Quality Systems

Considering interactions and understanding regulatory requirements are crucial when developing a drug or biologic product for use with a medical device.

EFSA’s evaluation of risk in food products raises implications for drug product formulations.

Low- and middle-income countries are at the greatest risk of receiving substandard and falsified COVID-19 vaccines.

A simplified process flow with associated definitions for pharmaceutical sampling and testing is proposed.

Inconsistent sampling and testing processes can lead to errors, resulting in data integrity issues and potentially incorrect decisions about pharmaceutical quality.

Pharmaceutical Technology checked in with AAPS and IPEC-Americas to get an update on how the organizations are navigating the pandemic and planning for the future.

There are expectations that changes to pharma regulations in the EU, forming part of the regions broader strategy for the industry, will be positive and should offer flexibility for industry to advance through innovation.

HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.

Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.

NICE has reconsidered its decision on Janssen's Erleada (apalutamide), issuing two positive final appraisal determinations (FADs) on the therapy.

NICE has recommended tofacitinib (Xeljanz, Pfizer)as an option for treating active polyarticular juvenile arthritis and juvenile psoriatic arthritis.

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

The orphan drug designation for TCR² Therapeutics’ Gavo-cel will facilitate research into a treatment for cholangiocarcinoma.

The Coalition for Epidemic Preparedness Innovations stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines are available for clinical trials.

FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.

Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.

The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.

Orphan drug designation for Polaryx’s PLX-200 will facilitate research into its use treating Krabbe Disease, a rare lysosomal genetic disorder.

As interest in cell and gene therapies continues to grow, the need for safe and consistent reagents to support research, development, and manufacture efforts also increases.

The functionality of a digital quality management system (QMS) provides visibility into critical supplier activity and helps ensure a high-quality product.

Vincent Colicchio, vice president, supply chain and external manufacturing at Dr. Reddy’s Laboratories, discusses how a lack of proper supplier oversight can impact the pharmaceutical industry and the drug supply chain.

Microbial experts should employ proactive practices on the manufacturing floor, rather than relying on testing.

Intelligent analytical tools detect impurities to help ensure the quality of small-molecule drug ingredients.

FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.

A report from the bipartisan Congressional Budget Office analyzes how drug pricing policies could reduce the number of new therapies coming to market.

Siegfried Schmitt, vice president, Technical at Parexel, provides best practices for switching from paper-based to automated processes.

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

FDA will now require new and updated warnings about the increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions.

SK and GSK announce the initiation of a Phase III clinical study of SK’s COVID-19 vaccine candidate, GBP510, in combination with GSK’s pandemic adjuvant.

Merck and Ridgeback Biotherapeutics announced the initiation of the Phase III clinical trial to evaluate an investigational oral antiviral therapeutic for the prevention of COVID-19 infection.