Teva’s market overhang and legal uncertainty intensifies with DOJ charges it conspired to fix generic drug prices. Five other companies have pled guilty and reached deferred prosecution agreements.

Annual large US employer health benefits survey also evaluates plans for managing the cost of cell and gene therapies in the coming years, anticipating growing use of outcomes-based contracts, but very limited uptake of payment-over-time models.

Expanding on difficult conversations during the recent BIO Digital meeting, the group aims to take actions that will increase diversity and inclusion in health care, science and industry.

New report shows average out-of-pocket cost per prescription of $10.67 in 2019 was unchanged from 2018. But while the number of dispensed drugs barely increased, sales jumped more than 5%.

The $2.1bn investment under the US’ Operation Warp Speed will fund development, scale-up of US manufacturing and the first 100 million doses. 

House committee seeks reassurances on a range of issues, including the security of a US vaccines supply chain against a background of rising tensions with China.

The public biotech’s first foray into the microbiome started well, but a clinical trial failure followed by a success has now left Seres with both regulatory and commercial issues.

Idhifa is approved in the US for relapsed or refractory AML patients with IDH2 mutations based on Phase I/II complete responses but did not meet the overall survival endpoint in the Phase III IDHENTIFY.

US FDA Commissioner Stephen Hahn cites 35% improvement in study, but critics are dismayed by fudging of science and political pressure.

BioMarin’s confidence that its first-ever hemophilia gene therapy would be cleared by the US FDA was shaken by a complete response letter that the company claims changed the requirements for approval.

Facing an appeal on a favorable US district court decision, Mylan has opted to launch the first generic Tecfidera in the US “at risk,” after obtaining FDA approval and seeing Biogen’s bid for injunctive relief shot down earlier this month.

Complete Response Letter is a major setback for Gilead and its partner Galapagos.