Quality/GMPs

Updating your audits and inspections program ensures inspection preparedness, says Siegfried Schmitt, vice president, Technical at Parexel.

FDA’s latest approval of Imfinzi (durvalumab) in combination with chemotherapy for treating resectable non-small cell lung cancer before and after surgery is based on Phase III trial results showing that the regimen reduced the risk of recurrence, progression, or death by 32%.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers.

Downstream processes may be streamlined by using automation.

The program, for which visits will be scheduled through September 2025, does not replace or supplement a regulatory inspection.

Enamine’s library of 5400 TPD-related linkers, and 13,000 more linker molecules, is now being integrated into Cresset’s Spark tool for library searching.

Biopharmaceutical production faces the challenge of ensuring the quality of raw materials due to a lack of specific guidelines. By implementing effective risk assessment strategies and working with reliable, selected solution providers, biopharmaceutical manufacturers can minimize these challenges and improve product quality.

The implementation of new quality control methods must be reported to regulators, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara (ustekinumab), in the European market, marking the second biosimilar brought to market by this partnership.

The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.

In the second episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.

GSK’s submission is supported by Phase III trials showing significant progression-free survival benefit and positive overall survival trends using Blenrep combinations compared to standard care.

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

Communication and meetings with FDA after receiving a warning letter demonstrates a serious response, says Siegfried Schmitt, vice president, Technical at Parexel.

EMA has accepted GSK’s application seeking treatment with Jemperli (dostarlimab) plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer.

The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

In the premiere episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

FDA has granted expanded approval to Sarepta Therapeutics for Elevidys to treat DMD in non-ambulatory patients, in addition to ambulatory patients.

Immunology company argenx gets its third FDA-approved indication for VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy.

This alert follows a similar one from the European Medicines Agency in October 2023 amid a rise in demand for the diabetes medication that, in turn, created a shortage.

The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.