Quality Systems

Assessing Legacy Drug Quality

A data-driven strategy can assess the quality of legacy drugs.

Expert Insights on Annex 1 Revisions

The Annex 1 revisions are driven by a quality risk management approach.

Survey of QPs on Remote Certification

More efficient and effective communication on adapted quality processes is needed.

Prioritizing Cleaning Validation

Failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

Sinovac’s Eupolio Vaccine Gains Market Authorization in China

July 22, 2021

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

EC Grants Marketing Authorization for bluebird bio’s Gene Therapy SKYSONA

July 22, 2021

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

Samsung Biologics Partners with Kineta for Anti-VISTA Antibody Immunotherapy

July 21, 2021

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.

PRAC Finds Link to Very Rare Cases of Myocarditis and Pericarditis with Comirnaty and Spikevax

July 15, 2021

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.

EMA Advises Against Using Janssen’s COVID-19 Vaccine in People with Capillary Leak Syndrome

July 15, 2021

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 Concludes There is No Link Between Zynteglo and AML

July 15, 2021

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).

Drug Prices Targeted in Biden Competition Initiative

July 14, 2021

White House proposal includes measure to make drugs more affordable.

Purisys Adds ISO Certifications

July 12, 2021

Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers

FDA Grants Priority Review for AstraZeneca Asthma Biologic

July 09, 2021

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

MHRA Gives Diurnal the Nod for Efmody

July 08, 2021

MHRA has granted marketing authorization for Diurnal Group’s Efmody as a treatment of adult and adolescent patients with CAH in Great Britain.