Following a priority review, Shingrix may become the next hit vaccine in China as millions seek preventative care, but GSK is being cautious over supply plans.

Biopharma manufacturers might not like the cost offsets that would cover the out-of-pocket maximum for patients in Medicare's drug program; committees seek comment on range of issues.

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.

Only one of 232 brand-generic patent suit settlements in the US during FY 2016 contained a side deal or commitment not to market an authorized generic.

Pharmaceutical companies must heed growing international calls to be more transparent on how R&D is funded, say NGOs.

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 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.

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.