Quality/GMPs

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

FDA is incentivizing drug manufacturers through higher data integrity requirements.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

Societal CDMO has been awarded a new manufacturing and packaging task order agreement by National Cancer Institute.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

Pfizer has issued a voluntary nationwide recall of lots of Accupril due to N-nitroso-quinapril content.

EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.

EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.

FDA has approved commercial production at Kite’s new CAR T-cell therapy manufacturing facility in Frederick, Maryland.

New guidance from FDA and legislation from Congress promote clinical trial diversity.

Mylan Pharmaceuticals is issuing a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label in the batch.

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

FDA is reviving efforts to establish a Quality Management Maturity program.

Orchard Therapeutics announces reimbursement agreement, which will make Libmeldy available for all eligible MLD patients in Italy.

Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.

Democrats have proposed a measure to facilitate access to less costly comparator drugs needed in clinical trials, while another bill aims to increase transparency in the costs of clinical trials.

FDA has granted Priority Review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.