After selecting the bio-health sector as one of three major industries to nurture, South Korea unveils new strategy to triple the industry’s global market share and improve regulations in line with global standards, with a focus on the pharma and medical device sectors. While industry supports the move, some uncertainties could slow the government’s efforts.

A draft resolution on the transparency of medicine prices and R&D costs is being discussed this week by World Health Organization members, but the pharmaceutical industry says some measures will be damaging for medicines access.

Conditions should be attached to the public funding of biomedical R&D in response to escalating prices of drugs developed with public money, a new report says.

US FDA's Qualified Infectious Disease Product program is growing slowly, but still growing.

Conditions should be attached to the public funding of biomedical R&D in response to escalating prices of drugs developed with public money, a new report says.

US FDA dashes hopes for accelerated approval of mirvetuximab soravtansine based on subgroup data, but will work with ImmunoGen to design a new trial focused on highly FRα-positive patients.

US FDA heard a predictably wide range of advice on the appropriate standards for approving biosimilar and interchangeable insulin during a public hearing on the topic. What is surprising is how few sponsors decided to speak out.

Pfizer VP blames rebate strategies of innovators for difficulty in getting biosimilars on formularies while Express Scripts official says it is all about net cost during House hearing on lowering Rx drug prices.

On eve of congressional hearing, the pharmacy benefit manager assures Amgen that Repatha is available to its employees.

The US FDA has issued question-and-answer guidance to help pharmacies better understand and comply with its final rule establishing its 503A bulks list. The guidance addresses how the agency developed the list of approved bulk drug substances and how to appeal decisions to get substances placed on the list.

Post hoc data from a long-term safety study of Samsung’s trastuzumab biosimilar and Genentech’s reference product suggest event-free survival rates differ based on a shift in one of Herceptin’s key quality attributes; Genentech said it proactively alerted health authorities when the shift was detected and the evidence does not indicate a clinical impact on patient outcomes.