Regulatory Focus™ > News Articles > Regulatory Recon: FDA Warns of Severe Joint Pain With DPP-4 Inhibitors (31 August 2015)

Regulatory Recon: FDA Warns of Severe Joint Pain With DPP-4 Inhibitors (31 August 2015)

Posted 31 August 2015 | By Michael Mezher 

Regulatory Recon: FDA Warns of Severe Joint Pain With DPP-4 Inhibitors (31 August 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

  • FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain (FDA) (Reuters) (SCRIP-$)
  • How a company focused on diabetes management for children is expanding to adults (MedCityNews)
  • Cholesterol Wars: The Reimbursement Battle Begins (CardioBrief)
  • Janssen Pharmaceuticals Accused of Hiding Risperdal's Breast Effects In Boys (Forbes)
  • Pfizer's Geno Germano On Impatience, Innovation And The Influence Of Culture (SCRIP-$)
  • Making A Priority Of Priority Drugs: Review Performance By CDER Division (Pink Sheet-$)
  • Generic Firms Fear FDA Pill Size Guidance Helps Brands Stifle Competition (Tan Sheet-$)
  • Once More, With Statistics: FDA Defends Division Productivity Differences (Pink Sheet-$) (Focus)
  • Medtronic says trials find gene linked to sudden cardiac death (Reuters) (Press) (MassDevice)
  • Pressure On CMS To Add UDI To Claims Forms Continues (Gray Sheet-$)
  • Alnylam, Medicines cholesterol drug lasts months after one shot (Reuters)
  • Amarin, FDA To Discuss Settling Off-Label Promotion Dispute (Law360-$)

In Focus: International

  • After GSK, its now Pfizer facing China's corruption crackdown (BioSpectrum)
  • Stem cell researcher cleared of misconduct after U-turn (FierceBiotech)
  • Europe's IMI Plans Projects On 'Big Data' In Health Outcomes (Pink Sheet-$)
  • Sun Pharma, Wockhardt recall drugs from US market (Economic Times)
  • Indian pharma industry capable of discovering new drugs, says Sun Pharma's Dilip Shanghvi (Economic Times)
  • CDSCO delegates DDC Bengaluru to issue NoCs for mfg unapproved drugs for exports (PharmaBiz)
  • CFDA Deputy Head Takes On Key Liaison Role (PharmAsiaNews-$)
  • China finalizes stem cell guidance (BioCentury)
  • Japan's MHLW gives nods for Remicade, VFend, Tracleer, INOflo new indications (FiercePharmaAsia)
  • Sierra Leone Reports Ebola Death (NYTimes) (Reuters)

US: Pharmaceuticals and Biotechnology

  • FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain (FDA) (Reuters) (SCRIP-$)
  • How a company focused on diabetes management for children is expanding to adults (MedCityNews)
  • Cholesterol Wars: The Reimbursement Battle Begins (CardioBrief)
  • Janssen Pharmaceuticals Accused of Hiding Risperdal's Breast Effects In Boys (Forbes)
  • Want to improve drug adherence, pharma? Get tracking (FiercePharmaMarketing)
  • Pfizer's Geno Germano On Impatience, Innovation And The Influence Of Culture (SCRIP-$)
  • Once More, With Statistics: FDA Defends Division Productivity Differences (Pink Sheet-$) (Focus)
  • Making A Priority Of Priority Drugs: Review Performance By CDER Division (Pink Sheet-$)
  • Generic Firms Fear FDA Pill Size Guidance Helps Brands Stifle Competition (Tan Sheet-$)

