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Kidney improvement sustained by Abbott drug-study

NEW YORK, June 24 (Reuters) – Diabetics with moderate to severe chronic kidney disease showed significant and sustained improvement in kidney function through 52 weeks of treatment with a novel drug being developed by Abbott Laboratories (ABT.N), according to data from a midstage clinical trial. The oral drug, bardoxolone methyl, is the first medicine to demonstrate improvement in kidney function in patients with the...

Pfizer’s Remoxy Fails to Win FDA Approval

WASHINGTON — The latest attempt at an abuse-resistant formulation of oxycodone (Remoxy) failed to win approval from the FDA, according to a statement from Pfizer. Late Thursday, the company said it had received a complete response letter from the FDA, which described the reasons for the FDA’s decision. The FDA had turned down an earlier version of the drug in 2008, but Pfizer’s King Pharmaceuticals...

New Drug Effectively Treats Hepatitis C

WEDNESDAY, June 22 (HealthDay News) — The recently approved drug Incivek, combined with two standard drugs, is highly effective at treating hepatitis C, a notoriously difficult-to-manage liver disease, two new studies show. The drug works not only in patients just starting treatment, but in those who failed earlier treatment, the research found. The hepatitis C virus can lurk in the body for years, causing liver...

Safety Dooms Novel Staph Vaccine

A phase II/III trial of V710, an investigational vaccine for the prevention of Staphylococcus aureus infection, has been stopped for good following a risk-benefit analysis, according to Merck and Intercell AG. In April, the Data Monitoring Committee recommended suspending enrollment even though a pre-specified interim analysis showed that the trial did not meet futility criteria. No explanation was given. But a decision...

FDA Okays New HIV Drug

WASHINGTON — The FDA has approved rilpivirine (Edurant) for the treatment of HIV patients who have not yet begun therapy. The drug, a non-nucleoside reverse transcriptase inhibitor, is intended to be used as part of highly active anti-retroviral therapy (HAART) with at least two other medications, the agency said. Rilpivirine, also known as TMC278, is to be taken once a day with food and offers another medication...

UPDATE 1-US panel says Optimer’s antibiotic ...

Optimer Pharmaceuticals Inc’s (OPTR.O) experimental antibiotic is safe and effective in treating a bacterial infection that causes diarrhea, a U.S. advisory panel said on Tuesday. The advisory panel of 13 independent experts voted unanimously that the drug was effective but said there were concerns regarding the drug’s use in pregnant women and children. However, the panel was divided on whether the oral drug,...
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