An FDA warning letter cites deficiencies at the Pfizer-owned manufacturing facility poised to produce a Momenta/Sandoz generic competitor. It’s unclear how long Pfizer might take to resolve the violations, which include particulates in finished products.
Teva Pharmaceutical Industries Ltd. has gotten some breathing room with news that the launch of a generic rival to the important 40mg version of its blockbuster multiple sclerosis drug Copaxone (glatiramer) has been delayed due to a manufacturing issue.
An FDA warning letter, made publicly available Feb. 28, cites several manufacturing violations at the Pfizer Inc.-owned facility in...
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.
