Mecasermin, rhIGF-1 Neurology A recombinant orphan drug for treating ALS. See Amyotrophic lateral sclerosis.
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Cephalon, which in June sparked a rally in biotechnology stocks, now joins the ranks of biotechnology disappointments after surprising some investors who bet that its Myotrophin drug would sail smoothly through the FDA approval process, analysts said.
said that results of a nine-month clinical trial of 266 ALS patients showed the drug Myotrophin was the first treatment to slow progression of the disease.
chose UAMS Medical Center as one of eight hospitals to participate in a year-long, second-phase clinical trial of the drug Myotrophin in treatment of patients with amyotrophic lateral sclerosis (Lou Gehrig's disease).
18, 1996 amended complaint, like the claims in the earlier filed complaints, are based on alleged misrepresentations and omissions of material facts concerning Cephalon's North American and European clinical trials of Cephalon's drug, Myotrophin, in the treatment of amyotrophic lateral sclerosis.
The year-to-date and fourth quarter 1998 decreases resulted primarily from reduced expenditures associated with the MYOTROPHIN Injection program and a reduction in expenses required under certain of the company's sales and marketing agreements.
4 million related to the co-funding of development expenses and the purchase of certain rights for Myotrophin (insulin-like growth factor) with Cephalon, Inc.
Cephalon's president and chief executive officer, "now that Chiron Corporation has completed its installation of manufacturing facilities in California for potential commercial scale production of Myotrophin with a larger capacity than that available at Beltsville.
and Kyowa Hakko as a result of the decreased expenditures with the MYOTROPHIN Injection program.
Cephalon is developing PROVIGIL as a treatment for daytime sleepiness associated with narcolepsy and, in collaboration with Chiron Corporation (Nasdaq: CHIR), is developing MYOTROPHIN as a treatment for amyotrophic lateral sclerosis (ALS, or motor neurone disease).
NASDAQ:CHIR), announced today that findings from the second Phase III clinical study of Myotrophin(R) (rhIGF-1) reached statistical significance on the primary measure and confirmed previous findings that patients with amyotrophic lateral sclerosis (ALS) who received Myotrophin experienced less disease severity and slower progression of disease compared to patients who received placebo.
22 /PRNewswire/ -- Myotrophin, an experimental drug for Lou Gehrig's disease, appears to slow the disease's symptom progression.
Under the Prescription Drug User Fee Act, which establishes performance goals for FDA reviews of new product applications, the FDA's review of the MYOTROPHIN NDA was expected to be completed by November 11, 1997.