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  • Vifor Pharma and Angion report topline results from phase-II GUARD trial of ANG-3777 in cardiac surgery associated acute kidney injury

    Vifor Pharma and Angion Biomedica Corp announced results from the exploratory phase-II GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.

  • NPPA fixed retail prices of 20 formulations

    The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 20 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 93rd Authority meeting dated 15.11.2021. The drug candidate Dapagliflozin and metformin extended release is included in 17 formulations out of 20 for which price fixation is applied. Dapagliflozin was patented by AstraZeneca and there are sixteen USA patents protecting this drug and one Paragraph IV challenge.

  • Actemra/RoActemra approved by the European Commission to treat patients with severe COVID-19

    Roche announced that the European Commission has extended the marketing authorisation for Actemra®/RoActemra® (tocilizumab) to include the treatment of COVID-19 in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. This decision comes just hours after the recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), reflecting the urgent need for Actemra/RoActemra as a potential treatment option during the COVID-19 public health emergency.

  • Preclinical Studies Demonstrate Sotrovimab Retains Activity Against the Full Combination of Mutations in the Spike Protein of the Omicron SARS-CoV-2 Variant

    GlaxoSmithKline plc and Vir Biotechnology, Inc announced an update to preclinical data on bioRxiv1, a preprint server, demonstrating that sotrovimab, an investigational monoclonal antibody, retains in vitro activity against the full known Omicron spike protein, the new SARS-CoV-2 variant (B.1.1.529). The preclinical data was generated through pseudo-virus testing of the combined known mutations of the Omicron variant, which included the maximum number of changes (37 mutations) identified to date in the spike protein.

  • Immune system-stimulating nanoparticle could lead to more powerful vaccines

    A common strategy to make vaccines more powerful is to deliver them along with an adjuvant — a compound that stimulates the immune system to produce a stronger response.

    Researchers from MIT, the La Jolla Institute for Immunology, and other institutions have now designed a new nanoparticle adjuvant that may be more potent than others now in use. Studies in mice showed that it significantly improved antibody production following vaccination against HIV, diphtheria, and influenza.

  • Calibre Scientific Acquires Benson Polymeric

    Calibre Scientific is pleased to announce the acquisition of Benson Polymeric, a manufacturer of polymer-based HPLC columns and resin. Benson Polymeric further enhances Calibre Scientific’s growing presence in the chromatography sector.

  • Morepen gets USFDA Approval for Fexofinadine (Allegra)

    Morepen Laboratories Limited has received USFDA approval for its anti-allergy drug Fexofinadine Hydrochloride that is market in India under the popular brand name Allegra, among others and is the block buster drug of the innovator company Sanofi Aventis, France. Fexofinadine is most widely used, second generation antihistamine drug for the treatment of allergy symptoms and hay fever.

  • Frequently asked questions on SARS-CoV-2 Variant OMICRON

    The Union Ministry of Health and Family Welfare has issued answers to Frequently Asked Questions (FAQs) on the new variant of COVID19, classified as Omicron (B.1.1.529) by the WHO on 26th November 2021.

  • LintonPharm Announces First Patient Dosed in Phase 1 Clinical Trial of Catumaxomab for Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin

    LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, today announced that the first patient has been dosed in the Company’s Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

  • Premas Biotech and Oravax Medical to Test Their Triple Antigen Oral Vaccine Candidate Against Omicron

    Premas Biotech announced that its joint venture Oravax will initiate testing of their oral virus-like particle (VLP) vaccine candidate against Omicron variant of SARS-CoV 2 virus through preclinical, in vitro and challenge studies to assess its efficacy for the new mutant strain. Premas Biotech, Oramed Pharmaceuticals, MyMD Pharmaceuticals, and certain other shareholders formed Oravax Medical to bring an oral COVID-19 vaccine to the market.

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