Phase III
AstraZeneca and MedImmune announced top-line results from its TULIP 1 Phase III clinical trial of anifrolumab in adults with moderate-to-severe systemic lupus erythematosus (SLE). Unfortunately, the drug didn’t meet the trials primary endpoint of statistically-significant reduction in disease activity.
The biotech industry is fast-moving and dynamic, and staying on top of all the news can be hard for our busy readers. Here’s a look back at some of the top stories you may have missed this month.
Three of Vivek Ramaswamy’s companies reported activity today including corporate changes, a licensed therapy and investment of $100 million.
A betting man may have placed a pretty strong wager on the U.S. Food and Drug Administration’s approval of Akcea Therapeutics’ Waylivra (volanesorsen), a treatment for the rare lipid disorder familial chylomicronemia syndrome (FCS).
Shares of AbbVie are inching up this morning after the company announced it had secured regulatory approval for Imbruvica as a treatment for patients with a rare blood disease.
Ann Arbor, Mich.-based Esperion Therapeutics is starting off the week with several positives. The company first reported final results from a long-term safety study of bempedoic acid 180 mg versus placebo in high-risk patients with atherosclerotic cardiovascular disease (ASCVD) whose disease is inadequately controlled by statins.
Transthyretin Cardiomyopathy is a rare heart disease that can lead to heart failure. This weekend Pfizer presented data that shows its Phase III tafamidis therapy reduced the risk of death in patients with a distinct form of the disease by 30 percent, giving the drug the chance to become the first approved medication for these patients.
Janssen Pharmaceutical and Bayer saw the good, the bad and the potential for ugly this week with their blockbuster blood-thinner Xarelto (rivaroxaban). The drug gained approval for a new indication in Europe, failed a late-stage trial and is staring down the barrel of patent loss in 2023 while battling legal threats.
Shares of Innovate Biopharmaceuticals are up more than 7 percent in premarket trading after the company announced it signed an agreement with privately-held Amarex Clinical Research to provide data management and biostatistics for its planned Phase III celiac disease trial.
Pfizer and Astellas Pharma announced they have amended the protocols for two Phase III clinical trials, ARCHES and EMBARK, to evaluate Xtandi (enzalutamide) in hormone-sensitive prostate cancer (HSPC). Both trials will wrap sooner than planned as a result.
PRESS RELEASES