Industry News

The Chinese facility was cited for data integrity violations.

Nine public health organizations submitted a letter to members of US House and Senate committees citing concerns with FDA’s decision to make changes to a section of the FDA and NIH Workforce Authorities Modernization Act.

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.

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

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

A new study reveals a potential new approach to treat sickle cell disease and beta thalassemia using CRISPR-Cas9 gene-editing technology.

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

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

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

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.

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

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.

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.

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.

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

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

The North Carolina-based company will expand Pfizer's capabilities in gene therapy research

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

FDA and industry seek speedy Congressional approval of new user fee plan.

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

The conference will return to the COEX center in Seoul for the third year from August 23¬–25, 2016.

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

On July 19, 2016, Pfizer announced that the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). According to the company, WHO prequalification allows for the global use of Prevenar 13 MDV by the United Nations agencies and countries worldwide that require WHO prequalification.The MDV presentation of Prevenar 13 offers benefits to developing countries, including a 75% reduction in:

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.