News

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.

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.

The design of Baxter BioPharma Solutions’ aseptic filling lines provides a case study in customizing containment systems for multi-product lines

The collaboration will focus on methods to eradicate cancer stem cells

The acquisition will add to the company's cell therapy base and potential impact in treating rare diseases.

An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.

The new materials handling laboratory will be used for storage, dispensing, inventory management, and distribution of non-GMP materials.

Congressional partisanship creates noise, but no funding for Zika virus research.

Galvani Bioelectronics will be based in Stevenage, UK, and headed by Kris Famm, GSK's vice president of bioelectronics R&D

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.