Industry News
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The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.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FDA Releases Draft Guidance on Promotional Labeling and Advertising
The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.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.
McNeil Fined $25 Million for Adulterated Medications
McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.
Canon Announces New Biomedical Company
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.
Manufacturers Weigh Strategies to Prevent Drug Shortages
Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.
EMA Establishes Drug Identification Task Force
The agency is enlisting members of European pharmaceutical associations and industry representatives to participate in IDMP task force.
FDA Issues Guidance on Drug Compounding
The agency releases five draft guidance documents related to drug compounding and repackaging.
FDA Updates Approved REMS
FDA gives an update on currently approved Risk Evaluation and Mitigation Strategies.
New Financial Strategies Needed to Support Biomedical Innovation
The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.
CDER and Biotech Quality Assessment
The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.
FDA Releases Guidance Documents on Risk Information and IND Applications
The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.
Will Economic Returns from Drugs Continue to Disintegrate?
The recent mergers, partnerships, and incentive-laden deals in pharma may keep the industry from continuing to experience diminishing returns, according to IMS’ Michael Kleinrock.
