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  • Takeda submits NDA for a drug uitlised in Perianal Fistulas in Crohn’s disease at Japan

    Takeda Pharmaceutical Company Limited announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (development code: Cx601) for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease (CD).

  • USFDA Approves Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel)

    Bristol Myers Squibb announced that the U.S.

  • Bayer to manufacture mRNA vaccine in Germany

    In a joint press briefing today together with German Health Minister Jens Spahn, Minister-President of North Rhine-Westphalia, Armin Laschet, and Chief Executive Officer of CureVac N.V., Franz-Werner Haas, Member of the Board of Management, Bayer AG and President of the Bayer’s Pharmaceuticals Division, Stefan Oelrich, made the following statement  “Following discussions with the German government it has become clear that current manufacturing capacities for vaccines need to be increased, particularly for potential variants of the SARS-CoV-2 virus.

  • Eisai Launch Parkinson’s Disease Treatment Equfina in South Korea

    Eisai Co., Ltd announced that Eisai Korea Inc., Eisai’s subsidiary in South Korea, has launched the Parkinson’s disease treatment Equfina® (safinamide mesilate, “safinamide”). This is the first launch of Equfina in the Asian region excluding Japan.

  • Takeda Completes Sale of TachoSil to Corza Health

    Takeda Pharmaceutical Company Limited announced that it has completed the previously announced sale of TachoSil Fibrin Sealant Patch (TachoSil) to Corza Health, Inc for €350 million.

  • Glenmark Pharmaceuticals receives ANDA approval for Amphetamine Sulfate Tablets

    Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Amphetamine Sulfate Tablets USP, 5 mg and 10 mg, the generic version of Evekeo®1 Tablets, 5 mg and 10 mg, of Arbor Pharmaceuticals, LLC.

    According to IQVIATM sales data for the 12 month period ending November 2020, the Evekeo® Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately $21.5 million*.

  • BioArctic receives European patent for new antibodies targeting Alzheimer’s disease

    BioArctic AB announced that the European Patent Office (EPO) has issued a decision to grant European patent EP 2 448 968 B1 for novel antibodies that could be developed into a treatment for Alzheimer’s disease. The antibodies target a shorter (truncated) form of amyloid beta (pE3-Aβ) and are linked to the company’s project AD1503. The patent enters into force on 27 January 2021 and expires in 2030.

  • Zydus granted Orphan Drug Designation by the USFDA for Saroglitazar in the treatment of patients with Primary Biliary Cholangitis (PBC)

    United States Food and Drug Administration (USFDA) has granted ‘Orphan Drug Designation’ (ODD) to Saroglitazar for the treatment of patients with Primary Biliary Cholangitis (PBC). Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. This follows the grant of ‘Fast Track Designation’ by the USFDA to Saroglitazar Mg for PBC in December 2020.

  • Merck winds up development of COVID-19 vaccine

    MSD outside the United States and Canada announced that the company is discontinuing development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, and plans to focus its SARS-CoV-2/COVID-19 research strategy and production capabilities on advancing two therapeutic candidates, MK-4482 and MK-7110. This decision follows Merck’s review of findings from Phase 1 clinical studies for the vaccines.

  • Alembic Pharmaceuticals receives USFDA Approval for Midodrine Hydrochloride Tablets USP

    Alembic Pharmaceuticals Limited announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine Tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals USA, Inc. (Takeda). Midodrine Hydrochloride Tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).

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