Adam Zamecnik

Following the FDA's approval of A 150mg version of Accord' Herceptin biosimilar, the US agency has now greenlit a higher 400mg strength version of the rival.

In a closely anticipated US Senate Committee hearing, Novo's CEO was grilled by US senator Bernie Sanders and others on the high price of Ozempic and Wegovy in the country.

Iconovo's efforts in bringing its Breo Ellipta rival to the market continue, with positive news received from the FDA on the substitutability of the firm's ICOpre proprietary inhaler. The firm is now seeking a partner to take the product to the next stage.

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.

Years after the patent application's initial filing in 2007, the Indian Patent Office has dismissed ViiV's claims in response to multiple opposition filings launched against the pharma player.

Only a month after filing their second biosimilar application with Japanese regulators, Alvotech and Fuji have submitted a further one for an undisclosed biosimilar as part of their local partnership.

After sharing multiple updates to the regulatory status of its ketamine formulation, PharmaTher received a complete response letter from the FDA, which required minor information and clarifications from the company.

Only days after its initial announcement, Hypera Pharma has refused EMS' proposed merger on grounds of undervaluation and different strategic priorities.

Attended by several government delegates, the opening of the multi-million dollar antibiotic plant highlighted the Indian government's ongoing policy to bolster domestic pharmaceutical manufacturing.