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  • USFDA issues Form 483s to three sites of Biocon

    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 initiates Phase IV clinical trial for Desidustat

    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 launches allergic rhinitis nasal spray in the US

    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 Receives Tentative Approval from USFDA for Dasatinib Tablets

    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.

  • Japan health Ministry nod Evusheld of AstraZeneca

    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.

  • US government to support USD 11 Mn for packaging of monkeypox vaccine

    ​​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.​

  • Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian

    Bayer announced the start of a Phase III clinical development program OCEANIC to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor, as a potential new treatment in patients with atrial fibrillation and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack.

  • Novartis Scemblix gets EU approval

    Novartis said its Scemblix was approved by the European Commission for adult patients with chronic myeloid leukemia (CML), offering a new treatment approach for patients with intolerance to other therapies, as reported by Reuters.

    Scemblix provides much-needed and long-awaited new option for patients with chronic myeloid leukemia (CML) who suffer with intolerance or inadequate response after at least two previous tyrosine kinase inhibitor (TKI) treatments.

  • Nigeria introduces Bharat Biotech Rotavac vaccine for children

    Bharat Biotech International Limited rotavirus oral vaccine Rotavac has been introduced by Nigeria to immunize its children from the life- threatening diarrhoeal disease that affects millions of children worldwide.

    Nigeria currently accounts for 14 percent of all childhood rotavirus deaths globally, making it the country with the second-highest number of rotavirus deaths in the world. Rotavirus infection causes about 50,000 child fatalities under the age of five each year in Nigeria.

  • Moderna sues Pfizer BioNTech over patent infringement

    Moderna is filing patent infringement lawsuits against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Dusseldorf in Germany. Moderna believes that Pfizer and BioNTech copied two key features of it patented technologies.

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