US Food & Drug Administration grants Zydus Cadila tentative approval to market cancer drug

INDIA – Zydus Cadila has received tentative approval from the United States Food and Drug Administration (USFDA) to market Ibrutinib tablets used in the treatment of certain types of cancers. The company will market Ibrutinib tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg in the US though it will be manufactured at the group’s formulation manufacturing facility at Ahmedabad. Zydus Cadila now has 319 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of its filing process.…

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Zydus cadila animal health business sold to multiples alternate asset management-led consortium

INDIA – Cadila healthcare and its wholly-owned subsidiary Zydus Animal Health and Investment has completed sale of its animal healthcare established markets undertaking to Multiples Alternate Asset Management-led consortium for (US$391,667) Rs 2,921 crore. Zydus Animal Health and Investment entered into a definitive pact for sale of its animal healthcare established markets undertaking to Multiples Alternate Asset Management-led consortium. This deal involves transfer of immovable assets, movable assets, inventory, brands and intangible assets, contracts, licenses and permissions, business records, employees along with employee benefit funds, insurance policies, other assets and…

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Breakthrough as phase 1 clinical malaria vaccine trial results come positive with proof to give strong lasting protection against malaria

US – The National Institute of Allergy and Infectious Diseases’ (NIAID) phase 1 clinical trials of its malaria vaccine, Sanaria (PfSPZ), have found that the regimen conferred unprecedentedly high levels of durable protection when volunteers were later exposed to disease-causing malaria parasites. Trials were conducted at the National Institutes of Health (NIH) Clinical Centre in Bethesda, Maryland led by Patrick E. Duffy, M.D., of the NIH National Institute of Allergy and Infectious Diseases (NIAID), and Stephen L. Hoffman, M.D., CEO of Sanaria Inc., Rockville, Maryland. In the CVac trials, healthy…

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Zydus’ HIV generic drug ready for market use following approval from the US Food & Drug Administration

INDIA – Zydus Cadila, a drug manufacturing company based in India, has received approval from the US Food & Drug Association(USFDA) to market generic Emtricitabine and Tenofovir Disoproxil Fumarate tablets used for treatment of HIV infection. According to Zydus Cadila, the drugs are to be used alongside other medications to help control HIV infectons to decrease the amount of HIV in one’s body so that the immune system can work better. Manufacturing of the drugs is set to be done in Zydus’ facility based in Ahmedabad, India. HIV as an…

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Cadila, Bayer joint venture partnership gets a three-year extension

INDIA – Zydus Cadila, a leading Indian Pharmaceutical company and Bayer (South East Asia), a subsidiary in Singapore that deals in distribution of prescription drugs, have decided to extend their joint venture by three years with effect from June. The two companies first entered into the joint venture agreement ten years ago with a joint name Bayer Zydus Pharma and operated mainly from Mumbai with a business model revolving around the sales and marketing of pharmaceutical products in India and across the world. During the previous joint venture, Bayer’s global…

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