Regulatory Focus™ > News Articles > Regulatory Recon: Top FDA Officials Defend Approval of OxyContin for Children (8 September 2015)

Regulatory Recon: Top FDA Officials Defend Approval of OxyContin for Children (8 September 2015)

Posted 08 September 2015 | By Michael Mezher 

Regulatory Recon: Top FDA Officials Defend Approval of OxyContin for Children (8 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 and @RAPSorg on Twitter.

In Focus: US

  • Did Forged Signature Clear Way for Dangerous Blood-Clot Filter? (NBC News) (CNBC) (Press)
  • The Price for Lowering Cholesterol (NYTimes)
  • End of Summer Grades for 24 Pharma and Biotech Giants (Forbes)
  • FDA’s Untitled Letter Posting Driven By ‘Significant Public Interest,’ Not Stock Market (Pink Sheet-$)
  • Why the FDA Approved OcyContin for Kids as Young as 11 (Washington Post)
  • Where Could The Next Priority Review Voucher Come From? (Pink Sheet-$)

In Focus: International

  • EU Enters Last Leg Of Regulatory Journey: Adoption Before 2016? (Clinica-$)
  • Bangladeshi Firms Roll Out $12-13 Harvoni Generic (SCRIP-$)
  • Companies struggle to get new medicines adopted across Europe (Reuters)
  • India denies patent on Pfizer's Xeljanz (PMLive) (Economic Times)
  • Canada lifts ban against two drug facilities in India (Toronto Star)
  • EMA launches project to boost early patient access to drugs (Pharmafile)

US: Pharmaceuticals and Biotechnology

  • FDA approves new orphan drug to treat rare autosomal recessive disorder (FDA) (Press)
  • FDA’s Metric System: Quality Scores Are High Priority For Agency, But Industry Concerns Keep Pace Slow (RPM Report-$)
  • Zarxio Ruling Threatens Biosimilar Industry, Firms Warn In Support Of Rehearing (Pink Sheet-$)
  • PDUFA VI: BIO Survey Finds FDA Communication Problems (Pink Sheet-$)
  • Biosimilar User Fee Negotiations Won't Start Until 2016 (Pink Sheet-$)
  • Biosimilar Naming Reg Could Pit FDA Against WHO (Pink Sheet-$)
  • Sandoz' NEUPOGEN Biosimilar Now on the Market (Patent Docs)
  • FDA's 'Trade-Off' Balancing Act: Room for Disease Severity? (SCRIP-$)
  • Biomarkers: FDA Working To Define 'Reasonably Likely To Predict' Standard (Pink Sheet-$)
  • Biosimilar not interchangeable: Sandoz and Pfenex call for US FDA guidelines (BioPharma-Reporter)
  • Waking From a Drug Coma: How to Bring a Drug Out of Discontinued Status (FDA Law Blog)
  • Challenges That Hinder the Translation of Clinical Advances Into Practice: Results From an International Assessment in Colorectal Cancer. (PubMed)
  • Leveraging MEDLINE indexing for pharmacovigilance - inherent limitations and mitigation strategies. (PubMed)

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

  • Valeant And Progenics Announce FDA Acceptance Of NDA Submission For Oral RELISTOR (Press)
  • Janssen’s myeloma drug wins FDA priority review (PMLive)
  • Opdivo plus Yervoy effective first-line in lung cancer (PMLive)
  • Pfizer's quit-smoking drug not linked to depression or heart risks (Reuters)
  • Follow-up Data from Two Pivotal Opdivo (nivolumab) Trials Demonstrates Sustained Survival Results in Patients with Previously Treated Squamous Non-Small Cell Lung Cancer (Press)
  • Biogen Enrolls First Patient in Global Phase 3 Study of Investigational Treatment Aducanumab (BIIB037) for Early Alzheimer’s Disease (Press)
  • Promedior Announces Initiation of a Phase 2 Clinical Study of PRM-151 in Idiopathic Pulmonary Fibrosis (IPF) (Press)

US: Medical Devices

  • New medical device concept could reduce time to diagnose infections (MNT)
  • MDDI Readers Give FDA a Rough Review (MDDI)
  • Superbug victim’s family sues Pentax (MassDevice)
  • Novartis to start human tests with Google lens in 2016 (Reuters)
  • Cognitive impairment imaging: Neuraceq Phase III results published (MNT)
  • FDA Adds Huge Amount Of Medical Device Data To openFDA Platform (MedDeviceOnline) (Focus)
  • Why Making Devices Easy-to-Use is Not So Easy (MDDI)

