Keeping Track: Imbruvica Snags First-Line CLL Claim; Gilead TAF Strategy Advances

The latest drug development news and highlights from our FDA Performance Tracker.

The week may not have had any major novel approvals, but FDA's clearances are prime examples of pharmaceutical companies taking care of business. AbbVie Inc. and Johnson & Johnson's Imbruvica took another step toward cementing its dominant position in the chronic lymphocytic leukemia market with a first-line indication, and Gilead Sciences Inc. made progress with its succession plans for its antiviral Viread.

On the other side of the coin, reports to the Securities and Exchange Commission cast light on topics that firms may have preferred to keep in the dark. Recent filings by Merck & Co. Inc

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

More from Clinical Trials

Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By 

A report by the European pharmaceutical industry criticizes the EU’s clinical trials framework, highlighting regulatory fragmentation, inefficiencies and the need for targeted reforms.

UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 

In light of the UK’s MHRA announcing a major overhaul of its clinical trial legislation, the agency’s deputy director for clinical investigations and trials Andrea Manfrin tells the Pink Sheet what sponsors can expect from the new regulation.

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

More from R&D

EU Shaping Biotech Act To Unleash SME Potential

 

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By 

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.