Bionovo receives CMC approval for Menerba
EMERYVILLE, Calif. The Food and Drug Administration has approved a manufacturing plan for a drug to treat hot flashes in menopausal women.
Bionovo said Thursday that the FDA had accepted its chemistry, manufacturing and controls plan for the drug Menerba. The decisions and agreements are considered binding on the company and the FDA.
“This CMC approval represents a revolutionary set of ‘firsts,’” Bionovo chairman and CEO Isaac Cohen said. “This is the first time that the FDA’s botanical drug development CMC guidance has been applied to an oral drug in a major indication.”
Loveable book character now in gummy vitamins
SAN CLEMENTE, Calif. Hero Nutritional Products on Tuesday announced the launch of "Clifford, The Big Red Dog" gummy vitamins for children.
"Hero Nutritionals shares a common goal with Scholastic, the publisher of ‘Clifford, The Big Red Dog,’ a well-loved children’s icon for 50 years," stated Jennifer Hodges, Hero Nutritional Products CEO. "Clifford promotes good citizenship, manners and education, and Hero Nutritional Products promotes wellness and nutrition, both providing the building blocks for normal healthy growth and development. … Hero’s goal of promoting health goes hand in hand with Clifford’s 10 ‘Be Big’ ideas.”
"Clifford, The Big Red Dog" gummy vitamins have high levels of folic acid and zinc and contain 100% of the recommended children’s daily amount of vitamin D per serving, and contain natural vitamin E and vitamin C. The gummy vitamins also have omega oils made with cranberry seeds for healthy normal development of children.
"Clifford, The Big Red Dog" gummy vitamins will be available in food, drug, grocery and mass merchandise stores including Target, Walgreens, Lewis Drug and Rite Aid.
A50-count (25 serving) bottle retails for a suggested $7.99 and will come in two multivitamin + brain health varieties including the original multi-fruit flavor and a new sweet and tart sour flavor. Special promotions can be found on the Clifford vitamin website.
Novartis’ Cushing’s disease drug shows promising results in trial
EAST HANOVER, N.J. Swiss drug maker Novartis said its investigational drug is the first to show promise in a late-stage clinical trial for Cushing’s disease, a potentially fatal hormonal disorder.
Novartis announced Wednesday that the drug SOM230 (pasireotide) had reduced cortisol levels in patients with Cushing’s disease. The disease results from a benign pituitary tumor that causes the adrenal glands to produce excess cortisol. This can lead to metabolic and cardiovascular problems and death. Results will be presented at the 14th congress of the European Neuroendocrine Association.
“There is a critical need for a medical treatment for people with Cushing’s disease because currently available options, such as surgery or radiotherapy, are ultimately not effective for many of the patients who suffer from this debilitating disease,” said William Ludlam, director of the Seattle Pituitary Center at the Swedish Neuroscience Institute in Seattle. “The results of this study suggest that pasireotide may help patients achieve biochemical control of their Cushing’s disease and its symptoms by directly targeting the pituitary tumor that triggers excess cortisol production.”