The company said its experimental drug capivasertib was able to help patients with an advanced form of breast cancer live longer, when combined with the drugmaker’s older cancer treatment Faslodex regardless of biomarker status.

Mirum Pharmaceuticals announced that Livmarli oral solution met its primary endpoint in the Phase III MARCH study in young patients with progressive familial intrahepatic cholestasis.

The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while simultaneously examining several endpoints.

Bristol Myers Squibb announced Thursday that its blockbuster checkpoint inhibitor Opdivo hit the primary endpoint in the Phase III CheckMate-76K trial for a particularly intractable form of melanoma. 

The number of clinical trials started in Britain each year dropped by 41% between 2017 and 2021, posing a “clear and serious threat” to its reputation as a clinical research destination, an industry report said on Thursday.

A Phase II trial studying PTC Therapeutics’ PTC518 in Huntington’s disease (HD) has been paused in the United States following a request from the FDA for additional data, the company announced Tuesday afternoon.

We cannot underestimate the negative impact – not only on individual lives but also on wider society – of participant populations not being proportionately represented in clinical trials.

Merck & Co. Inc. opted to jointly develop and potentially sell a personalized mRNA vaccine with Moderna Inc. for a $250 million upfront payment on Wednesday, sending the vaccine maker’s shares up over 8%.

Novavax Inc. said on Wednesday data from studies in adults and adolescents showed that the booster dose of its COVID vaccine produced robust antibodies against several Omicron variants, including BA.1, BA.2 and BA.5.

Data from an ongoing Phase III trial showed Sanofi/Regeneron’s Dupixent (dupilumab) can induce histological disease remission in young eosinophilic esophagitis (EoE) patients ages 1–11 years, the companies announced Tuesday.