US: Assorted and Government

  • Michigan Bill to allow substitution for interchangeable biosimilars (BioPharma-Reporter)
  • Sanofi’s Genzyme pays $33m, enters DPA in criminal Seprafilm case (MassDevice)
  • HHS Proposes Big Changes to "Common Rule" Policy for Protection of Human Research Subjects; Call for Comments Open Through December 7 (Policy and Medicine) (Federal Register) (Focus)
  • Government Regulation of Commercial Speech: is Amarin Pharma’s Breakout Moment? (Harvard Bill of Health)
  • CDC funding helps states combat prescription drug overdose epidemic (CDC)
  • Trade Groups Suggest Office Upgrade For FDA Supplement Division (Tan Sheet-$)
  • Shingles vaccine not cost effective before age 60 (Reuters)
  • 6th Circ. Told Ethicon Surgical Stapler Suit Belongs In US (Law360-$)
  • GSK Tells 3rd Circ. To Uphold Dismissal Of Avandia Suit (Law360-$)

Upcoming Meetings and Events

Europe

  • EC approves multiple myeloma treatment Farydak (EuropeanPharmaceuticalReview)
  • EU needs compulsory transparency register to reign in Big Pharma lobbying (EurActiv)
  • EBE releases white paper on personalized medicine (PharmaLetter-$)
  • Eurofarma's Martha Novelli Penna On Innovation And Acting (SCRIP-$)
  • UK backs use of Merck cancer immunotherapy after price discount (Reuters)
  • UK's Latest Cancer Drug Cull Draws Renewed Calls For Reform (SCRIP-$)
  • Responsible Person training supported by MHRA Inspectorate (EuropeanPharmaceuticalReview)
  • NICE hands Merck & Co’s Keytruda speedy recommendation (PMLive)
  • NICE tackles public over antimicrobials (OnMedica) (NICE)
  • Seven new medicines approved for NHS Scotland (PharmaTimes)

India

  • India to issue guidelines to regulate antibiotic usage (BioSpectrum) (Economic Times)
  • Jan Aushadhi – Generic Drug Stores Scheme Under Fire Again (24 Insight)
  • WHO sounds alarm over big Indian supplier of tuberculosis drugs(Reuters) (In-Pharma Technologist) (Focus)
  • CDSCO sub-committee for online pharmacy to meet on September 7, slated to deliberate on dedicated norms (PharmaBiz)
  • DoP working towards attracting global investors to invest in drug research & manufacture with right policies (PharmaBiz)
  • India's Hep-C Market: The Old Order Changeth?  (SCRIP-$)
  • Several drug cos fail to recall date expired medicines from market in West Bengal (PharmaBiz)
  • DTAB turns down health ministry's proposal to amend Rule 3-A of D&C Rules to declare NIB as CDL for testing vaccines (PharmaBiz)

China

  • Arcam: Chinese Customer Receives CFDA Approval for EBM Manufactured Orthopedic Implant (Press)

Japan

  • Mesoblast files for approval of stem cell product in Japan (BioSpectrum)
  • Allergan Japan implements new software to meet regulatory requirements (BioSpectrum)

Ebola Outbreak

  • Rapid test, vaccine may end Ebola outbreak (MedCityNews)

Other International

  • Four Tips For Harnessing Growth In East Africa (SCRIP-$)
  • Drugs for Neglected Diseases initiative Unveils New Plan for Neglected Patients (DNDi)
  • 'Transparent Regulatory Systems' A Key Component of APEC 2020 Roadmap (APEC)
  • Korean Green Light For Samsung Bioepis’s Biosimilar Etanercept (PharmAsiaNews-$) (SCRIP-$)
  • Pricing Policies Mean Cheap Drugs Dominate Turkish Market (PharmAsiaNews-$)

General Health and Other Interesting Articles

  • Family carves out its own path in fight against 4-year-old’s rare disease (Washington Post)
  • Plague Cases in U.S. on the Rise (NYTimes)
  • What Diseases Can You Get from a Water Fountain? (NYTimes)

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.


Categories: Recon, Regulatory News

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