The FDA has accepted Bristol Myers Squibb's application for Breyanzi as a second-line treatment for relapsed or refractory large B-cell lymphoma. The regulator has assigned it priority review with a decision deadline of June 24.
On Thursday, the House Committee on Oversight and Reform will hold a hearing to present its findings on an investigation of the pricing strategies of U.S. companies producing the world's most expensive drugs. The committee also will assess how President Biden’s Build Back Better Act will reduce drug prices.
Shares of Natco Pharma surged 20 per cent to Rs 1,188.95, also its new high, on the BSE in intra-day trade on Monday after the company said it has received approval from the US health regulator for the generic version of Celgene s multiple myeloma drug, Revlimid (Lenalidomide) capsules in US. Lenalidomide capsule is indicated for treatment of adults with multiple myeloma, mantle cell lymphoma and myelodysplastic syndromes.
In the past three days, the stock has zoomed 30 per cent. At 09:48 am, Natco Pharma was trading 11 per cent higher at Rs 1,101 on the BSE, as compared to 0.24 per cent rise in the S&P BSE Sensex. The trading volumes on the counter jumped over five-fold with a combined 3.8 million equity shares changing hands on the NSE and BSE.
Natco Pharma gets USFDA nod for two products
Updated:
Updated:
May 22, 2021 16:17 IST
Natco and Arrow will launch the approved product on agreed-upon launch dates in the future, a release said.
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Natco and Arrow will launch the approved product on agreed-upon launch dates in the future, a release said. Natco Pharma has received final approval from the U.S. Food and Drug Administration for abbreviated new drug applications (ANDA) for two products, including an anti-cancer drug for which the company and its marketing partner had settled a litigation with Celgene.
On Lenalidomide capsules, which is indicated in treatment of certain types of cancers, Natco said it has received final approval for 5mg, 10mg, 15mg, and 25mg strengths and tentative approval of the 2.5 mg and 20mg strengths.