Alkermes says separating cancer from its portfolio and pipeline of neuroscience products could put the company on a path to profitability. Meanwhile, the new cancer company would be an independent and publicly traded entity with a lead immunotherapy in pivotal testing for two types of cancer.
Alkermes antipsychotic drug Lybalvi now has FDA approval. Though the field of neuropsychiatric drugs is crowded with generic medications, Alkermes believes Lybalvi, designed to mitigate the weight gain side effect common with mood disorder drugs, could have an advantage.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
In an open letter published by BIO, the executives emphasized the importance of science-driven evaluation of medicines and regulatory independence. The letter came amid growing concern about political pressure over the FDA, as well as lack of diversity in trials and companies being too quick to announce data that are inconclusive.
An analyst wrote that while the new drug, Vumerity, has a good chance of winning FDA approval later this year, it is uncertain whether the superior gastrointestinal tolerability it demonstrated will be enough to protect Tecfidera from generic competition.
The company's shares were down more than 4 percent in Monday morning trading after the agency's decision, which itself followed a negative AdCom vote in November.
The company plans to file a New Drug Application next year. An analyst wrote that it's unclear if the drug will require review by an advisory committee.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
Briefing documents from the Psychopharmacologic Drugs Advisory Committee earlier this week had cast doubt on the chances of a positive vote.
The Psychopharmacologic Drugs Advisory Committee will meet on Thursday to vote on whether to recommend the FDA approve the drug, ALKS 5461, an opioid for major depressive disorder.
Schizophrenia medication treatment could become easier and more effective with Alkermes' FDA approval for Aristada.