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news.Accentia files preliminary IND for MS drug
The company has requested a meeting with the FDA within the next 60 days to discuss a proposed pivotal Phase III clinical trial involving approximately 270 patients with
The company has requested a meeting with the FDA within the next 60 days to discuss a proposed pivotal Phase III clinical trial involving approximately 270 patients with
Trastuzumab-DM1 comprises ImmunoGen’s cell-killing agent, DM1, linked to Genentech’s HER2-targeting antibody, Herceptin (trastuzumab), and is in development by Genentech for the potential treatment of HER2-expressing metastatic breast cancer.
The drug, LX6171 was well-tolerated at all dose levels and showed excellent systemic exposure, Lexicon said. Over the seven day trial, no dose-limiting toxicities were observed and exposure
Under the terms of the agreement, Crucell will receive an upfront payment, milestone payments, annual maintenance fees, and royalties on net product sales. Other financial details were not
In April 2005, the companies signed an agreement which provided Quark with access to Silence Therapeutics’ novel proprietary siRNA technology, AtuRNAi. The agreement led to a compound, RTP801i,
The company’s shares increased 5.2% in extended-hours trading as a result. Despite data indicating that the drug may increase the risk of heart attacks in some patients, the
Compared to the standard juvenile cells, adult Sertoli cells have enhanced protective properties that are particularly effective at protecting co-transplanted cells from being destroyed by the body’s immune
The Phase II study is an out-patient, dose-ranging clinical trial that will evaluate two dose levels of the single-dose, oral Ty800 vaccine and will follow each subject for
The lawsuit was filed by Ohio-based nonprofit organization Care to Live on July 30. The FDA made its decision not to approve the vaccine in May this year
The company based its decision on the vote by the oncologic drugs advisory committee (ODAC) to the FDA on July 24, 2007 that the FDA should wait for