Industry News

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.

This two-day event was held on September 15th and 16th.It was a uniquely planned event, where the focus was on understanding how organisations can build an apt strategy for achieving manufacturing excellence and using digital and automation as tools for modernising.
The conference ensured continuous engagement of the audience & speakers through various discussions in the form of Case-Study solving, Panel Discussion and group discussions to understand and create a viable Business Strategy for exponential growth.

BridgeBio Pharma, Inc , a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, and Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases owned by Zydus Lifesciences Ltd. announced the European Commission (EC) has granted marketing authorization for NULIBRY  (fosdenopterin) for Injection as the first therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.

Heron Therapeutics, Inc  a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs,  announced that the U.S. Food and Drug Administration (FDA) has approved APONVIE (aprepitant) injectable emulsion, for intravenous use for the prevention of postoperative nausea and vomiting (PONV) in adults.