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Speedy drug-review process 'broken'...
Speedy drug-review process 'broken' - The Boston Globe - Boston.com - Business
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Speedy drug-review process 'broken'
Markey seeks fines for firms that don't complete studies
By Diedtra Henderson, Globe Staff | June 1, 2005
WASHINGTON - Almost 13 years after the Food and Drug Administration made it easier for companies to speed life-saving medicines to patients, US Representative Edward J. Markey says the system of accelerated drug review is ''broken" and fails to protect patients. ADVERTISEMENT Markey, Democrat of Malden, said he came to that conclusion after reviewing documents he requested from the FDA and the Securities and Exchange Commission detailing whether drug companies conducted required clinical trials and reported that information to shareholders. Since 1992, companies pledged to complete 91 clinical trials in exchange for the FDA's speediest drug review. Some 42 of the promised studies remain unfinished, including... New drug targets brain tumors...
myDNA.com - News: New drug targets brain tumors
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New drug targets brain tumors
To learn more visit myDNA's Brain Tumors Center
Read More
Preliminary results from a Phase II clinical trial show patients with recurrent glioblastoma multiforme, a form of primary brain cancer, experienced a significant tumor response rate with minimal side effects when treated with enzastaurin, an oral, targeted agent under development at Eli Lilly and Company (LLY).(1)
Enzastaurin is the first targeted agent of Lilly Oncology to enter into late stage clinical developm... Lilly Targeted Agent Shows Promise in Treating Primary Brain ......
Lilly Targeted Agent Shows Promise in Treating Primary Brain Cancer
Lilly Targeted Agent Shows Promise in Treating Primary Brain Cancer
Investigational Oral, Targeted Agent Shrinks Tumor with
Minimal Side Effects in Glioblastoma
INDIANAPOLIS, May 17 /PRNewswire-FirstCall/ - Preliminary results from a
Phase II clinical trial show patients with recurrent glioblastoma multiforme,
a form of primary brain cancer, experienced a significant tumor response rate
with minimal side effects when treated with enzastaurin, an oral, targeted
agent under development at Eli Lilly and Company (LLY).(1) Enzastaurin is the
first targeted agent of Lilly Oncology to enter into late stage clinical
development heralding a new phase of innovation for the group, which has
produced Gemzar(R) (gemcitabine HCl) and Glioblastoma, a type of brain cancer, is part of the larger group of tumors that impact the central nervous system, known as gliomas. Patients with highly recurrent glioblastoma are usually at a more advanced stage of the disease and correspondingly may face altered brain function or death... 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 | 26 | 27 | 28 | 29 | 30 | 31 | 32 | 33 | 34 | 35 | 36 | 37 | 38 | 39 | 40 | 41 | 42 | 43 | 44 | 45 | 46 | 47 | 48 | 49 | 50 | 51 | 52 | 53 | 54 | 55 | 56 | 57 | 58 | 59 | 60 | 61 | 62 | 63 | 64 | 65 | 66 | 67 | 68 | 69 | 70 | 71 | 72 | 73 | 74 | 75 | 76 | 77 | 78 | 79 | 80 | 81 | 82 | 83 | 84 | 85 | 86 | 87 | 88 | 89 | 90 | 91 | 92 | 93 | 94 | 95 | 96 | 97 | 98 | 99 | All news |