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For GSK, Lots Of Drugs In R&D, But Many Are Long-Term

 
• By Jessica Merrill

Management highlighted pipeline drugs in respiratory disease, HIV, immuno-oncology and vaccines, but a lot of the drugs in development are early- to mid-stage where the success rate remains uncertain. The meeting isn’t likely to change investor sentiment in the near-term.

GlaxoSmithKline PLCheld an expansive R&D update Nov. 3, laying out a strategy to file up to 20 drugs with regulators before 2020, seven of which could launch in that timeline. But few investors are likely to walk away from the four-hour meeting with a changed sentiment on the firm in the near-term, where it is facing strong headwinds from slowing sales of its top-seller Advair Diskus.

Many of the late-stage opportunities like Nucala (mepolizumab) for severe asthma, the Shingrix shingles vaccine and the interleukin-6 blocker sirukumab...

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Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 
• By Eliza Slawther

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

More from R&D

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Korea Pre-Review Consultations Help Accelerate R&D

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.