Industry News

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The agency releases five draft guidance documents related to drug compounding and repackaging.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

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.

The Center for Drug Evaluation and Research seeks a more flexible system for assessing biotech product quality.

The agency releases guidance documents on Individual Patient Expanded Access Applications and disclosing risk information to patients.

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.

FDA releases a Q&A with the Drug Shortage team leader from the Center for Drug Evaluation and Research.

President Obama unveils his “Precision Medicine Initiative”.

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

The agency creates an electronic central repository to facilitate drug safety assessment reports.

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.

The European Medicines Agency has published a guide to help industry and regulatory authorities implement safety-monitoring standards.

FDA aims is to collect data regularly from manufacturers that will indicate the ability of a firm and its facilities to produce high-quality therapies on a continual, error-free basis.

The European Medicines Agency plans on sharing generic-drug assessment reports with regulators outside the European Union.

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Catalent Pharma Solutions and Sanofi-Aventis R&D have entered into a collaboration to develop Sanofi’s proprietary antibodies using Catalent’s SMARTag antibody drug conjugate (ADC) platform.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

The FDA center released a list of the guidance documents it plans to publish in 2015.

In 2014, FDA approved 41 new molecular entities, which is the highest number since 1996.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

Roivant Neurosciences acquired GlaxoSmithKline’s selective 5-HTC receptor antagonist for the treatment of various neurological disorders, specifically Alzheimer’s disease.

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.