Cipla's Advair Generic US Debut May Be Pushed Out But 'Value Intact'

Cipla to pursue two-site, de-risked filing approach for large respiratory assets even as it awaits an FDA compliance classification for its Indore facility, which will determine the launch timelines for its much-awaited generic Advair in the US.

Investors Await Clarity On gAdvair Launch Timeline • Source: Shutterstock

Launch timelines for Cipla Limited’s long-awaited generic (g) Advair (salmeterol/fluticasone) in the US now hinge on whether its Indore site in India makes the compliance cut, but the firm claimed that even if things don’t go its way, the value proposition for the product remains unaltered.

The inspection classification of the Indore site by the US Food and Drug Administration was expected around mid-May and an...

More from Business

BREAKING NEWS: Merck & Co. Leaps Into COPD Space With $10bn Verona Buy

 
• By 

The UK firm's chronic obstructive pulmonary drug Ohtuvayre has been enjoying a stellar launch.

Wave of Biopharma Licensing Deals in India: ‘The Model Is Working’

 

From vonoprazan and inclisiran to nirsevimab, big pharma has licensed several products to Indian firms as have other biopharma players. Experts discuss the intricacies of such licensing deals amid signs of more action in store and whether geopolitics could dull partnering with Chinese firms.

Actithera Raises $75m To Enter Competitive FAP-Targeting Radioligand Field

 

While companies such as Eli Lilly and Roche have faced setbacks to their fibroblast activation protein-targeting oncology therapies, Actithera believes its radiopharmaceuticals platform will prove more successful.

Concentra Picks Up Cargo In Latest Troubled Biotech Buyout

 

The Kevin Tang-led firm will pay $4.38 per share for Cargo, which laid off most of its workforce following the failure of a Phase II CAR-T trial.

More from Scrip

J&J Seeks Schizophrenia Relapse Indication For Caplyta

 

The company is expecting US FDA approval of the drug in a bigger indication, major depressive disorder, later this year.

Concentra Picks Up Cargo In Latest Troubled Biotech Buyout

 

The Kevin Tang-led firm will pay $4.38 per share for Cargo, which laid off most of its workforce following the failure of a Phase II CAR-T trial.

Venture Funding Plummets In Q2 As Mega-Rounds Falter

 
• By 

Evaluate’s second quarter data show that VC rounds of $100m or more totaled $2.36bn, down from $5.25bn in Q2 of 2024. Overall, the Q2 total dropped year-over-year to $4.92bn from $7.95bn.