Quality Systems

Being fully versed on the ins and outs of design quality can improve the project design phase life cycle.

The alterations are the result of an agency review of findings from a clinical trial, and data from required postmarket studies.

In an interview with Pharmaceutical Technology®, Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.

The Biotech and Biomanufacturing Hub will help European companies access funding, navigate regulations, and speed up market access.

Artificial intelligence, among other technological advances, is pushing innovation boundaries.

Treatments for autoimmune diseases, multiple cancers, and skin blistering have been recommended for marketing approval.

Preeya Beczek from Beczek.COM gives her thoughts on the areas to watch with the new US administration and how Europe might be finalizing preparations for previous legislative changes in an interview with Pharmaceutical Technology®.

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

Cerebrotendinous xanthomatosis, or CTX, is a metabolic disorder caused by a gene mutation that results in a deficiency of an important enzyme in the ability of the human body to break down fats.

Seladelpar, which is marketed in the US as Livdelzi, was recommended for an orphan drug designation by CHMP in December 2024.

Tenosynovial giant cell tumor (TGCT) is rare and non-malignant, forming in or near joints, but which if left untreated can cause damage to joints and surrounding tissue, potentially leading to significant disability.

The agency has received certification with the Eco-Management and Audit Scheme for its commitment to environmental sustainability.

The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.

The pledge signifies ArisGlobal’s commitment to upholding high standards and best practices for the responsible use of artificial intelligence.

Agnes Cwienczek, director of Product Management at ArisGlobal, talks with Pharmaceutical Technology® about how careers for women in STEM fields can be nurtured.

In this exclusive Drug Digest video interview Anil Kane from Thermo Fisher Scientific will be tackling the topic of advances in small-molecule manufacturing and several other experts will provide brief commentaries on associated topics.

With the approval, FDA granted SpringWorks a rare pediatric disease priority review voucher.

Acoramidis was approved by FDA in November 2024 and is prescribed in the US under the brand name Attruby.

Pharmaceutical Technology® sat down with Kate Coleman from Arriello to run through the major trends from 2024, including the importance of technological advances, and how these may progress in 2025.

The company is recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches because of possible multi-stacking of patches.

EMA introduced its New Fee Regulation in January 2025, but what impact will the new fees and charges have on medicine developers?

Bio/pharma companies have a lot to consider when tackling social media communications, especially within Europe.

Pharmaceutical Technology® spoke with Andy Burns, vice president, MDI Business Development at Kindeva, about how sustainability requirements are impacting contract development and manufacturing organizations, specifically for the development and manufacture of inhalation drugs.

The platform is live with full functionality for use by marketing authorization holders and national competent authorities to report drug supply information.

Pharmaceutical Technology® spoke with Saharsh Davuluri, Vice-Chairman and Managing Director, Neuland Laboratories, to see how the push to sustainability is impacting contract manufacturers.

One lot of Phenylephrine hydrochloride Injection, USP, 10 mg/mL is being recalled due to particulate matter found in a vial.

Pharmaceutical Technology® spoke with Charles Ruban, president and CEO, Verdot, about the focus of moving to sustainability practices in pharmaceutical manufacturing.

Pharmaceutical Technology chats about the increasing prevalence of challenging APIs in the development pipeline and the hurdles facing formulators and manufacturers as a result of this trend with Jens Schmidt from Lonza.

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.