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Aurobindo shares plunge on US import alert

 
• By Anju Ghangurde

Shares of Aurobindo Pharma were on a downward spiral on Indian bourses on 24 February over concerns that an import alert from the US FDA for products from one of its units could hurt the firm and trigger follow-on regulatory action in other markets.

Shares of Aurobindo Pharma were on a downward spiral on Indian bourses on 24 February over concerns that an import alert from the US FDA for products from one of its units could hurt the firm and trigger follow-on regulatory action in other markets.

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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BridgeBio Takes A Victory Lap With First Full Quarter Of Attruby Sales

 
• By Mandy Jackson

BridgeBio reported $36.7m in Q1 2025 sales of its ATTR-CM drug Attruby, tripling consensus forecasts. Vyndaquel-maker Pfizer acknowledged the product’s impact during the quarter.

Novartis Gains Further Renal Territory With Regulus Acquisition

 
• By Alaric DeArment

The San Diego biotech’s lead product candidate is an antisense oligonucleotide-based therapy slated to enter Phase III development in the third quarter.

J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
• By Jessica Merrill

The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.