Industry News

The Critical Path Institute launched a consortium to help develop therapies for newborns.

CPhI Worldwide announces the 2015 Expert Panel, including 2014 panel veterans and three new members.

Supply chain consortium establishes a working group to address quality problems in India.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

A range of packages is available for industry partners to implement charity giving.

MaxCyte announces a strategic partnership with Johns Hopkins University to develop CAR T-Cell therapies for cancer.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

The European Medicines Agency releases findings from marketing authorization application analysis.

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

The author explores various biocontainers-both old and new-in the single-use space.

Drug makers back alternative to FDA labeling update rule.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

The bill, originally introduced in 2013, seeks to terminate sequestration to payments for certain drugs and biologicals.

Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.

The agency releases five draft guidance documents related to drug compounding and repackaging.

FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.