Regulatory Focus™ > News Articles > Regulatory Recon: DoJ Subpoenas Mylan Over Generic Antibiotic Pricing (4 December 2015)

Regulatory Recon: DoJ Subpoenas Mylan Over Generic Antibiotic Pricing (4 December 2015)

Posted 04 December 2015 | By Michael Mezher 

Regulatory Recon: DoJ Subpoenas Mylan Over Generic Antibiotic Pricing (4 December 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Shkreli's KaloBios buys Chagas disease drug rights, shares soar (Reuters)
  • FDA Pushes Final Generic Labeling Rule To July (Law360-$) (SCRIP-$) (Focus)
  • DOJ antitrust unit subpoenas Mylan over pricing of doxycycline (Reuters) (SEC Filing)
  • Martin Shkreli Questioned By Express Scripts' Chief Medical Officer (Forbes)
  • Martin Shkreli Admits He Messed Up: He Should've Raised Prices Even Higher (Forbes)
  • Gene summit organizers urge caution on human gene editing (Reuters) (NYTimes) (STAT) (Xconomy)
  • How Big Pharma Should Spend Its Money (Forbes)
  • Promising Early Results from Apple's ResearchKit (Geeks Talk Clinical)
  • Why Apple Dumbs Down Your Smartphone (Forbes)
  • Surprise: Theranos CEO Says Company Is Doing More Tests Than Ever (Forbes)
  • In a Rare Move, FDA Initiates Procedures to Suspend Approval of an ANDA (FDA Law Blog)

In Focus: International

  • Liberia's last two Ebola patients recover, leave hospital (Reuters)
  • China political advisors urge cutting red tape on generic drugs: Xinhua (Reuters)
  • Thailand Moves To New, More Harmonized, Medical Device Regulatory System (SCRIP-$)
  • Russian government restricts purchases of vital foreign drugs (PharmaLetter-$)
  • Generic drugs face April 2016 price caps in Japan (FiercePharmaAsia) (Japan Times)

US: Pharmaceuticals and Biotechnology

  • Why We Still Don't Have Personalized Medicine, 15 Years After Sequencing Human Genomes (DD&D)
  • Happy Thefts-giving: Drugmakers need to be extra vigilant during the holidays says expert (In-Pharma Technologist)
  • FDA Finalizes Guidance For Formal Meetings Between FDA and Biosimilars Applicants (Nat Law Review) (Focus)
  • Lilly Ends Basal Insulin Peglispro Development Program (Press) (Reuters)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Trevena Announces FDA Grant of Fast Track Designation to Oliceridine (TRV130) for the Management of Moderate-to-Severe Acute Pain (Press)

US: Medical Devices

  • FDA Updates eCopy Program for Medical Device Submissions Guidance (FDA)
  • Small, private Newton biotech nabs FDA approval for tube-feeding assist (Boston Business Journal)
  • Breast Implant Woes: Effects Of Flawed Regulation And Bad Journalism Linger After 25 Years (Forbes)
  • FDA lifts final warning letters for AngioDynamics (MassDevice)
  • FDA Issues Complete Response Letter to Indivior for Opioid Overdose Nasal Spray (PharmPro)

US: Assorted and Government

  • The Senate Finally Votes to Repeal Obamacare (The Atlantic) (Politico)
  • Why Sovaldi? (Harvard Bill of Health)
  • Greed Kicking The Savings Out of Generic Drugs? (SCRIP-$)
  • A Radical Proposal For Bringing Down The Cost Of Cancer Drugs (Forbes)
  • What The Healthcare Industry Can Learn From Starbucks, Nordstrom And Amazon (Forbes)
  • Martin Shkreli, Twitter And Moving Markets In 140 Characters Or Less (Forbes)
  • Pfizer-Allergan Merger Raises Concerns That Fraud Is Part Of 'Corporate DNA' (Forbes)
  • XBiotech Faces Class Action Over Drug Study Problems (Law360-$)

Upcoming Meetings and Events              

Europe

  • Prominent European Cardiologists Decry Curbs On Industry Support For Docs Attending Medical Meetings (CardioBrief)
  • Price of cancer drugs varies by up to 388% between European countries, Australia, and New Zealand (MNT)
  • Irish and Dutch researchers develop "smart dressing" to transform wound care (MNT)
  • Gilead To File Truvada For HIV Prevention In EU In Early 2016 (SCRIP-$)
  • Pfizer to close UK research centre (PharmaPhorum)
  • EU Grants Marketing Authorization to GSK's Nucala (DD&D)

India

  • Sun Pharma gets boost with US FDA approval for Gleevec (Economic Times)
  • FDA approves Aurobindo's generic Actonel (DSN)

China

  • TaiGen prepping NDA in China for antibiotic (BioCentury)

Japan

Canada

Australia

  • TGA pilot of IMDRF Table of Contents for medical device submissions (TGA)

Other International

  • Lessons From The African Ebola Trial (Pink Sheet-$)
  • Singapore researchers close in on 'liquid biopsy' to track cancer progress, treatment (FiercePharmaAsia)

General Health & Interesting Articles

  • Is Prescription Opioid Abuse A Crime Problem Or A Health Problem? (NPR)
  • Superbug known as 'phantom menace' on the rise in US (Washington Post) (CDC)
  • Even low-levels of common metal linked to weaker bones (Reuters)
  • Link between congenital heart disease and neurodevelopment issues in children found (NIH)
  • Maternal mortality declining but still above goal (Reuters)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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