Displaying 1–25 of 56 results for Alkermes
An advisory panel to the U.S. FDA voted against approving Alkermes’ treatment for depression in patients with an inadequate response to standard antidepressant therapies.
Alkermes announced that it received a Refusal to File letter from the U.S. FDA regarding its New Drug Application (NDA) for ALKS 5461, a once-daily, oral investigational depression medicine.
Biogen and Alkermes will develop and commercialize ALKS 8700 for the treatment of relapsing forms of multiple sclerosis.
Alkermes' Aristada (aripiprazole lauroxil) extended release injection is approved to treat adults with schizophrenia
Recro acquisition includes worldwide rights to IV/IM meloxicam and contract manufacturing facility in Gainesville, Georgia
Along with the facility, the manufacturing and royalty revenue associated with products made at the facility will be sold to Recro Pharma Inc.
Manufacturing HP active pharmaceutical ingredient drugs is a challenge best met with a thorough assessment of risk and a robust containment strategy
This white paper outlines some of the elements that should be considered by a sponsor pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
This case study demonstrates how a commercial manufacturing partnership between a pharmaceutical contract manufacturer and a large pharmaceutical company resulted in the establishment of a high volume process for Highly Potent Active Pharmaceutical Ingredients.
This case study provides an overview of the implementation of a framework that addressed both the usual technical challenges and also the business challenges in a recent real-world tech transfer involving the commercial manufacture of a solid oral dose product.
Alkermes successful approach to creating a high-volume process for highly potent APIs
Case Study: Conducting a Joint Risk Assessment for Technical Transfer
Case Study: A Successful Approach to Commercial Scale Final Dosage Manufacture of Drug Product Containing Highly Potent API
February 2013 issue of Pharmaceutical Manufacturing magazine
Alkermes proven risk-analysis rubric assures healthier, more profitable partnerships by requiring companies to analyze the technical and business risks.
Anything from excess moisture to variable API loading can affect tablet quality. PAT methods and equipment innovations can reduce variability.
More than 20 on-demand webcast presentations from industry experts and leading solutions providers. NIR, Raman and Particle Characterization technologies and applications that are improving pharmaceutical product and process quality.
This case study demonstrates a large pharmaceutical contract manufacturing engagement in which there has been ﬁve years trouble free supply with OTIF (On-Time-InFull) consistently >95%.
This case study demonstrates the successful transfer of a low solubility compound into one of our manufacturing sites and achieving as a result, an OTIF (On-Time-InFull) consistently over 95%.
Outsourcing is no longer a tactical decision but rather a partner-driven strategic activity. This paper presents essential success factors in fostering and maintaining long-term partnerships in pharmaceutical outsourcing. After completing the registration form you will have access to download the...
At Interphex 2012, Jim Botkin, Senior VP of Operations for Alkermes plc, discusses the extent of his organization's services and capabilities following the recent merger with Elan Drug Technologies. Botkin also discusses the importance of risk-based compliance to the success of any contract ...
How Alkermes implemented Risk-MaPP to maximize operator and patient safety.