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

Posted 02 August 2018 | By Ana Mulero 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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)
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In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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 $20M opioid conspiracy (The Detroit News)
  • After Raising Prices for 100s of Drugs, Industry Pledges Restraint (Bloomberg)
  • Rise in Digital Technologies Changing Patient and HCP Expectations for Pharma (PharmExec)
  • Spending On Prescription Drugs In The US: Where Does All The Money Go? (Health Affairs)
  • Genentech I/O chief Dan Chen heads to an upstart biotech looking to create a landmark advance on antibodies (Endpoints)
  • Teva's Copaxone holds its own in wake of Mylan's generic price cut (Fierce)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • As a new study spotlights a growing role for LRRK2 in Parkinson’s, Denali clears an early trial hurdle (Endpoints)
  • Amryt Pharma wins key US drug designation (Irish Times)
  • Celtaxsys cystic fibrosis drug reduces key symptom in mid-stage study (Reuters)
  • CRISPR-guided DNA polymerases enable diversification of all nucleotides in a tunable window (Nature)
  • Spring Bank Announces Positive Study Results from the Inarigivir ACHIEVE Trial (Press)
  • BioTime Announces the Start of an Investigator Initiated Study of Premvia Designed and Conducted by Dr. Gordon H. Sasaki (Press)
Medical Devices
  • Fetal DNA sequencing potentially could reduce need for invasive prenatal diagnostic procedures (NIH)
  • BD shares down despite Street-beating FY2018 Q3 (MassDevice)
  • CSI, Aerolase partner on laser atherectomy device (MedTech Dive)
  • The Future Of Medical Technology: Chatbots [Infographic] (Forbes)
  • TMCx names 23 companies to latest accelerator cohort (Houston Business Journal-$)
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
India Australia
  • 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)
General Health & Other Interesting Articles
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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