Quality/GMPs

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD.

Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.

The ever-increasing complexity of biotherapeutic molecules presents unique analytical challenges for developers.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

White House proposal includes measure to make drugs more affordable.

FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

New biologic modalities, such as cell and gene therapies, pose increasing difficulties in viral clearance testing methods.

Help prevent contamination in a facility by zone.

A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.

The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill.