The Pharmacy Council of India (PCI) has officially notified an amendment to the Master of Pharmacy (M.Pharm) Course Regulations, introducing Medical Devices as a new postgraduate specialisation across Indian universities starting from the 2027–28 academic year. Delivered in English under the Credit-Based Semester System (CBSS), the four-semester, two-year programme is designed to equip pharmacy graduates with specialized technical, manufacturing, and regulatory expertise to meet the rapidly expanding demands of the medtech sector.

​The curriculum provides structured training across academic theory, practical laboratory work, and advanced research. The first semester covers core fundamentals, including medical device technology, regulatory affairs, manufacturing processes, biocompatibility, and toxicology, accompanied by practical laboratory sessions. The second semester broadens into emerging innovations, quality control, risk assessment, safety management, clinical evaluation, market access, intellectual property rights (IPR), and entrepreneurship, alongside seminars and advanced lab work. The final two semesters focus entirely on research methodology, biostatistics, journal clubs, and intensive dissertation projects.

​To ensure high standards of practical training, the regulations permit students to conduct research either at approved on-campus facilities or through formal Memorandums of Understanding (MoUs) with recognized external partners. These eligible partner institutions include CDSCO-approved manufacturers, nationally recognized device testing laboratories, Institutes of National Importance, Indian Pharmacopoeia Commission materiovigilance centres, accredited Clinical Research Organisations (CROs), and specialized R&D facilities. This strategic regulatory addition establishes a vital academic bridge between traditional pharmacy training and the modern medical device industry.

Written by: Pragna Biswas

Graphics by: Pramit Hazra

Ipsen  has officially completed its acquisition of KartosTherapeutics, a clinical-stage biopharmaceutical company. The transaction integrates navtemadlin, an investigational, first-in-class oral MDM2 inhibitor in Phase 3 clinical development, directly into Ipsen’s expanding oncology and hematologypipeline.

​Navtemadlin is currently being evaluated in the global Phase 3 POIESIS study as an add-on therapy to ruxolitinib in patients with intermediate- and high-risk TP53 wild-type myelofibrosiswho experience a suboptimal response to standard-of-care ruxolitinib alone. Designed to restore natural p53 tumor-suppressor activity, early clinical data suggest that navtemadlinhas the potential to convert suboptimal treatment responses into clinically meaningful and disease-modifying outcomes.

​Myelofibrosis is a rare and severe myeloproliferative neoplasm characterized by progressive bone marrow failure, debilitating symptoms, splenomegaly, and a heightened risk of progression to acute myeloid leukemia (AML). While ruxolitinib serves as the standard first-line treatment, an estimated 50% to 75% of patients discontinue therapy within three years, resulting in a median overall survival of only one to two years following discontinuation. Navtemadlin aims to directly address this substantial therapeutic gap.

​Under the terms of the merger agreement, Ipsen completed the upfront payment of $450 million, with Kartos shareholders eligible for up to $1.3 billion in additional regulatory and sales-based milestones. The transaction is projected to become accretive to Ipsen’s core operating income starting in 2029.

​The completed acquisition positions Ipsen to establish a dedicated franchise in hematologic malignancies while advancing transformative therapies for patients with high unmet medical needs.

Written by: Pragna Biswas

Graphics by; Pramit Hazra