Alkermes
NEWS
Almost three months to the day after an FDA advisory committee overwhelmingly rejected Alkermes’ major depressive disorder treatment, ALKS-5461, the company received word that the regulatory agency will not approve the medication.
Here’s a look at this week’s calendar for decisions coming down from the U.S. Food and Drug Administration (FDA).
Alkermes, headquartered in Dublin, announced positive topline data from ENLIGHTEN-2, its pivotal Phase III trial of ALKS 3831 (olanzapine/samidorphan) for schizophrenia.
Boston Business Journal recently created a list of 15 Massachusetts life science companies that in their third-quarter reports, allocated the highest percentage of total costs to research and development. Here’s a look.
Alkermes now faces a difficult uphill battle to gain regulatory approval for ALKS-5461 as a treatment for MDD.
One of the drugs being discussed this week by a U.S. Food and Drug Administration advisory committee is Waltham, Mass.-based Alkermes’ ALKS-5461. The drug itself has some controversy.
Depression affects almost 20 million Americans yearly and major depressive disorders affect nearly 300 million people worldwide. The annual market for these disorders is approximately $83 billion.
Here’s a look at who shook things up in the world of pharma and biotech this week.
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
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