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  • US court decision favours Astrazeneca's Symbicort in patent litigation

    The US District Court for the Northern District of West Virginia has decided in favour of AstraZeneca in litigation against Mylan Pharmaceuticals Inc. (Mylan) and Kindeva Drug Delivery L.P. (Kindeva), determining that asserted claims in three of AstraZeneca’s patents protecting Symbicort (budesonide/formoterol) in the US are not invalid.

    admin Thu, 03/04/2021 - 15:37
  • Olympus may acquire Israeli Medical Device Company Medi-Tate

    Olympus made its initial investment in Medi-Tate in November 2018, under an agreement that included the rights to distribute Medi-Tate products and gave Olympus an option to acquire 100% of the Israeli company at a later date. Medi-Tate is a medical device manufacturer engaged in the research and development, production, and sale of devices for the minimally invasive treatment of benign prostatic hyperplasia (“BPH”). The company’s flagship product “iTind” has received a European CE mark and is FDA cleared for use in the U.S.

    admin Fri, 02/26/2021 - 15:39
  • Astrazeneca withdraws Imfinzi indication in advanced bladder cancer in FDA

    AstraZeneca announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients with locally advanced or metastatic bladder cancer. This decision was made in consultation with the Food and Drug Administration (FDA).

  • Sun Pharmaceuticals settled a case with SEBI

    Sun Pharmaceutical settled for a case pertaining to alleged violation of listing obligation and disclosure requirements norms with regulator Securities and Exchange Board of India (SEBI). The aggregate settlement charges were paid around Rs 2.9 crores.

    The show cause notices issued by SEBI on May 19, 2020 to Sun Pharmaceutical Industries Limited, and the Whole-time Directors and certain officers at the relevant time.

  • FDA approves Libtayo® as first immunotherapy indicated for patients with advanced basal cell carcinoma

    The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.

  • ViiV healthcare got EU approval for Rukobia in multidrug resistant HIV

    ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc with Pfizer Inc.

  • J&J Spravato got EU approval for Depression

    The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has authorised the expanded use of SPRAVATO® (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of MDD, as acute short term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.

  • 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.

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