Quality Systems

Articles

CDMOs offer expertise and customization options for sponsors of orphan drugs.

Fostering Orphan Drugs

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The draft PREVENT Pandemic Act aims to secure supply chains, expand health data collection, and support access to vital medical products

Pandemic Preparedness Legislation Bolsters FDA Oversight

NICE has updated its Technology Appraisal Guidance TA599 for AstraZeneca’s Lokelma. 

NICE Updates Guidance for Lokelma as Treatment for Adults with Hyperkalemia

Merger with Phlexglobal expands provider’s technological capabilities.

PharmaLex furthers its clinical and regulatory reach

Delays in sponsors providing postapproval evidence of effectiveness for therapies benefitting from streamlined FDA regulatory pathways are generating pressure for further review and reform of the agency’s accelerated approval  process. 

Concerns Mount over Limited Evidence for Accelerated Approvals

AstraZeneca's Tagrisso has been accepted for use as a monotherapy for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations in Scotland.

AstraZeneca’s Tagrisso Accepted for Use in Scotland to Treat EGFR Mutated Advanced Lung Cancer

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

FDA Publishes 2021 Year in Review

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

COVID-19 Vaccines Safe for Use During Pregnancy, EMA States

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

European Commission Approves Lumykras (Sotorasib) to Treat KRAS G12C-Mutated Advanced Non-Small Cell Lung Cancer

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.

Regulatory Oversight and Compliance