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

Posted 13 July 2018 | By Ana Mulero 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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 $4.7 Billion in Baby Powder Lawsuit (NYT)
  • FDA Budget Matters: Investing in Advanced Domestic Manufacturing (FDA Voice)
In Focus: International
  • Brexit ambition is ‘fine’ but execution is key, says Brexit Health Alliance (PharmaTimes)
  • Health Canada ordered to release confidential drug company data on HPV vaccines (CBC News)
  • China crackdown on polluting firms leaves Indian pharma industry in quandary as API prices rise 40% in four months (Pharmabiz)
  • This Startup Is Developing Finger-Prick Blood Tests, But Don't Call It Theranos 2 (Forbes)
  • EMA’s Pharmacovigilance Risk Assessment Committee recommends restricting use of prostate cancer medicine Xofigo (EMA)
  • Swiss Regulators Moving to Online Medical Device Certification (Emergo Group)
Pharmaceuticals & Biotechnology
  • U.S. court denies Jazz Pharma bid to revive patents on narcolepsy drug (Reuters)
  • The Next Plague Is Coming. Is America Ready? (The Atlantic)
  • Did Pfizer Blink, And What Will Pharma Do Now? (Forbes) (STAT-$)
  • 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-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Celgene tweaks trial of myeloma CAR-T bb2121, raising dose (Fierce)
  • Delays in the Publication of Important Clinical Trial Findings in Oncology (JAMA)
  • AbbVie raises hopes for blood cancer patients (pharmaphorum)
  • The National Comprehensive Cancer Network (NCCN) Guidelines Recommend BRAFTOVI (encorafenib) in Combination with MEKTOVI (binimetinib) as a Category 1 Treatment Option for Patients with Advanced BRAF-mutant Melanoma (Press)
Medical Devices
  • University of Iowa Healthcare rolls out first autonomous AI diagnostic system cleared by the FDA (Healthcare IT News)
  • EchoNous wins FDA nod for EchoNous Vein ultrasound catheter guide (MassDevice)
  • Gala Therapeutics wins FDA IDE nod for early feasibility trial of RheOx system (MassDevice)
  • BioElectronics Files FDA Application for Treatment of Musculoskeletal Pain (Press)
US: Assorted & Government
  • Federal auditor hits Tom Price for improper travel (Politico) (OIG)
  • HHS says it will reduce vetting of migrant kids (Politico)
  • VA creates new Office of Electronic Health Record Modernization (Healthcare IT News)
  • House forms committee to track VA Cerner EHR modernization project (Healthcare IT News)
  • Medicare May Soon Pay Doctors For Diagnosis Via Text Message (Forbes)
  • Verma: Changes Coming to Stark Self-Referral Law (MedPage Today)
  • Privacy laws are hurting the care of patients with addiction (STAT)
  • Amazon and start-up Xealth are planning a pilot where doctors would 'prescribe' products to be delivered after patients leave the hospital (CNBC)
  • Fentanyl-related deaths double in six months; US government takes some action (CNN)
  • House Panel Votes To Delay ACA Employer Mandate Until 2019 (Law360-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • 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)
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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