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…
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…
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…
Once again, Gilead Sciences is touting a Trodelvy (sacituzumab govitecan-hziy) win in patients with HR+/HER2- metastatic breast cancer. Source: Drug Industry Daily
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…
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). Source: Drug Industry Daily
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).…
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.…
After years of trying to pass legislation that would allow the U.S. government to negotiate with drugmakers on prescription drug prices for the Medicare program, the Democrat-controlled U.S. House of…
Bavarian Nordic is chiding the FDA after the agency recommended intradermal (ID) administration of Jynneos, the company’s monkeypox vaccine, in its Aug. 11 Emergency Use Authorization (EUA). Source: Drug Industry…