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Bouncing back from FDA rejection, Alkermes psychiatric drug wins approval

MedCity News
Bouncing back from FDA rejection, Alkermes psychiatric drug wins approval
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.
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An Alkermes drug developed to offer antipsychotic effects while mitigating the weight gain associated with many depression medicines is now FDA approved as a new treatment options for patients.
The regulatory decision announced Tuesday covers use of the Alkermes drug, Lybalvi, for two indications: schizophrenia and bipolar disorder I. It follows a contentious advisory committee meeting last October, during which several physicians expressed concern about the drug’s risks in patients who are already taking opioid medications, and an FDA rejection of the drug a month later due to a manufactur ....

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If Big Pharma is from Mars and digital health startups from Venus, PharmStars wants to play Cupid

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Dave Rich, Author at MedCity News

Dave Rich
Dave Rich, CEO of Ensurem (an online, multi-carrier insurance brokerage in the retail Medicare solutions market with a large and swift capacity to assist over 300,000 seniors per month trying to navigate Medicare coverage options) has held various positions over his 35-year career in the insurance industry. Experienced in both the home office environment and independent distribution companies, Dave has a unique understanding of home-office decision-making as well as agent and consumer preferences. For the last 10 years, Dave has held the positions of Chief Operating Officer and Chief Marketing Officer of Amerilife Group LLC., one of the largest insurance marketing companies in the country. ....

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Council of Europe organizes training for the new BFUG Secretariat

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100+ workers sue Houston Methodist over mandatory Covid-19 vaccination policy

The lawsuit alleges that the policy is akin to forcing employees to participate in a medical experiment as none of the vaccines available have received full FDA approval. But Houston Methodist rebutted these claims saying the vaccines are safe and effective, and requiring employees to get vaccinated is in the best interest of the patient. ....

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