Regulatory Focus™ > News Articles > Regulatory Recon: FDA Slams Data Release by Orexigen, as Troubling Implications Become Clear (6 Marc

Regulatory Recon: FDA Slams Data Release by Orexigen, as Troubling Implications Become Clear (6 March 2015)

Posted 06 March 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Slams Data Release by Orexigen, as Troubling Implications Become Clear (6 March 2015)

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

In Focus: US

  • Top FDA Official Jenkins Says Orexigen Study Result 'Unreliable,' 'Misleading' (Forbes) (WSJ-$)
  • How Orexigen's Actions Might Throw the Entire Drug Industry 'Under the Bus' (Forbes)
  • FDA's Moscicki: 52 Biosimilars Under Development (MedCityNews)
  • The FDA Issues Final Guidances for Animal Drug Depletion Studies (FDA)
  • Guidance: Clinical Trial Imaging Endpoint Process Standards (FDA) (FDA)
  • FDA staff backs injection to reduce double chin (Reuters) (Pink Sheet-$) (Tarius)
  • FDA Releases New Bioequivalence Guidances, Including on Suboxone, Topamax and Belviq (FDA)
  • FDA Study Shows 99% of Milk Doesn't Contain any Trace of Antibiotics (AP) (FDA)
  • FDA: Unapproved Duodenoscope OK to Use (MedPage Today) (Washington Post)
  • FDA Petitioned to Ban Power Morcellators (FDA)
  • GI Dynamics' EndoBarrier Trial Placed on Enrollment Hold (Press) (Mass Device)
  • Hamburg Warns Some Of Congress’ ‘Cures’ May Be ‘Dangerous’ (Pink Sheet-$)

In Focus: International

  • EMA to reduce fees from April (SCRIP-$)
  • EFPIA Backs TTIP, Citing its Potential to Harmonize Regulations (EFPIA)
  • NICE backs BMS/Pfizer bloodthinner Eliquis for VTE (PharmaTimes) (PMLive) (Pharmafile)
  • French agency prioritizes drug/device safety, innovation and early access (SCRIP RA-$)
  • WHO consults on updating 23-year-old guide on GMP for biologicals (SCRIP RA-$)
  • Chinese authorities plan 22-month crackdown on food and drug safety (Food Quality News)

As the EU Gears up for Major Device Changes, What do Regulatory Pros Need to Know?

  • In Europe, medical devices currently are regulated much the same way they have been since the 1990s. Now, almost 20 years and several major scandals later, EU officials are preparing a massive overhaul of the region's medical device regulatory directives in the hopes of modernizing the system—if only they could agree on what those changes should look like. (Regulatory Focus)
  • Find out what changes are likely to affect medical devices and IVDs next year in this 11 March 2015 webcast featuring expert Erik Vollebregt. (RAPS Webcast)

US: Pharmaceuticals and Biotechnology

  • Top FDA Official Jenkins Says Orexigen Study Result 'Unreliable,' 'Misleading' (Forbes) (WSJ-$)
  • How Orexigen's Actions Might Throw the Entire Drug Industry 'Under the Bus' (Forbes)
  • FDA's Moscicki: 52 Biosimilars Under Development (MedCityNews)
  • The FDA Issues Final Guidances for Animal Drug Depletion Studies (FDA)
  • Guidance: Clinical Trial Imaging Endpoint Process Standards (FDA) (FDA)
  • FDA Warns About Tainted Drug With the Best/Worst Name We've Ever Seen (FDA)
  • FDA staff backs injection to reduce double chin (Reuters) (Pink Sheet-$) (Tarius)
  • FDA Releases New Bioequivalence Guidances, Including on Suboxone, Topamax and Belviq (FDA)
  • Under FDA Lens, Mylan On Makeover Drive At Agila (PharmAsia-$)
  • Hamburg Says Biosimilar Guidances Expected Very Soon (IHP-$)
  • Hamburg: Abuse-Deterrent Opioid Guide Will Be Out By Congressional Deadline (IHP-$)
  • 21st Century Cures: Making Breakthrough Therapy designations more effective (BioPharmaDive)
  • Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV Container Due to Particulate Matter (Press)
  • FDA Analyzes Data on Flu Vaccines and Subsequent Seizures (FDA)
  • Zosyn Injection Shortage: New FDA Information (MPR)
  • Orexo US launches new 8.6/2.1 mg ZUBSOLV (buprenorphine/naloxone) sublingual tablet CIII: 8.6/2.1mg (Press)

