| |AUGUST 20248CARBOGEN AMCIS CONCLUDES FDA INSPECTIONS AT TWO MANUFACTURING SITESDREN BIO & NOVARTIS PARTNER TO DEVELOP NOVEL TARGETED MYELOID ENGAGERSCARBOGEN AMCIS, a top pharmaceutical process development and API manufacturing company in Switzerland, has passed FDA inspections at its Neuland and Aarau locations. The FDA performed standard inspections in Neuland for five days from June 17-21, 2024, and in Aarau for three days from June 24-26, 2024. The inspections ended without any Form 483 observations or important critical findings, confirming the identification of No Actions Indicated (NAIs)."The successful inspections at our Aarau and Neuland sites highlight CARBOGEN AMCIS's consistent track record of high-quality development and manufacturing. This achievement reinforces our commitment to delivering the superior quality our customers expect," said Pascal Villemagne, CEO of CARBOGEN AMCIS. "Our Quality Team collaborates closely with every CARBOGEN AMCIS facility to uphold a robust and reliable quality policy across the company.""I am delighted about these positive reports from the FDA," said Arpit Vyas, Global Managing Director of the Dishman Group. "This accomplishment reflects years of dedication and hard work by our team, maintaining the highest standards of quality and building on our extensive record of successful regulatory audits and inspections."ARBOGEN AMCIS is a part of the Dishman Carbogen Amcis Group. They offer services for drug development and commercialization to pharmaceutical and biopharmaceutical industries, throughout all phases of drug development. PODren Bio, Inc, a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune, and other serious diseases, announced that it has entered into a strategic collaboration with Novartis Pharma AG, a subsidiary of Novartis AG. The collaboration will focus on the discovery and development of therapeutic bispecific antibodies for cancer using Dren Bio's proprietary Targeted Myeloid Engager and Phagocytosis Platform.Our agreement with Dren Bio is a promising opportunity to discover novel bispecific antibody therapies for cancer, building on our longstanding expertise in immuno-oncology science at Novartis," said Shiva Malek, Ph.D., Global Head of Oncology for Biomedical Research at Novartis. "We're excited to collaborate to bring forward new therapeutic options for patients living with cancer, complementing our strategic efforts across a wide range of modalities, including targeted therapies, biologics, radioligand therapies and CAR-Ts.""We are thrilled to establish this new collaboration with Novartis, a global leader in oncology," said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. "Combining the proven capabilities of Novartis in oncology drug development with Dren Bio's novel platform could enable the advancement of important new therapies for patients."Amit Mehta, Ph.D., Chief Operating Officer and Chief Business Officer of Dren Bio, added, "Dren Bio's Targeted Myeloid Engager and Phagocytosis Platform is designed to deplete various disease-causing agents and has led to a rich and diverse pipeline. This collaboration will benefit from Novartis' impressive track record of developing novel medicines and help further expand the reach of our platform." POTOP STORIES | |AUGUST 20248
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