Quality Systems

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.

Excessive drug pricing is being scrutinized across Europe, as hefty fines are set to send out a clear message of intolerance to anti-competition conduct.

Congress questions FDA on plans to catch up and move forward with facility inspections.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

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

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

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.

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.

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 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).

White House proposal includes measure to make drugs more affordable.

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

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

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

The company is recalling one lot of Topotecan Injection 4 mg/4 mL (1 mg/mL) after a glass particle was found in a vial.