Arena Pharmaceuticals pulled the plug on its application for approval of the obesity drug Belviq with European regulators, another blow to the commercial and regulatory effort behind the treatment. The San Diego-based biotech revealed the decision to withdraw the app in its first-quarter financial report late Thursday afternoon.
A Lonza plant in the U.S. has been struggling for 18 months to get its manufacturing practices back up to FDA expectations. But the shortcomings are now leading to shortages for one of its key clients.
Back in early 2012, a number of physicians around the U.S. began fielding some unusual requests from Alzheimer's patients for a prescription covering Targretin (bexarotene), a cancer drug sold by Eisai.
The Japanese drugmaker will use the plant to tap growing demand in that country, as well as an export base for other emerging markets in Asia.
GE Healthcare's PET imaging agent designed to help spot Alzheimer's disease drew in another international drug company partner developing a treatment in the space.
Welcome to this week's roundup of hirings and firings throughout the industry. Please send the good word (or the bad) from your shop to Michael Gibney ( email | Twitter ) or Emily Mullin ( email |...
Russia is a coveted, if challenging, market for drugmakers looking for new sources of revenue. Its double-digit market growth has not escaped the notice of Japan's Eisai, which is planning a major launch of a number of its products there.
Eisai's Fycompa is a first-of-its-kind seizure drug, a glutamate receptor antagonist and a blockbuster hopeful. The FDA gave the epilepsy drug its approval last year and the Japanese drugmaker is seeking approvals around the world. But Eisai has run into the German pricing agency buzzsaw, and, like its peers, says it is outraged at its treatment.
Back in 2007 when Japan's Eisai agreed to pay $325 million in cash for the U.S.-based Morphotek, the pharma company had high hopes for the biotech's pipeline-leading drug focused on ovarian cancer. But those hopes could not live up to a pivotal test as farletuzumab, also known as MORAb-003, failed to hit a statistically significant goalpost for progression-free survival.
Eisai scored FDA approval for its new epilepsy drug Fycompa. It's the first seizure drug of its kind--a glutamate receptor antagonist--and a blockbuster hopeful for the Japanese drugmaker, which is aiming for top-three status in the seizure drug market.