We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Piling more criticism on the already-embattled Emergent Biosolutions, the FDA has issued a warning letter citing significant sterility issues at the company’s Camden facility in Baltimore, Md., and stating that Emergent’s management oversight and control over the manufacture of drugs is inadequate. Read More
Drug and biologics manufacturers submitting electronic individual case safety reports (ICSR) and ICSR attachments to the FDA Adverse Event Reporting System database should follow a new technical guide the agency released yesterday. 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
The bivalent vaccine also elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the Spikevax booster, Moderna said. 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
The FDA handed Illinois Tool Works’ drug manufacturing facility in Olathe, Kan., a six-observation Form 483 citing several repeated quality lapses following an inspection from March 28 to April 1. 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
Brainstorm Cell Therapeutics is counting on a corrected subanalysis of a phase 3 trial to change the FDA’s mind about NurOwn, an unusual investigational treatment for amyotrophic lateral sclerosis (ALS). Read More