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  • Leo Pharma gets CHMP nod for Adtralza for dermatitis

    LEO Pharma A/S, a global leader in medical dermatology announced that the Committee for Medicinal Products for Human Use  of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization of Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

  • Zydus receives Emergency Use Approval from DCGI for the use of Pegylated Interferon alpha-2b, Virafin

    Zydus Cadila announced that the company has received Restricted Emergency Use Approval from the Drug Controller General of India (DCGI) for the use of  Virafin, Pegylated Interferon alpha-2b (PegIFN) in treating moderate COVID-19 infection in adults. A single dose subcutaneous regimen of the antiviral Virafin will make the treatment more convenient for the patients. When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications.

  • J&J single shot COVID-19 Vaccine phase 3 data published

    Johnson and Johnson announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson and& Johnson (Janssen).

  • Thermo Fisher Scientific to Acquire PPD, Inc

    Thermo Fisher Scientific Inc the world leader in serving science, and PPD, Inc a leading global provider of clinical research services to the pharma and biotech industry announced that their boards of directors have approved a definitive agreement under which Thermo Fisher will acquire PPD for $47.50 per share for a total cash purchase price of $17.4 billion plus the assumption of approximately $3.5 billion of net debt.

  • Niramai receives CE mark approval enabling entry into EEA, Asia, Africa & Middle East

    Niramai, the deep-tech healthcare company offering an innovative AI-based, radiation-free breast cancer screening test has now received the CE mark approval, ISO 13485 and MDSAP (Medical Device Single Audit Programme) international certifications. The CE mark approval indicates that the product may be sold freely in any part of the European Economic Area (EEA) as well as applicable to many Asian, African and Middle East countries.

  • Germany and Canada halted use of the AstraZeneca vaccine in elderly patients

    Germany and Canada have restricted the use of the AstraZeneca vaccine to people over 60 and 55 respectively, due to fear that it can lead to deadly blood clots.

    Health Minister of Germany, Jens Spahn and state officials agreed unanimously on Tuesday to only give the vaccine to people aged 60 or older unless they belong to a high-risk category for serious illness from COVID-19 and have agreed with their doctor to take the vaccine despite the small risk of a serious side-effect.

  • Max Healthcare raises Rs. 1200 crore through QIP

    Max Healthcare Institute Ltd (MHC), India’s second largest private hospital chain operator by revenue in Fiscal 2020 announced the successful completion of its Qualified Institutions Placement (QIP). MHC raised INR 1,200 Cr (approx. USD 165 Mn) through its QIP, which saw participation from highly reputable global and domestic investors. MHC has accordingly issued 6,14,12,482 fresh equity shares of face value of INR 10 per equity share at a price of INR 195.40 per equity share.

  • 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.

  • 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.

  • 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).

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