Regulatory Focus™ > News Articles > 8 > Recon: Insys to Pay $150M to Settle DOJ Investigation; AZ Settles Texas Suit for $110M

Recon: Insys to Pay $150M to Settle DOJ Investigation; AZ Settles Texas Suit for $110M

Posted 08 August 2018 | By Ana Mulero 

Recon: Insys to Pay $150M to Settle DOJ Investigation; AZ Settles Texas Suit for $110M

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

In Focus: US
  • Insys to Pay $150 Million to Settle Justice Department Investigation (WSJ) (Reuters) (Fierce)
  • AstraZeneca settles Texas drug lawsuits for $110 million (Reuters) (STAT) (Law360-$)
  • Trump’s new tone with drug makers: gratitude (STAT) (Bloomberg) (Reuters)
  • Trump Forces Pharma to Face More Medicare Drug-Price Negotiation (Bloomberg) (Focus)
  • EpiPen up for sale? Pharmaceutical maker Mylan considering 'alternatives' (USA Today) (WSJ)
  • Prescription drugs fuel CVS' earnings beat as sales in the front of the store lag (CNBC) (Forbes)
  • RegenXBio Gene Therapy Shows Early Promise For Eye Disease; Cholesterol Treatment Results Mixed (Forbes) (Endpoints) (Fierce)
  • FDA approves treatment for two rare types of non-Hodgkin lymphoma (FDA)
  • Backed with $140 million, startup launches three-pronged attack on liver diseases (San Francisco Business Times-$) (Xconomy) (Endpoints)
  • SQZ raises $72M as cell therapies close in on clinical trials (Fierce) (Endpoints) (MedCity News)
  • Boston Scientific inks $160m deal for peripheral stent maker Veniti (MassDevice) (Fierce)
  • Apple, Fitbit Get Heart Sensor Patent Slashed At PTAB (Law360-$)
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In Focus: International
  • Drugmaker Novo Nordisk sales disappoint, sees lower 2019 U.S. prices (Reuters) (Financial Times-$) (Bloomberg-$) (PharmaTimes)
  • Samsung outlines blockbuster investment plan for biopharmaceuticals, part of a $22B play on next-gen tech (Endpoints) (Reuters) (The Hindu) (Financial Times)
  • A drug priced out of reach in Africa could save lives from a neglected killer (STAT)
  • Drone company flying blood around Rwanda says Australia could be next (SBS)
  • Health workers in Congo being vaccinated against Ebola: WHO (Reuters)
  • Health authorities required to provide information, observation for rabies vaccines recipients (Xinhua)
Pharmaceuticals & Biotechnology
  • GOP congressman from New York charged with insider trading (AP News) (CNBC) (Business Insider) (NBC) (Axios) (The Washington Post)
  • Early-Stage Biotechs May Damage Your Financial Health (Bloomberg)
  • Texas lethal-injection drug case will stay open to public (Dallas Morning News)
  • The Size of the 340B Program and Its Impact on Manufacturer Revenues (Health Affairs)
  • How employers are shaking up pharmacy benefits for 2019  (CNBC)
  • Cheaper alternatives are challenging big pharma (Financial Times)
  • Quick-fire fundraisings give Apexigen $73M for I-O push (Fierce)
  • Medicaid Expansion Making Diabetes Meds More Accessible To Poor, Study Shows (KHN)
  • As Opioid Crisis Rages, Some Trade ‘Tough Love’ For Empathy (KHN)
  • Maryland mom tested positive for opiates after eating bagel (AP News)
  • Would reforming the U.S. patent system help to lower drug prices? (STAT-$)
  • Drug pricing could be a slam-dunk campaign issue for Democrats — if only they had a plan (STAT)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Vertex gets approval to treat toddlers with cystic fibrosis drug (The Boston Globe)
  • Gemphire stock drops to all-time low as lead drug delayed (BioPharma Dive)
  • Teva confident in September approval for migraine drug despite latest Celltrion plant citation (Fierce)
