The US FDA’s observations at its radiopharma manufacturing facility in Canada could be a headwind for Jubilant Pharmova, but reorientation of US generics manufacturing is expected to boost profits. Scrip takes a look at the likely impact.
The US Food and Drug Administration (FDA) has had a significant influence on the direction Indian pharma companies’ revenues could head in a financial year given the dependence of these companies on North America and the role played by the agency as the geography’s gatekeeper.
For instance, Lupin Limited went through an extended winter phase when one or the other of its manufacturing units...
Merck’s immuno-oncology blockbuster was the world’s best-selling drugs by revenues for the second year in a row, with an almost $12bn lead over its closest rival, Novo Nordisk’s GLP-1 drug Ozempic.
The company will ramp up manufacturing of its Jynneos vaccine to meet demand in worst-affected African countries and stockpiling richer nations.
Serum Institute is working on an mpox vaccine while other Indian firms are weighing options after the WHO sounded an alert and a new case was reported in neighboring Pakistan. Scrip looks at factors that could favor development and/or manufacture of an mpox vaccine at Indian majors.
Linvoseltamab has missed out on an August US approval, but Regeneron remains confident it will emerge as the best-in-class BCMAxCD3 bispecific therapy.
Companies stand a better chance of securing public reimbursement in Mexico for innovative medicines if they understand changing approaches to healthcare. The shift means the emergence of managed entry agreements and a focus on economic impact, explains AMIIF, Mexico's research-based pharmaceutical industry association.
Novartis’s APMA chief outlines the company’s tailored approach to deliver long-term outcomes, novel access solutions via innovative financing options and shape the CVD disease ecosystem in the extraordinarily diverse region. Partnering to build AI infrastructure is another key prong.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to bring about a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the key players that have been part of pricing discussions.
