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GSK Set For Breo Launch, But Access Will Require Time

 
• By Jessica Merrill

GlaxoSmithKline will launch its once-daily COPD treatment Breo in the U.S. in October, Senior VP-Respiratory Jorge Bartolome said in an interview. The company will market Breo as the first once-daily ICS/LABA combination offering 24-hour lung function improvement. But already some payers are denying coverage.

After a minor delay, GlaxoSmithKline PLC is prepared to launch Breo Ellipta (fluticasone/vilanterol), the first once-daily inhaled corticosteroid/long-acting beta2-agonist intended to eventually supplant AdvairDiskus as the world’s leading respiratory drug. Breo Ellipta will be available in the U.S. for chronic obstructive pulmonary disease before the end of October, Senior VP-Respiratory Jorge Bartolome said in an interview Oct. 8.

The launch is critical for GSK and investors will be closely watching. Breo was developed to extend the life of GSK’s respiratory franchise beyond Advair, which is expected to face...

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Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

Mayne’s Nextstellis Promo Wrong To Suggest Better Safety Than Other Contraceptives, FDA Says

 
• By Sue Sutter

A professional slide deck for the drospirenone/estetrol oral contraceptive inappropriately suggests it is safer than other estrogen-containing products and understates risks, Office of Prescription Drug Promotion said in the first “untitled” letter issued since reductions-in-force.

Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
• By Sue Sutter

The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.

US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
• By Sue Sutter

Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.

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Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.