Industry News

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).

Torrent Pharmaceuticals Limited (Torrent Pharma) has entered into definitive agreements to acquire 100% of Curatio Healthcare (I) Private Limited (Curatio) for Rs. 2,000 crores. The consideration includes Rs. 115 crores (on the date of signing) of cash and cash equivalents in the acquired business indicating an Enterprise Value of Rs. 1,885 crores.

Pfizer Inc and BioNTech SE announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a 10-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.

Natco Pharma has launched Chlorantraniliprole (CTPR) 18.5% SC under the Brand Name of NATGEN in the Indian Market.

NATCO estimates the current market size of CTPR containing products in India to be over INR 2000 crores.

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product loncastuximab tesirine (Zynlonta), intended for the treatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma.

The applicant for this medicinal product is ADC Therapeutics (NL) B.V.

Shilpa medicare gets CDSCO approval for Tranexamic Acid Spray, Hemostatic Spray. The product is protected by granted patents in India till 2037 and in US, Australia, Russia and South Africa till 2038. Shilpa is continuously pursuing patent prosecution in other countries and for further protection.