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Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical…
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Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has notified the company that it will not meet the Prescription Drug User Fee Act (PDUFA) goal dates for the New…
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Roche announced that Venclexta (venetoclax) in combination with azacitidine has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for…
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Takeda Pharmaceutical Company Limited announced an additional agreement with Moderna and the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to import and distribute…
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Relmada Therapeutics, Inc. a late-stage biotechnology company addressing diseases of the central nervous system (CNS), announced the acquisition of development and commercial rights to…
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Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve(casirivimab and imdevimab), for the treatment of patients with mild to moderate…
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BioNTech SE und Kite, a Gilead Company announced the two companies have entered into a purchase agreement for BioNTech to acquire Kite’s solid tumor neoantigen T cell receptor (TCR)…
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BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly owned subsidiary of Bayer AG, announced that the U.S. Food and Drug Administration (FDA) has granted Fast…
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RxCelerate, a leading international out-sourced drug discovery and development platform, announced that it has established a venture capital fund, RxCapital, to invest in companies…
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SMi Group reports: Navigating new legislations and strategies to comply with regulatory requirements The MDR and IVDR updates will have a profound impact on the medical device…
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