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

  • Catalyst Pharmaceuticals Announces FDA Orphan Drug Designation of Firdapse for Treatment of Congenital Myasthenic Syndromes (Press)

US: Pharmaceuticals and Biotechnology: General

  • FDA Study Shows 99% of Milk Doesn't Contain any Trace of Antibiotics (AP) (FDA)
  • Is the Biotech Bubble Ready to Pop? (Bloomberg)
  • Costco Wants to End Use of Human Antibiotics in Chicken (CNBC) (Reuters)
  • The $42 Billion Drug? Why AbbVie May Have Overpaid for Pharmacyclics (Pharmalot)
  • U.S. Biosimilar Approvals Poised to Grow, But Market Uptake Faces Several Challenges (Press)

US: Medical Devices

  • FDA: Unapproved Duodenoscope OK to Use (MedPage Today) (Washington Post)
  • FDA Petitioned to Ban Power Morcellators (FDA)
  • GI Dynamics' EndoBarrier Trial Placed on Enrollment Hold (Press) (Mass Device)
  • J&J Ordered to Pay $5.7 Million Over Incontinence Implant (Bloomberg) (Fierce) (Reuters)
  • Cybersecurity Might Not Be Sexy, but It is Important (MDDI)
  • The dirt on duodenoscopes (Washington Post)
  • Boston hospitals take precautions with scope linked to superbug (AP)
  • Court Rules in Favor of Drobot, Hospitals in "Counterfeit" Screw Cases (Press)
  • Aerocrine AB Receives FDA Clearance for NIOX VERO® BlueTooth Wireless Enhancement (Press)
  • Hospira Plum A+ and Plum A+3 Infusion Systems Alarm Volume Failure (FDA)
  • Life Spine Announces FDA Clearance of Forty Transition Connector Implants to Thoracolumbar and Cervical Systems (Press)

US: Assorted And Government

  • Hamburg Warns Some Of Congress’ ‘Cures’ May Be ‘Dangerous’ (Pink Sheet-$)
  • FDA Weekly Enforcement Report (FDA)
  • FDA's Former Deputy Commissioner Writes About How he Prefers to be Lobbied (Milbank)

Upcoming Meetings

Ebola Outbreak

  • Merck, NewLink Ebola jab starts PhIII trial (PharmaTimes) (Press)
  • Guinea Ebola Vaccine Trial Uses Smallpox Strategy (NBC)
  • A Mishap Sheds Light on an Ebola Vaccine (NYTimes)

Europe

  • EMA to reduce fees from April (SCRIP-$)
  • EFPIA Backs TTIP, Citing its Potential to Harmonize Regulations (EFPIA)
  • NICE backs BMS/Pfizer bloodthinner Eliquis for VTE (PharmaTimes) (PMLive) (Pharmafile)
  • French agency prioritizes drug/device safety, innovation and early access (SCRIP RA-$)
  • WHO consults on updating 23-year-old guide on GMP for biologicals (SCRIP RA-$)
  • EC Authorizes Use of Genzyme's Sevelamer HCl (EC)
  • Brintellix first antidepressant with cognition claim in Europe (PMLive)
  • Next Steps for Vorapaxar: EU PAD Label and Antidote Development? (Decision Resources)
  • National uptake of EUnetHTA’s outputs (EUnetHTA)

China

  • Chinese authorities plan 22-month crackdown on food and drug safety (Food Quality News)

Australia

  • Clinical performance requirements and risk mitigation strategies for HIV tests (TGA)

Other International

  • Asian Agencies Report on Progress in Addressing Emerging Regulatory Challenges at CASSS Biotech CMC Strategy Forum in Japan (IPQ)

Clinical Trials

  • Prediction of drug clearance in children: a review of different methodologies (PubMed)

General Regulatory And Interesting Articles

  • Ebola has the Spotlight, but Africa's Biggest Challenge is Still its Other Neglected Diseases (Geographical Mag)
  • Cholesterol-Cutting Statins Found to Raise Diabetes Risk by 46% (Bloomberg)

Regulatory Reconnaissance #507 – 6 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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