OMEN Pharma 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
Quest Diagnostics, a prominent provider of diagnostic information services, has entered into a definitive agreement with OMERS to acquire LifeLabs, a leading provider of community laboratory tests serving millions of Canadians. The transaction, valued at approximately CAN $1.35 billion (approximately USD $985 million) including net debt, marks a significant move aimed at enhancing healthcare accessibility … Read more
Hutchmed (China) Limited has announced a significant development in the regulatory pathway of tazemetostat for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) in China. The company disclosed that the New Drug Application (NDA) for tazemetostat has been accepted for review by the China National Medical Products Administration (NMPA), which has … Read more
Johnson & Johnson Reports Significant Survival Benefit in Phase 3 Study of Carvykti for Multiple Myeloma Johnson & Johnson has announced promising findings from the phase 3 CARTITUDE-4 trial, showing that Carvykti (ciltacabtagene autoleucel; cilta-cel) provides a statistically significant improvement in overall survival compared to standard therapies for patients with relapsed or lenalidomide-refractory multiple myeloma … Read more
Boehringer Ingelheim and Gubra Launch Phase 1 Study of BI 3034701, a Promising Triple Agonist Peptide for Obesity Treatment Boehringer Ingelheim, a renowned biopharmaceutical firm committed to research, and Gubra have initiated a phase 1 clinical trial (NCT06352437) for BI 3034701, a novel long-acting triple agonist peptide aimed at revolutionizing obesity treatment. Obesity affects over … Read more
AstraZeneca’s application for sipavibart has been accepted by the European Medicines Agency (EMA) through an accelerated assessment procedure. This application is specifically for using sipavibart as a preventive treatment (pre-exposure prophylaxis) against Covid-19 in immunocompromised patients. Sipavibart is an experimental long-acting antibody designed to protect immunocompromised patients from Covid-19. These patients often do not respond … Read more
WHO Issues Landmark Guideline to Boost Global Tobacco Cessation Efforts The World Health Organization (WHO) has released its inaugural guideline on tobacco cessation, urging comprehensive strategies that include behavioral support by healthcare professionals, digital interventions, and pharmacological treatments. Addressing the needs of over 750 million tobacco users worldwide who desire to quit various forms of … Read more
