Alkermes

Questex LLC | November 29, 2018

Alkermes' schizophrenia drug met its primary endpoints in a second phase 3 trial, setting it up for an FDA filing in mid-2019. Patients taking the drug gained less weight on average than patients taking olanzapine, the antipsychotic on which it is based. Olanzapine is one of the most commonly prescribed treatments for schizophrenia, but can cause a number of side effects, including metabolic issues and extreme weight gain. Because of this, Eli Lilly, which markets olanzapine as Zyprexa, had ...

Pharmaphorum Media Limited | February 04, 2019

Alkermes is facing a significant delay for its ALKS 5461 candidate for major depressive disorder after the FDA turned down its marketing application. The negative outcome for the review isn’t surprising given that an FDA advisory committee voted by 21-2 in November that the drug’s benefit-risk profile is not adequate to support its approval for treatment-resistant MDD. However, the outcome is something of a worst-case scenario for Alkermes as it seems the US regulator wants a new cli...

Pharmacy Business | January 14, 2020

The government on Monday announced a collaboration with Novartis to launch a clinical trial for ‘yet to be approved’ drug inclisiran. The drug could benefit thousands of patients at risk of heart disease in coming years. The ground-breaking collaboration includes Novartis, NHS England and the National Institute for Health Research (NIHR) and Oxford University. The Department of Health and Social Care (DHSC) expects this to position the UK as a world-leading destination to develop cut...

Business Wire Press Releases | January 16, 2020

Today announced it has signed a long-term agreement with Thermo Fisher Scientific to develop and manufacture medications with Civica as the owner of the regulatory pathway. By working with Thermo Fisher to develop Civica-owned Abbreviated New Drug Applications (ANDAs), Civica will secure the manufacture of certain essential medications, further mitigating the risk of drug shortages in the future. This partnership has an initial seven-year term and represents a key component of Civica’s man...