Industry News

Subject Expert committee of CDSCO recommends for grant of permission to import and market Delamanid Dispersible Tablets 25mg against pulmonary multi drug resistant tuberculosis (MDR-TB) in adults, adolescents, children and infants.

Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for the treatment of retinitis pigmentosa (RP) via intravitreal injection.

Panacea Biotec, one of India's leading biotechnology companies, has received long-term supply awards worth USD 127.30 million (around INR 1,040 Crore) from UNICEF and Pan American Health Organization (PAHO) for supply of its WHO pre-qualified fully liquid Pentavalent vaccine, Easyfive-TT'" (DTwP-HepB-Hib).

Pfizer Inc announced the completion of its acquisition of Global Blood Therapeutics, Inc. (GBT), a biopharmaceutical company dedicated to the discovery, development and delivery of life-changing treatments that provide hope to underserved patient communities starting with sickle cell disease (SCD). The acquisition reinforces Pfizer’s commitment to SCD, building on a 30-year legacy in the rare hematology space.

It has come to notice that controversial syrups exported by India based Maiden Pharmaceutical are linked to the death of 66 children in Gambia. Regulators informed that the company has manufactured and exported these products only to Gambia.

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities. The FDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner.

MSD announced the opening of a new secondary packaging facility to support the production of vaccines and biologics, including the company’s cancer immunotherapy products. MSD also broke ground for a new inhaler production facility for the manufacture of new generation inhaler medicines in Singapore.

Glenmark Pharmaceuticals Limited an innovation‐driven global pharmaceutical company, became the first to launch Thiazolidinedione Lobeglitazone (Lobeglitazone) in India for the treatment of type 2 diabetes in adults. Marketed under the brand name LOBG; it contains Lobeglitazone (0.5 mg) and to be taken once daily under prescription to improve glycemic control in adult diabetic patients.

World Health Organization (WHO) alerts against Indian made cough syrups after 66 children died in Gambia. The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India. WHO is conducting further investigation with the company and regulatory authorities in India.

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.