Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Merck's Zontivity Approved by FDA (9 May 2014)

Regulatory Reconnaissance: Merck's Zontivity Approved by FDA (9 May 2014)

Posted 09 May 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients (SCRIP-$) (BioCentury) (FDA) (Fierce) (Forbes) (Reuters) (Pharmafile) (PharmaTimes)
  • BIO chief says FDA must evolve drug trial, approval processes (BioFlash)
  • Petition Seeks Behind-the-Counter Status for Lipitor (FDA)
  • Boston Scientific gets subpoena over defibrillators (Reuters) (Law 360-$)
  • FDA Want to Develop a Regulatory Framework to Govern Proteomics (FDA)
  • HHS Secretary Nominee Burwell Pledges To Promote Innovation At FDA (Pink Sheet-$) (SCRIP-$)

In Focus: International

US: Pharmaceuticals/Biotechnology

  • FDA approves Zontivity to reduce the risk of heart attacks and stroke in high-risk patients (SCRIP-$) (BioCentury) (FDA) (Fierce) (Forbes) (Reuters) (Pharmafile) (PharmaTimes)
  • BIO chief says FDA must evolve drug trial, approval processes (BioFlash)
  • Petition Seeks Behind-the-Counter Status for Lipitor (FDA)
  • B. Braun extends recall of saline solution (Fierce)
  • FDA nod for first 'made in China' MAb  (SCRIP-$)
  • New Warning Letter for Compounding Pharmacy (FDA)
  • Cold medicine ingredient no better than placebo, study finds (CBS)
  • Teva Sues FDA Over Failure to Substantively Respond to COPAXONE Citizen Petition (FDA Law Blog)
  • J&J Gives AIDS Drug Rights to Charity for Vaginal Ring (Bloomberg)

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

  • Prima BioMed's CVac Granted Fast Track Designation by FDA (Press)

US: Pharmaceuticals and Biotechnology: General

  • Pregnant on Opiates: When Following Doctors' Orders Breaks the Law (NBC)
  • FTC Says Noerr Doesn't Shield AndroGel Pay-For-Delay Deal (Law 360-$)
  • HPV vaccine for boys: Some insurance companies deny coverage (ABC)
  • Will insurer cost-sharing limit consumer access to drugs? (Fierce)

US: Medical Devices

  • Boston Scientific gets subpoena over defibrillators (Reuters) (Law 360-$)
  • St. Jude's a-fib tech aces trial as FDA awaits (Fierce) (Press)
  • FDA Want to Develop a Regulatory Framework to Govern Proteomics (FDA)
  • US expedited device PMA guidance might be a 'program with no downside' (Clinica-$)
  • 7 Reasons for Ineffective CAPAs (Medical Device Summit)
  • FDA Schedules Ophthalmic Devices Panel Meeting to Discuss KAMRA Inlay Corneal Implant (FDA)
  • Thoratec's HeartMate II Device Central to Long-Form Story on a Heart Transplant (AZ Central)

US: Dietary Supplements

  • Dan Fabricant's FDA Insights (Nutritional Outlook)
  • AHPA launches free, publicly-accessible Botanical Identity References Compendium (NI-USA)
  • POM V. Coke May Impact Many FDA-Regulated Products (Law 360-$)
  • Criminal Charges For Repeat Spiked Supplement Marketer (Tan Sheet-$)

US: Assorted And Government

  • HHS Secretary Nominee Burwell Pledges To Promote Innovation At FDA (Pink Sheet-$) (SCRIP-$)
  • Dolly the Sheep's Clones Deemed Unpatentable by U.S. Court  (Bloomberg) (Patent Docs) (Law 360-$) (Bloomberg)
  • Google Buys Cancer Treatment Software Company for $130M (Slate)
  • Research studies likely compromised by black male incarceration (MNT)

Europe

India

  • Ratings Group: Pharma exports to US unaffected by import alerts  (India Times) (PharmAsia-$)
  • Pfizer, Roche Drop Out Of India-U.S. Lobbying Group Over IPR Policy (PharmAsia-$)

Japan & China

Other International

  • Phillipines FDA Fines Eli Lilly Over Unregistered Products (GMA News)

General Regulatory And Interesting Articles

  • NIH study demonstrates that a new cancer immunotherapy method could be effective against a wide range of cancers (NIH)
  • The Calling of an Engineer (Scientific American)

Regulatory Reconnaissance #315 - 9 May 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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.


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