According to Dec. 3 announcement by Novo Nordisk, the Food and Drug Administration "has approved a low-dose local estrogen therapy, a 10 mcg formulation of the estradiol vaginal tablet Vagifem for atrophic vaginitis." The FDA based its approval "for the lower dose...on a 52-week randomized, placebo-controlled multicenter trial with 309 participants with an average age of 57.6." Trial results indicated that "women using the estradiol tablets showed statistically significant improvement after 12 weeks of treatment, compared with those using a placebo in correcting vaginal pH," as well as in "correcting vaginal maturation index."
FDA approves IV formulation of Revatio for pulmonary arterial hypertension. The Food and Drug Administration "has approved an intravenous formulation of the pulmonary arterial hypertension drug sildenafil (Revatio) for patients who are temporarily unable to take the medication in its oral form." The FDA-approved injection "is administered in single-dose, 10 mg vial three times a day, which corresponds to a 20 mg oral tablet three times daily." .
EU regulators approve COPD treatment.
Novartis AG reports that its treatment for chronic obstructive pulmonary disease, Onbrez, has received approval to be marketed in the European Union. The drug, which is inhaled once a day, was shown in studies to be better in improving lung function and symptoms of breathlessness than older treatments Spiriva (tiotropium bromide) and Serevent (salmeterol).
Simocyclinone could lead to powerful new drugs to beat resistance.
According to research published in the Science Journal, "a 'double-headed' antibiotic could lead to powerful new drugs to beat resistance." Recently, UK investigators examined "a naturally occurring molecule made by soil bacteria called simocyclinone," which "sticks to bacteria in two places making it more potent and reducing the chance that bacteria will adapt to resist it." Although simocyclinone is itself unsuitable "for use in patients, it is hoped drugs can be created based on the same principle." By targeting "an enzyme in bacteria called DNA gyrase" and latching on in two places or 'pockets, simocyclinone creates an effect 100 times more powerful than if each 'head' attached to the bacteria individually."
WHO finds no further Tamiflu-resistant H1N1 spread in US, UK.
The World Health Organization reported that there is no evidence that Tamiflu-resistant viruses have spread beyond the walls of two hospitals where they caused clusters of cases among immunocompromised patients. WHO said investigations into the outbreaks, in hospitals in Wales and the United States, have so far turned up no evidence the resistant viruses have spread from infected patients to the staff, to other patients in the hospitals or to the nearby communities. WHO official Charles Penn said, "We're confident in saying that at the moment it looks to be limited, but ... it's a question of continually monitoring." CP adds, "The two clusters involved eight patients in a hospital in Cardiff, Wales and four at Duke University Hospital in Raleigh, NC, who were severely immunocompromised. Three of the patients in North Carolina have died."
Tamiflu-resistant swine flu cases reported in Maryland, Virginia.
The Washington Post reports that three people have been hospitalized with a Tamiflu-resistant strain of the H1N1 virus. The patients, two in Maryland and one in Virginia, have prompted "infectious disease specialists to call for renewed caution even as the intensity of the pandemic has declined nationwide." Diane Helentjaris, head of Virginia's office of H1N1 response, said the cases were "not unexpected at all, when you have many, many people taking an antiviral medication." The American Press reports that the Maryland patients, who were both admitted to Johns Hopkins Hospital, were treated there and have been discharged.Officials at the Maryland Department of Health and Mental Hygiene are notifying the state's acute-care hospitals, physicians and other healthcare providers to be on the lookout of other possible cases."