Industry News

Pfizer Inc. and BioNTech announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals ages 12 years and older.

And on the same day,  Moderna, Inc. has also received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Omicron-targeting bivalent COVID-19 booster vaccine.

The U.S. Food and Drug Administration has approved Xenpozyme for the treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency in adult and pediatric patients.

Xenpozyme is the first therapy indicated specifically for the treatment of ASMD (acid sphingomyelinase deficiency), and is currently the only approved treatment for this disease.

Aspen Pharmacare has concluded a ten-year agreement with Serum Institute of India, the world’s largest vaccine producer, for Aspen SA operations to manufacture, market and distribute four Aspen-branded routine vaccines in Africa, excluding certain markets due to the Serum Institute having grated prior rights to third parties.

U.S. Food and Drug Administration (USFDA) issues Form 483s to three sites of Biocon Biologics at India and Malaysia. USFDA issues 11 observations each for the two sites in Bengaluru and 6 observations for the Malaysia site.

USFDA conducted three on-site inspections of Biocon Biologics seven manufacturing facilities spanning two sites in Bengaluru, India and one at Johor, Malaysia. These inspections started with the Bengaluru site on August 11, 2022 and concluded with the Malaysia site on August 30, 2022.

Zydus Lifesciences initiates Phase IV clinical trial for Desidustat in patients with Chronic Kidney Disease (CKD) induced anemia.

Desidustat sold under a brand name Oxemia which is a prescription drug approved in India for patients with Chronic Kidney Disease (CKD) induced anemia, and can be taken only under the advice and guidance of a Nephrologist or an internal medicine specialist.

Hikma Pharmaceuticals and Glenmark Specialty S.A., a subsidiary of Glenmark Pharma launches Ryaltris in the US. It is a combination of olopatadine hydrochloride and mometasone furoate and formulated as a nasal spray. Ryaltris is approved by the US Food and Drug Administration (FDA) for the treatment of symptoms of seasonal allergic rhinitis (SAR) in adult and pediatric patients 12 years of age and older.

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.

The Japan health Ministry has approved Evusheld of AstraZeneca for COVID-19. Evusheld is an investigational medicine used in adults and adolescents for pre-exposure prophylaxis for prevention of COVID-19.

In December 2021, the U.S. Food and Drug Administration had approved AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together)for emergency use for prophylaxis of COVID-19. And followed by March 2022, EMA's human medicines committee (CHMP) has recommended granting a marketing authorisation for Evusheld.

​​The US government said yesterday that it would provide about USD 11 million to support the packaging of Jynneos monkeypox vaccine at a U.S. based manufacturers facility, as reported by Reuters.​