Regulatory Focus™ > News Articles > Regulatory Recon: Results of Clinical Trials Rarely Reported on Time (12 March 2015)

Regulatory Recon: Results of Clinical Trials Rarely Reported on Time (12 March 2015)

Posted 12 March 2015 | By Alexander Gaffney, RAC

Regulatory Recon: Results of Clinical Trials Rarely Reported on Time (12 March 2015)

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

In Focus: US

In Focus: International

  • EUCROF calls on EMA not to publish CRO inspection reports as part of transparency efforts (Outsourcing Pharma)
  • Spain to reduce the prices of new biosimilars by up to 30% (PharmaLetter-$)
  • EU, IMI Launch New Flu Vaccine Evaluation Initiative (EUVaccine)
  • India’s Device Makers Face Heightened Scrutiny Of Marketing Practices (PharmAsia-$)
  • India plans to launch mobile app for information related to medicines (India Times)
  • Compulsory licenses, prices and drug quality (S4S)

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US: Pharmaceuticals and Biotechnology

  • Drug Industry vs. NIH-Funded Trials: Who Reports on Time? (In the Pipeline) (NEJM) (Forbes) (Forbes) (MedPage Today) (NPR) (Press) (MNT)
  • Harder-to-abuse OxyContin doesn't stop addicts (CBS)
  • Texas Pharma Co. Agrees To Pause Drugmaking After Recall (Law 360-$) (FDA) (DOJ) (Fierce) (Reuters)
  • New Research Report Exposes the Lack of Diversity in Genetic Studies (Latin Post)
  • FDA Beats Ranbaxy Suit Despite 'Serious' Approval Errors (Law 360-$) (Decision) (Courthouse News)
  • FDA proposal to allow drug reps to circulate data draws protests (Reuters) (Washington Post) (PhRMA) (Public Citizen)
  • Direct-Acting Oral Anticoagulant Review Scorecard: Head-to-Head Study – of FDA Divisions (RPM Report-$)
  • FDA Makes Several Changes to its Massive ANDA Rule (FDA)
  • Biosimilars Court Cases Could Define Manufacturing Data Disclosure (FDAnews-$)
  • Packaging company CEO slams FDA over drug labeling (Healthcare Packaging)
  • FDA Advisory Committee to Review CV Outcomes Trial Results for Saxagliptin and Alogliptin (Tarius)
  • Hospira Recalls Drug due to Mold Contamination (FDA)
  • Group Proposes New Expanded Access System (Reason)
  • Biosimilars bill approved by Colorado Legislature (BizJournal)
  • Are New Oral Anticoagulant Dosing Recommendations Optimal for All Patients? (JAMA)
  • Arkansas Senate panel supports abortion pill restrictions (AP)
  • Florida Right to Try Bill Advances (Press)
  • Pfizer Forced to Recall Six Medicines Without Childproof Caps (BioSpace)
  • Man pleads guilty to selling bogus tanning drug (Tennessean)
  • 2015 Parenteral Drug Association/Food and Drug Administration Joint Conference (FDA)

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

  • Acadia Parkinsons Drug Is Delayed Again (The Street) (Fierce) (Xconomy) (Reuters) (Press) (BioCentury) (SCRIP-$)
  • Iroko Pharmaceuticals Announces Acceptance of U.S. Filing for SoluMatrix Meloxicam in Osteoarthritis Pain (Press)
  • What to look out for at the ACC meeting  (SCRIP-$)
  • Nightstar receives U.S. and European Orphan Drug Designation for gene therapy to treat Choroideremia (Press)

US: Pharmaceuticals and Biotechnology: General

  • Drugmakers Turn Heat on Insurers by Backing Copay Limits (Bloomberg)
  • CVS says biotech drug copies may bring price cuts of 40-50% (Reuters)
  • 23andMe Enters The Drug Business -- Just As Apple Changes It (Forbes) (AP)
  • Biobetters may fare better than biosimilars in some therapeutic areas, says analyst (BioPharma Reporter)

US: Medical Devices

  • May 2015 Advisory Committee to Investigate Duodenoscopes Linked to Superbug Outbreak (FDA)
  • J&J's DePuy Synthes recalls orthopedic surgical tool, but not ready to replace (Fierce)
  • J&J's Ethicon settles Prolift pelvic mesh bellwether (Mass Device)
  • AdvaMed Floats Legislative Language For CMS Device Trial Coverage (IHP-$)
  • Online offers of personalized cancer medicine may not be trustworthy (Reuters)
  • Upcoming FDA AdComm to Discuss Pre-1976 Hearing Devices (FDA)
  • House Subcommittee Presses FDA On Flu Assays For Vaccine Preparedness (Gray Sheet-$)

US: Dietary Supplements

  • New White Paper on DNA Barcode Testing Refutes Results from New York Attorney General’s Investigation of Botanical Supplements (CRN) (White Paper) (NPI) (DSN) (Tan Sheet-$)
  • GNC: Independent, third party tests ‘conclusively’ confirm Herbal Plus products meet all requirements (NI-USA)
  • FDA warning on 26 tainted ED products illustrates point of widespread counterfeiting, expert says (NI-USA)
  • More Supplement Manufacturers Complying with FDA GMP Regulations, But Room for Improvement (NPI)

US: Assorted And Government

  • What the Recent Case of Perez v. Mortage Bankers Assocation Means for FDA (Drug and Device Law)
  • FDA's Weekly Enforcement Report (FDA)
  • FDA Foreign Offices Highlight Top Priority Activities (Registrar Corp)
  • New Regulatory Legislation, the Regulatory Improvement Act (Senate)
  • "Palcohol" powdered alcohol wins federal approval (CBS)
  • Worker at Tulane possibly exposed to bioterror bacteria (USA Today)

Upcoming Meetings

Ebola Outbreak

  • Trial of Tekmira's TKM-Ebola treatment starts in Sierra Leone (Reuters)
  • Analyst: Decline in Cases Curbs Ebola Drug Clinical Trials (PharmPro)
  • Waning interest is biggest risk in race to overcome Ebola: WHO (Reuters)

Europe

  • EUCROF calls on EMA not to publish CRO inspection reports as part of transparency efforts (Outsourcing Pharma)
  • Spain to reduce the prices of new biosimilars by up to 30% (PharmaLetter-$)
  • EU, IMI Launch New Flu Vaccine Evaluation Initiative (EUVaccine)
  • Eisai gets longer to argue Cancer Drugs Fund ruling (PharmaPhorum)
  • Volcano receives CE mark for iFR Scout Pullback software to help diagnose serial lesions and diffuse coronary disease (Press)

India

  • India’s Device Makers Face Heightened Scrutiny Of Marketing Practices (PharmAsia-$)
  • Government plans to launch mobile app for information related to medicines (India Times)
  • Natco Pharma gets nod to sell Hepatitis C medicine in India (India Times)

China

  • Will op-ed in China state press bring pharma reform? (Fierce)

Other International

  • Compulsory licenses, prices and drug quality (S4S)
  • WHO issues its first hepatitis B treatment guidelines (WHO)

Clinical Trials

  • What A Scathing External Report On Protections In Research Missed -- Or Ignored (Forbes)

General Regulatory And Interesting Articles

  • Another Review Finds Homeopathy Worthless (SBM) (Vox)
  • International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences (PubMed)
  • Experimental cancer therapy shown to dramatically prolong life (CBS)
  • Security company sees biometrics as one solution to prescription drug abuse (MedCityNews)
  • Ultrasound Shows Promise in Mice for Treating Alzheimer’s (WSJ-$)

Regulatory Reconnaissance #512 – 12 March 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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