Biotechnology BioNtech reports Car-T/mRNA booster study results at ESMO BioNtech SE has reported preliminary Phase I/II results with BNT211-01 (NEO-PTC-01) and CarVAC at ESMO conference in Madrid Testing different dose levels of its adoptive cell therapy BNT.221-01, a combination of Claudin 6 (CLDN6)-targeted Car-T cells (derived from NEO-PTC-01, initially developed by tody’s BioNTech subsidiary Neon Therapeutics) and the mRNA-based Car-T booster CarVac (CAR-T cell […] Written by BIOCOM AG October 27, 2023October 27, 2023 Saving Bookmark this article Bookmarked
Biotechnology Antiverse and GlobalBio Inc. extend collaboration Antiverse Ltd and GlobalBio Inc. have extend their cancer antibody partnership to progress two PD-1 modulators to preclinial development AI specialist Antiverse Ltd (Cardiff, UK) and antobody engeeniering expert GlobalBio, Inc. (New York, USA) will be extending their collaboration to advance immune checkpoint inhibitors in cancer therapy. The initial collaboration successfully resulted in the generation […] Written by BIOCOM AG October 21, 2023October 21, 2023 Saving Bookmark this article Bookmarked
Biotechnology SpliceBio has made up a US $216m alliance with Spark Therapeutics SpliceBio has licenced its intein technlogy to Roche’s gene therapy subsidiary Spark Therapeutics to develop a gene therapy targeting an undisclosed inherited retinal disease. Under a globally exclusive licence option agreement with Roche AG, SpliceBio secures an upfront payment, opt-in and milestone payments up to $216m plus royalties in exchange to its recombinant split […] Written by BIOCOM AG October 18, 2023October 18, 2023 Saving Bookmark this article Bookmarked
KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–Sep. 3, 2024– KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat… Written by Admin September 17, 2024September 17, 2024 Saving Bookmark this article Bookmarked
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KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–Sep. 3, 2024– KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat… Written by Admin September 17, 2024September 17, 2024 Saving Bookmark this article Bookmarked
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Austria wants to be at the top of the podium in research and development In 2023, the share of R&D expenditure in Austria’s nominal gross domestic product (GDP) was 3.26%. This put Austria in third place in the EU after Belgium and Sweden. In 2024, the ratio will be 3.34% according to the estimate global by Statistics Austria, corresponding to a record sum of 16.64 billion euros. The Federal […] Written by Arno Fricke September 17, 2024September 17, 2024 Saving Bookmark this article Bookmarked
Understanding PMDA Validation Rules v5.0 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has always led the charge in ensuring the safety and efficacy of drug development. Their latest update, the PMDA Validation Rules version 5.0, which took effect on April 1, 2024, marks another significant step in this mission. Let’s break down what these new rules mean and […] Written by Admin July 10, 2024July 10, 2024 Saving Bookmark this article Bookmarked
Enhance Your SEND Submissions! Join PointCross on May 29th, 2024, at 12 PM EST / 9 AM PST for a must-attend webinar: The Most Common Issues in Preparing SEND. Ideal for professionals in data submission and regulatory compliance, this webinar offers valuable insights from our seasoned experts. Why Attend? Why PointCross? With over 10 years of experience and more […] Written by Admin May 23, 2024May 23, 2024 Saving Bookmark this article Bookmarked