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

• 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 $160m deal for peripheral stent maker Veniti (MassDevice) (Fierce)
• Apple, Fitbit Get Heart Sensor Patent Slashed At PTAB (Law360-$)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• Release of ICH M9 Guidance Draft (Health Canada)

• 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)