So far better than so good on swine flu – H1N1 – clinical trials
This is my site Written by Alex on September 15, 2009 – 9:06 am   

Update: The FDA has approved the vaccine for human use. More on this tomorrow…

Published results of clinical trials so far indicate one dose of the swine flu vaccine being tested could be enough to inoculate the more than 159 million people in the U.S. who are expected to be at risk to contract the flu this season. That’s good news but – and this is big – these trials are being hurried along. The process as much as the vaccine is a test and the results could be surprising in unanticipated ways. I am loathe to be a downer about this (although I appear to one of the only ones who is not doing backflips over the apparent success so far of all efforts in HINI clinical trials) because the effort to test the vaccine is impressive, appropriate, and in the best interest of the public health. But, as always, stay tuned for all shoes to hit the ground.

In other news, the American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries, a topic close to my heart since my trip to Uganda to see the unfortunate exploitation of people there … and Vivus, a drug developer, said Wednesday that its weight-loss drug produced strong results in two late-stage clinical trials, a new medication to deliver oxygen to damaged tissue is moving ahead in trials, and a new drug for gonorrhea is also doing well in tests – all good news!

One Vaccine Shot Seen as Protective for Swine Flu – New York Times – by Donald G. McNeil Jr. – Defying the expectations of experts, clinical trials are showing that the new H1N1 swine flu vaccine protects with only one dose … See all stories on this topic

American Medical News examines clinical trials outsourcing – News-Medical.net – American Medical News examines the ethical considerations of outsourcing pharmaceutical clinical trials to developing countries. The article highlights how … See all stories on this topic

Vivus, Racing Rivals, Says Diet Drug Did Well in Trials – New York Times – by Andrew Pollack – Vivus, a drug developer, said Wednesday that its weight-loss drug produced strong results in two late-stage clinical trials … See all stories on this topic

Hospital, TGen trials hold promise for patients – AZ Central.com – Scottsdale Healthcare’s flagship program involves cancer clinical trials held at the TGen Clinical Research Services at Scottsdale Healthcare located inside … See all stories on this topic

Dynavax trials hepatitis B vaccine – Pharmacy Europe – Data from PHAST clinical trials reportedly show a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six … See all stories on this topic

Oramed Pharmaceuticals Commences Human Clinical Trials of an Oral … Reuters – “The move from preclinical trials to human clinical trials of ORMD-0901 marks a strategic milestone for the company. We have expanded our platform … See all stories on this topic

Oxygen Biotherapeutics earns $6M investment from Vatea Fund – Bizjournals.com – the company won clearance from regulators to begin clinical trials in Switzerland on Oxycyte, a compound that enhances the delivery of oxygen to damaged … See all stories on this topic

DOR BioPharma Announces NIH Grant Award to Support Phase 1/2 … Reuters … manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not exceed … See all stories on this topic

Calvin B. Harley to Retire as Chief Scientific Officer of Geron – Reuters – The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials in different cancers. … See all stories on this topic

Rib-X to move gonorrhoeae drug to clinical trials – Mass High Tech – by Mass High Tech staff Rib-X Pharmaceuticals Inc. will be bringing its drug treatment for gonorrhoeae to clinical trials, through an agreement with the US … See all stories on this topic

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