Industry News

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.

Lupin Limited has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Ankleshwar manufacturing facility, located in Gujarat, India.

The inspection of the facility was conducted from August 16-19, 2022 by USFDA. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.

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)