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

  • Alnylam, Medicines cholesterol drug lasts months after one shot (Reuters)
  • TiGenix's Cx601 Meets Primary Endpoint in Phase III Study (BioSpace)
  • Bayer (BAY) Moves to Phase III Studies After Finerenone Cuts Deaths in Mid-Stage Trial (BioSpace) (FierceBiotech)
  • Sunovion Announces FDA Approval of a New Indication for Aptiom (Press)
  • Telesta Receives FDA BLA Filing Notification Letter and Priority Review Designation for MCNA(1) (Press)
  • Well-Funded Seres Races To Be First To Market With A Microbiome Drug (Pink Sheet-$)
  • Successful BNC101 IND Submission Paves Way for Development of Promising Cancer Stem Cell Drug Candidate (Press)
  • FDA approves Synjardy tablets (DSN)
  • Asterias's stem cell therapy shows promise in study (Reuters)
  • Intarcia vs. Novo: Which has the most appealing diabetes PhIII program? (FierceBiotech)
  • Sunovion's Seizure Drug Aptiom Wins Monotherapy Use (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections (FDA)
  • Pfizer resists calls for greater clincal trial transparency (The Guardian)

US: Medical Devices

  • Medtronic says trials find gene linked to sudden cardiac death (Reuters) (Press) (MassDevice)
  • Pressure On CMS To Add UDI To Claims Forms Continues (Gray Sheet-$)
  • Wireless pacemaker gets cautious endorsement (CBS News)
  • Leadless pacemaker study assesses safety and efficacy (MNT)
  • Top 10 Tips For Selecting A Medical Device Contract Manufacturer (MedDeviceOnline)
  • FDA clears MagVenture’s MagVita TMS (MassDevice)
  • Great Basin Submits 510(k) Application to the FDA for Staph ID/R Blood Culture (Press)
  • Biotronik wins CE Mark for BioMonitor 2 (MassDevice)
  • Bovie Medical Receives FDA 510(k) Approval for New J-Plasma® Pistol Grip Configurations (Press)
  • Mitralign Receives FDA Approval for Percutaneous Tricuspid Repair Early Feasibility Study (Press)
  •  

US: Assorted and Government

  • Amarin, FDA To Discuss Settling Off-Label Promotion Dispute (Law360-$)
  • Fraud Claims Against Lilly Tossed In Cymbalta Labeling Row (Law360-$)

Upcoming Meetings and Events              

Europe

  • Heart disease rates continue to decrease (EurActiv)
  • Stem cell researcher cleared of misconduct after U-turn (FierceBiotech)
  • Europe's IMI Plans Projects On 'Big Data' In Health Outcomes (Pink Sheet-$)
  • Mylan Shareholders OK Tender As Perrigo Draws Irish Regulators’ Rebuke (Pink Sheet-$)

Canada

  • Regulatory Decision Summary: VIIBRYD (Health Canada)
  • Updates to the Guidance Document: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy to reflect Plain Language Labelling Regulations (Health Canada)

India

  • Sun Pharma, Wockhardt recall drugs from US market (Economic Times)
  • Indian pharma industry capable of discovering new drugs, says Sun Pharma's Dilip Shanghvi (Economic Times)
  • Aurobindo Pharma gets US FDA nod for generic osteoporosis drug (Economic Times)
  • India Not Prepared to Make Changes to Price Control Regime Anytime Soon (24 Insight)
  • CDSCO delegates DDC Bengaluru to issue NoCs for mfg unapproved drugs for exports (PharmaBiz)
  • Tafinlar Set For Indian Approval? (SCRIP-$)

China

  • CFDA Deputy Head Takes On Key Liaison Role (PharmAsiaNews-$)
  • China finalizes stem cell guidance (BioCentury)
  • After GSK, its now Pfizer facing China's corruption crackdown (BioSpectrum)

Japan

  • Japan's MHLW gives nods for Remicade, VFend, Tracleer, INOflo new indications (FiercePharmaAsia)

Australia

  • Australia To Fund Mekinist, Xalkori But More Evidence Will Be Needed (SCRIP-$)

Ebola Outbreak

Other International

  • 'Stem cell may extend life span' (BioSepctrum)
  • Korea Toujeo OK Sets Stage for Tresiba Clash (SCRIP-$)
  • An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish? (RxTrace)

General Health and Other Interesting Articles

Regulatory Reconnaissance #629 – 31 August 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 @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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