1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

In Brief: GSK, Bristol/Pfizer See Approvals, Baxter Holds Its Own in Hemophilia

 
• By Emily Hayes, Lisa LaMotta, and Derrick Gingery

Recent Phase III releases include data for Actavis’ ceftazidime/avibactam for gram-negative abdominal infections and Baxter’s long-acting Factor VIII hemophilia drug BAX 855. GSK’s fluticasone approved for asthma and Bristol/Pfizer’s Eliquis expands labeling.

GlaxoSmithKline PLC has its sixth product for asthma with FDA’s Aug. 20 clearance of the inhaled corticosteroid Arnuity Ellipta (fluticasone furoate) as maintenance treatment for patients ages 12 and older. Arnuity is one half of the firm’s recently approved Breo Ellipta, which also includes the long-acting beta-2 adrenergic agonist (LABA) vilanterol. Breo is currently approved for the treatment of chronic obstructive pulmonary disease (COPD), but GSK and partner Theravance Biopharma Inc. recently filed a supplemental NDA seeking approval in asthma Also see "GSK’s Breo Ellipta Marches Forward For Asthma, Efficacy Undistinguished From Advair" - Pink Sheet, 30 July, 2014.. The combination currently carries a warning of an increased risk of death from asthma problems, a known issue for LABAs.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

EU Regulators Push For Better Support For Sponsors On Using Animal Study Alternatives

 
• By Eliza Slawther

The European Medicines Agency’s innovation network has recommended how the EU’s regulatory framework could be updated to support drug developers in using new approach methodologies, which are drug testing methods that reduce or replace animal studies.

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

More from R&D

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

New Carbon Monitoring Initiative Could Help Future Proof Clinical Research

 
• By Francesca Bruce

A new European initiative will help trial sponsors better understand whether digitization and decentralized clinical trials of drugs generate less carbon than traditional methods.

Major Analysis To Help MHRA Fill Gaps In UK Clinical Trials Landscape

 
• By Vibha Sharma

A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.