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AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin) cut the risk of cardiovascular death and worsening heart failure by 16.4 percent relative to placebo, researchers announced at the European Society of Cardiology Congress in Barcelona. Read More
Combined with talk therapy, two strong doses of psilocybin – the active chemical of “magic mushrooms” – reduced heavy drinking by 83 percent, significantly more than when subjects just had therapy alone, according to researchers at NYU Langone University. Read More
CSL has posted positive phase 3 topline results for garadacimab, a drug designed to prevent potentially dangerous attacks of swelling related to a rare genetic disorder called hereditary angioedema. Read More
It’s not just academia- and industry-funded trials that are lacking in transparency; a recent audit by the Office of Inspector General (OIG) has found that the National Institutes of Health (NIH) failed to ensure that the results of the trials it funded were posted on ClinicalTrials.gov in line with federal reporting requirements. Read More
Despite getting a renewed green light from the FDA, Homology Medicines is putting the brakes on its phase 2 trial of a gene therapy for phenylketonuria (PKU) and shifting resources to a potentially more profitable path. Read More
Blueprint Medicines has enough pivotal data in hand to seek a new indication for Ayvakit (avapritinib) as a treatment for nonadvanced systemic mastocytosis and plans to file a supplemental new drug application later this year. Read More
With the announcement of a failed phase 3 breast cancer trial hot on the heels of a negative phase 2, Sanofi has decided to pull the plug on amcenestrant, an investigational oral selective estrogen receptor degrader (SERD). Read More
Merck and Orna Therapeutics announced that they are joining in a new partnership to advance development of the Cambridge, Mass., startup company’s RNA and lipid nanoparticle delivery platform to treat cancer, genetic disorders and infectious diseases. Read More
Novartis has a third strike-out in a series of trials pitting its anti-inflammatory drug Ilaris (canakinumab) against nonmetastatic non-small cell lung cancer (NSCLC). Read More
Partners Daiichi Sankyo and AstraZeneca said a phase 3 trial of Enhertu (trastuzumab deruxtecan) to treat HER2-positive metastatic breast cancer met its primary and secondary endpoints, with the expected blockbuster drug showing a significant improvement in progression-free survival and overall survival. Read More