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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.

Breo, Arnuity and the slate of new respiratory products that GSK has been developing with Theravance are meant to serve as follow-ons to the blockbuster Advair (fluticasone propionate/salmeterol), which has approval in COPD and asthma but will face generic competition in the next few years

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

 
• By Eliza Slawther

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

 
• By Michael McCaughan

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.

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

 
• By Vibha Sharma

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.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.

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FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

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.

US FDA Rare Disease Case Studies Provide Development Models For Sponsors

 
• By Laura Helbling

Sanofi’s Xenpozyme and Sentynyl’s Nulibry are the first two case studies the FDA is using to continue educating rare disease sponsors on best practices.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.