Quality Systems

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

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

Life sciences data sets can be vast and complex to process, but up to now bringing intelligent automation systems up to speed and validating them has felt debilitatingly onerous. Large language models tackle these barriers head on. Ramesh Ramani and RaviKanth Valigari, technology innovators at ArisGlobal, explain.

The US currently relies heavily on imports from China and other overseas nations for APIs needed to manufacture drug products of critical importance to US patients.

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.

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

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

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

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

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

FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.

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.

Here, Pavan Kumar Kunala from Almac Sciences runs through the different types of tests used to analyze drug substances to ensure quality and safety.

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.

PRAC is reviewing the risk of secondary malignancies in patients treated with CAR T-cell medicines.

Key information is needed for excipients and their potential impact on continuous manufacturing processes.

A statistical analysis for determining an expiration date can be applied to replicates or their corresponding averages as suggested in industry guidelines.

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

The final drug product relies on the quality and reliability of the raw materials used in its production.

Lonza’s Joe Garrity and Jerry Jiang discuss the importance of not only automating CGT manufacturing, but also standardizing across processes.

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.

Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

An ordered process describing calculations activities for compounded dosage forms is described.

The units are being recalled because of incomplete crimp seals and one complaint of a leaking unit.

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.