Displaying 1–25 of 56 results for Alkermes

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FDA panel says no to Alkermes depression pill

(News)

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.

FDA rejects Alkermes depression drug

(News)

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, Alkermes Partner on Multiple Sclerosis Drug

(News)

Biogen and Alkermes will develop and commercialize ALKS 8700 for the treatment of relapsing forms of multiple sclerosis.

FDA Approves Alkermes' Injectable Schizophrenia Drug

(News)

Alkermes' Aristada (aripiprazole lauroxil) extended release injection is approved to treat adults with schizophrenia

Recro Pharma Acquires Certain Alkermes' Assets

(News)

Recro acquisition includes worldwide rights to IV/IM meloxicam and contract manufacturing facility in Gainesville, Georgia

Alkermes Sells Georgia Manufacturing Facility

(News)

Along with the facility, the manufacturing and royalty revenue associated with products made at the facility will be sold to Recro Pharma Inc.

Risky Business: High Potency Products

(Article)

Manufacturing HP active pharmaceutical ingredient drugs is a challenge best met with a thorough assessment of risk and a robust containment strategy

Outsourcing High Potency Product Manufacturing: Key Selection Criteria

(Whitepaper)

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.

Highly Potent Technical Transfer and Commercial Manufacturing

(Whitepaper)

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.

Joint Risk Assessment During Technical Transfer

(Whitepaper)

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.

High Potency Tech Transfer

(Article)

Alkermes successful approach to creating a high-volume process for highly potent APIs

Case Study: Conducting a Joint Risk Assessment for Technical Transfer

(Whitepaper)

Case Study: Conducting a Joint Risk Assessment for Technical Transfer

Case Study: A Successful Approach to Commercial Scale Final Dosage ...

(Whitepaper)

Case Study: A Successful Approach to Commercial Scale Final Dosage Manufacture of Drug Product Containing Highly Potent API

February 2013

February 2013 issue of Pharmaceutical Manufacturing magazine

Tech Transfer Risk

(Article)

Alkermes’ proven risk-analysis rubric assures healthier, more profitable partnerships by requiring companies to analyze the technical and business risks.

Troubleshooting Tableting

(Article)

Anything from excess moisture to variable API loading can affect tablet quality. PAT methods and equipment innovations can reduce variability.

On-Demand: Ensuring Pharmaceutical Product & Process Quality with ...

(Article)

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.

Case Study: Five Year Trouble Free Manufacturing for Large Pharma Company

(Whitepaper)

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%.

Product & Process Transfer of a Low Solubility Compound with 6 year OTIF > 95%

(Whitepaper)

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%.

Pharmaceutical Outsourcing: Success Factors in Long-term Strategic Partnerships

(Whitepaper)

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...

INTERPHEX 2012: Alkermes Expands Its Core Capabilities and Emphasizes Compliance

(Multimedia)

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 ...

Control Cross-Contamination Risk with HAPIs: Using a Risk-MaPP Master Matrix

(Article)

How Alkermes implemented Risk-MaPP to maximize operator and patient safety.

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