Strategy

Alvotech is the latest to join several other competitors who have already submitted their denosumab biosimilar marketing authorization applications to the EMA.

Delegates from European institutions and industry representatives unpacked the many challenges of improved access to critical medicines on the continent in a session at this year’s European Health Forum.

Days after Gilead’s signing of voluntary licensing with six generic manufacturers for its HIV drug Sunleca, ViiV announced its commitment to ramping up Apretude’s supply to countries in need.

Predetermined change control plans have potential to accelerate US FDA review timelines for device modifications, but visibility remains low as to whether the program is behaving as advertised and delivering efficiencies sought by sponsors. Joshua Oyster, partner in Ropes & Gray’s Washington, D.C. office, offers perspective.

Teva has broken new ground by filing its first independent biosimilar to the US Food and Drug Administration, for a proposed biosimilar to Amgen’s Prolia treatment for osteoporosis in postmenopausal women. However, the Israeli firm made no mention of its proposed Xgeva biosimilar, which it states is in Phase III clinical trials.

Deal Snapshot: The Cambridge, UK-based company could be in line for payments just shy of $2bn if its partnership with the US giant comes up trumps.

Neuraxpharm is making further waves outside of Europe, launching operations in the Middle East just a year after entering Central and South America.

The FDA has placed zetomipzomib on clinical hold a year after Kezar decided to focus solely on the product.    

The Avillion-partnered treatment has succeeded in the BATURA trial, adding to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of disease severity.

In addition to its recently established Precision Health division, Bayer Consumer Health is using artificial intelligence to save time on routine tasks and to manage supply and demand, the firm’s head of digital transformation and IT, Cristina Nitulescu, tells HBW Insight.