Lupin In Tailspin After Two-In-One FDA Warning Letter

After a weak second quarter, Lupin had a nasty surprise with the FDA issuing a combined warning letter for two of its Indian manufacturing sites. The FDA action is expected to setback US product approvals, though Lupin maintained that its “structural story of growth” remained intact.

Compliance
LUPIN HAS RECEIVED A COMBINED WARNING LETTER FOR TWO PLANTS

Investors slammed Lupin Ltd. on Indian bourses after the company said that the US FDA had issued a “combined” warning letter for two of its Indian sites – both seen as key to the firm’s US product launch momentum.

The warning letter issued by the FDA on Nov. 6 pertains to Lupin’s formulations manufacturing facilities in Goa and Indore...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

More from Business

Test Roche Head Of Pharma Strategy Karsten Jung On Rebuilding The Portfolio

 

The Swiss pharma company is rebalancing the portfolio, emphasizing best-in-class drugs and moving into new areas like cardiovascular and metabolic disease.

Quick Listen: Scrip’s Five Must-Know Things

 
• By 

In this week's episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab.

Article Without An Author Listed

Here is a short description.

Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

More from Scrip

EHA: Lilly’s Jaypirca Posts First Phase III Triplet Win In CLL While BTK Degraders Advance

Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.

EHA: Lilly’s Jaypirca Posts First Phase III Triplet Win In CLL While BTK Degraders Advance - Clone

Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.