Alkermes adds bipolar I disorder to its FDA wishlist; Congo confirms first Ebola case in large city
→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.
→ Health officials in the Congo have confirmed the first case of Ebola in the busy transportation hub of Goma. The case raises the specter of the spread of the lethal virus in a city with more than 2 million people, though officials in the Congo have downplayed the possibilities of an epidemic in the city.