In response to recent closures affecting 36% of inspected drug manufacturing units nationwide due to non-compliance with Revised Schedule M standards, the Pondicherry Drug Manufacturers Association (PDMA) is set to host a seminar aimed at educating industry stakeholders on the updated Good Manufacturing Practices (GMP). Scheduled for July 13 in the union territory, the seminar … Read more
Budget 2024-25: Pharma, Healthcare Leaders Call for Strategic Investments and Policy Reforms As India gears up for the Union Budget 2024-25, leaders from the pharmaceutical and healthcare sectors are advocating for strategic investments, policy reforms, and incentives to bolster innovation and accessibility in healthcare. The Indian Pharmaceutical Alliance (IP Alliance), Metropolis Healthcare, Alyve Health, and … Read more
Indian pharmaceutical companies regularly leverage events like the Indian Pharmaceutical Congress (IPC) to showcase their latest advancements in drug development, technology integration, and adherence to global quality standards. Industry leaders emphasize that IPC serves as a crucial platform for demonstrating India’s capabilities in innovation and its significant contributions to global healthcare through affordable medicines and … Read more
Medigene AG, a company specializing in immuno-oncology, has received a patent from the Chinese Patent Office for its T cell receptor (TCR) targeting NY-ESO-1 and LAGE 1a. These antigens are known to be associated with various types of solid tumors and have been extensively studied and validated. The patent protects Medigene’s innovative approach to developing … Read more
GSK and CureVac Restructure Partnership for mRNA Vaccine Development GSK plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq: CVAC) have announced a major restructure of their collaboration, shifting to a new licensing agreement aimed at optimizing investment and focusing on mRNA vaccine development. Since 2020, GSK and CureVac have collaborated on mRNA vaccines targeting infectious diseases. … Read more
Study Urges Enhanced Academia-Industry Collaboration at NIPERs to Foster Self-Reliance A recent study conducted by the Entrepreneurship Development Institute of India, commissioned by the Department of Pharmaceuticals, underscores the critical need for National Institutes of Pharmaceutical Education and Research (NIPERs) to bolster multidisciplinary research efforts. According to the study, titled “Bridging academia-industry gap to achieve … Read more
Sobi Begins FDA Submission Process for SEL-212, Advancing Potential Treatment for Chronic Refractory Gout Sobi has commenced a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for SEL-212, based on positive outcomes from the DISSOLVE I and II pivotal trials. SEL-212 represents an innovative biologic therapy aimed at addressing chronic … Read more
Centralized Guidelines for Export No Objection Certificates (NOCs): A Paradigm Shift in Drug Manufacturing Regulations In a significant regulatory overhaul, the Central Drugs Standard Control Organisation (CDSCO) of India has introduced comprehensive guidelines for obtaining export No Objection Certificates (NOCs) for the manufacture of unapproved, banned, or new drugs solely intended for export. This move … Read more
Telangana Emerges as a Prime Destination for Pharma Investment, Attracting Leading Companies Telangana’s strategic initiatives in fostering innovation, manufacturing excellence, and sustainable development have positioned it as a pivotal hub in the Indian pharmaceutical sector. The state’s proactive measures have drawn substantial investments from companies based in Karnataka and beyond, including major players like Biocon, … Read more
The Indian Pharmacopoeia Commission – Materiovigilance Programme of India (IPC-MvPI) has been provisionally approved by the Quality Council of India (QCI) to operate as a certification body for the ICMED 9000 and ICMED 13485 certification schemes, marking a significant milestone in the realm of medical device quality assurance in India. The ICMED 9000 certification integrates … Read more