  • Alector Receives Orphan Drug Designation from the U.S. FDA for AL001 for the Treatment of Frontotemporal Dementia (Press)
  • Janssen Submits U.S. & EU Regulatory Applications Seeking Approval of DARZALEX (daratumumab) Split Dosing Regimen (Press)
Medical Devices
  • FDA Details Vision for Regulating In Vitro Clinical Tests to Legislators (GenomeWeb)
  • How Genetic Tests Muddy Your Odds Of Getting A Long-Term-Care Policy (KHN)
  • Boston Scientific to cut 85 jobs at Burlington site (Boston Business Journal-$)
  • The $250 Biohack That’s Revolutionizing Life With Diabetes (Bloomberg)
  • Scientist Ducks Prison In Medical Device Bribery Scheme (Law360-$)
  • The Genetic Test Some Men Don’t Know They Need (WSJ)
  • Cook Medical introduces a new length of Zilver PTX (Press)
  • Tandem Diabetes Care Announces Publication of PROLOG Study Results in Diabetes Care Journal (Press)
US: Assorted & Government
  • Primaries cement the health care status quo (Axios)
  • The Shadow Rulers of the VA (ProPublica)
  • CVS Says Aetna Deal on Track to Close by Early Fourth Quarter (Bloomberg-$)
  • NIH’s Lax Effort to Stop Harassment ‘Unacceptable': Lawmakers (Bloomberg-$)
  • GM Cuts Different Type of Health-Care Deal (WSJ)
  • Public Hearing: Future Format of the National Drug Code (FDA)
  • Intervention for first-time moms and their infants improves child weight through age 3 (NIH)
  • NIH researchers discover highly infectious vehicle for transmission of viruses among humans (NIH)
Upcoming Meetings & Events Europe
  • Pharma survey: No Brexit is the best option (PMLiVE)
  • Esmya: new measures to minimise risk of rare but serious liver injury (EMA)
  • EMA: working for every patient in Europe (EMA)
  • Updated: Assistive technology: definition and safe use (MHRA)
  • New test for sepsis could improve survival rates thanks to Dstl scientists (Gov UK)
  • Deaths from hepatitis C have fallen by 11 per cent in the last year (Gov UK)
  • Agilent Announces Update on PD-L1 CE-IVD in Urothelial Carcinoma (Press)
  • CERENOVUS Receives European Regulatory Approval For BRAVO Flow Diverter to Treat Intracranial Aneurysms (Press)
  • Chinese cancer drug maker BeiGene drops 5 per cent on Hong Kong debut (South China Morning Post)
  • Over 36.8 billion won worth of banned valsartan-based drugs sold last year (Korea Biomedical Review)
  • Takeda gets approval for antihypertension drug Edarbyclor (Korea Biomedical Review)
  • Malaysian Regulators Push Back Medical Device Labeling Requirement Deadline (Emergo Group)
  • China strengthens medical sector supervision (Xinhua)
  • China to include more cancer drugs on medical insurance list (Xinhua)
  • Health authorities investigating case involving children in Shaanxi province (China Daily)
  • Future of healthcare could lie in artificial intelligence technology (China Daily)
  • Japan medical school confirms altering scores to limit women (AP News)
  • DTAB gives green signal to uniform implementation of new labelling norms from April 1, 2019 (Pharmabiz)
  • Valsartan: Safety advisory - products in Australia not affected by overseas recalls (TGA)
  • Updates on GMP clearance application forms (TGA)
  • Custom knee replacements and new-age condoms win NSW medtech grants (The Sydney Morning Herald)
Canada General Health & Other Interesting Articles
  • Silicon Valley’s quest to live forever (The New Yorker)
  • Study: 1 in 7 children of Zika-infected moms have problems (AP News)
  • To Save on Health Care, Change What the Doctor Orders (Bloomberg)
  • CVS to offer nationwide telemedicine service through smartphone video (USA Today)
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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