Quality Systems

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.

According to the company, Lumykras (Sotorasib) is the first targeted therapy approved in the European Union for patients with the KRAS G12C mutation.

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.

The Centers for Medicare and Medicaid Services took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab).

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.

Pharming Group, has been granted a positive opinion by EMA for its Paediatric Investigation Plan for leniolisib.

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

Particle analysis provides assurances of the quality and performance of the final dosage form in pharmaceutical development.

Sample preparation tends to be manually labor intensive, but automating this step helps streamline the glycosylation monitoring workflow.

Persistent bottlenecks in biocatalyst development can be alleviated through fully automated enzyme analysis.

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.

An obvious theme for 2021 has been COVID-19, but the next 12 months will see industry and its people experiencing further change.

Workforce training is crucial for biopharmaceutical manufacturing.

DTx manufacturers are taking advantage of the new regulatory flexibility, afforded by the COVID-19 pandemic, to pilot new products and generate real-world evidence to support regulatory filing and reimbursement.

Continued process verification for a cleaning validation program begins once the validation study is complete.

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

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.

Overall, 2021 proved to be another good year for drug approvals in Europe, albeit with a slight disappointment for Alzheimer’s patients, but what should industry be watching out for in 2022?

January is the kind of month that can make your head spin.

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 has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient mifepristone.

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