Pharmaceutical Technology Editors

The Chinese facility was cited for data integrity violations.

The Group is focusing on standardizing data exchanges between the enterprise serialization management function and product packaging lines.

The bio-incubator, located at the James Cook University Hospital, will give early-stage biotechnology and life-sciences companies access to facilities to support biomedical research.

Flawed testing and analysis and a failure to analyze the root cause of customer complaints were among the top problems noted in FDA's letter to the Florida-based transdermal drug manufacturer.

The agency publishes guidance on the appropriate classification of co-crystal solid-state forms.

The company received breakthrough therapy designation for esketamine, a treatment for major depressive disorder with imminent risk for suicide.

Piramal Enterprises has entered into an agreement to acquire 100% stake in Ash Stevens all by cash for a consideration of $42.95 million plus an earn-out consideration capped at $10 million.

Irvine Scientific’s new product range includes chemically-defined, serum-free media, to increase productivity of viral vectors and recombinant proteins in suspension cultures.

A KPMG survey reveals that approximately 84% of pharma and medical device executives plan to add jobs in next 12 months.

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

CPhI Pharma Awards’ panel doubles in size and welcomes experts from around the world.

Mallinckrodt announced a planned merger agreement with Stratatech Corporation, a regenerative medicine company.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

The EDA offered Allergan tax credits in order to encourage the company to remain in the state.

The GMP-certified facility will produce TruTag microtags for global pharmaceutical customers.

Quebec, Canada-based contract development and manufacturing organization has joined the Pharma & Biopharma Outsourcing Association.

Pearl River had set the scene for vaccine breakthroughs, cGMP challenges, and ambitious Lean and operational excellence programs

The work will focus on addressing a key bottleneck to progress: he complexity and instability of HIV envelope proteins, which has limited the amount of material that can be evaluated in clinical trials.

Researchers at the ARC Centre of Excellence in Convergent Bio-Nano Science (CBNS) in Melbourne, Australia have developed a drug-delivery technology that circumvents first pas metabolism in the liver, thereby, enabling higher drug levels to reach the systemic circulation.

The company announced that Bioverativ will be the name of its new hemophilia spin-off business, which is expected to launch in early 2017.

Coperion K-Tron, Fette Compacting, Glatt Air Technologies, and others presented an interactive seminar at Rutgers University.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

Herma’s wrap-around, high-speed labelling machine will be available for demonstration at its new facility in New Jersey.

BMS will reacquire the rights to ASLAN002 (BMS777607) from ASLAN Pharmaceuticals in China, Australia, Korea, Taiwan, and other Asian territories.

FDA issued a warning letter to contract testing laboratory, Adamson Analytical Laboratories, for CGMP violations.

The company is voluntarily recalling one lot of product due to particulate matter.

The company is voluntarily recalling liquid products due to possible Burkholderia cepacia contamination.

The three-year report emphasizes the roll of collaboration in drug safety.