Regulatory Focus™ > News Articles > Regulatory Recon: Did FDA Expand the Approval of a Sleep Drug by Accident? (12 June 2015)

Regulatory Recon: Did FDA Expand the Approval of a Sleep Drug by Accident? (12 June 2015)

Posted 12 June 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Did FDA Expand the Approval of a Sleep Drug by Accident? (12 June 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Watchdog accuses FDA of wrongly expanding Vanda sleep drug use (Reuters) (Pharmalot)
  • E&C Floats Draft LDT Bill Creating FDA In Vitro Center, Defining Risk Categories, Mandating Review Timeline (IHP-$)
  • Lawmakers Consider Unique Identifiers For LDTs In Draft Legislation (IHP-$)
  • FDA panel unanimously backs GSKs asthma biologic (PharmaTimes) (Tarius) (BioCentury) (Pink Sheet-$) (Reuters) (MedPage Today)
  • Big Pharma Torches FDA In Amarin's Free Speech Suit (Law 360-$)
  • Groups Lobby to Add UDI to Claims Forms (MDDI)

In Focus: International

  • EMA's PRAC Starts Review of SGLT2 Inhibitors for Diabetes (EMA)
  • Central repository for safety reports - one year to go before mandatory use (EMA)
  • MHRA’s Rawlins Says New Approach Needed For Clinical Trials (Pink Sheet-$)
  • A Chinese Ebola Drug Raises Hopes, and Rancor (NYTimes)
  • India takes first step towards regulating medical devices (Reuters)
  • Canada's High Court Legalizes Edibles, Other Forms Of Medical Marijuana (Forbes)

US: Pharmaceuticals and Biotechnology

  • Watchdog accuses FDA of wrongly expanding Vanda sleep drug use (Reuters) (Pharmalot)
  • FDA panel unanimously backs GSKs asthma biologic (PharmaTimes) (Tarius) (BioCentury) (Pink Sheet-$) (Reuters) (MedPage Today)
  • Big Pharma Torches FDA In Amarin's Free Speech Suit (Law 360-$)
  • Amarin lawsuit about more than fish oil (MM&M)
  • FDA clears Novartis' Promacta for paediatric ITP patients (PharmaTimes) (Press)
  • Keeping Blood Transfusions Safe: FDA's Multi-layered Protections for Donated Blood (FDA)
  • Conducting Vaccine Effectiveness Surveillance in Sentinel’s PRISM Program (Sentinel)
  • Whistleblowers accuse Merck of withholding info on mumps vaccine (Fierce)
  • FDA Regulation of HCT/Ps – Impact of New Guidances on Manufacturers and Users (MasterControl)
  • 505(b)(2)s: To List or Not to List – That is the Question (Camargo)
  • NYTimes Editorial Board Weighs in on Sprout's Libido-Boosting Drug (NYT)
  • 8 Product-Hopping Takeaways From Namenda Ruling (Law 360-$)
  • Failure To Report Claims – A Bad Idea Whose Time Is Passing (D&D Law)
  • US FDA upgrades Jubilant Life's US plant status (India Times)

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

  • Pfizer Trial of Antidepressant Pristiq on Children Doesn’t Meet Primary Goal (WSJ-$) (Press)
  • Lilly and Incyte's baricitinib aces phase III trials (PMLive)
  • Seres Therapeutics Receives FDA Breakthrough Therapy Designation for Its Lead Product Candidate, SER-109 (Press)
  • Agios' top cancer drug notches more remissions on the way to Phase III (Fierce) (Reuters)
  • AVEO Announces FDA Update for Tivozanib in Colorectal Cancer (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​The curious incident of the $44,000 prescription (CBS)
  • Oregon to allow year-long birth control supplies (CBS)
  • Prisoners Sue Massachusetts for Withholding Hepatitis C Drugs (Pharmalot)
  • Bipartisan Duo Introduces Cancer Drug Coverage Parity Act (House)
  • Medicare Drug Plans Favor Generic Opioids Over Those Designed To Avoid Abuse, Study Finds (KHN)

US: Medical Devices

  • E&C Floats Draft LDT Bill Creating FDA In Vitro Center, Defining Risk Categories, Mandating Review Timeline (IHP-$)
  • Lawmakers Consider Unique Identifiers For LDTs In Draft Legislation (IHP-$)
  • Groups Lobby to Add UDI to Claims Forms (MDDI)
  • FDA announces Class 1 recall of Zimmer, HeartWare and Maquet devices (Fierce)
  • FDA Looking to Down-classify Electric Positioning Chairs (FDA)
  • Philips Response To ResMed Update On Phase IV SERVE-HF Study Of Adaptive Servo-Ventilation (ASV) Therapy In Central Sleep Apnea And Chronic Heart Failure (FDA)

US: Assorted And Government

  • Compliance Officers Turned Whistleblowers – Can They Do That? (PCM)

Upcoming Meetings and Events

Europe

  • EMA's PRAC Starts Review of SGLT2 Inhibitors for Diabetes (EMA)
  • Central repository for safety reports - one year to go before mandatory use (EMA)
  • MHRA’s Rawlins Says New Approach Needed For Clinical Trials (Pink Sheet-$)
  • EMA Management Board: highlights of June 2015 meeting (EMA)
  • UK project on accelerating patient access looks at new development pathways (SCRIP RA-$)
  • Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases (EMA)
  • Few UK medicines likely to be affected by the proposed European Medicines Agency’s guidelines on phthalates (Open BMC)

India

  • India takes first step towards regulating medical devices (Reuters)
  • MSF campaigns to uphold cheap Indian generics (Pharmafile) (Reuters)
  • India to exempt some AIDS, TB drugs, and diagnostics from import taxes (Fierce) (Reuters)
  • Soon, doctors to write prescriptions in capital letters (India Times)

China

  • A Chinese Ebola Drug Raises Hopes, and Rancor (NYTimes)
  • WHO approves China flu vaccine, lauds growing industry (Reuters)

Canada

  • Canada's High Court Legalizes Edibles, Other Forms Of Medical Marijuana (Forbes)

General Regulatory And Interesting Articles

  • Sleeping Pill Use Raises Car Crash Risk, Study Finds (NBC)
  • Blood donors in Sweden receive a text message when their blood is used (MedCityNews)
  • Patients 'sceptical' about biosimilars, says EULAR (PMLive)
  • Stretchy spinal implant presents new paralysis treatment (Reuters)

Regulatory Reconnaissance #574 – 12 June 2015

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 @AlecGaffney 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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