Regulatory Focus™ > News Articles > Regulatory Recon: AZ's New Opioid-Induced Constipation Drug Gets FDA Approval (17 September 2014)

Regulatory Recon: AZ's New Opioid-Induced Constipation Drug Gets FDA Approval (17 September 2014)

Posted 17 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: AZ's New Opioid-Induced Constipation Drug Gets FDA Approval (17 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here, or check out some of the mostnews-worthy sessions here.

In Focus: US

  • AstraZeneca and Nektar win FDA OK for blockbuster-hopeful opioid-induced constipation drug (Fierce) (AP) (Pharma Times) (MedPage Today) (Reuters) (Press) (BizJournal) (SCRIP-$) (BioCentury) (Pink Sheet-$) (FDA)
  • U.S. lawmakers want to curb antibiotic use on farms (Reuters)
  • New Antibiotic Approvals Are Declining, But the Reality is More Nuances Than You'd Believe (CDDEP)
  • FDA Hosts Meeting to Put Pediatric Drug Development Under the Microscope - What Did They See? (FDA Law Blog)
  • Drug promotion: FDA's new occupation? (SCRIP-$) (FDA)
  • FDA Panel to Mull Cardiac Risks of Testosterone Tx (MedPage Today)
  • Things That Will Definitely be Abused: Chocolate-flavored Cough Syrup (MPR)

In Focus: International

  • Willmott named new EU Parliament rapporteur on device regulation (Clinica-$)
  • South Africa soldiers on with device reg overhaul but knots still need untying (Clinica-$)
  • Boston Scientific Receives CE Mark for Tremor Device (Press)

US: Pharmaceuticals and Biotechnology

  • AstraZeneca and Nektar win FDA OK for blockbuster-hopeful opioid-induced constipation drug (Fierce) (AP) (Pharma Times) (MedPage Today) (Reuters) (Press) (BizJournal) (SCRIP-$) (BioCentury) (Pink Sheet-$) (FDA)
  • U.S. lawmakers want to curb antibiotic use on farms (Reuters)
  • New Antibiotic Approvals Are Declining, But the Reality is More Nuances Than You'd Believe (CDDEP)
  • FDA Hosts Meeting to Put Pediatric Drug Development Under the Microscope - What Did They See? (FDA Law Blog)
  • Drug promotion: FDA's new occupation? (SCRIP-$) (FDA)
  • FDA Panel to Mull Cardiac Risks of Testosterone Tx (MedPage Today)
  • Clarus’ Oral Testosterone Poised To Shake Up Market – If It Can Overcome Efficacy Concerns (Pink Sheet-$) (Tarius)
  • US FDA Posts Advisory Committee Materials for Updates of Research Programs About Monoclonal Antibodies and Therapeutic Proteins (Tarius)
  • Does neurology need a faster FDA? (Lancet)
  • ​Big increase in deaths from narcotic painkiller overdoses (CBS)
  • Big Cities Take Aim at Prescription Painkillers (AP)
  • FDA panel to discuss Daiichi Sankyo's Savaysa (BioCentury) (FDA)
  • GS1 Healthcare US Publishes Updated Guidance For DSCSA (RxTrace)
  • Things That Will Definitely be Abused: Chocolate-flavored Cough Syrup (MPR)
  • An FDA overview of rodent carcinogenicity studies of angiotensin II AT-1 receptor blockers: pulmonary adenomas and carcinomas (PubMed)
  • Dispute could delay Florida rollout of limited medical marijuana (Reuters)

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

  • Gilead's experimental drug fails mid-stage study (Reuters) (Press) (Fierce)
  • Merck Presents First Phase 3 Data in Japanese Patients for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes (Press)
  • What next for Sanofi Dengue vaccine? (SCRIP-$)
  • Impax Pharmaceuticals Announces Extension of RYTARY FDA Review Date to January 9, 2015 (Press)
  • Doc Offers Glimpse Into Arena Pharma Weight-Loss Combination Therapy (The Street)

US: Pharmaceuticals and Biotechnology: General

  • Inconsistent Labeling on Grapefruit Juice-Drug Interactions May Cause Harm (PCM)

US: Medical Devices

  • Pittsburgh outfit launches blood Dx to measure pediatric transplant rejection risk (Fierce)
  • Boston Scientific's 1-year data on Lotus TAVI device (Mass Device)
  • Abbott: Absorb is comparable to drug-eluting stents (Fierce)
  • Medtronic CoreValve data demonstrate favorable cost effectiveness compared to open-heart surgery in high risk patients (MNT)
  • Wearable artificial kidney safety testing receives go-ahead (Medical Xpress)
  • Medtronic's IN.PACT Admiral beats PTA in outcomes, costs (Mass Device)
  • 23andMe reverses its decision to move to more lax privacy settings (Vox)
  • Stago receives FDA approval for automated, highly sensitive D-dimer test (Press)

US: Dietary Supplements

  • Rock Creek seems to be near end of supplement road as FDA rejects NDI filing (NI-USA)

US: Assorted And Government

  • CMS Asked to Eliminate Some Payments From Sunshine Database (Pharmalot)

Upcoming Meetings

Ebola Outbreak

  • An Ebola vaccine was given to 10 volunteers, and there are ‘no red flags’ yet (WaPo)
  • Ebola Vaccine Trials Follow New Model: Quick Expansion To Health Care Workers (Pink Sheet-$)
  • Why Obama is commiting 3,000 troops to fight Ebola (Vox) (Reuters)
  • Survivor: Ebola response sluggish, 'deaf ears'  (SCRIP-$)
  • Ebola Outbreak Presents Special Challenges For U.S. Military (NPR) (WSJ-$)
  • Ebola potential vaccine to be tested on healthy British volunteer (Guardian) (Reuters)
  • Official: Rogue state could weaponize Ebola (The Hill)
  • Nigerian Regulators Arrest Importers of Fake Ebola Kits (WSG)

Europe

  • Willmott named new EU Parliament rapporteur on device regulation (Clinica-$)
  • Boston Scientific Receives CE Mark For The Vercise Deep Brain Stimulation (DBS) System For Treating Patients With Tremor (Press)
  • Symetis ACURATE neo Transcatheter Aortic Heart Valve Approved in Europe (MedGadget)

Other International

  • South Africa soldiers on with device reg overhaul but knots still need untying (Clinica-$)
  • Biosimilars take the stage as regulatory debate goes global (SCRIP-$)

Clinical Trials

  • Reanalyses of Randomized Clinical Trial Data (JAMA)
  • Global Standards Initiative for Clinical Research Sites Advances (Press)

General Regulatory And Interesting Articles

  • Post-immunization epilepsy likely not related to vaccine: study (Reuters)
  • A Specific Form Of Baldness Could Be Linked To Aggressive Prostate Cancer (Forbes)
  • Urine test for cervical cancer virus offers alternative to smear (Reuters)

Regulatory Reconnaissance #401 – 17 September 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.

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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