Quality/GMPs

The agency discusses its response to COVID-19 and other milestones in its year-end review.

The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.

The UK’s National Institute of Health and Care Excellence has recommended the use of Janssen’s Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) to treat adults with multiple myeloma.

FDA granted Oncoloze’s OM-301 an orphan drug designation for the treatment of acute myeloid leukemia (AML).

FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.

FDA has cleared an IND from Poseida Therapeutics, allowing continued development of the company’s allogeneic CAR-T cell therapy candidate for treating multiple solid tumors.

FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19.

The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.

FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.

Warp speed is amazoning pharma practices and protocols.

Survey respondents reflect on the state and future of the bio/pharma employment.

Modeling techniques can improve process control and monitoring in biopharmaceutical production.

Upstream processing is better optimized with the help of automated workflows.

Qualified algorithms enable validation of machine learning models that can be used for process optimization.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

New and emerging biotherapeutic molecules drive the need for innovative solutions to meet cold-chain requirements.

Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.

Tezpire (tezepelumab-ckko) has been approved as an add-on maintenance treatment for severe asthma.

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

FDA approved American Regent’s Injectafer (ferric carboxymaltose injection) for the treatment of pediatric patients with iron deficiency anemia.

General agreement that FDA needs a confirmed commissioner may speed Califf’s appointment.

The European Medicines Agency has accepted Sanofi’s marketing authorization application for olipudase alfa, a potential new therapy for acid sphingomyelinase deficiency, a rare disease.

GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.

Guide addresses challenges of applying GMPs to autologous cell therapy manufacturing.