Quality by Design in APIs
The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs.

Effective and Efficient Weighing of Potent Compounds
The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.

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The Elements of Training
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

Congress Clarifies Drug Compounding, Tracking Policies
After months of public hearings, congressional committees unveiled a compromise bill that provides more clarity and predictability to drug oversight programs.

Merck Cuts 8,500 Positions, Moves Headquarters
Merck announced plans to reduce its workforce by 8,500 and move its headquarters in order to sharpen its commercial and R&D focus.

Capsugel Expands Global Manufacturing for Finished-Dosage Forms
Capsugel’s Dosage Form Solutions business unit will expand facilities in France, the UK, and the US.

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AbbVie and Galapagos Alliance to Develop Cystic-Fibrosis Therapies
A global collaboration between AbbVie and Galapagos is set to commercialize novel potentiator and combination therapies in cystic fibrosis.

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Boehringer Ingelheim Voluntarily Recalls Certain Lots of Spiriva Handihaler Capsules
Boehringer Ingelheim initiates a recall due to the potential for extrinsic foreign particles in the API used to manufacture Spiriva Handihaler (tiotropium bromide inhalation powder) capsules.

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Sanofi Renews Research Agreement with French Alliance and Begins Construction in Algeria
Sanofi’s plans strengthen its life-sciences presence at home in France and abroad in Africa.

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GEA, G-CON, and Pfizer Collaborate on Continuous Manufacturing Process
The collaboration with Pfizer aims to develop next-generation, continuous manufacturing for solid-dosage pharmaceuticals.

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EMA Releases HIV Treatment Guideline for Consultation
EMA revises HIV treatment guideline.

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FDA Publishes ANDA Submission Guidance
FDA publishes guidance on ANDA submissions.