Regulatory Focus™ > News Articles > Regulatory Recon: Clinton Proposes New Rules for Drug Makers (22 September 2015)

Regulatory Recon: Clinton Proposes New Rules for Drug Makers (22 September 2015)

Posted 22 September 2015 | By

Regulatory Recon: Clinton Proposes New Rules for Drug Makers (22 September 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

In Focus: International

  • Brazil aims to make biosimilars the foundation of its biotechnology sector (BioWorld)
  • Post ANZTPA, New Zealand Plans New Medical Device Regulatory System (Emergo)
  • Novo Nordisk injecting 70m in Iran for insulin pen production plant (InPharma-Technologist) (Pharmafile)

US: Pharmaceuticals and Biotechnology

  • Exclusive: Americans overpaying hugely for cancer drugs - academic study (Reuters)
  • Generic Drug Price Increases: Implications for Medicaid (Harvard Law Blog)
  • Mylan Moves to Cancel ‘Stichting’ Takeover Defense (WSJ-$)
  • Lack of regulatory clarity dominates US biosimilar debate post Zarxio (BioPharma-Reporter)
  • Amgen Covering Its Bases In Hospira Biosimilars Suit (SCRIP-$)
  • Pfizer and GSK in antidepressant safety probes (Pharmafile)
  • Should Martin Shkreli be allowed to play the Good Samaritan defense? (FierceBiotech)

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

  • Pradaxa Bleeding Events Prompt FDA To Revise Generic Bioequivalence Criteria (Pink Sheet-$)
  • Bird Flu Vaccine Conditionally Approved, but Still Can’t Be Sold (NY Times)
  • AstraZeneca taps crowd sourcing to find cancer drug cocktails (Reuters)
  • New ulcerative colitis data could help Pfizer's Xeljanz pick up the pace (FiercePharma)
  • Roche receives FDA CLIA waiver for flu A/B test for use on its cobas Liat PCR System (Press)

US: Medical Devices

  • Reports of Bad Reactions Rise for Sterility Device (WSJ-$) (Mass Device) (Reuters)
  • FDA is classifying oral electronic vision aids into Class II (FDA)
  • Ceterix Orthopaedics wins FDA 510(k) for NovoStitch Plus (Mass Device)
  • Great Lakes NeuroTech wins $1.9m NIH grant for Parkinson’s DBS research (Mass Device)
  • Medtronic launches real-world study for SuperDimension lung device (Mass Device)
  • Interrad Medical wins DoD, VA supply contract (Mass Device)
  • Arthrex looks to Supreme Court in patent spat with KFx Medical (Mass Device)

US: Assorted and Government

  • FDA Generic Office Director Uhl Returns From Medical Leave (Pink Sheet-$)
  • Updating Quality Standards for Nuclear Medicine and Radioactive Materials (USP)
  • The Government Really Means It This Time (FDA Law Blog)
  • Science Evolution At FDA ‘Transformative,’ Advisors Say (Gray Sheet-$)

Upcoming Meetings and Events              

Europe

  • EMA Guidance On Redacting Commercially Confidential Info In Clinical Reports Nears (SCRIP-$)

Australia

  • Speed Up Access To Cancer Drugs, Australia's Senate Tells Government (SCRIP-$)

India

  • Asia's biggest vaccine maker to seek fast-track nod for dengue drug in India (Reuters)
  • Govt committee set to study steep trade margins on medicine brands (Economic Times)
  • Indian regulators add to list of notified devices, formulate QMS requirements for medical devices (Mass Device)
  • Pharmexcil to organise international meet focused on promoting API exports (PharmaBiz)

China

  • China's BGI and Huawei partner on Big Data genomic system storage (FiercePharmaAsia)
  • Shanghai-based ZAI Lab in-licenses autoimmune candidate from UCB (FiercePharmaAsia)

Japan

  • Japan Pushing Forward In Global Scrum For Cancer Leads (PharmAsiaNews)

Other International

  • A Day of Reckoning for Aging Facilities: Is It Time to Invest in Change? (SCRIP-$)
  • Novartis CEO says company to make heart failure drug Entresto at Singapore plant (FiercePharmaAsia)

General Health and Other Interesting Articles

  • The New Technique That Finds All Known Human Viruses in Your Blood (Atlantic)
  • Current status of pluripotent stem cells: moving the first therapies to the clinic (Nature)
  • J. Craig Venter to offer DNA data to consumers (MIT Technology Review) (Reuters)
  • U.S. Paid Healthcare.gov Contractor $4 Million to Fix Its Own Mess (Bloomberg)

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.


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