ConTIPI’s expanded agreement with Indegene includes several services across the commercialization process, including sales, PRMA (pricing, reimbursement and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing and commercial operations support.
FDA advisers raised concerns regarding the efficacy and risk-benefit profile of Genentech’s Polivy as a first-line treatment for large B-cell lymphoma ahead of a March 9 advisory committee meeting.
BioSpace sat down with Katy Powell, a psychiatric mental health nurse practitioner in Portland, Oregon, to discuss the relative risks and benefits associated with psychedelic-assisted therapy.
Managing regulatory information in the pharmaceutical industry is challenging in post-pandemic Europe. The introduction of new requirements surrounding substances, products, organizations, and referential (SPOR) data and a new shared target operating model (TOM) across Industry and regulators are forcing companies to rethink their approach to managing regulatory information and submissions. This is driving new data management initiatives to align existing regulatory data with master data systems, streamline data submissions, and improve data maintenance capabilities, according to Jens-Olaf Vanggaard, senior director, Global Safety, Regulatory & Quality Solutions, IQVIA.
“Our goal is as early as August given we’re going to file all the data in June, by the end of June… hopefully in the August timeframe, the vaccine is authorised,” said Chief Executive Stephane Bancel.