Regulatory Focus™ > News Articles > Regulatory Recon: Purple Pill Gets the Green Light : FDA Approves Generic Nexium (27 January 2015)

Regulatory Recon: Purple Pill Gets the Green Light : FDA Approves Generic Nexium (27 January 2015)

Posted 27 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Purple Pill Gets the Green Light : FDA Approves Generic Nexium (27 January 2015)

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

In Focus: US

In Focus: International

  • Central repository to facilitate assessment of medicines safety reports (EMA)
  • EU orphan drug exclusivity: A court case worth noting (Lexology)
  • New EU products in 2014: a batch of breakthroughs, a bevy of anticancers and a troupe of orphans (SCRIP-$)
  • Indian Patent Office Rejects Almost Half Of All Pharma Patents (Two-Four Insight)
  • Optimizing the order of hypotheses in serial testing of multiple endpoints in clinical trials. (PubMed)

Sponsored Message: How can you Learn to Prepare Compliant eCTD Submissions?

  • Roll up your sleeves for a two-day, introductory workshop on how to prepare an effective electronic Common Technical Document (eCTD) submission. This in-person workshop includes skill-building, interactive exercises, case studies and small group discussions. This program is best for entry to mid-level regulatory professionals who want to or are required to become more familiar with the role, benefits and challenges of eCTD submissions. Register here http://raps.org/ectd/

US: Pharmaceuticals and Biotechnology

  • FDA Approves Generic Nexium, Snubbing Ranbaxy's 180-Day Exclusivity (FDA) (PMLive) (Press) (Law 360-$) (WSJ-$) (SCRIP-$) (FDA Law Blog) (Reuters) (Pink Sheet-$) (Fierce)
  • Demographics of Clinical Trials Participants in Pivotal Clinical Trials for New Molecular Entity Drugs and Biologics Approved by FDA From 2010 to 2012. (PubMed)
  • Adverse Event Reports Rising, FDA Staffing Levels Not Keeping Pace (Pink Sheet-$)
  • As FDA speeds drug approval, VCs pour cash into pharma: report (Philly Pharma)
  • FDA AdComm to Assess Avedro's riboflavin ophthalmic solutions with UV-A irradiation (FDA)
  • FDA schedules patient-focused meeting on breast cancer (BioCentury)
  • Sandoz Says Amgen Biosimilar Claims Conflict With ACA (Law 360-$)
  • FDA to Hold Meeting on Sunscreen Innovation Act With Industry on 4 February 2015 (FDA)
  • How Takeda is integrating the patient perspective into drug development (BioCentury-$)
  • Ibuprofen, Not Morphine, Urged for Kids with Tonsillectomy Pain (Reuters)
  • FDA Approves Pulmozyme with eRapid Nebulizer; CF Patients See 2 - 3 Minute Treatment Times (Press)
  • Novo Nordisk Receives FDA Approval for Norditropin FlexPro 30 mg/3.0 mL for Patients with Growth Hormone Disorders (Press)

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

  • Novartis expects 10 NME filings by end-2016 (PharmaPhorum)
  • How AM-Pharma's adaptive Phase II trial could speed up development for recap (BioCentury-$)
  • BioCryst treatment receives fast track FDA designation (Press)
  • Depression Drug That Works in One Day Passes Key Test (Forbes) (Press)
  • FDA Accepts CTD Holdings' Drug Master File for Second-Generation Orphan Drug (Press)

US: Pharmaceuticals and Biotechnology: General

  • Prices for Prescription Medicines Rose How Much Last Year? 10.9% (Pharmalot)
  • Clinton Foundation To Help Make Anti-Overdose Drug Much More Affordable (HuffPo) (Forbes)
  • NIH's Collins: Opioids Often Not the Answer for Long-Term Pain (NIH)
  • New dispute over Copaxone patent (SCOTUSblog)
  • SCOTUS remands Shire, Actavis (BioCentury)

US: Medical Devices

  • mHealth advocates praise new version of SOFTWARE Act (mHealthNews) (GovernmentHealthIT) (Fierce) (Draft Bill)
  • Ventana seeks FDA premarket approval for ALK IHC companion diagnostic to benefit lung cancer patients (Press)
  • Combo Products: Rules, Regulations, Strategies (MDDI)
  • November 2014 PMA Approvals (FDA)
  • FDA Nod in Hand, Health IT Software Maker Decisio Hits the Market (Xconomy)
  • EOS Imaging Receives FDA Clearance for Micro Dose (Press)

US: Dietary Supplements

  • Six Senators Urge FDA to Ban Retail Sale of Powdered Caffeine (Senate)
  • Susan Mayne takes over at CFSAN (The Packer)
  • FTC Members Spar Over ‘Protected’ Speech On ‘Dr. Oz’ In Supplement Claim Enforcement (Tan Sheet-$) (The Hill) (Vox) (Reuters)

US: Assorted And Government

  • Extra $1.2 billion in funding sought to fight antibiotic-resistant bacteria (Washington Post)
  • Should FDA Consider Costs When Reviewing Products? Half of Consumers Say it Should (MDDI) (Pink Sheet-$)
  • Welcome to Warsaw, Indiana. Does the industry’s medical-device tax story reflect reality on the ground? (MedCityNews)

Upcoming Meetings

Ebola Outbreak

  • Scientists ask if Ebola immunizes as well as kills (Reuters)

Europe

  • Central repository to facilitate assessment of medicines safety reports (EMA)
  • EU orphan drug exclusivity: A court case worth noting (Lexology)
  • New EU products in 2014: a batch of breakthroughs, a bevy of anticancers and a troupe of orphans (SCRIP-$)
  • Neurostim dry eye startup backed by Kleiner Perkins, NEA readies for CE mark (Fierce)
  • Does real world evidence matter in Health Technology Assessments? (PharmaPhorum)
  • Enlivex secures EU orphan drug status for ApoCell to treat GvHD (Press)
  • pSivida Reports ILUVIEN Receives Marketing Authorization in Two More EU Countries (Press)

India

  • Indian Patent Office Rejects Almost Half Of All Pharma Patents (Two-Four Insight)
  • Panel on amendments in D&C Rule forms 7 sub-groups on drugs, medical devices, clinical trials, biologicals, etc (PharmaBiz)

Canada

  • How Health Canada Failed to Uphold Its Own Pharmaceutical Ad Standards (HuffPo)

Australia

  • Australia's TGA issues updated guidelines on drug supply chain releases (Fierce)

Clinical Trials

  • Demographics of Clinical Trials Participants in Pivotal Clinical Trials for New Molecular Entity Drugs and Biologics Approved by FDA From 2010 to 2012. (PubMed)
  • Optimizing the order of hypotheses in serial testing of multiple endpoints in clinical trials. (PubMed)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #480 – 27 January 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe