Urtė Fultinavičiūtė

Altus' breakable extended-release tablet technology will be Spektus' holy grail in developing novel and differentiated therapies in the psychiatry space.

Decentralized Trials & Research Alliance (DTRA) launched its first initiative to combat the lack of mutual understanding in the decentralised clinical trial (DCT) community.

In a joint proposal with its partners, the Medicines Patent Pool explores challenges in monoclonal antibody equity in low- and middle-income countries and provides actionable solutions to increase development and manufacturing.

An FTC report has shown evidence of “troubling rebating practices” between pharma companies and PBMs, lowering access to generics and biosimilars. While off-patent groups commended the agency, the PBM association said the report falls short of being definitive or fact-based.

AI could help biosimilar developers with the development and manufacture of their products, but dependence on high-quality training datasets poses potential challenges.

Three off-patent associations from both sides of the Atlantic want to strengthen their collaborative synergies, securing the supply of generics and biosimilars.

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

Endo continues to stride its financial revival path, with the latest plans to list common stock on the NYSE. Also, the firm has just launched a generic tiopronin rival to Travere Therapeutics' Thiola.

The UK's MHRA has approved the first generic raltegravir to treat HIV in adults and certain pediatric patients and deemed the drug interchangeable with the originator Isentress.

Marketed as Bhava, Zydus' bevacizumab rival to Roche's Avastin begins the firm's biosimilar journey in the Latin American country.