Industry News

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.

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.

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

Cancer cell lines could provide viable pathways to determining how tumors respond to specific anti-cancer drugs.

UPS will expand its clinical trial logistics capabilities to include drug and vaccine development.

The company will collaborate with the Walter Reed Army Institute of Research to co-develop a Zika vaccine candidate.

Biosimilar makers may have to wait an additional 180 days after receiving FDA approval before they can bring their drugs to market, according to a United States Federal Circuit Court ruling. On July 5, 2016 the court ruled in Amgen v. Apotex that after a biosimilar receives FDA approval, companies must notify reference product sponsors and wait 180 days before bringing the drug to market, a requirement in the Biologics Price Competition and Innovation Act.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

FDA cited Guangzhou Haishi Biological Technology Co., Ltd. with CGMP violations.

The agency says, for now, it’s business as usual.The European Medicines Agency (EMA) says the future location of the agency will be determined by common agreement between representatives of the Member States, according to a July 6, 2016 statement. Until then, EMA says it will be conducting business as usual, and the outcome of the June 23 referendum will not affect the agency’s operations.