Brand drug companies might be able to use patent settlements with generic and biosimilar makers to get out of the drug price negotiations that will be created under the US legislation nearing enactment, but sponsors could run into regulatory and antitrust obstacles.

Experts shared views at a recent conference in Seoul on how the Korean biopharma industry has evolved and what needs to be done to move forward in the next 10 years. Policy efficiency and family ownership in the sector came in for particular scrutiny, with some calling for sweeping changes. 

Investors and pharma stakeholders scramble to extend the time period before small molecule drugs are subject to government mandated discounts as Senate drug pricing legislation moves toward a floor vote.

Where once there were promising prospects for cross-strait collaboration, biopharma firms in mainland China and Taiwan may now find themselves looking elsewhere for partners following a controversial visit to Taipei by US House Speaker Nancy Pelosi.

US drug pricing legislation that has picked up momentum could stymie R&D investment and curb the revenue tail for some big drugs, industry says, but CEOs also expect they can navigate the challenge. 

While a two-hour-plus online discussion between the leaders of the world's two largest economies had some encouraging signs for the biopharma sector, more remains to be done and multiple other factors are playing into a mix of decoupling pressures.

Kenny, a mainstay of our publications for three decades, has passed away in London.

Sarepta has experience pursuing accelerated approvals in the US for Duchenne muscular dystrophy therapies, but with a costly gene therapy will payers require data from a controlled Phase III study?

The major has won US priority review for a commercially crucial label expansion of its breast cancer drug Enhertu while Tezspire and Ultomiris attracted positive CHMP opinions across the Atlantic.

Rather than terminating a deal for the French biotech's VLA2001 vaccine, the European Commission has put in a tiny order of 1.25 million doses which could bring the curtain down on Valneva's COVID-19 programs.

A protein-based vaccine for COVID-19 reaches the US at last, but Novavax looks set miss out once again as the fall deadline for BA.4/5 variant-targeting vaccines approaches.

Latest iteration of drug pricing legislation from Senate Democrats would also firm up the number of drugs HHS must choose for price negotiation each year and no longer treats insulin as a separate class for purposes of negotiation.