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

Zika vaccine development is hindered by technical challenges and funding shortfalls.

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.

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.

Catalent Pharma Solutions teamed with Zumutor Biologics to develop antibodies with enhanced ADCC activity.

Opdivo did not meet primary endpoints in Phase III trials investigating the drug as a monotherapy for untreated advanced non-small cell lung cancer in patients whose tumors expressed PD-L1.

MilliporeSigma will provide support to Y-mAbs for the development of its monoclonal antibody for the treatment of pediatric brain cancer.

The report addressed how the agency might support medicine development for patients’ unmet medical needs.

The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.

Sanofi Pasteur will deliver the first of more than 65 million influenza vaccines to the United States throughout the 2016–2017 flu season.

The NIH has launched a Phase I clinical trial in humans of an investigational Zika vaccine.

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

The manufacturing subsidiary of Astellas Pharma in Oklahoma has been transferred to CMO Avara and renamed Avara Pharmaceutical Technologies.

The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.

FDA approved Natco and Alvogen’s generic Tamiflu to treat and prevent influenza.

After divesting 79 generics businesses, the company completed its acquisition of Actavis Generics, including its over-the-counter business, on August 2. The following day, it bought Anda, Inc., the fourth largest generics distributor in the United States.

Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.

The company will install new vial-filling and lyophilization capacity, including an isolator-based filling machine. The new filling equipment will result in a five-fold increase in the company's current filling capacity.