Recon: FDA Panel Backs Malaria Drug; Senate Report on Trump Lawyer and Novartis

• Senate Democrats blast former Trump attorney for 'selling access' to White House (ABC News) (Endpoints) (STAT) (Business Insider) (Bloomberg) (Report)
• HHS OIG Report on Tom Price’s Flights (Report) (NYT-$)
• Amgen, UCB are back pitching once-rejected osteoporosis drug to the FDA — but big hurdles lie ahead (Endpoints) (Fierce)
• FDA Panel Backs Tafenoquine for 'Radical Cure' of Malaria (MedPage Today)
• CMS proposes change in the drug payment amount under Medicare Part B (Reuters) (Medscape)
• Novartis Wins Patent Fight Over Best-Selling MS Drug (Bloomberg-$) (Fierce) (BioPharma Dive)
• CVS, Aetna shares rise on report DoJ won't challenge their merger deal (CNBC) (Axios)
• Advaxis clinical hold lifted, but stock not so much (BioPharma Dive) (Endpoints)
• Johnson & Johnson Told to Pay $4.7 Billion in Baby Powder Lawsuit (NYT)
• FDA Budget Matters: Investing in Advanced Domestic Manufacturing (FDA Voice)

• Brexit ambition is ‘fine’ but execution is key, says Brexit Health Alliance (PharmaTimes)
• Health Canada ordered to release confidential drug company data on HPV vaccines (CBC News)
• China crackdown on polluting firms leaves Indian pharma industry in quandary as API prices rise 40% in four months (Pharmabiz)
• This Startup Is Developing Finger-Prick Blood Tests, But Don't Call It Theranos 2 (Forbes)
• EMA’s Pharmacovigilance Risk Assessment Committee recommends restricting use of prostate cancer medicine Xofigo (EMA)
• Swiss Regulators Moving to Online Medical Device Certification (Emergo Group)

• U.S. court denies Jazz Pharma bid to revive patents on narcolepsy drug (Reuters)
• The Next Plague Is Coming. Is America Ready? (The Atlantic)
• Did Pfizer Blink, And What Will Pharma Do Now? (Forbes) (STAT-$)
• Octave Biosciences scores $14M and George Scangos for its board (Fierce)  (Endpoints)
• Hugin comes under fire in New Jersey Senate campaign ad for hiking drug prices (STAT-$)
• Drug wholesalers sue New York over an opioid stewardship program (STAT-$)
• Big Pharma Ditches Antibiotic Research When It’s Needed Most (Mother Jones)
• A Pfizer executive explains why she sees a group of 90,000 people as the most important stakeholders in the drugmaker (Business Insider)
• ​​​​​​​SuperValu Loses Sanctions Bid In Suit Over Drug Pricing (Law360-$)
• Novo Nordisk Beats ERISA Suit With Anti-Assignment Clause (Law360-$)

• Celgene tweaks trial of myeloma CAR-T bb2121, raising dose (Fierce)
• Delays in the Publication of Important Clinical Trial Findings in Oncology (JAMA)
• AbbVie raises hopes for blood cancer patients (pharmaphorum)
• The National Comprehensive Cancer Network (NCCN) Guidelines Recommend BRAFTOVI (encorafenib) in Combination with MEKTOVI (binimetinib) as a Category 1 Treatment Option for Patients with Advanced BRAF-mutant Melanoma (Press)

• University of Iowa Healthcare rolls out first autonomous AI diagnostic system cleared by the FDA (Healthcare IT News)
• EchoNous wins FDA nod for EchoNous Vein ultrasound catheter guide (MassDevice)
• Gala Therapeutics wins FDA IDE nod for early feasibility trial of RheOx system (MassDevice)
• BioElectronics Files FDA Application for Treatment of Musculoskeletal Pain (Press)

• Federal auditor hits Tom Price for improper travel (Politico) (OIG)
• HHS says it will reduce vetting of migrant kids (Politico)
• VA creates new Office of Electronic Health Record Modernization (Healthcare IT News)
• House forms committee to track VA Cerner EHR modernization project (Healthcare IT News)
• Medicare May Soon Pay Doctors For Diagnosis Via Text Message (Forbes)
• Verma: Changes Coming to Stark Self-Referral Law (MedPage Today)
• Privacy laws are hurting the care of patients with addiction (STAT)
• Amazon and start-up Xealth are planning a pilot where doctors would 'prescribe' products to be delivered after patients leave the hospital (CNBC)
• Fentanyl-related deaths double in six months; US government takes some action (CNN)
• House Panel Votes To Delay ACA Employer Mandate Until 2019 (Law360-$)
• Cities Planning Supervised Drug Injection Sites Fear Justice Department Reaction (NPR)
• Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery--Influences of Sex and Gender; Public Meeting (FDA)

• FDA Advisory Committee Calendar

• Annual review of good clinical practice referrals (MHRA)
• Sight nabs CE Mark for its tabletop complete blood count reader (Fierce)
• Insulet extends deal with Glooko in Europe (DDBN)
• NICE turns down Darzalex combo for pre-treated multiple myeloma (PharmaTimes)

• Children and PTSD: Health risks linger long after acute psychological trauma ends (CNBC)
• CardioFocus introduces HeartLight Endoscopic Ablation System in Japan (Pharmabiz)

• India’s share of pharma production for exports has tripled since 1985, says senior vice-president of USP (Financial Express)
• Suresh Prabhu asks pharma companies to invest in R&D (Economic Times)
• Indian Pharma Industry's Revenues Estimated To Have Surged 7.4% In 2017 (Business Standard)
• Healthcare policy: Clock is ticking for Indian healthcare (Financial Express)
• Indian medical device manufacturers seek implementation of packaged commodity rules without delay (Pharmabiz)
• Gujarat FDCA to conduct surprise inspections on non-compliant mfg units based on GMP guidelines (Pharmabiz)

• MGC Pharma scores GMP licence (The Australian)
• Changes to Therapeutic Goods Advertising in Australia (Lexology-$)

• Ottawa heightens scrutiny on opioid manufacturers’ marketing (The Globe and Mail)
• Why Canadian insurers are wary of covering medical marijuana (Reuters)
• Canada Court Mulls Meaning of ‘Inventive,’ Upholds Shire Patent (Bloomberg-$)
• Notice: Implications of the Tobacco and Vaping Products Act for Health Products Regulated Under the Food and Drugs Act (Health Canada)

• Alexa is a terrible doctor (Quartz)
• Tracking C-section pain patterns may benefit surgical patients (Reuters)
• Medicare won't cover all your health care expenses. Here's how to prepare (CNBC)
• Healthcare VC Investing Could Hit A Record High In 2018 (Forbes)
• Health care needs more physician CEOs like Atul Gawande (STAT)