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Recon: Novartis Makes Payments to Trump Lawyer Following Kickback Allegations in China, Greece and Korea

Posted 09 May 2018 | By Zachary Brennan 

Recon: Novartis Makes Payments to Trump Lawyer Following Kickback Allegations in China, Greece and Korea

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA drug shortages: EpiPen Added to List (FDA) (Bloomberg) (Reuters) (NBC)
  • Novartis made payments to Michael Cohen (NY Times-$) (Stat) (Endpoints) (Mass Device) (S&P Global) (Fierce) (Fierce)
  • Jazz Pharmaceuticals to settle U.S. probe for $57 million (Reuters)
  • A stealthy Harvard startup wants to reverse aging in dogs, and humans could be next (MIT Tech Review)
  • Hospitals in US sound alarm on impending chemotherapy shortages (Financial Times-$)
  • Medicine’s Wild West: 10 new genetic tests enter the market each day (Washington Post-$)
  • Crowdfunding for Unproven Stem Cell–Based Interventions (JAMA)
  • Trump’s 'America First' agenda on drug pricing could backfire around the world (Politico)
  • Can a Judge Solve the Opioid Crisis? (WSJ-$)
  • 5 unintended consequences of addressing the opioid crisis (Politico)
  • Drug executives express regret over opioid crisis, one tells Congress his company contributed to the epidemic (Washington Post-$) (WSJ-$) (Politico) (Stat) (Focus)
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In Focus: International
  • After $62 Billion Shire Win, Takeda CEO Faces More Headaches (Bloomberg) (Endpoints)
  • Congo Declares New Ebola Outbreak After 2 Confirmed Cases (NPR)
  • Ebola Returns Just as Trump Asks to Rescind Ebola Funds (The Atlantic)
  • Govt tweaks certification norms to aid pharma trade (LiveMint)
  • UK synthetic antibody firm raises £1.5m (PharmaTimes)
  • Abcam ends pursuit of £270M Horizon Discovery buyout (Fierce)
  • European approval for tablet formulation of Lynparza in ovarian cancer (Pharmafile)
Pharmaceuticals and Biotechnology
  • The Amish pool resources for their medical care. A budget-busting gene therapy puts them in a bind (Stat)
  • Evelo Bio grabs $85M as the latest early-stage biotech debuts on Nasdaq (Endpoints) (Fierce)
  • Games and greed delay the market entry of money-saving biosimilars (Stat)
  • How These Key Learnings Shaped Pfizer's Biosimilar Business (Biosimilar Development)
  • Genentech Defends Herceptin Dosing Patents Before PTAB (Law360-$)
  • Regenerative and Stem Cell Therapy Practices (FSMB)
  • This Isn't The Big One: Darzalex Wins US Approval In First-Line Multiple Myeloma (Scrip-$)
  • Hold On a Second, Valeant Is Still Valeant (Bloomberg) (NY Times-$)
  • Akili Grabs $55M, Seeking FDA Approval of First Video Game Therapy (Xconomy)
  • Daiichi Sankyo in pursuit of Novartis’ Rydapt with next-generation FLT3 drug (Fierce)
  • Walmart Will Implement New Opioid Prescription Limits By End Of Summer (NPR)
  • A World Without Rebates: Is FDA’s Gottlieb Offering New Vision? (Scrip-$)
  • Gilead Lawsuits: California HIV Patients File Class Action and Personal Injury Cases Over Key HIV Drug (Press)
Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
  • Therapy focus – J&J confirms hope for new mechanism in depression (EP Vantage)
Medical Devices
  • FDA permits marketing of new endoscopic device for treating gastrointestinal bleeding (FDA)
US: Assorted and Government
  • Senators Probe 'Enormous' Insulin Price Spikes (Medpage Today) (Senate Aging Committee)
  • CDC director to take pay cut of more than $165k (The Hill) (NY Times-$)
  • FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)
  • USP Nystatin Reference Standard Customer Support Guidance (USP)
  • Fiscal Year 2019 Commerce, Justice, Science Appropriations Bill Released (House Appropriations)
Upcoming Meetings and Events                Europe
  • EFPIA position on proposal for a Regulation of the European Parliament and the Council on HTA and amending Directive 2011/24/EU (EFPIA)
  • Breast implants and anaplastic large cell lymphoma (TGA)
  • Medical devices and IVDs: Suspensions from the ARTG (TGA)
  • Low-cost Hep C cure showing good results (Bangkok Post)
  • China Sees First Independent Province Approve Imported Medical Device (China Med Device)
  • Applicability of ISO 15015197 2013 version regarding glucometer test strips-Reg (CDSCO)
General Health and Other Interesting Articles
  • Be thankful you were born after the smallpox vaccine (Vox)
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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