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  • 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.

  • Jazz Pharmaceuticals to acquire GW Pharmaceuticals in USd 7.2 billion

    Jazz Pharmaceuticals plc and GW Pharmaceuticals plc announced the companies have entered into a definitive agreement for Jazz to acquire GW for USD 220.00 per American Depositary Share (ADS), in the form of USD 200.00 in cash and USD 20.00 in Jazz ordinary shares, for a total consideration of USD 7.2 billion, or USD 6.7 billion net of GW cash. The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter of 2021.

  • 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.

  • Phase 3 trial recruitment starts for COVID-19 vaccine of Janssen

    The University of Kentucky has been selected as a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase 3 clinical research study ENSEMBLE 2, which is evaluating the safety and efficacy of a two-dose regimen of Janssen’s COVID-19 vaccine candidate.

  • 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).

  • Umbralisib has received US FDA accelerated approval for relapsed or refractory lymphomas

    Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company, announced that its novel next generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics has secured USFDA accelerated approval for the treatment of : (1) adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and (2) adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy.

  • International Harmonising of the standards and specifications will boost the Medical devices Industry in India

    Health and Pharmaceutical Manufacturing & Medical Devices Committee, PHDCCI in association with Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Govt. of India organized third series of Self Sufficiency in Medical Technology on “India to be an attractive destination for MedTech” on 5th February 2021

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

    Bristol Myers Squibb announced that the U.S.

  • India is also providing vaccines to neighboring countries

    In this difficult time when the whole world has suffered from an unknown, invisible and unknowable virus COVID-19, India is ready to provide its cut to the world community. India, which has become the Corona vaccine, is running the world's largest vaccination campaign today. Not only this, along with the vaccination of Corona to Indians, India is also providing vaccines to many other countries.

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