Industry News

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Zydus Lifesciences Limited U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Amantadine Extended-Release Capsules USP 68.5 mg and 137 mg (USRLD: Gocovri).

Subject Expert Committee of CDSCO recommends to grant permission to Biocon to conduct phase 2 clinical trial for Itolizumab for Injection (r-DNA origin) 100 mg per vial.

Amylyx Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved RELYVRIO (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS). RELYVRIO (previously known as AMX0035 in the U.S.) significantly slowed the loss of physical function in people living with ALS in a randomized, placebo-controlled clinical trial. RELYVRIO can be taken as a monotherapy or with existing approved treatments.

Merck known as MSD outside of the United States and Canada, announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW)

Lupin has received a warning letter from the USFDA for their Tarapur, Maharashtra facility. The U.S. FDA had inspected the Lupin Tarapur site from March 22, 2022 to April 4, 2022.

Initially, USFDA has closed the inspection at Lupin’s Tarapur manufacturing facility with four observations.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Bayer announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Eylea (aflibercept) intravitreal injection 40 mg/mL for the treatment of preterm infants with retinopathy of prematurity (ROP).

The U.S. Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic (CDx) to aid in selection of patients with RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer and RET-mutation positive advanced or metastatic medullary thyroid cancer (MTC) who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).