- Ulcerative Colitis news are updated once a hour
- We deliver news from more than 500 sources on ulcerative colitis
NewsAdvertisers: |
Rigel Gets Milestone Payment from Merck and CytoDyn Annual Meeting ...... CytoDyn, Inc. (OTCBB:CYDY) has firmed up the date for its Annual Meeting to be held at 11:00 AM Pacific Time on January 31, 2006 in Studio City (Los Angeles), California. Shareholders attending will hear a scientific presentation on the status of the development track for CytolinŽ, the first targeted immune therapy for treating HIV/AIDS that was shown to significantly decrease viral burden in preliminary clinical studies that completed the Phase 1(a) and Phase 1(b)/Phase 2(a) stages of development. The differences between this new approach to treating HIV/AIDS and the current drugs will be explained. Attendees will also be updated on the Company's progress in executing its business plan and will have the opportunity to talk to management. The CEO's Annual Report may be downloaded from the Company's web site at www.cytodyn.com. Drug development firm AtheroGenics Inc. on Monday said it will receive a $50 million payment from AstraZeneca PLC (NYSE:AZN) after regulators cleared a licensing deal between the companies. AtheroGenics and AstraZeneca have partnered for the worldwide development and co... FDA Grants Fast Track Designation To Oral HCV Protease Inhibitor ......
FDA Grants Fast Track Designation To Oral HCV Protease Inhibitor SCH 503034, Schering-Plough Reports
home
xml feeds
news alerts
weekly newsletter
advertise
accessibility
contact
PositiveSingles.com - the largest STD-single dating site! Archive Search Medical Abbreviations www.medilexicon.com FDA Grants Fast Track Designation To Oral HCV Protease Inhibitor SCH 503034, Schering-Plough ReportsCategory: Liver Disease/Hepatitis News Article Date: 30 Jan 2006 - 20:00pm (UK) Schering-Plough today reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational oral hepatitis C protease inhibitor (SCH 503034), currently in Phase II clinical development for the treatment of chronic hepatitis C virus (HCV) infection. The FDA granted Fast Track designation for the following reasons: The proposed first indication for SCH 503034 is for treatment of HCV in patients with HCV genotype 1 virus who have not responded to combination therapy with pegylated interferon and ribavirin, the current standard of care, thus representing an unmet medical need. SCH 503034 is an orally active inhibitor of the hepatitis C virus serine protease that inhibits HCV replication. This mechanism is distinct from those of current therapies, thus SCH 503034 represents a novel class of HCV inhibitor. Fast Track designation allows FDA to expedite review of drugs and biologics for serious or life-threatening conditions and which demonstrate the potential to add... CHMP Recommends Approval Of Remicade(R) For Treatment Of ......
"The CHMP's positive opinion represents a milestone in the treatment of "In the pivotal clinical studies, patients receiving REMICADE achieved high rates of clinical response and clinical remission as well as mucosal healing and reduced rates of hospitalization. These are excellent results for this patient population that had failed available therapeutic options."
The CHMP recommendation is an important step towards a European Commission approval. A Commission approval of the application will result in Marketing Authorization with unified labeling that will be valid in all EU-member states, including the current 25 member states as well as Iceland and Norway.
The positive opinion for REMICADE for UC is based on data from the ACT 1 and ACT 2 clinical trials. ACT 1 and ACT 2 were multicenter, Phase 3, randomized, double-blind, placebo-controlled, clinical trials conducted to evaluate t... 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 |
| Health and Fitness | Health Living |