Regulatory Focus™ > News Articles > Regulatory Recon: House Releases New Draft of 'Cures' Bill (20 May 2015)

Regulatory Recon: House Releases New Draft of 'Cures' Bill (20 May 2015)

Posted 20 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: House Releases New Draft of 'Cures' Bill (20 May 2015)

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

In Focus: US

  • New Draft of the 21st Century Cures Act Released (E&C)
  • Detailed Drug Risks in TV Ads ‘Waste of Time,’ FDA Official Says (Bloomberg)
  • Avalanche! Congress is Buried Under a Slew of FDA-Related Legislation as the 21st Century Cures Act Makes Its Official Debut (FDA Law Blog) (Congress)
  • FDA Cites Akorn’s Exhibit Banner At ASHP Clinical Conference (Pink Sheet-$) (FDA) (Promo)
  • Priority Review Voucher Extension Scaled Back In New Cures Bill (Pink Sheet-$)
  • Two sterile compounders hit by FDA warning letters for violating cGMP (Outsourcing Pharma)
  • J&J Will Pay $7.8M To Exit Ark. Risperdal Marketing Suit (Law 360-$) (AP)
  • Blood clots prompt trial pause for Edwards' Fortis mitral valve (Mass Device) (MDDI) (Fierce)
  • Senators Push Park Doctrine Prosecution For Spiked Supplement ‘Criminal Endeavors’ (Tan Sheet-$) (Senate) (Senate)

In Focus: International

  • EFPIA Reiterates Support of Clinical Trial Data Sharing (EFPIA)
  • Amgen cholesterol drug could get EU green light this week (Reuters)
  • Indian pharma eyes skill-based experts in regulatory affairs, occupational therapists & product marketing (PharmaBiz)
  • High Cost of Sovaldi Hepatitis C Drug Prompts a Call to Void Its Patents (NYTimes)
  • Health Policy 101: How the Trans-Pacific Partnership Will Impact Prescription Drugs (Brookings)
  • Generics industry keeps up pressure on ICH (SCRIP RA-$)

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US: Pharmaceuticals and Biotechnology

  • Avalanche! Congress is Buried Under a Slew of FDA-Related Legislation as the 21st Century Cures Act Makes Its Official Debut (FDA Law Blog) (Congress)
  • Detailed Drug Risks in TV Ads ‘Waste of Time,’ FDA Official Says (Bloomberg)
  • FDA Cites Akorn’s Exhibit Banner At ASHP Clinical Conference (Pink Sheet-$) (FDA) (Promo)
  • Priority Review Voucher Extension Scaled Back In New Cures Bill (Pink Sheet-$)
  • Critical Path Institute Launches New Neonatal Consortium (Press)
  • California Assembly passes right-to-try bill (BioCentury)
  • 'Right to Try' Bill Passes Nevada Senate (Daily Herald)
  • Illinois Right to Try Bill Advances, Sent to Governor (Chicago Tribune)
  • Two sterile compounders hit by FDA warning letters for violating cGMP (Outsourcing Pharma)
  • Pharmacy in 2012 U.S. meningitis outbreak to pay victims $200 million (Reuters) (law 360-$)
  • J&J Will Pay $7.8M To Exit Ark. Risperdal Marketing Suit (Law 360-$) (AP)
  • More on FDA's New Animal Drug Compounding Guideline (FDA Law Blog) (FDA Law Blog)
  • Orexigen CEO Pledged To Keep Data Secret, But Not From Himself (Forbes)
  • Supreme Court Denies Last Pending Request for Review in Reglan Preemption Case (FDA News-$)

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

  • Sarepta Therapeutics Announces Plans to Submit Rolling NDA for Eteplirsen (Press) (The Street) (BizJournal) (BioCentury)
  • Eagle Pharmaceuticals Submits NDA for Ready-to-Use Bivalirudin to FDA (Press)
  • Bristol-Myers Squibb Receives Amended U.S. FDA Breakthrough Therapy Designation for Investigational Daclatasvir-based Hepatitis C Regimen (Press)
  • Sunovion Pharmaceuticals Inc. Announces Positive Results for Latuda (lurasidone HCl) in First Placebo-Controlled Trial of Patients with Major Depressive Disorder with Mixed (Subsyndromal Hypomanic) Features (Press)
  • Intercept falls on Phase III NASH trial design (BioCentury)
  • J&J says will submit 10 medicines to regulators by 2019 (Reuters)
  • Lpath eye drug fails mid-stage study (Reuters)
  • Alnylam Receives Orphan Drug Designation from the United States Food & Drug Administration for Revusiran, an Investigational RNAi Therapeutic for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis (Press)

US: Pharmaceuticals and Biotechnology: General

  • Senators McConnell & Markey Partner on National Effort to Address Prescription Drug and Heroin Crisis (Senate) (The Hill)

US: Medical Devices

  • Blood clots prompt trial pause for Edwards' Fortis mitral valve (Mass Device) (MDDI) (Fierce)
  • Communicating Device Issues to Patients Requires Aligned Message (MDS)
  • FDA Completes Review of Guided Therapeutics’ LuViva Advanced Cervical Scan PMA Application (Press)
  • FDA clears BrainScope smartphone-based EEG device to detect traumatic brain injury (Fierce)
  • CE Mark and FDA Clearance in the United States for Implanet's New JAZZ Diameters (Press)
  • Emmes Announces FDA Clearance of New Medical Device (Press)

US: Dietary Supplements

  • Senators Push Park Doctrine Prosecution For Spiked Supplement ‘Criminal Endeavors’ (Tan Sheet-$) (Senate) (Senate)
  • Legislation by litigation? CSPI investigating Saw Palmetto claims (NI-USA)
  • Many Probiotics Taken for Celiac Disease Contain Gluten (NYTimes)

US: Assorted And Government

  • New Draft of the 21st Century Cures Act Released (E&C)
  • 21st Century Cures Markup Moved to Tomorrow (E&C)
  • FDA: $1bn needed to cover 'Cures' costs (SCRIP-$)
  • New batch of FDA Warning Letters (FDA)
  • House panel seeks expanded GAO review of smallpox incident at NIH (Washington Post)
  • FDA Teams With National Forum to Reduce Deaths from Heart Disease: Program is first of its kind (FDA)

Upcoming Meetings

Europe

  • EFPIA Reiterates Support of Clinical Trial Data Sharing (EFPIA)
  • Amgen cholesterol drug could get EU green light this week (Reuters)
  • Celgene's psoriasis drug Otezla gets thumbs down from IQWiG (SCRIP-$)
  • Abbott wins CE Mark for next-gen Absorb device (MassDevice)

India

  • Maharashtra FDA writes to National Pharmaceutical Pricing Authority to regulate prices of stents (India Times)
  • Indian pharma eyes skill-based experts in regulatory affairs, occupational therapists & product marketing (PharmaBiz)

Other International

  • High Cost of Sovaldi Hepatitis C Drug Prompts a Call to Void Its Patents (NYTimes)
  • Health Policy 101: How the Trans-Pacific Partnership Will Impact Prescription Drugs (Brookings)
  • Generics industry keeps up pressure on ICH (SCRIP RA-$)

General Regulatory And Interesting Articles

  • Cholesterol drugs may curb strokes among low-risk older adults (Reuters)
  • Studies Confirm Brain Plaque Can Help Predict Alzheimer’s (NYTimes)

Regulatory Reconnaissance #561 – 20 May 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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