makers Protest Trump China Tariffs, Say Getting New Suppliers Through FDA Difficult (Inside Health Policy-$)
• Cluster of presumptive Ebola cases in North Kivu in the Democratic Republic of the Congo (WHO)

• Special Report: Biotech incubator taps investors through in-house brokerage (Reuters)
• Facing Wave of Opioid Lawsuits, Drug Companies Sprinkle Charity on Hard-Hit Areas (Endpoints)
• Did a blockbuster drug make hundreds gamble compulsively? A legal fight may decide what science can’t confirm (STAT)
• Geron’s prodigious fundraising activity signals low confidence in J&J relationship (STAT-$)
• Taking A Wider View Of Precision Oncology (Forbes)
• Cigna CEO: We'll Pay For Drugs That Work With Express Scripts Clout (Forbes)
• A System Without Rebates: The Drug Channels Negotiated Discounts Model (Drug Channels)
• Feds bust doctors in $20M opioid conspiracy (The Detroit News)
• After Raising Prices for 100s of Drugs, Industry Pledges Restraint (Bloomberg)
• Rise in Digital Technologies Changing Patient and HCP Expectations for Pharma (PharmExec)
• Spending On Prescription Drugs In The US: Where Does All The Money Go? (Health Affairs)
• Genentech I/O chief Dan Chen heads to an upstart biotech looking to create a landmark advance on antibodies (Endpoints)
• Teva's Copaxone holds its own in wake of Mylan's generic price cut (Fierce)

• As a new study spotlights a growing role for LRRK2 in Parkinson’s, Denali clears an early trial hurdle (Endpoints)
• Amryt Pharma wins key US drug designation (Irish Times)
• Celtaxsys cystic fibrosis drug reduces key symptom in mid-stage study (Reuters)
• CRISPR-guided DNA polymerases enable diversification of all nucleotides in a tunable window (Nature)
• Spring Bank Announces Positive Study Results from the Inarigivir ACHIEVE Trial (Press)
• BioTime Announces the Start of an Investigator Initiated Study of Premvia Designed and Conducted by Dr. Gordon H. Sasaki (Press)

• Fetal DNA sequencing potentially could reduce need for invasive prenatal diagnostic procedures (NIH)
• BD shares down despite Street-beating FY2018 Q3 (MassDevice)
• CSI, Aerolase partner on laser atherectomy device (MedTech Dive)
• The Future Of Medical Technology: Chatbots [Infographic] (Forbes)
• TMCx names 23 companies to latest accelerator cohort (Houston Business Journal-$)
• MITA comments on FDA precertification program (MITA)
• Siemens CEO Kaeser plays his last card on strategy (Reuters)
• Abbott Expands its Directional Deep Brain Stimulation Therapy by Offering New MR-Conditional Labeling (Press)
• Sensus Healthcare Receives FDA 501(k) Clearance to Market Next-Generation SRT-100+ Superficial Radiation Therapy for Treating Non-Melanoma Skin Cancer and Keloids (Press)
• OrthoPediatrics Announces Expanded Indication for FIREFLY Pedicle Screw Navigation Guides (Press)
• Modulated Imaging Receives FDA Clearance for its New Clarifi Imaging System (Press)
• Next Generation nVNS Therapy gammaCore Sapphire Now Available for Patients with Migraine and Episodic Cluster Headache in United States (Press)
• The Qt Company and MedAcuity Announce Partnership to Accelerate Medical Device Companies' Time-to-Market (Press)
• Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection off Ebola Virus (FDA)

• Letters to 340B Contract Pharmacies (E&C)
• The cosmetics industry has avoided strict regulation for over a century. Now rising health concerns has FDA inquiring (CNBC)
• Apple is hiring for its new health clinics, and it's focusing on keeping employees well (CNBC)
• Four cities sue Trump saying ObamaCare 'sabotage' violates Constitution (The Hill)
• California Insurance Commissioner Asks DOJ To Block CVS-Aetna Merger (Forbes)
• Humana: Walgreens Clinic Partnership Won't Prevent Walmart Deal (Forbes)
• Deleting Data • Holding Drugmakers Accountable (Bloomberg-$)
• Pandemic, HHS Funding on Congress’ Post-Summer To-Do List (Bloomberg)
• Arizona Medicaid Committee Must Disclose Drug-Company Ties (Bloomberg-$)
•  Welcome to the 21st Century – FDA Goes Greener! (Lachman Consultants)
• Government Entity (GE) 2018 Audit (FDA)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority (FDA)
• Obesity extends duration of influenza A virus shedding (NIH)
• CMS Proposes to Ever-So-Slightly Expand Stark Law Exceptions for Compensation Arrangements (National Law Review)

• FDA Advisory Committee Calendar

• Our response to EMA preparedness announcement (ABPI)
• Updated guidance: Valproate use by women and girls (MHRA)
• Janssen Receives Positive CHMP Opinion to Expand INVOKANA and VOKANAMET Labelling to Include Positive Data on Cardiovascular Morbidity and Mortality (Press)

• With high expectations on Provenge, Dendreon is sold (again) in $832M dea (Endpoints)
• Pushing boundaries in medical technology (Business Times)
• Revisions of PRECAUTIONS:Apremilast, etc. posted (PMDA)
• MITA comments on proposed changes to the China regulations for the supervision and the administration of medical devices (MITA)

• Maha govt issues notification to designate all drug inspectors as medical device officers (Pharmabiz)
• List of medical devices under public monitoring (Ministry of Health and Family Welfare)

• Database of section 19A approvals to import and supply medicines to address medicine shortages (TGA)
• Fairy capsules: Safety advisory (TGA)
• Guidance on the regulation of tampons in Australia (TGA)

• Health Canada recalls skin creams, lotions (The Canadian Press) (Montreal Gazette)
• AI Designs Radiation Therapy Treatment Plan For Cancer In Twenty Minutes(Forbes)
• Mindshare Medical Announces Health Canada Clearance For Nationwide Use Of RevealAI-Lung Product (Press)
• Health Canada Issues Medical Device License to ivWatch (Press)

• The Future of Aging: Bringing Hollywood to the Hospital (Forbes)
• The Trump Administration Will Boost 'Short-Term Health Plans'—Here's What That Means for You (Fortune)
• Podcast: Left to Its Own Devices: Medical Tech, Congress and the Public (Roll Call)