Market Access

International reliance mechanisms for approving drugs have an important place, but the UK regulator should increase focus on becoming a first approver of medicines, according to the British pharmaceutical industry.

Under the newly-announced UK-US trade deal, the UK will increase the thresholds used to evaluate the cost-effectiveness of new medicines, which should allow higher prices for innovative therapies.

Executives leading the commercialization of cell and gene therapies are informing how the industry approaches everything from manufacturing strategy to physician education.

The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.

Biological E joins the ranks of Pfizer, GSK and Serum with WHO prequalification for its pneumococcal vaccine. As WHO's purchase data for Serum’s PSV10 indicate significant opportunity, Scrip spoke to Biological E on supply readiness and its application for exemption from price control in India

Issues that had been concerns in Trump’s first term are realities now, but industry has also seen some successes. Trump’s personalistic style of governance means that larger firms may be at an advantage because of their greater flexibility to cut deals on individual products.

Zydus looks to fill up its coffers ahead of the next round of acquisitions, likely in the specialty drugs space, while US FDA approvals for generics to Lynparza and Vumerity and its first approvals in China and Canada point to a healthy pipeline.

The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.

Zydus looks to fill up its coffers ahead of the next round of acquisitions, likely in the specialty drugs space, while US FDA approvals for generics to Lynparza and Vumerity and its first approvals in China and Canada point to a healthy pipeline

Brazil’s medicines regulator, ANVISA, has hired new staff to help halve the time it takes to register a new medicine in Brazil.

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

Novo Nordisk’s deal with Emcure for semaglutide will launch Poviztra as a second obesity brand in India, improving access to weight loss treatments following a Lilly-Cipla deal for tirzepatide and seems a clever counter to Indian majors planning to launch generic semaglutide next year