Industry News
Bringing a Biologic from the Bench to the Marketplace
Michiel E. Ultee of Ulteemit BioConsulting discusses converting an early drug discovery into a product that is ready for clinical testing.
EDQM Releases 2014 Annual Report
The directorate highlights achievements accomplished during the year of its 50th anniversary.
ICH Steering Committee to Meet in Japan
The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.
FDA Releases Guidance on CMC Changes for Biologics
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.
Generic Opioids Create Policy Issues
Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.
MIT Scientist to Present at BIO 2015
MIT scientist Robert Langer will speak at BIO 2015 on a panel about venture capitalism in biotechnology.
“Cures” Debate Far From Over
The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.
International Neonatal Consortium Launched
The Critical Path Institute launched a consortium to help develop therapies for newborns.
CPhI Worldwide Announces 2015 Expert Panel
CPhI Worldwide announces the 2015 Expert Panel, including 2014 panel veterans and three new members.
Rx-360 Establishes Working Group in India
Supply chain consortium establishes a working group to address quality problems in India.
FDA Releases Q&A on Biosimilars
The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.
Vaccine Patch Could Eliminate Traditional Protocol for Vaccine Delivery
A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.
CPhI Worldwide Launches Charity Initiative with Global Angels
A range of packages is available for industry partners to implement charity giving.
MaxCyte Partners with Johns Hopkins on CAR T-Cell Therapies
MaxCyte announces a strategic partnership with Johns Hopkins University to develop CAR T-Cell therapies for cancer.
FDA Releases Draft Guidance on Promotional Labeling and Advertising
The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.
EMA Finds Scientific Advice Leads to Stronger Trial Design
The European Medicines Agency releases findings from marketing authorization application analysis.
Sartorius Stedim Biotech Acquires BioOutsource
The acquisition expands Sartorius Stedim Biotech’s service portfolio.
FDA Extends Comment Period on ANDA Rule
FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.
EMA Releases Medication Error Guidelines
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
FDA Offices Collaborate to Prevent Drug Shortages
Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.
Catalent Pharma Solutions Joins PBOA
Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.
ISPE Names 2015 Facility of the Year Category Winners
Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.
Fluid Storage in a Single-Use Era
The author explores various biocontainers-both old and new-in the single-use space.
Industry Responds to FDA Labeling Rule
Drug makers back alternative to FDA labeling update rule.
FDA Issues Guidance on NIR Analytical Procedures
The agency outlines recommendations for the development and submission of near infrared analytical procedures.
Hamburg Era Ends at FDA
Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.
FDA Issues Guidance on Environmental Assessments
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
FDA Issues Guidance on Lot Distribution Reports for Biologics
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
Cancer Drug Cost Bill Reintroduced
The bill, originally introduced in 2013, seeks to terminate sequestration to payments for certain drugs and biologicals.
Early Studies Suggest PCSK9 Inhibitors Cut Heart Attack Risk in Half
Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.
